Extensive, invasive testing is the last thing you want to go through when you’re worried about your health.

So the news that clinical trials to create breath-based diagnostic tools for cancer are in their final stages will be welcome to many.

The process, which would involve a patient simply breathing into a bag, could help to detect early stages of oesophagus, stomach, pancreas, colon, and even liver cancers.

Professor George Hanna of Imperial College London told The Observer that “these tumours formed more than 20% of all cancer cases in the world.”

So, how does it work?

The process so far has involved subjects “breath(ing) into the test for 10 minutes to collect a sample, which will then be processed.”

“Initially, I thought I might feel a bit claustrophobic wearing the mask, but I didn’t at all,” says patient Rebecca Coldrick.

After getting the sample, researchers will look for something called volatile organic compounds (VOCs).

“When cells carry out biochemical reactions as part of their metabolism they produce a range of VOCs,” says Cancer Research UK.

These can be exhaled from the body – hence the breathing test.

“If their metabolism becomes altered, such as in cancer and various other conditions, cells can release a different pattern of VOCs. The researchers aim to identify these patterns using Owlstone Medical’s Breath Biopsy® technology.”

If signs of cancer are found, the patient will then be sent on for further tests and screenings.

Breath tests could be especially useful for diagnosing hard-to-spot cancers early

There are a few reasons why breathing tests could help to spot certain cancers early on.

“It is easier to treat cancer that is diagnosed early. This is because it might be smaller and won’t have spread to other parts of the body. But finding some types of cancer early isn’t easy as there are very few symptoms,” says Cancer Research UK.

For hard-to-spot and early-stage cancers, Cancer Research says a breath test could prove useful.

For instance, “Monitoring patients to find those at high risk of developing a cancer, like oesophageal, is very intrusive for patients, who may not even develop the disease.”

“A non-invasive test using this technology could help to further differentiate those likely to develop oesophageal cancer from those less likely to develop the disease,” Cancer Research add.

Billy Boyle, co-founder and CEO at Owlstone Medical, says that the breath-based screening could help to prevent further stress from more invasive testing, too – “The concept of providing a whole-body snapshot in a completely non-invasive way is very powerful and could reduce harm by sparing patients from more invasive tests that they don’t need.“

And The Observer says that “breath tests will give very quick answers. As the system is likely to be automated, it will also be relatively inexpensive.”

Trials have come a long way

Prof George Hanna of Imperial College London told The Observer that researchers “have been working on this technique for more than 15 years and have now reached the stage where we are going through final clinical trials.”

“After that, we will need to get regulatory approval. So I anticipate that it will take another five years or so before we get cancer breath tests up and running in GP surgeries,” he says.

“if you think about it, it is a logical aim,” he adds. “Dogs can smell cancers in humans. In addition, we have breathalysers that can detect chemicals in the breath. So creating cancer breath tests was an inevitable goal.”

If you want to see the tests in action, Hanna is “planning to give public demonstrations of cancer breath-test technology at the Great Exhibition Road festival which will be held in London on 17-18 June” – though this will only be a demonstration, and will not actually test for cancer.



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CONNECTICUT — Cases of a little-known respiratory illness that is especially dangerous for young children — human metapneumovirus, or HMPV — and mimics the symptoms of other common respiratory diseases spiked this spring in the Northeast, according to Centers for Disease Control and Prevention health data.

A regional breakdown of HMPV cases shows nearly a 50 percent positivity rate among those antigen tested in Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island and Vermont around the second and third weeks in April. That's up about 25 percent from similar testing done a month earlier.

The symptoms of the lower lung infection include a deep cough, fever, runny nose, sore throat and shortness of breath, which are also symptoms of RSV, influenza and COVID-19. As cases of those illnesses began to subside, HMPV was just getting started in many parts of the country, according to the CDC data.

At the mid-March peak of HMPV, nearly 11 percent of specimen tests nationwide were positive. That’s about 36 percent higher than the average, pre-pandemic seasonal peak of 7 percent HMPV test positivity.

Viruses are responsible for a range of respiratory infections, from the common cold to severe bronchitis and pneumonia. With improvements in molecular testing, more viruses have been detected, including pneumovirus isolated two decades ago by Dutch scientists in children with respiratory illnesses.

Medical experts don’t know the full burden of HMPV because testing is rarely done until the patient has to be hospitalized. Dr. John Williams, a pediatrician at the University of Pittsburgh, told CNN that HMPV cases are at least equal to RSV and influenza.

The CDC recommends that physicians and clinics test for it regularly.

Respiratory infections are the leading cause of death in children under 5 worldwide and a major reason for hospitalizations of young children in developed countries. According to the CDC, HMPV also poses risks for older adults and people with weakened immune systems.

According to a 2020 study in The Lancet Global Health journal, an estimated 14 million children under 5 worldwide had HMPV infections in 2018, resulting in 600,000 hospitalizations and more than 16,000 deaths.

Several pharmaceutical companies are working on vaccines, including COVID-19 vaccine maker Moderna, which just completed a clinical trial testing an mRNA vaccine against HMPV.

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ACROSS AMERICA — Cases of a little-known respiratory illness that is especially dangerous for young children — human metapneumovirus, or HMPV — and mimics the symptoms of other common respiratory diseases spiked this spring, according to Centers for Disease Control and Prevention health data.

The symptoms of the lower lung infection include a deep cough, fever, runny nose, sore throat and shortness of breath, which are also symptoms of RSV, influenza and COVID-19. As cases of those illnesses began to subside, HMPV was just getting started in many parts of the country, according to the CDC data.

At the mid-March peak of HMPV, nearly 11 percent of specimen tests nationwide were positive. That’s about 36 percent higher than the average, pre-pandemic seasonal peak of 7 percent HMPV test positivity.

Viruses are responsible for a range of respiratory infections from the common cold to severe bronchitis and pneumonia. With improvements in molecular testing, more viruses have been detected, including pneumovirus isolated two decades ago by Dutch scientists in children with respiratory illnesses.

Medical experts don’t know the full burden of HMPV because testing is rarely done until the patient has to be hospitalized. Dr. John Williams, a pediatrician at the University of Pittsburgh, told CNN that HMPV cases are at least equal to RSV and influenza.

The CDC recommends that physicians and clinics test for it regularly.

Respiratory infections are the leading cause of death in children under 5 worldwide and a major reason for hospitalizations of young children in developed countries. According to the CDC, HMPV also poses risks for older adults and people with weakened immune systems.

According to a 2020 study in The Lancelot Global Health journal, an estimated 14 million children under 5 worldwide had HMPV infections in 2018, resulting in 600,000 hospitalizations and more than 16,000 deaths.

Several pharmaceutical companies are working on vaccines, including COVID-19 vaccine maker Moderna, which just completed a clinical trial testing an mRNA vaccine against HMPV.

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NEW YORK - Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO (Respiratory Syncytial Virus Vaccine), the company's bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years and older.

ABRYSVO is unadjuvanted and composed of two preF proteins selected to optimize protection against RSV A and B strains and was observed to be safe and effective.

'A vaccine to help prevent RSV had been an elusive public health goal for more than half a century. Today's approval is a monumental step forward in delivering on Pfizer's commitment to help alleviate the significant burden of RSV in higher-risk populations, which includes older adults,' said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. 'ABRYSVO will address a need to help protect older adults against the potentially serious consequences of RSV disease. We are extremely grateful to the clinical trial participants, study investigator teams and our dedicated Pfizer colleagues for their roles in making this vaccine available.'

The FDA's decision is based on the data from the pivotal Phase 3 clinical trial (NCT05035212) RENOIR (RSV vaccine Efficacy study iNOlder adults Immunized against RSV disease). RENOIR is a global, randomized, double-blind, placebo-controlled study designed to assess the efficacy, immunogenicity, and safety of a single dose of the vaccinein adults 60 years of age and older. RENOIR has enrolled approximately 37,000 participants, randomized to receive RSVpreF 120 g or placebo in a 1:1 ratio. The results were recently published in The New England Journal of Medicine. RENOIR is ongoing, with efficacy data being collected in the second RSV season in the study.

'This past RSV season demonstrated the serious consequences and potential health risks this virus poses for older adults,' said Edward E. Walsh, MD, Professor of Medicine, University of Rochester Medical Center, and principal RENOIR investigator. 'Today's FDA approval of ABRYSVO recognizes significant scientific progress, and importantly helps provide older adults potential protection against RSV and an opportunity to improve community health by helping prevent the disease.'

RSV is a contagious virus and a common cause of respiratory illness worldwide.2 The virus can affect the lungs and breathing passages of an infected individual, potentially causing severe illness or death.3,4,5 In the U.S., the burden RSV causes in older adults is considerable. The severity of RSV disease can increase with age and comorbidities, such as chronic obstructive pulmonary disease, asthma, and congestive heart failure.6

The U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) will meet on June 21, 2023, to discuss recommendations for the appropriate use of RSV vaccines in older adults. Pending the outcome of this meeting, Pfizer anticipates supply availability in Q3 2023 ahead of the anticipated RSV season this fall.

Earlier this month, Pfizer reported positive top-line results from the Phase 3 study evaluating the safety and immunogenicity of ABRYSVO coadministered with seasonal inactivated influenza vaccine (SIIV) in adults 65 years and older.7 Pfizer intends to publish these results in a peer-reviewed scientific journal. Earlier this month, Pfizer also announced it would be initiating multiple clinical trials evaluating RSVpreF in healthy children ages 2-5; children ages 5-18 with underlying medical conditions; adults ages 18-60 at high-risk due to underlying medical conditions and adults ages 18 and older who are immunocompromised and at high-risk for RSV.8

About ABRYSVO Regulatory Review

On March 24, 2022, Pfizer announced the FDA granted Breakthrough Therapy Designation for ABRYSVO for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older. This decision was followed by the FDA's acceptance of ABRYSVO's Biologics License Application (BLA) under priority review for older adults in November 2022.

Pfizer is currently the only company pursuing regulatory applications for an RSV investigational vaccine candidate for both an indication to help protect older adults, as well as an indication to help protect infants through maternal immunization. Previously, Pfizer announced that the FDA had granted priority review for a BLA for RSVpreF for the prevention of lower respiratory tract and severe lower respiratory tract disease caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals. Earlier this month, Pfizer announced that the FDA's Vaccines and Related Biological Products Advisory Committee voted that available data support the efficacy and safety of RSVpreF for the maternal indication. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date in August 2023.

In February 2023, it was announced that the European Medicines Agency (EMA) accepted for review Pfizer's Marketing Authorization Application (MAA) under accelerated assessment for RSVpreF, as submitted for both older adults and maternal immunization to help protect infants against RSV. The formal review process by the EMA's Committee for Medicinal Products for Human Use (CHMP) currently is ongoing. Also in February 2023, Pfizer Japan announced an application was filed with the Ministry of Health, Labor and Welfare for RSVpreF as a maternal immunization to help protect infants against RSV. In April 2023, Pfizer Canada announced Health Canada accepted RSVpreF for review for both individuals ages 60 and older and as a maternal immunization to help protect infants against RSV.

About Pfizer: Breakthroughs That Change Patients' Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com.

DISCLOSURE NOTICE

The information contained in this release is as of May 31, 2023. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about ABRYSVO (RSVpreF), including its potential benefits, an approval in the U.S. for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years and older, an application pending in the U.S. for RSVpreF for the prevention of lower respiratory tract and severe lower respiratory tract disease caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals, applications pending for RSVpreF in other jurisdictions and plans to initiate clinical trials in other populations, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of ABRYSVO (RSVpreF); the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim data, including the risk that final results from the Phase 3 trials could differ from the interim data;the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when biologic license applications may be filed in particular jurisdictions for ABRYSVO (RSVpreF) for any potential indications; whether and when any applications that may be pending or filed for ABRYSVO (RSVpreF) may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether ABRYSVO (RSVpreF) for any such indications will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of ABRYSVO (RSVpreF); uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities regarding ABRYSVO (RSVpreF) and uncertainties regarding the commercial impact of any such recommendations; uncertainties regarding the impact of COVID-19 on our business, operations and financial results and competitive developments.

Contact:

Email: [email protected]

Tel: +1 (212) 733-1226

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Last night, Pfizer Inc. announced the US Food and Drug Administration (FDA) approved their respiratory syncytial virus (RSV) vaccine, Abrysvo, for older adults. This approval allows the use of Abrysvo in individuals aged 60 years and older to prevent lower respiratory tract disease caused by RSV.

Abrysvo, Pfizer's bivalent RSV prefusion F (RSVpreF) vaccine, is composed of 2 preF proteins specifically chosen to optimize protection against RSV A and B strains. With this approval, the FDA indicates all available trial data has proven Abrysvo to be safe and effective.

“A vaccine to help prevent RSV had been an elusive public health goal for more than half a century," stated Annaliesa Anderson, PhD, senior vice president and chief scientific officer of vaccine research and development at Pfizer. “Abrysvo will address a need to help protect older adults against the potentially serious consequences of RSV disease. We are extremely grateful to the clinical trial participants, study investigator teams and our dedicated Pfizer colleagues for their roles in making this vaccine available.”

In the more than 50 years of working to develop an RSV vaccine, Abrysvo is the world’s second-ever to be granted approval. Last month, GSK’s Arexvy (RSVPreF3 +AS01E) was approved to prevent lower respiratory tract disease (LRTD) caused by RSV in adults 60 years and older.

The FDA's decision to approve Abrysvo as well was based on data obtained from the pivotal Phase 3 clinical trial (NCT05035212) known as RENOIR (RSV vaccine Efficacy study iNOlder adults Immunized against RSV disease). RENOIR is a global, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, immunogenicity, and safety of a single dose of the vaccine in adults aged 60 and older.

Approximately 37000 participants were enrolled in RENOIR, with half receiving RSVpreF 120 μg and the other half receiving placebo in a 1:1 ratio. RENOIR is an ongoing study, with efficacy data being collected during the second RSV season.

Edward E. Walsh, MD, Professor of Medicine at the University of Rochester Medical Center and principal investigator of the RENOIR trial, commented, "This past RSV season demonstrated the serious consequences and potential health risks this virus poses for older adults. Today’s FDA approval of Abrysvo recognizes significant scientific progress, and importantly helps provide older adults potential protection against RSV and an opportunity to improve community health by helping prevent the disease.”

RSV is a contagious virus that commonly causes respiratory illnesses worldwide. It primarily affects the lungs and breathing passages, often leading to severe illness or even death. In the US, RSV poses a considerable burden on older adults, with disease severity increasing with age and comorbidities such as chronic obstructive pulmonary disease, asthma, and congestive heart failure.

In most healthy individuals, RSV manifests with mild, cold-like symptoms. Most people recover within 2 weeks, often without knowing they had contracted RSV. Infants and young children, however, are also susceptible to the worst of RSV infection. Thus, Pfizer is also seeking approval to administer RSVpreF to pregnant persons, with the goal of preventing medically attended lower respiratory tract disease (MA-LRTD) and severe MA-LRTD caused by RSV in infants from birth to 6 months of age.

The maternal vaccine was recently recommended for approval by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), and a decision is expected by August 21, 2023.

Regarding the use of RSV vaccines in older adults, the US Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) is scheduled to meet on June 21, 2023, to discuss recommendations. Pending the outcome of this meeting, Pfizer expects Abrysvo to be available in the third quarter of 2023, just ahead of the anticipated RSV season this fall.

In addition to this recent approval, Pfizer reported positive top-line results earlier this month from a Phase 3 study that evaluated the safety and immunogenicity of Abrysvo coadministered with seasonal inactivated influenza vaccine (SIIV) in adults aged 65 and older.

Furthermore, Pfizer announced its plans to conduct multiple clinical trials evaluating RSVpreF in healthy children aged 2-5 years, children aged 5-18 years with comorbidities, adults aged 18-60 years with comorbidities, and adults aged 18 years and older who are immunocompromised and at high risk for adverse RSV outcomes.

Contagion is actively following all developments in the RSV space. Return soon for updates, or click here to browse our past breaking news coverage and interviews with lead researchers.

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The FDA has approved Pfizer Inc’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine Abrysvo to prevent lower respiratory tract disease caused by RSV in individuals 60 years of age and older. According to Pfizer, RSVpreF is based on foundational basic science discoveries, such as findings from the National Institutes of Health (NIH), detailing the crystal structure of prefusion F, a vital form of the viral fusion protein (F) used by RSV to attack human cells. NIH research indicates that antibodies specific to the prefusion form had high efficacy preventing viral infection, which indicates that a prefusion F-based vaccine may provide optimal protection against RSV, according to Pfizer.

“A vaccine to help prevent RSV had been an elusive public health goal for more than half a century. Today’s approval is a monumental step forward in delivering on Pfizer’s commitment to help alleviate the significant burden of RSV in higher-risk populations, which includes older adults,” said Annaliesa Anderson, PhD, senior vice president and chief scientific officer, Vaccine Research and Development, Pfizer, in a press release. “Abrysvo will address a need to help protect older adults against the potentially serious consequences of RSV disease. We are extremely grateful to the clinical trial participants, study investigator teams and our dedicated Pfizer colleagues for their roles in making this vaccine available.”

The approval was based on findings from the phase 3 (NCT05035212) RENOIR (RSV vaccine Efficacy study iNOlder adults Immunized against RSV disease) trial. The global, randomized, double-blind, placebo-controlled study evaluated the efficacy, immunogenicity, and safety of a single dose of RSVpreF in adults 60 years of age and older. The study randomized approximately 37,000 participants to receive RSVpreF 120 μg or placebo in a 1:1 ratio. Pfizer previously announced positive top-line findings from an interim efficacy analysis for RENOIR.

The analysis showed that RSVpreF produced vaccine efficacy of 66.7% (96.66% CI: 28.8%, 85.8%) against RSV-associated lower respiratory tract illness (LRTI-RSV) as defined by 2 or more symptoms. This finding prompted researchers to examine the more severe disease primary endpoint of LRTI-RSV as defined by 3 or more symptoms, which showed an efficacy rate of 85.7% (96.66% CI: 32.0%, 98.7%). Additionally, the trial showed that the investigational vaccine was well-tolerated with no safety concerns, according to Pfizer.

The FDA previously granted RSVpreF with Breakthrough Therapy Designation for this indication in March 2022 and granted Priority Review designation in December 2022.

RSV is a contagious virus and a common cause of respiratory illness that can affect the breathing passages and lungs of infected individuals. Among older US adults, RSV infections account for approximately 60,000–120,000 hospitalizations and 6000–14,000 deaths each year. In US children younger than 5 years of age, RSV infections are responsible for approximately 2.1 million outpatient visits and 58,000–80,000 hospitalizations each year.

The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet on June 21, 2023, to evaluate recommendations for the appropriate use of RSV vaccines in older adults. Pending the findings from the meeting, Pfizer said it anticipates supply availability for Abrysvo in Q3 2023 ahead of the anticipated RSV season in the fall.

“This past RSV season demonstrated the serious consequences and potential health risks this virus poses for older adults,” said principal RENOIR investigator Edward E. Walsh, MD, Professor of Medicine, University of Rochester Medical Center, in a press release. “Today’s FDA approval of ABRYSVO recognizes significant scientific progress, and importantly helps provide older adults potential protection against RSV and an opportunity to improve community health by helping prevent the disease.”

Reference

U.S. FDA Approves ABRYSVO™, Pfizer’s Vaccine for the Prevention of Respiratory Syncytial Virus (RSV) in Older Adults. Pfizer. News release. May 31, 2023. www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-abrysvotm-pfizers-vaccine-prevention

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Pfizer received approval from the FDA for ABRYSVO (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years and older. ABRYSVO is unadjuvanted and composed of two preF proteins selected to optimize protection against RSV A and B strains and was observed to be safe and effective.
 
The decision is based on data from the Phase 3 clinical trial RENOIR, a global, randomized, double-blind, placebo-controlled study designed to assess the efficacy, immunogenicity, and safety of a single dose of the vaccine in adults 60 years of age and older. RENOIR has enrolled approximately 37,000 participants, randomized to receive RSVpreF 120 μg or placebo in a 1:1 ratio. RENOIR is ongoing, with efficacy data being collected in the second RSV season in the study.
 
Trial results published in April showed 67% efficacy in preventing infections with at least two symptoms. Protection was even greater against more severe disease, defined as three or more symptoms of RSV-related illness.
 
RSV is a contagious virus and a common cause of respiratory illness worldwide. The virus can affect the lungs and breathing passages of an infected individual, potentially causing severe illness or death. The severity of RSV disease can increase with age and comorbidities, such as chronic obstructive pulmonary disease, asthma, and congestive heart failure.
 
The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet on June 21, 2023, to discuss recommendations for the appropriate use of RSV vaccines in older adults. Pending the outcome of this meeting, Pfizer anticipates supply availability in Q3 2023 ahead of the anticipated RSV season this fall.
 
Pfizer reported positive results from the Phase 3 study evaluating the safety and immunogenicity of ABRYSVO co-administered with seasonal inactivated influenza vaccine (SIIV) in adults 65 years and older. Pfizer is initiating multiple clinical trials evaluating RSVpreF in healthy children ages 2-5; children ages 5-18 with underlying medical conditions; adults ages 18-60 at high-risk due to underlying medical conditions; and adults ages 18 and older who are immunocompromised and at high-risk for RSV.

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Jakafi (ruxolitinib) is a brand-name oral tablet that’s prescribed for myelofibrosis, graft-versus-host disease (GVHD), and other blood conditions in some adults and children. As with other drugs, Jakafi can cause side effects, such as anemia and a low platelet count.

Jakafi belongs to a drug class called kinase inhibitors. The drug is not available in a generic version.

Read on to learn about potential common, mild, and serious side effects of Jakafi. For a general overview of the drug, including more details about its uses, see this article.

Mild side effects can occur with Jakafi use. They can vary depending on the condition you’re taking Jakafi to treat. (You can learn more about Jakafi’s uses in this article.) Jakafi’s side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

The information in the table below doesn’t include all possible mild side effects of the drug. For more information, you can refer to Jakafi’s prescribing information.

Mild side effects that people taking Jakafi for the following conditions have reported include:

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you develop a side effect while taking Jakafi and want to tell the FDA about it, visit MedWatch.

* An allergic reaction is possible after taking Jakafi. However, this side effect wasn’t reported in clinical trials. To learn more, see the “Side effect specifics” section below.

Jakafi may cause serious side effects, which vary depending on the condition you are taking Jakafi to treat. (You can learn more about Jakafi’s uses in this article.) The information in the table below may not include all possible serious side effects of the drug. For more information, you can refer to Jakafi’s prescribing information.

If you develop serious side effects while taking Jakafi, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Serious side effects that have been reported in people taking Jakafi for the following conditions include:

* For more information about this side effect, see the “Side effect specifics” section below.
† An allergic reaction is possible after taking Jakafi. However, this side effect wasn’t reported in clinical trials. To learn more, see the “Side effect specifics” section below.

Jakafi may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.

Can Jakafi cause long-term side effects?

Jakafi may cause long-term side effects. Drugs similar to Jakafi have caused serious side effects resulting in long-term health problems. These problems include:

If you have concerns about possible long-term side effects from Jakafi, talk with your doctor.

* This is a serious side effect of Jakafi. For more information about this side effect, see the “Side effect specifics” section below.

Does stopping Jakafi cause certain side effects?

It’s not likely you’ll experience side effects from stopping Jakafi. However, some people taking Jakafi in clinical trials for myelofibrosis saw their symptoms return when they stopped taking it. Symptoms for myelofibrosis can include:

Tell your doctor right away if you experience these or other unusual symptoms. If your symptoms seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Due to the risk of symptoms returning, your doctor will lower your Jakafi dosage slowly. As with other drugs, do not change your Jakafi dosage without your doctor’s recommendation. To learn more about Jakafi dosages, see this article.

If you have questions about what to expect during and after Jakafi treatment, talk with your doctor.

Learn more about some of the side effects that Jakafi may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Jakafi.

Anemia

Anemia was one of the most common side effects reported by people taking Jakafi in clinical trials. Anemia is having fewer red blood cells than usual.

Symptoms of anemia can include:

What you can do

If you notice any symptoms of anemia while taking Jakafi, let your doctor know. They’ll likely order a blood test to check for this side effect. In some cases, your doctor may recommend temporarily stopping Jakafi treatment. This may allow time for your body to make new blood cells. Or they may recommend a blood transfusion to get your red blood cell levels back to usual.

Low platelet count

Jakafi may cause a low platelet count. Platelets are a type of blood cell that help blood clot. If you have too few platelets, your blood may not clot as usual. You may experience bleeding symptoms. A low platelet count was a common side effect in Jakafi’s clinical trials.

Symptoms can include:

What you can do

Let your doctor know right away if you notice any of the symptoms listed above. They’ll likely order a blood test to check your platelet count. In some cases, your doctor may recommend a lower dosage of Jakafi. They may also have you stop taking the drug for a while. This may allow time for your body to make more platelets and increase your platelet level. For information about Jakafi dosages, see this article.

If your platelet count is too low, your doctor may recommend a platelet transfusion to increase the platelet levels in your blood.

Infections

In clinical trials of Jakafi, infections were a commonly reported side effect.

Symptoms can include:

Some of these infections were serious. Serious infections reported by people in clinical trials included:

What you can do

Let your doctor know about any new infections you may have. You may need treatment with an antibiotic or other medication to manage the infection. Your doctor may also recommend a lower dosage of Jakafi. For information about Jakafi dosages, see this article. Sometimes, they may have you stop taking the drug until your infection clears up.

Blood clots

Taking Jakafi may cause blood clots, but this was rare in clinical trials. A blood clot is a collection of blood inside a blood vessel, such as a deep vein thrombosis.

Symptoms vary depending on the clot location but can include:

What you can do

If you experience any of the symptoms above, call your doctor right away. However, some blood clots are medical emergencies. So if your symptoms are severe and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Allergic reaction

As with most drugs, Jakafi can cause an allergic reaction in some people. However, this side effects wasn’t reported in clinical trials.

Symptoms can be mild or serious and can include:

  • skin rash
  • itching
  • flushing
  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

What you can do

For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Jakafi. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Be sure to talk with your doctor about your health history before you take Jakafi. This drug may not be the right treatment option for you if you have certain medical conditions or other factors affecting your health. These are considered drug-condition or drug-factor interactions. The conditions and factors to consider include:

Tuberculosis. If you’ve had tuberculosis (TB), taking Jakafi increases the chance of the bacteria becoming active again. Due to this risk, your doctor will give you a TB test before you take Jakafi. The test identifies whether you have the TB bacteria in your body. If your test is positive, your doctor will determine whether Jakafi treatment is safe for you. If you develop TB while taking Jakafi, your doctor may pause the drug while they treat the infection.

Hepatitis B. If you have hepatitis B, taking Jakafi can increase the amount of this virus in your body. So let your doctor know if you’ve ever had treatment for hepatitis B. They’ll likely monitor your liver function to reduce the chance of hepatitis B flare-ups. Sometimes, increased liver enzymes may suggest liver damage.

Herpes zoster and herpes simplex. If you’ve had a herpes infection, taking Jakafi may cause the infection to come back. If it does, your doctor may have you stop taking Jakafi while they treat the herpes infection.

Allergic reaction. If you’ve had an allergic reaction to Jakafi or any of its ingredients, your doctor will likely not prescribe Jakafi. Ask your doctor what other medications may be better options for you.

Liver damage. Liver damage may increase your risk of Jakafi side effects. Due to this risk, your doctor may lower your dosage* if you have liver damage. They’ll also monitor you more closely during treatment.

Kidney problems. Kidney problems may increase your risk of Jakafi side effects. Due to this risk, your doctor may prescribe a lower dosage* of Jakafi if you have a kidney condition. They may also monitor your kidney function during treatment.

Factors that increase your risk of cardiac events. Jakafi treatment may increase the risk of cardiac events such as heart attack in people with certain risk factors. These factors include high blood pressure, diabetes, high cholesterol, and smoking. Your doctor will determine whether Jakafi treatment is safe for you based on your medical and smoking history.

* For information about recommended dosages of Jakafi, see this article.

Alcohol with Jakafi

There are no known interactions between Jakafi and alcohol. If you have questions about drinking alcohol while taking Jakafi, talk with your doctor.

Pregnancy and breastfeeding while taking Jakafi

Your doctor will likely recommend that you do not take Jakafi while you’re pregnant. Clinical trials of Jakafi didn’t include pregnant people. However, in animal studies, Jakafi caused harm in developing offspring.

Talk with your doctor if you’re pregnant or planning to become pregnant before starting Jakafi. They can help determine whether Jakafi is safe for you.

In animal studies, Jakafi was found to pass into breast milk. It’s unknown whether the same thing would happen to people. If you’re breastfeeding or planning to do so, your doctor can advise you on whether Jakafi is safe to take. They can also recommend other treatments for your condition.

Jakafi, like other drugs, can cause side effects. Some of these are mild and may go away over time. Others are serious and require medical attention. If you’d like to learn more about Jakafi, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from taking the drug.

Besides talking with your doctor, you can do some research on your own. These articles might help:

Disclaimer:Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

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A virus that virtually nobody has ever heard of has spread across the United States, causing a 36% spike in cases in 2023, according to new data from the Centers for Disease Control and Prevention.

Human metapneumovirus, or HMPV, is a respiratory disease that causes symptoms much like the common cold: cough, fever, congestion, runny nose, a sore throat, and shortness of breath, according to the Cleveland Clinic.

So, most people assume they have a cold or flu, but among young children, older adults, and people with weakened immune systems, HMPV can cause an illness severe enough to send them to the hospital.

It’s no surprise that most people have never heard of HMPV — the virus wasn’t even discovered until 2001.

When scientists tested blood samples as far back as the 1950s, however, they found evidence that the virus has been circulating for at least 50 years, CNN reports.

“Still, I find that many people even in health care are unfamiliar with this virus,” John V. Williams, professor of pediatrics, microbiology, and molecular genetics at the University of Pittsburgh, told the Conversation.

HMPV is “the most important virus you’ve never heard of,” Williams said.


image of HMPV virus
Infection with the HMPV virus is more common than even some health professionals think.
Getty Images/Science Photo Library RF

HMPV cases typically rise in January, peak in March and April, then drop as the weather warms in May.

The 2023 jump in cases of HMPV might be due to people having less immunity after years of mask-wearing and social distancing during the COVID-19 pandemic.

HMPV treatment

Most people with an HMPV infection get better after a few days spent resting, drinking fluids, and taking over-the-counter decongestants and pain medicine.

Most children have had HMPV by the time they reach the age of 5.

But for some young children, the disease can take a troubling turn.


image of child with HMPV coughing
Young children are especially vulnerable to an HMPV infection, which can cause serious complications.
Getty Images/iStockphoto

HMPV in babies

In a 2015 study from the Journal of the Pediatric Infectious Diseases Society, babies and children less than 2 years old were most likely to be hospitalized with HMPV.

And 18% of hospitalized kids were treated in the intensive care unit, while 6% required mechanical ventilation because of breathing difficulties.

A study published in the Lancet estimated that in 2018, HMPV caused 643,000 hospital admissions and 16,100 deaths worldwide among children younger than 5.

There’s currently no cure or vaccine for the disease, but that may change soon.

Moderna, a maker of a COVID-19 vaccine, has begun early clinical trials of a vaccine against HMPV.

Until such a vaccine is developed, doctors recommend the usual precautions against HMPV and other respiratory viruses: washing your hands regularly, avoiding people who are ill, and staying home if you feel sick.

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In Part 1 of this series, I noted that mRNA vaccines were hustled into commercial viability by Operation Warp Speed, a federal program set up in 2020 to accelerate the development of any vaccine that might stave off COVID-19's most severe symptoms.

The sudden appearance of a brand new kind of vaccine has generated concerns ranging from the spurious to the undeniable. Like all vaccines, the ones for COVID-19 can cause side effects -- a problem that may have a lot to do with how mRNA currently gets delivered -- and, as readers of Part 2 of the series have learned, Stanford Medicine researchers are bent on minimizing them. While Part 1 explained how the new vaccines work and how they're packaged for delivery to our immune systems, Part 2 focused on potential improvements in mRNA vaccine delivery that could both minimize side effects and get more bang for the dose.

To sum it up, lipid nanoparticles -- the mRNA delivery vehicles in commercial use today -- don't always deliver their mRNA cargo to their target cells, and sometimes deliver it to the wrong places. And only about one-tenth of the mRNA that reaches a targeted cell is actually converted into the protein meant to trigger an immune response. Potentially superior delivery technologies, which I described in detail in Part 2, may address those shortcomings.

The biggest source of mRNA vaccine skepticism, according to vaccinologist Bali Pulendran, PhD, the Violetta L. Horton Professor and professor of pathology and of microbiology and immunology, is rooted not in biology but in our own psychology -- specifically, an amorphous, free-floating fear of the unknown.

"The human mind rejects any new idea like the body rejects a transplanted organ," he said.

Everything, everywhere, all at once

COVID-19 was the launchpad for mRNA vaccine technology. As the world emerges from the worst of the pandemic, can the same platform dispatch mRNA vaccines aimed at pretty much any microbe of choice? 

Pulendran answers with a resounding yes.

"Any vaccine you can think of, the mRNA companies are working on it," said Pulendran, who has consulted with Moderna, Pfizer and BioNTech, three companies closely associated with the new technology. "Their world view is that mRNA technology will replace all preceding ones. The future is extremely bright for mRNA vaccines."

Pulendran noted a couple of criticisms that have been leveled at the mRNA-based COVID-19 vaccines. "They've been very good at preventing severe disease, hospitalization and death," he said. "So far, they haven't been so good at preventing infection for long periods of time -- particularly in the face of ever-newer viral variants - and they haven't been great at preventing transmission."

But transmission, or the spreading of a virus from person to person, is a problem common to all respiratory infections, he said. It's tough to completely prevent infection of the nose and throat with any vaccine, considering these outward-facing cavities' cells are constantly exposed to the air -- and, consequently, the microbes -- we inhale.

"To me, the most critical goal of a vaccine is to prevent severe or even moderate disease," Pulendran said. "A mild COVID 'cold' may even benefit us by keeping our immune system on its toes." On the other hand, he said, mRNA vaccines employing delivery systems that target the mucus-secreting linings of our airways and gut may prove more effective at durably preventing infection.

Was the technology that rescued people most susceptible to depredations of SARS-CoV-2 -- the virus that causes COVID-19 -- a one-hit wonder, or was it a cornucopia conferring protection from microbial menaces of every stripe? Time will tell.

And it won't take long. Clinical testing is underway for mRNA-based vaccines for influenza, HIV, cytomegalovirus (a ubiquitous microbe that usually causes no symptoms but can harm immunocompromised people), dengue, rabies and several other viruses, as well as for malaria, tuberculosis and other non-viral microbes. Moderna is submitting its mRNA-based vaccine directed at respiratory syncytial virus to the FDA for approval. Moderna and Merck are collaborating on a personalized skin-cancer vaccine employing mRNA, now in clinical trials.

These are all familiar, if uninvited, maladies. What humanity should most fear -- and what the plug-and-play mRNA vaccine technology promises to provide the most valiant and rapid defense against -- are those next unfamiliar monsters climbing over the hill toward us, which science-fiction movies always seem to depict as giants but are actually microscopic.

Read the other stories in this series:  

Part I: Special delivery - an mRNA explainer

Part II: Special delivery 2.0: CARTs

Photo by xyz+

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Prompt treatment with Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) after a moderate or severe chronic obstructive pulmonary disease (COPD) exacerbation can lower the risk of a future worsening episodes.

That’s according to data by AstraZeneca, which markets Beztri Aerosphere, in the late-breaking abstract, “Exacerbations and Real-world Outcomes (EROS) Among Patients With COPD Receiving Single Inhaler Triple Therapy of Budesonide/glycopyrrolate/formoterol Fumarate,” which was presented at the American Thoracic Society (ATS) 2023 International Conference this month in Washington, D.C.

The findings “build on the body of clinical evidence that Breztri is effective in reducing COPD exacerbation rates and can significantly reduce the risk of future exacerbations if used as soon as a patient’s COPD symptoms worsen,” Charlie Strange, MD, a professor at the Medical University of South Carolina and study investigator, said in a company press release.

An exacerbation or flare-up happens when symptoms suddenly worsen. Sometimes this is related to an infection, but other times the cause isn’t known.

Breztri Aerosphere, an inhaled therapy containing a combination of an anti-inflammatory compound alongside two molecules that help open up the airways, was approved to treat COPD in the U.S. in 2020 based on clinical trial data suggesting it could reduce the risk of exacerbations.

The ATS presentation included an analysis from 2,409 patients followed as part of a real-world registry study, called EROS. All the patients had a moderate or severe exacerbation and were treated with Breztri.

Recommended Reading

Breztri Aerosphere

Prompt vs. delayed treatment with Breztri Aerosphere

Patients were divided into three groups based on the timing of treatment: 434 received prompt treatment, starting within a month of the exacerbation. Another 1,187 had delayed treatment, starting between one and six months after the exacerbation. The remaining 788 were very delayed and started Breztri more than six months after an exacerbation.

Among those given prompt treatment, the mean rate of future exacerbations was 1.52 per year, follow-up data showed. The future exacerbation rate was two a year for patients with delayed treatment and 2.3 a year with very delayed treatment. That amounts to a 24% lower relapse risk with prompt treatment over delayed treatment and a 34% lower risk over very delayed treatment.

Rates of exacerbations deemed to be severe were similarly lower with prompt treatment over delayed treatment and the findings were similar regardless of the type of inhalers patients were using before starting Breztri.

“EROS was able to show that [Breztri] decreased future exacerbations regardless of the type of baseline inhalers being used prior to triple therapy. This gives us insight that triple therapies may be cost effective to a health system because of the ability to reduce the risk of future exacerbations when given to patients at the time of both moderate and severe exacerbations of COPD,” Strange said in an email to COPD News Today.

In a separate presentation, researchers analyzed insurance data to provide more insight on the health consequences of acute COPD exacerbations. The presentation was titled, “Incidence of Severe Cardiovascular Events Following Acute Exacerbation of Chronic Obstructive Pulmonary Disease in a Large Claims Database.”

The analysis included data on 355,978 people diagnosed with COPD between 2012-2019, of whom 145,838 had at least one exacerbation.

Results showed that, in the month after an exacerbation, the risk of an acute cardiovascular event (e.g., heart attack or stroke) was significantly increased by 32%. The risk of a cardiovascular event was higher after a severe exacerbation compared with a moderate exacerbation and remained elevated at least a year after the exacerbation.

“Our new data at ATS further highlight the cardiopulmonary risk of COPD exacerbations, with COPD increasing the risk both in the lung and heart,” said Robert Fogel, MD, vice president of global medical affairs, respiratory and immunology at AstraZeneca.

The results “demonstrate that the occurrence of severe cardiovascular events, including heart attack, heart failure and stroke, was increased by 32 percent after a single moderate or severe exacerbation of COPD, particularly in the first 90 days, and this risk stayed elevated for an entire year, even in those newly diagnosed with COPD,” Fogel said. “What these data tell us is that we need to treat COPD exacerbations as the urgent events they are and prioritize prompt, proactive treatment to prevent them from occurring.”

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In a recent article published in JAMA Network, researchers performed a prospective observational cohort study to develop symptom-based criteria to identify post-acute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (PASC) cases, otherwise known as long COVID.

Study: Development of a Definition of Postacute Sequelae of SARS-CoV-2 Infection. Image Credit: MeekoMedia/Shutterstock.comStudy: Development of a Definition of Postacute Sequelae of SARS-CoV-2 Infection. Image Credit: MeekoMedia/Shutterstock.com

Background

They proposed that PASC is a new condition arising due to SARS-CoV-2 infection, and unlike in prior reports, researchers did not rely on its predefined clinical symptoms. Researchers consider PASC a condition where relapsing, persistent, or new symptoms are present beyond 30 days of recovery from SARS-CoV-2 infection.

The PASC effects, short- and long-term, are substantial; it affects one's health-related quality of life and financial income while also burdening healthcare infrastructure.

Most published PASC studies have fetched inconsistent estimates of PASC prevalence focused on the symptom frequency of an individual due to the lack of a comparison group and their retrospective design. 

Moreover, heterogeneity in PASC symptoms makes it challenging to define PASC precisely. It manifests as conditions with variable and often overlapping etiologies (e.g., organ injury, gut dysbiosis, immune dysregulation).

Understanding the mechanisms governing PASC is of significant public health importance as it could help devise preventive and therapeutic intervention strategies.

However, it requires data collection from a large prospective cohort study of SARS-CoV-2–infected vs. –uninfected individuals, specifically designed to characterize PASC. Additionally, this study should use appropriate analytical techniques and monitor symptoms that persist after recovery. 

It is equally important to consider that changes in PASC incidence and its manifestations throughout the COVID-19 pandemic varied for several reasons, such as the emergence of new SARS-CoV-2 strains, introduction and subsequent availability of new treatments, and repeat (breakthrough) infections.

In the United States (US), the National Institutes of Health initiated Researching COVID to Enhance Recovery (RECOVER) to understand, prevent, and treat PASC.

About the study

In the present study, researchers analyzed data from the RECOVER adult cohort for diagnosing PASC based on patients' self-reported symptoms. They delineated and described several unique PASC subphenotypes with differential impacts on health and well-being.

The authors expected that selection bias based on PASC would be minimal and estimates more accurate among the subcohort enrolled in 30 days post-acute SARS-CoV-2 infection. Also, RECOVER captured PASC's self-reported symptoms using standard questionnaires developed with the help of patient representatives.

The team recruited all participants from 85 US sites and asked them to make office visits and complete remote surveys.

The participant enrollment is ongoing; however, in this analysis, they considered 13,754 adult participants enrolled before April 10, 2023. These participants belonged to the acute and post-acute cohorts, i.e., enrolled ≤30 days or >30 days to three years since the index date (December 1, 2021), respectively.

Also, the study participants needed to complete a study visit six months or later. SARS-CoV-2 infection before enrollment was the primary exposure of the study, and the main outcome was the presence of 44 symptoms to help researchers develop a PASC definition based on a composite symptom score.

The team reported symptoms overall and for three subcohorts, acute Omicron, post-acute pre-Omicron, and post-acute Omicron. They anticipated that symptom frequency estimates within the acute Omicron subcohort aligned more with the corresponding population frequencies.

For this analysis, they considered symptoms with severity threshold frequency 2.5%. Finally, they reported symptom frequencies by infection status and used weighted logistic regression to compute adjusted odds ratios (aORs).

The team used the least absolute shrinkage and selection operator (LASSO) to differentiate the symptoms of infected and uninfected participants. Next, they assigned a score to each sign based on the estimated coefficients. 

In this way, each participant received a composite symptom score, and the researchers selected an optimal score threshold for PASC using 10-fold cross-validation.

Results

A total of 9,764 participants met the study criteria, of which 8,646 and 1,118 were SARS-CoV-2-infected and uninfected, respectively. Of 44, 37 symptoms had frequency 2.5%, and all had aORs 1.5.

Symptoms like PEM, fatigue, dizziness, brain fog, and gastrointestinal (GI) symptoms showed a>15% absolute difference in frequencies among infected vs. uninfected individuals.

However, the frequencies of these symptoms (with severity thresholds) were comparable in infected participants. Without severity thresholds, the observed corresponding symptom frequencies were higher.

Despite a higher proportion of unvaccinated individuals in the post-acute pre-Omicron subcohort, the distributions of comorbidities and demographics were comparable across all three subcohorts. The post-acute pre-Omicron subcohort also had the highest symptom frequencies.

Strikingly, only 12 symptoms out of 44 contributed to the PASC score; however, the authors noted a correlation between their increasing levels and progressively worsening well-being and functioning, especially among participants infected in the pre-Omicron era.

Also, PASC frequency was higher among those with recurrent infections who got infected first during the Omicron era.

Another observation was that SARS-CoV-2 infection-related long-term symptoms spanned multiple organ systems, likely due to persistent viral reservoirs, autoimmunity, or direct differential organ injury. 

Conclusions

In this study, the researchers developed a novel framework for PASC diagnoses that incorporated contributions of multiple self-reported symptoms. An updated algorithm could also consider a patient's biological features. 

Together, it could enable the development of PASC biomarkers to get a sneak peek into the mechanistic underpinnings of PASC to inform the choice of therapeutic interventions in future PASC clinical trials.

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Brain fog, shortness of breath, loss of taste and smell are well-known long COVID symptoms AFP/File
Brain fog, shortness of breath, loss of taste and smell are well-known long COVID symptoms AFP/File

A groundbreaking study funded by the National Institutes of Health (NIH) has shed light on the symptoms of long Covid, a condition that continues to affect millions of Americans. However, the study has not provided a standardised definition of the condition, emphasising that it is a crucial initial step toward establishing a common language for scientists to develop effective treatments. 

Dr Leora Horwitz, the study author, expressed optimism about the future of research in this area. The study, published in the Journal of the American Medical Association, analysed data from nearly 10,000 adults participating in the NIH's RECOVER trial. It focused on 12 of the most frequently reported symptoms associated with long Covid, including fatigue, brain fog, dizziness, cough, and chest pain.

The aim of the study was not to limit the definition of long Covid to these specific symptoms, but to guide future research by examining their impact on the body. The researchers also introduced a scoring system to assess the severity of symptoms for individual patients, facilitating further investigations. However, the study has faced criticism for not providing immediate solutions or treatments. 

Critics argue that it falls short of meeting the expectations of individuals still struggling with long Covid symptoms and the doctors treating them. The vagueness of certain terms, such as "brain fog" and "abnormal movements," has also been questioned.

The study revealed that unvaccinated long Covid patients and those infected before the emergence of the Omicron variant tend to experience more severe symptoms. Additionally, the research identified symptom clusters, such as post-exertional malaise and fatigue. 

The findings are expected to pave the way for clinical trials of long Covid treatments later this year, addressing the needs of the more than 100 million Americans affected by long Covid. Dr Tanayott Thaweethai, one of the study authors, emphasised the importance of comprehensive and thorough research to understand the complexities of this chronic disease.

The study's publication marks a significant step forward in defining long Covid and establishing a foundation for scientific discovery and treatment development. Dr. Rachel L. Levine, assistant secretary for health, acknowledged the desire of long Covid patients to understand their condition better. While this study represents a crucial milestone, the researchers view it as only the beginning, calling for further research in the field. 

With millions of individuals seeking hope in the form of effective treatments, the study serves as a launching point for future investigations into long Covid and its wide-ranging impacts.

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Pfizer and BioNTech Provide Update on COVID-19 Vaccine Supply Agreement with the European Commission

NEW YORK and MAINZ, GERMANY, MAY 26, 2023 - Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have reached an agreement with the European Commission (EC) to amend their existing contract to deliver COVID-19 vaccines to the European Union.

The amended agreement reflects the companies' commitment to working collaboratively to help address ongoing public health needs, while respecting the principles of the original agreement. It includes rephasing of delivery of doses annually through 2026. In addition, the agreement includes an aggregate volume reduction, providing additional flexibility for EU Member States. The EC will maintain access to future adapted COVID-19 vaccines and the ability to donate doses, in alignment with the original agreement.

COVID-19 vaccination has played an important role in saving lives and livelihoods across Europe. In the first year of their rollout, vaccines were estimated to have averted over 4 million COVID-19-related deaths in Europe and 6 million hospitalizations globally, saving hospital resources worth €56 billion.i,ii The vaccination campaign in Europe helped reopen millions of large and small businesses across the region and helped stabilize the wider European economy, which saw a national average 7% reduction in GDP during the first pandemic year, 2020.iii,iv,v,vi,vii

U.S. INDICATION & AUTHORIZED USE

AUTHORIZED USE

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older.

IMPORTANT SAFETY INFORMATION

Tell your vaccination provider about all of your medical conditions, including if you:

•have any allergies

•have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)

•have a fever

•have a bleeding disorder or are on a blood thinner

•are immunocompromised or are on a medicine that affects the immune system

•are pregnant, plan to become pregnant, or are breastfeeding

•have received another COVID-19 vaccine

•have ever fainted in association with an injection

•The vaccine may not protect everyone

•A person should NOT get Pfizer-BioNTech COVID-19 Vaccine, Bivalent if they have had a severe allergic reaction after a previous dose of Pfizer-BioNTech COVID-19 Vaccine*, Pfizer-BioNTech COVID-19 Vaccine, Bivalent, or COMIRNATY® (COVID-19 Vaccine, mRNA) or to any ingredients in these vaccines.

•There is a remote chance that the vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of the vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination. If you experience a severe allergic reaction, call 9-1-1 or go to the nearest hospital

Seek medical attention right away if you have any of the following symptoms:

•difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness, and weakness

•Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received Pfizer-BioNTech COVID-19 Vaccine, Bivalent, Pfizer-BioNTech COVID-19 Vaccine, or COMIRNATY (COVID-19 Vaccine, mRNA). The observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males, and the observed risk is highest in males 12 through 17 years of age. In most of these people, symptoms began within a few days following receipt of the second dose of vaccine. The chance of having this occur is very low.

Seek medical attention right away if the vaccine recipient has any of the following symptoms:

•Chest pain

•Shortness of breath or difficulty breathing

•Feelings of having a fast-beating, fluttering, or pounding heart

Additional symptoms, particularly in children, may include:

•Fainting

•Unusual and persistent irritability

•Unusual and persistent poor feeding

•Unusual and persistent fatigue or lack of energy

•Persistent vomiting

•Persistent pain in the abdomen

•Unusual and persistent cool, pale skin

•Fainting can happen after getting injectable vaccines, including Pfizer-BioNTech COVID-19 Vaccine, Bivalent. For this reason, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination

•People with weakened immune systems may have a reduced immune response to Pfizer-BioNTech COVID-19 Vaccine, Bivalent

Side effects that have been reported with Pfizer-BioNTech COVID-19 Vaccine, Bivalent, Pfizer-BioNTech COVID-19 Vaccine, or COMIRNATY (COVID-19 Vaccine, mRNA) include:

oSevere allergic reactions

oNon-severe allergic reactions such as rash, itching, hives, or swelling of the face

oMyocarditis (inflammation of the heart muscle)

oPericarditis (inflammation of the lining outside the heart)

oInjection site pain/tenderness

oTiredness

oHeadache

oMuscle pain

oChills

oJoint pain

oFever

oInjection site swelling

oInjection site redness

oNausea

oFeeling unwell

oSwollen lymph nodes (lymphadenopathy)

oDecreased appetite

oDiarrhea

oVomiting

oArm pain

oFainting in association with injection of the vaccine

oDizziness

oIrritability

These may not be all the possible side effects of these vaccines. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.

•Individuals should always ask their healthcare providers for medical advice about adverse events. Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1‐800‐822‐7967 or report online to www.vaers.hhs.gov/reportevent.html. In addition, individuals can report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985

Please click for Pfizer-BioNTech COVID-19 Vaccine, Bivalent Vaccination Provider and Recipient and Caregiver EUA Fact Sheets

*Monovalent formulation is no longer authorized for use in the United States.

About Pfizer: Breakthroughs That Change Patients' Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Pfizer Disclosure Notice

The information contained in this release is as of May 26, 2023. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about Pfizer's efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162 mRNA vaccine program, and the Pfizer-BioNTech COVID-19 Vaccine, the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), the Comirnaty Original/Omicron BA.1 Vaccine, and Comirnaty Original/Omicron BA.4/BA.5 Vaccine, defined collectively herein as COMIRNATY, including an amendment to the companies' COVID-19 vaccine supply agreement with the European Commission, planned regulatory submissions, qualitative assessments of available data, potential benefits, expectations for clinical trials, potential regulatory submissions, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply) involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with pre-clinical and clinical data (including Phase 1/2/3 or Phase 4 data for COMIRNATY, any monovalent, bivalent or variant-adapted vaccine candidates or any other vaccine candidate in the BNT162 program) in any of our studies in pediatrics, adolescents, or adults or real world evidence, including the possibility of unfavorable new pre-clinical, clinical or safety data and further analyses of existing pre-clinical, clinical or safety data or further information regarding the quality of pre-clinical, clinical or safety data, including the risk that additional data against newer Omicron sublineages could differ from previously reported data; the ability to produce comparable clinical or other results for COMIRNATY, any monovalent, bivalent or variant-adapted vaccine candidates or other vaccines that may result from the BNT162 program or any other COVID-19 program, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies, in real world data studies or in larger, more diverse populations following commercialization; the ability of COMIRNATY, any monovalent, bivalent or variant-adapted vaccine candidates or any future vaccine to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that pre-clinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program or other COVID-19 programs will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from existing or pre-clinical and clinical studies; whether and when submissions to request emergency use or conditional marketing authorizations for COMIRNATY or any future vaccines in additional populations, for a potential booster dose for COMIRNATY, any monovalent or bivalent vaccine candidates or any potential future vaccines (including potential future annual boosters or re-vaccinations), and/or other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for COMIRNATY, any monovalent or bivalent vaccine candidates or any other potential vaccines that may arise from the BNT162 program, including a

potential variant-based, higher dose, or bivalent vaccine or any other potential vaccines, and if obtained, whether or when such emergency use authorizations or licenses, or existing emergency use authorizations, will expire or terminate; whether and when any applications that may be pending or filed for COMIRNATY (including any requested amendments to the emergency use or conditional marketing authorizations), any monovalent, bivalent or variant-adapted vaccine candidates (including the sBLA submission to the FDA to extend the approval of COMIRNATY to include the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine), or other vaccines that may result from the BNT162 program or any other COVID-19 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine's benefits outweigh its known risks and determination of the vaccine's efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including the authorization or approval of products or therapies developed by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers, including our relationship with BioNTech; the risk that other companies may produce superior or competitive products; risks related to the availability of raw materials to manufacture or test a vaccine; challenges related to our vaccine's formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant-based or next generation vaccines; the risk that we may not be able to maintain manufacturing capacity or access to logistics or supply channels commensurate with global demand for our vaccines, which would negatively impact our ability to supply our vaccines within the projected time periods; whether and when additional supply agreements will be reached or existing agreements will be completed or renegotiated; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public confidence in, or awareness of COMIRNATY; the uncertainties inherent in business and financial planning, including, without limitation, risks related to Pfizer's business and prospects, adverse developments in Pfizer's markets, or adverse developments in the U.S. or global capital markets, credit markets, regulatory environment or economies generally; uncertainties regarding the impact of COVID-19 on Pfizer's business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at

at www.sec.gov and www.pfizer.com.

About BioNTech

Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bispecific immune checkpoint modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.com.

BioNTech Forward-looking Statements

This press release contains "forward-looking statements" of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech's efforts to combat COVID-19; the collaboration between BioNTech and Pfizer including the program to develop a COVID-19 vaccine and COMIRNATY (COVID-19 vaccine, mRNA) (BNT162b2) (including an amendment to the companies' COVID-19 vaccine supply agreement with the European Commission, qualitative assessments of available data, potential benefits, expectations for clinical trials, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply); our expectations regarding the potential characteristics of BNT162b2, any monovalent or bivalent vaccine candidates or any future vaccine, in our clinical trials and/or in commercial use based on data observations to date; and the ability

of BNT162b2, any monovalent or bivalent vaccine candidates or any future vaccine, to prevent COVID-19 caused by emerging virus variants. Any forward-looking statements in this press release are based on BioNTech's current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including Phase 1/2/3 or Phase 4 data), including the data for BNT162b2, any monovalent or bivalent vaccine candidates or any other vaccine candidate in the BNT162 program in any of our studies in pediatrics, adolescents, or adults or real world evidence, including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the expected time point for additional readouts on efficacy data of BNT162b2, any monovalent or bivalent vaccine candidates or any future vaccine, in our clinical trials; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the timing for submission of data for, or receipt of, any marketing approval or Emergency Use Authorization; our contemplated shipping and storage plan, including our estimated product shelf life at various temperatures; the ability of BioNTech to supply the quantities of BNT162, any monovalent or bivalent vaccine candidates or any future vaccine, to support clinical development and market demand; that demand for any products may be reduced or no longer exist which may lead to reduced revenues or excess inventory; the availability of raw materials to manufacture a vaccine; our vaccine's formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by BioNTech or Pfizer; the ability to successfully develop other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant-based vaccines; the ability to maintain or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached or existing agreements will be completed or renegotiated; the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public vaccine confidence or awareness; and uncertainties regarding the impact of COVID-19 on BioNTech's trials, business and general operations; the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; the ability to effectively scale our production capabilities; and other potential difficulties.

For a discussion of these and other risks and uncertainties, see BioNTech's Quarterly Report on Form 6-K for the quarter ended March 31, 2023, filed with the U.S. Securities and Exchange Commission ("SEC") on May 8, 2023, which is available on the SEC's website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

Pfizer:
Media Relations
+1 (212) 733-1226
[email protected]

Investor Relations
+1 (212) 733-4848
[email protected]

BioNTech:
Media Relations
Jasmina Alatovic
+49 (0)6131 9084 1513
[email protected]

Investor Relations
Victoria Meissner, M.D.

+1 617 528 8293

[email protected]

# # #

i Watson OJ, et al. Global impact of the first year of COVID-19 vaccination: a mathematical modelling study. Lancet Infect Dis. doi: 10.1016/S1473-3099(22)00320

ii Bell Eleanor et al. Estimates of the Global Burden of COVID-19 and the Value of Broad and Equitable Access to COVID-19 Vaccines. Vaccines. 2022 Aug 15;10(8):1320. doi: 10.3390/vaccines10081320

v Oliu-Barton M, Pradelski B, Woloszko N, et al. The effect of COVID certificates on vaccine uptake, health outcomes, and the economy. Nat Commun. 2022 Jul 8;13(1):3942

vi Richards F, Kodjamanova P, Chen X, Li N, Atanasov P, Bennetts L, et al. Economic burden of COVID-19: A systematic review. ClinicoEconomics Outcomes Res. 2022;14:293-307

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AstraZeneca (NASDAQ:) announces Ultomiris (ravulizumab) has been approved in Japan as the first and only long-acting C5 complement inhibitor for the prevention of relapses in patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD), including neuromyelitis optica.

The approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) was based on positive results from the CHAMPION-NMOSD Phase III trial, which were recently published in the Annals of Neurology and selected as an abstract of distinction at the 2023 American Academy of Neurology Annual Meeting.2 In the trial, Ultomiris was compared to an external placebo arm from the pivotal Soliris PREVENT clinical trial.

Ultomiris met the primary endpoint of time to first on-trial relapse as confirmed by an independent adjudication committee. Zero relapses were observed among Ultomiris patients with a median treatment duration of 73 weeks (relapse risk reduction: 98.6%, hazard ratio (95% CI): 0.014 (0.000, 0.103), p<0.0001) and continuing through a median duration of 90 weeks.2

NMOSD is a rare and debilitating autoimmune disease that affects the central nervous system (CNS), including the spine and optic nerves.3-5 Most people living with NMOSD experience unpredictable relapses, characterised by a new onset of neurologic symptoms or worsening of existing neurologic symptoms, which tend to be severe and recurrent and may result in permanent disability.6-8 The diagnosed prevalence of adults with NMOSD in Japan is estimated at approximately 4,000.9

Ichiro Nakashima, MD, Professor at the Division of Neurology, Tohoku Medical and Pharmaceutical University, Sendai, Japan said: “As a single NMOSD relapse can result in long-term and life-altering disability, relapse prevention is the primary treatment goal in this disease and essential to help patients maintain quality of life. With no relapses observed in the pivotal CHAMPION-NMOSD trial, the approval of this long-acting C5 complement inhibitor in Japan is a significant advance for patients with AQP4 Ab+ NMOSD, offering dosing every eight weeks and the potential to live relapse-free.”

Marc Dunoyer, Chief Executive Officer, Alexion, said: “Alexion transformed the NMOSD landscape by uncovering the exceptional efficacy of C5 complement inhibition in reducing the risk of relapses for patients. With today’s approval, we continue to deliver on our commitment to the NMOSD community, offering patients an innovative long-acting treatment option that has the potential to eliminate relapses with convenient dosing every eight weeks. We are proud to expand the reach of Ultomiris as we work to improve patients’ lives around the world.”

Overall, the safety and tolerability of Ultomiris in the CHAMPION-NMOSD trial were consistent with previous clinical studies and real-world use, and no new safety signals were observed. The most common adverse events (AEs) were COVID-19, headache, back pain, arthralgia and urinary tract infection. All cases of COVID-19 were non-serious and considered to be unrelated to Ultomiris.2

Ultomiris was recently approved in the European Union (EU) for the treatment of adult patients with NMOSD who are AQP4 Ab+, and regulatory reviews are ongoing in additional countries, including in the United States (US).

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NEW YORK and MAINZ, GERMANY, MAY 26, 2023 - Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have reached an agreement with the European Commission (EC) to amend their existing contract to deliver COVID-19 vaccines to the European Union.

The amended agreement reflects the companies' commitment to working collaboratively to help address ongoing public health needs, while respecting the principles of the original agreement. It includes rephasing of delivery of doses annually through 2026. In addition, the agreement includes an aggregate volume reduction, providing additional flexibility for EU Member States. The EC will maintain access to future adapted COVID-19 vaccines and the ability to donate doses, in alignment with the original agreement.

COVID-19 vaccination has played an important role in saving lives and livelihoods across Europe. In the first year of their rollout, vaccines were estimated to have averted over 4 million COVID-19-related deaths in Europe and 6 million hospitalizations globally, saving hospital resources worth €56 billion.[i],[ii] The vaccination campaign in Europe helped reopen millions of large and small businesses across the region and helped stabilize the wider European economy, which saw a national average 7% reduction in GDP during the first pandemic year, 2020.[iii],[iv],[v],[vi],[vii]

U.S. INDICATION & AUTHORIZED USE

AUTHORIZED USE

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older.

IMPORTANT SAFETY INFORMATION

Tell your vaccination provider about all of your medical conditions, including if you:

  • have any allergies
  • have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
  • have a fever
  • have a bleeding disorder or are on a blood thinner
  • are immunocompromised or are on a medicine that affects the immune system
  • are pregnant, plan to become pregnant, or are breastfeeding
  • have received another COVID-19 vaccine
  • have ever fainted in association with an injection
  • The vaccine may not protect everyone
  • A person should NOT get Pfizer-BioNTech COVID-19 Vaccine, Bivalent if they have had a severe allergic reaction after a previous dose of Pfizer-BioNTech COVID-19 Vaccine*, Pfizer-BioNTech COVID-19 Vaccine, Bivalent, or COMIRNATY® (COVID-19 Vaccine, mRNA) or to any ingredients in these vaccines.
  • There is a remote chance that the vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of the vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination. If you experience a severe allergic reaction, call 9-1-1 or go to the nearest hospital

Seek medical attention right away if you have any of the following symptoms:

  • difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness, and weakness
  • Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received Pfizer-BioNTech COVID-19 Vaccine, Bivalent, Pfizer-BioNTech COVID-19 Vaccine, or COMIRNATY (COVID-19 Vaccine, mRNA). The observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males, and the observed risk is highest in males 12 through 17 years of age. In most of these people, symptoms began within a few days following receipt of the second dose of vaccine. The chance of having this occur is very low.

Seek medical attention right away if the vaccine recipient has any of the following symptoms:

  • Chest pain
  • Shortness of breath or difficulty breathing
  • Feelings of having a fast-beating, fluttering, or pounding heart

Additional symptoms, particularly in children, may include:

  • Fainting
  • Unusual and persistent irritability
  • Unusual and persistent poor feeding
  • Unusual and persistent fatigue or lack of energy
  • Persistent vomiting
  • Persistent pain in the abdomen
  • Unusual and persistent cool, pale skin
  • Fainting can happen after getting injectable vaccines, including Pfizer-BioNTech COVID-19 Vaccine, Bivalent. For this reason, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination
  • People with weakened immune systems may have a reduced immune response to Pfizer-BioNTech COVID-19 Vaccine, Bivalent

Side effects that have been reported with Pfizer-BioNTech COVID-19 Vaccine, Bivalent, Pfizer-BioNTech COVID-19 Vaccine, or COMIRNATY (COVID-19 Vaccine, mRNA) include:

  • Severe allergic reactions
  • Non-severe allergic reactions such as rash, itching, hives, or swelling of the face
  • Myocarditis (inflammation of the heart muscle)
  • Pericarditis (inflammation of the lining outside the heart)
  • Injection site pain/tenderness
  • Tiredness
  • Headache
  • Muscle pain
  • Chills
  • Joint pain
  • Fever
  • Injection site swelling
  • Injection site redness
  • Nausea
  • Feeling unwell
  • Swollen lymph nodes (lymphadenopathy)
  • Decreased appetite
  • Diarrhea
  • Vomiting
  • Arm pain
  • Fainting in association with injection of the vaccine
  • Dizziness
  • Irritability

These may not be all the possible side effects of these vaccines. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.

  • Individuals should always ask their healthcare providers for medical advice about adverse events. Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1‐800‐822‐7967 or report online to vaers.hhs.gov/reportevent.html. In addition, individuals can report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985

Please click for Pfizer-BioNTech COVID-19 Vaccine, Bivalent Vaccination Provider and Recipient and Caregiver EUA Fact Sheets

*Monovalent formulation is no longer authorized for use in the United States.

About Pfizer: Breakthroughs That Change Patients' Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Pfizer Disclosure Notice

The information contained in this release is as of May 26, 2023. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about Pfizer's efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162 mRNA vaccine program, and the Pfizer-BioNTech COVID-19 Vaccine, the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), the Comirnaty Original/Omicron BA.1 Vaccine, and Comirnaty Original/Omicron BA.4/BA.5 Vaccine, defined collectively herein as COMIRNATY, including an amendment to the companies' COVID-19 vaccine supply agreement with the European Commission, planned regulatory submissions, qualitative assessments of available data, potential benefits, expectations for clinical trials, potential regulatory submissions, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply) involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with pre-clinical and clinical data (including Phase 1/2/3 or Phase 4 data for COMIRNATY, any monovalent, bivalent or variant-adapted vaccine candidates or any other vaccine candidate in the BNT162 program) in any of our studies in pediatrics, adolescents, or adults or real world evidence, including the possibility of unfavorable new pre-clinical, clinical or safety data and further analyses of existing pre-clinical, clinical or safety data or further information regarding the quality of pre-clinical, clinical or safety data, including the risk that additional data against newer Omicron sublineages could differ from previously reported data; the ability to produce comparable clinical or other results for COMIRNATY, any monovalent, bivalent or variant-adapted vaccine candidates or other vaccines that may result from the BNT162 program or any other COVID-19 program, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies, in real world data studies or in larger, more diverse populations following commercialization; the ability of COMIRNATY, any monovalent, bivalent or variant-adapted vaccine candidates or any future vaccine to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that pre-clinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program or other COVID-19 programs will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from existing or pre-clinical and clinical studies; whether and when submissions to request emergency use or conditional marketing authorizations for COMIRNATY or any future vaccines in additional populations, for a potential booster dose for COMIRNATY, any monovalent or bivalent vaccine candidates or any potential future vaccines (including potential future annual boosters or re-vaccinations), and/or other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for COMIRNATY, any monovalent or bivalent vaccine candidates or any other potential vaccines that may arise from the BNT162 program, including a potential variant-based, higher dose, or bivalent vaccine or any other potential vaccines, and if obtained, whether or when such emergency use authorizations or licenses, or existing emergency use authorizations, will expire or terminate; whether and when any applications that may be pending or filed for COMIRNATY (including any requested amendments to the emergency use or conditional marketing authorizations), any monovalent, bivalent or variant-adapted vaccine candidates (including the sBLA submission to the FDA to extend the approval of COMIRNATY to include the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine), or other vaccines that may result from the BNT162 program or any other COVID-19 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine's benefits outweigh its known risks and determination of the vaccine's efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including the authorization or approval of products or therapies developed by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers, including our relationship with BioNTech; the risk that other companies may produce superior or competitive products; risks related to the availability of raw materials to manufacture or test a vaccine; challenges related to our vaccine's formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant-based or next generation vaccines; the risk that we may not be able to maintain manufacturing capacity or access to logistics or supply channels commensurate with global demand for our vaccines, which would negatively impact our ability to supply our vaccines within the projected time periods; whether and when additional supply agreements will be reached or existing agreements will be completed or renegotiated; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public confidence in, or awareness of COMIRNATY; the uncertainties inherent in business and financial planning, including, without limitation, risks related to Pfizer's business and prospects, adverse developments in Pfizer's markets, or adverse developments in the U.S. or global capital markets, credit markets, regulatory environment or economies generally; uncertainties regarding the impact of COVID-19 on Pfizer's business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at

at www.sec.gov and www.pfizer.com.

About BioNTech

Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bispecific immune checkpoint modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.com.

BioNTech Forward-looking Statements

This press release contains "forward-looking statements" of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech's efforts to combat COVID-19; the collaboration between BioNTech and Pfizer including the program to develop a COVID-19 vaccine and COMIRNATY (COVID-19 vaccine, mRNA) (BNT162b2) (including an amendment to the companies' COVID-19 vaccine supply agreement with the European Commission, qualitative assessments of available data, potential benefits, expectations for clinical trials, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply); our expectations regarding the potential characteristics of BNT162b2, any monovalent or bivalent vaccine candidates or any future vaccine, in our clinical trials and/or in commercial use based on data observations to date; and the ability of BNT162b2, any monovalent or bivalent vaccine candidates or any future vaccine, to prevent COVID-19 caused by emerging virus variants. Any forward-looking statements in this press release are based on BioNTech's current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including Phase 1/2/3 or Phase 4 data), including the data for BNT162b2, any monovalent or bivalent vaccine candidates or any other vaccine candidate in the BNT162 program in any of our studies in pediatrics, adolescents, or adults or real world evidence, including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the expected time point for additional readouts on efficacy data of BNT162b2, any monovalent or bivalent vaccine candidates or any future vaccine, in our clinical trials; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the timing for submission of data for, or receipt of, any marketing approval or Emergency Use Authorization; our contemplated shipping and storage plan, including our estimated product shelf life at various temperatures; the ability of BioNTech to supply the quantities of BNT162, any monovalent or bivalent vaccine candidates or any future vaccine, to support clinical development and market demand; that demand for any products may be reduced or no longer exist which may lead to reduced revenues or excess inventory; the availability of raw materials to manufacture a vaccine; our vaccine's formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by BioNTech or Pfizer; the ability to successfully develop other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant-based vaccines; the ability to maintain or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached or existing agreements will be completed or renegotiated; the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public vaccine confidence or awareness; and uncertainties regarding the impact of COVID-19 on BioNTech's trials, business and general operations; the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; the ability to effectively scale our production capabilities; and other potential difficulties.

For a discussion of these and other risks and uncertainties, see BioNTech's Quarterly Report on Form 6-K for the quarter ended March 31, 2023, filed with the U.S. Securities and Exchange Commission ("SEC") on May 8, 2023, which is available on the SEC's website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

Pfizer:
Media Relations
+1 (212) 733-1226
[email protected]

Investor Relations
+1 (212) 733-4848
[email protected]

BioNTech:
Media Relations
Jasmina Alatovic
+49 (0)6131 9084 1513
[email protected]

Investor Relations
Victoria Meissner, M.D.
+1 617 528 8293
[email protected]

# # #

[i] Watson OJ, et al. Global impact of the first year of COVID-19 vaccination: a mathematical modelling study. Lancet Infect Dis. doi: 10.1016/S1473-3099(22)00320

[ii] Bell Eleanor et al. Estimates of the Global Burden of COVID-19 and the Value of Broad and Equitable Access to COVID-19 Vaccines. Vaccines. 2022 Aug 15;10(8):1320. doi: 10.3390/vaccines10081320

[iii] Eurostat. Gross Domestic Product for European Union (27 Countries from 2020) [CPMNACSCAB1GQEU272020], retrieved from FRED, Federal Reserve Bank of St. Louis; Available from: fred.stlouisfed.org/series/CPMNACSCAB1GQEU272020

[iv] Eurostat. Small and medium-sized enterprises: an overview. Published May 14, 2020. Available from: ec.europa.eu/eurostat/web/products-eurostat-news/-/ddn-20200514-1

[v] Oliu-Barton M, Pradelski B, Woloszko N, et al. The effect of COVID certificates on vaccine uptake, health outcomes, and the economy. Nat Commun. 2022 Jul 8;13(1):3942.

[vi] Richards F, Kodjamanova P, Chen X, Li N, Atanasov P, Bennetts L, et al. Economic burden of COVID-19: A systematic review. ClinicoEconomics Outcomes Res. 2022;14:293-307.

[vii] Economist Intelligence Unit. Real GDP (% change pa). Available from: data.eiu.com

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North Carolina, May 25: A new study has shown that human T cells have an important role to play in controlling Respiratory Syncytial Virus (RSV) infection, a highly contagious and seasonal respiratory virus that mainly causes common cold symptoms in healthy adults but can cause more serious lung infections in infants, the immunocompromised and older individuals. Foods For Lungs: From Beetroot to Purple Cabbage, Here Are Five Things You Should Eat For Healthy Breathing.

Strikingly, RSV infection remains the most common reason for hospitalization of infants and young children. Health officials have recently promoted flu vaccines and reformulated COVID boosters as they prepare for a respiratory infection season that could rival some of the worst cold and flu seasons in history.

A new study published in JCI Insight, led by Angela Wahl, PhD, Raymond Pickles, PhD, and J. Victor Garcia, PhD, with the International Center for the Advancement of Translational Science (ICATS), the Department of Microbiology and Immunology, and the Institute for Global Health and Infectious Diseases (IGHID) at the UNC School of Medicine has shown that human T cells have an important role to play in controlling infection.

"Vaccine strategies for RSV have largely focused on the induction of an antibody response. Using novel precision animal models of RSV infection, we've gained novel insight into how the human immune system, and in particular human T cells, controls and clears RSV infection," said Wahl, assistant professor of medicine and assistant director of the UNC ICATS. Heat Can Trigger Mental Health Issues, Govt Hospitals See 50% Increase in Cases of Psychosis and Bipolar Disorders Due to Rise in Temperatures.

"Our data show that T cells can independently control RSV infection in human lung tissue in the absence of an RSV-specific antibody response. While a vaccine-induced RSV-specific T cell response would not be able to prevent infection, it could accelerate virus clearance and ameliorate disease if vaccine-elicited antibodies fail to prevent infection, due to antigenic variability among circulating strains."

The research team used two novel precision animal models to analyze RSV-induced human lung pathology and human immune correlates of protection at pre-determined time points. They showed that primed human CD8+ T cells or CD4+ T cells effectively and independently controlled RSV replication in human lung tissue in the absence of an RSV-specific antibody response.

This preclinical data support the development of RSV vaccines, eliciting effective T-cell responses to improve RSV vaccine efficacy.

"It remains to be determined if vaccine efficacy fluctuates during RSV seasons due to variations in the circulating strains, and how long protection would last. But vaccines which can elicit T cell immunity may provide long-term protection against RSV infection and limit the severity of subsequent lung disease" said J. Victor Garcia, professor of medicine and director of UNC ICATS.

"With our recent experience with a global pandemic caused by SARS-CoV-2 and the success of vaccines which are formulated to elicit neutralizing antibody responses, it will be critical to understanding how vaccine design can be tuned to also mount an effective T cell response against viral pathogens including RSV to more effectively clear infection from the lung," said Raymond Pickles of the UNC Microbiology and Immunology Department who was also involved in this study.

An effective and safe RSV vaccine is a priority for the WHO Initiative for Vaccine Research, but the incomplete understanding of how the human immune response controls RSV infection has proven to be a major hurdle towards developing an effective vaccine.

On May 3, the U.S. Food and Drug Administration approved GSK's Arexvy vaccine for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older. Pfizer and Moderna also have two candidate vaccines that have shown efficacy against RSV-associated respiratory tract in Phase III clinical trials.

(This is an unedited and auto-generated story from Syndicated News feed, LatestLY Staff may not have modified or edited the content body)



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A symposium at the 2023 American Thoracic Society (ATS) International Conference encouraged attendees to “think outside the lung,” with expert presenters giving overviews of common comorbidities that warrant consideration in patients who present with chronic obstructive pulmonary disease (COPD).

The session broadly discussed the burden of comorbidities in COPD and highlighted 3 common comorbidities: anxiety and depression, cardiovascular disease, and skeletal muscular dysfunction. Challenges and opportunities for screening patients with COPD for comorbidities were also a focus of the presentation.

Miguel J. Divo, MD, MPH, assistant professor of medicine at Harvard and clinician at Brigham and Women’s Hospital in Boston, MA, gave insight into the occurrence of comorbidities overall in COPD and their impact on patient outcomes.

“Roughly, every patient that we diagnose is going to have between 4 to 6 different co-occurring diseases, and this is not accounting for COPD," Divo said, citing a study of 27,000 patients in Spain. "From there, we need to then ask the question, ‘Is this unique for COPD?’” When compared with a cohort of the same size comprised of people without a COPD diagnosis, those with COPD had 2 more comorbidities than those without COPD regardless of age group, he explained.

What’s more, these comorbidities were happening roughly 15 years earlier in individuals with COPD vs those not diagnosed with COPD, he said.

Divo also highlighted data on quality of life and mortality showing that as the number of comorbidities increases, the probability of worse quality of life is higher. Additionally, having more comorbidities has been directly associated with increased mortality, he said.

“So what are the culprits? If I take a lot of those studies that I'm mentioning [and] all the other different aspects of patient-centered outcomes, these are the big players: cancer, cardiovascular disease, musculoskeletal disease, metabolic and endocrinopathies, and mental health.”

COPD and Mental Health

Anxiety and depression in COPD are crucial comorbidities to examine, as they are very prevalent in the population overall, said Victor Kim, MD, FAASM, professor of thoracic medicine and surgery at Temple University in Philadelphia, PA. While evidence supports a link between mood disorders and COPD, anxiety and depression may be underdiagnosed in clinical settings, he said.

“Despite the commonness, half of those individuals with anxiety and depression don't seek pharmacologic treatment. And from the standpoint of a doctor concentrating on pulmonary diseases, it may be under-recognized or deprioritized by the patient and clinician,” Kim said.

The prevalence of depression is even higher in those with COPD, Kim noted, highlighting an analysis in which 26% of a cohort of individuals with COPD reported depressive symptoms, compared with 12% and 7% of smokers and non-smokers, respectively. In a matched cohort, signs of depression were significantly more common in those with airflow obstruction.

In the cohort, depressive symptoms were more common in individuals with post airflow obstruction, current smokers, females, and younger vs older patients. Other cohorts replicate similar data in terms of depression symptom prevalence in COPD, Kim said.

In another study, anxiety and depression were shown to be more common among those with more severe respiratory symptoms and exacerbations based on Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) scores, Kim said. And depression is associated with other outcomes, he noted.

For example, one study uncovered an interesting correlation between 6-minute walk distance test results and depression. While patients in the study only showed minor differences in lung function, those with depression walked about 50 meters less than individuals without depression.

Comorbid anxiety and depression may also be predictive of respiratory exacerbations, according to research in 2 large cohorts of COPD patients. Patients with both anxiety and depression showed an increased risk of exacerbations, Kim explained. In other treatment settings, such as cardiovascular disease, mood disorders are also thought to translate to worse outcomes.

With current data in mind, Kim concluded that treating the whole patient with comorbidities in mind is key for improving outcomes in respiratory conditions and other diseases.

Cardiovascular Disease and COPD

It has long been known that cardiovascular disease is a common occurrence among patients with COPD, and their co-occurrence is often the subject of research. Yet, not much is being done to advance the management of parallel COPD and cardiovascular disease, explained Jennifer K. Quint, PhD, FRCP, MSc, professor of respiratory epidemiology at Imperial College London in the United Kingdom.

A number of underlying risk factors contribute to the co-occurrence of cardiovascular disease and COPD, including smoking, physical inactivity, diet, air pollution, and more.

“This all leads to accelerated inflammation,” Quint said. “We also know that COPD itself, as it worsens, can potentially impact on cardiovascular disease.”

The current guidelines for treating cardiovascular disease in patients with COPD are clear and recommend treating it the way any cardiovascular disease case would be treated, but research has shown that those with both conditions do not receive beta blockers for cardiovascular conditions as often as those who do not have co-occurring COPD.

Due to the overlapping mechanisms of the conditions, some of the treatments used for COPD may impact cardiovascular diseases, and treatments for cardiovascular disease may impact COPD, she noted. Research in this area is important, with some past research suggesting that some treatments for COPD may be protective from a cardiovascular standpoint, Quint said.

While such concepts have been reported time and again, the crucial next step is determining how care can be tailored to these conditions when they occur simultaneously. In the same vein, Quint noted that because there is substantial overlap in the biological mechanisms and risk factors for COPD and cardiovascular disease, research into how cardiovascular disease more easily in the COPD population is needed.

“If we don't diagnose it and we don't manage it, then we're not going to be able to ultimately change the outcomes,” she said.

Skeletal Muscle Dysfunction and COPD

Harry B. Rossiter, PhD, a researcher at the Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Center in Torrance, CA, began his portion of the presentation by noting that 12%-40% of patients with COPD experience muscle loss and weakness and explaining a cycle of muscle loss that these patients can fall into.

“Typically, when we're thinking about COPD and skeletal muscle, we think about the fact that these patients have dyspnea on exertion of forced inactivity, which leads to muscle wasting, which in turn causes an increased ventilator demand,” Rossiter said. “So these patients have both higher ventilator demands and low ventilatory capacity.”

The implications of muscle loss can be serious, he added, highlighting a study of nearly 200,000 hospital admissions that found about 10% of COPD patients to express a muscle loss phenotype, which was also the second strongest predictive variable for increased length of stay for patients with COPD exacerbations.

Inactivity is not the only mechanism behind muscle wasting, Rossiter explained, and inactivity alone does not explain the loss of muscle mass and mitochondrial function that COPD patients experience. While a number of factors may come into play, the mechanisms are not entirely clear yet.

As for potential treatments to break the cycle of muscle loss and weakness in patients with COPD, Rossiter noted that he has worked on clinical trials involving myostatin inhibitors and selective androgen receptor modulators. In his experience with clinical trials, he has found that adding exercise to drug interventions for muscle mass loss is key for simultaneous muscle strength building.

Screening Potential and Barriers to Implementation

While it would be ideal to simply screen all patients diagnosed with COPD for known comorbidities to facilitate timely and beneficial treatment, implementing such a widespread process is easier said than done, said Jessica Bon, MD, MS, associate professor of medicine in the Division of Pulmonary, Allergy and Critical Care Medicine at the University of Pittsburgh in Pittsburgh, PA.

Reiterating the prevalence of comorbidities in patients with COPD, Bon noted that the guidelines for screening among these patients are vague. While GOLD now discusses comorbidities such as cardiovascular disease and osteoporosis comprehensively and recognizes that they occur at all severities of COPD, the screening guidelines essentially stop there, Bon said.

“The problem is we know that some of these comorbidities are high risk, and the general guidelines may not be enough,” Bon said, and added that the comorbidities discussed in the session remain underdiagnosed.

Going forward, the development of widespread, appropriate, cost-effective screening protocol is needed to mitigate gaps in the identification of comorbidities in patients with COPD.

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Dublin, May 24, 2023 (GLOBE NEWSWIRE) -- The "Global Cystic Fibrosis Treatment Market Report and Forecast 2023-2031" report has been added to ResearchAndMarkets.com's offering.

The global market value in 2022 was USD 8.3 billion, driven by the increasing prevalence of the disease and the introduction of new therapies across the globe.

The Global Cystic Fibrosis Treatment Market size is anticipated to grow at a CAGR of 13.4% during the forecast period of 2023-2031 to achieve a value of USD 25.7 billion by 2031.

Cystic Fibrosis Market: Introduction

Cystic fibrosis (CF) is a genetic disorder that primarily affects the lungs and digestive system. It causes thick and sticky mucus to build up in the airways and other organs, leading to frequent infections, lung damage, and difficulty in breathing. CF is caused by a mutation in the gene that codes for the cystic fibrosis transmembrane conductance regulator (CFTR) protein, which regulates the transport of salt and water in and out of cells. There is currently no cure for CF, and treatment aims to manage symptoms and prevent complications.

CF is a rare disease, affecting approximately 70,000 people worldwide. It is most commonly diagnosed in infancy or early childhood, but can also be diagnosed in adults. The incidence of CF varies depending on the population, with higher rates in people of European descent. Treatment options for CF include airway clearance techniques, antibiotics to treat infections, and medications that target specific symptoms of the disease. In severe cases, lung transplantation may be necessary. Research is ongoing to develop new therapies and improve the quality of life for people with CF.

Key Trends in the Cystic Fibrosis Market
Some key trends in the cystic fibrosis market include:

  • Emergence of new treatments: With ongoing research and development in the field, new and more effective treatments for cystic fibrosis are being developed. These treatments are aimed at addressing the underlying cause of the disease, rather than just treating the symptoms
  • Increased focus on personalized medicine: As understanding of the genetics of cystic fibrosis improves, there is a growing focus on personalized medicine. This involves tailoring treatment plans to the specific genetic mutations of individual patients, in order to achieve the best possible outcomes
  • Rising prevalence of cystic fibrosis: While cystic fibrosis is a relatively rare disease, its prevalence is increasing globally. This is in part due to improved diagnosis and screening, which has allowed more people to be identified and treated
  • Growing awareness and advocacy: There is a growing awareness of cystic fibrosis among the general public, which has helped to drive increased funding for research and development, as well as better access to care for patients
  • Advancements in gene therapy: Gene therapy has shown promise as a potential treatment for cystic fibrosis, and ongoing research in this area is expected to yield new and more effective therapies in the coming years

Cystic Fibrosis Market Segmentation
Market Breakup by Treatment Methods

Market Breakup by Drug Class

  • Cystic Fibrosis Transmembrane Conductance Regulator (CFTR)
  • Bronchodilators
  • Mucolytic
  • Pancreatic Enzyme Supplement
  • Others

Market Breakup by Drug Molecule Type

Market Breakup by Route of Administration

Market Breakup by Treatment Channel

Market Breakup by Distribution Channel

  • Hospital Pharmacy
  • Retail Pharmacy
  • Online Pharmacy
  • Others

Cystic Fibrosis Market by Region

North America

  • United States of America
  • Canada

Europe

  • United Kingdom
  • Germany
  • France
  • Italy
  • Others

Asia Pacific

  • China
  • Japan
  • India
  • ASEAN
  • Australia
  • Others

Latin America

  • Brazil
  • Argentina
  • Mexico
  • Others

Middle East and Africa

  • Saudi Arabia
  • United Arab Emirates
  • Nigeria
  • South Africa
  • Others

Cystic Fibrosis Market Scenario

Cystic fibrosis is a genetic disorder that affects the respiratory, digestive, and reproductive systems. It is caused by a mutation in the CFTR gene, which leads to the production of thick and sticky mucus in the body. This mucus can cause blockages in the lungs, pancreas, and other organs, leading to serious health problems such as lung infections, malnutrition, and infertility.

The market for cystic fibrosis treatments has been rapidly growing due to the increasing prevalence of the disease and the introduction of new therapies. In recent years, several new drugs have been approved for the treatment of cystic fibrosis, including CFTR modulators, which target the underlying genetic defect and have been shown to improve lung function and reduce the frequency of exacerbations.

The market is also seeing a shift towards personalized medicine, with the development of treatments that target specific mutations in the CFTR gene. This approach has the potential to improve treatment outcomes and reduce healthcare costs by ensuring that patients receive the most effective therapies for their specific genetic mutations.

Overall, the cystic fibrosis market is expected to continue to grow in the coming years, driven by ongoing research and development efforts, increasing awareness of the disease, and the growing demand for personalized treatment options.

Cystic Fibrosis Market: Competitor Landscape

The key features of the market report include patent analysis, grants analysis, clinical trials analysis, funding and investment analysis, partnerships, and collaborations analysis by the leading key players. The major companies in the cystic fibrosis market are as follows:

  • AbbVie Inc
  • Allergan
  • Chiesi Farmaceutici SpA
  • F. Hoffmann-La Roche Ltd
  • Gilead Sciences
  • Novartis AG
  • Pharmaxis Ltd
  • PTC Therapeutics
  • Vertex Pharmaceuticals
  • Demegen, Inc
  • Mor Research Applications
  • Alaxia
  • Alcresta Therapeutics, Inc
  • AstraZeneca
  • Genentech, Inc
  • Pfizer Inc
  • Mylan N.V
  • Alcresta Therapeutics, Inc
  • Teva Pharmaceutical Industries Ltd
  • Bayer AG

Key Attributes:

Report Attribute Details
No. of Pages 160
Forecast Period 2023 - 2031
Estimated Market Value (USD) in 2023 $9.4 Billion
Forecasted Market Value (USD) by 2031 $25.7 Billion
Compound Annual Growth Rate 13.4%
Regions Covered Global

Key Topics Covered:

1 Preface

2 Executive Summary

3 Cystic Fibrosis Disease Overview

4 Patient Profile

5 Cystic Fibrosis Epidemiology Analysis

6 Global Cystic Fibrosis Market Overview

7 Global Cystic Fibrosis Market Landscape

8 Cystic Fibrosis Challenges and Unmet Needs

9 Cost of Treatment

10 Global Cystic Fibrosis Market Dynamics

11 Global Cystic Fibrosis Market Segmentation

12 North America Cystic Fibrosis Market

13 Europe Cystic Fibrosis Market

14 Asia Pacific Cystic Fibrosis Market

15 Latin America Cystic Fibrosis Market

16 Middle East and Africa Cystic Fibrosis Market

17 Regulatory Framework

18 Patent Analysis

19 Grants Analysis

20 Clinical Trials Analysis

21 Funding and Investment Analysis

22 Partnership and Collaborations Analysis

23 Supplier Landscape

24 Cystic Fibrosis Market- Distribution Model (Additional Insight)

25 Key Opinion Leaders (KOL) Insights (Additional Insight)

26 Company Competitiveness Analysis (Additional Insight)

27 Payment Methods (Additional Insight)

For more information about this report visit www.researchandmarkets.com/r/4vtxq4

About ResearchAndMarkets.com
ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.


        

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In a recent study published in the Journal of the Academy of Nutrition and Dietetics, researchers examine the relationship between chocolate consumption and both all-cause and cause-specific mortality in women.

Study: Chocolate Consumption in Relation to All-Cause and Cause-Specific Mortality in Women: The Women’s Health Initiative. Image Credit: Dean Drobot / Shutterstock.comStudy: Chocolate Consumption in Relation to All-Cause and Cause-Specific Mortality in Women: The Women’s Health Initiative. Image Credit: Dean Drobot / Shutterstock.com

The health effects of chocolate

The short- and long-term health impacts of chocolate consumption have gained significant attention in recent years. However, studies investigating the link between chocolate intake and cardiovascular disease (CVD) have yielded conflicting results.

To this end, one recent study found no association between chocolate intake and coronary heart disease (CHD) or stroke, despite previous studies suggesting a potential inverse relationship. To date, researchers have not explored the link between chocolate consumption and the risk of mortality from specific causes.

About the study

The Women’s Health Initiative (WHI) is a national health study that aims to prevent heart disease, colorectal and breast cancer, and osteoporotic fractures among postmenopausal women through long-term strategies. Between 1993 to 1998, researchers recruited postmenopausal women between 50 and 79 years of age from 40 clinical centers in the United States for either a clinical trial (CT) or an observational study (OS).

The WHI evaluated diet at the beginning of the study using a validated food frequency questionnaire (FFQ) that was self-administered and derived from the Health Habits and Lifestyle Questionnaire. The WHI FFQ consisted of three parts, including 122 food items that asked about portion size and intake frequency, 19 questions about fat intake, and four summary questions about the usual consumption of vegetables, fruits, and added fats to be compared with specific food item data.

The WHI FFQ analyzed a nutrient database sourced from the Nutrition Data System for Research. This database includes over 140 nutrients and compounds, such as energy, sodium, and saturated fat.

The baseline data from the WHI FFQ was used to evaluate chocolate consumption. The FFQ inquired about the frequency of consuming one ounce of chocolate candies and candy bars over the past three months.

Five categories of chocolate intake frequency based on the responses of the participants were established. These included no intake, less than one serving per week, one to three servings every week, four to six servings each week, and one serving each day.

Study findings

Over a period of 1,608,856 person-years, 25,388 deaths were recorded, with 7,069 deaths due to CVD, 7,030 deaths due to cancer, and 3,279 deaths due to dementia. Women who consumed more chocolate tended to have unhealthy habits such as smoking, higher energy intake, less physical activity, lower diet quality, and consuming more coffee or tea.

A correlation was found between higher chocolate intake in women and a lower likelihood of having diabetes and high blood cholesterol at the start of the study. However, these women were more likely to have a higher body mass index (BMI).

Study participants who consumed chocolate had a lower risk of all-cause mortality as compared to those who did not consume chocolate. The risk was even lower for those who consumed chocolate more frequently, with the lowest risk observed in those who consumed one serving each day. These findings were adjusted for various factors such as age, socioeconomic status, race and ethnicity, dietary and lifestyle factors, history of diseases, BMI, and history of diseases.

Chocolate consumption had a slight impact on CVD mortality, with those consuming less than one serving each week having a slightly lower risk of CVD, while those who consumed one to three servings every week had the lowest risk. Women who consumed one serving each day had a risk similar to those who did not consume chocolate at all. Chocolate consumption showed similar associations with CHD and CVD mortality; however, no association with stroke mortality was found.

Individuals who consumed chocolate had a lower risk of lung cancer mortality compared to those who did not, with the lowest risk observed among those who consumed four to six servings each week. Consuming chocolate was also associated with a reduced risk of mortality from dementia, excluding Alzheimer's disease.

Conclusions

Consuming chocolate appears to be associated with a slightly lower risk of mortality. More specifically, a moderate chocolate intake of three servings every week was particularly beneficial, even after accounting for various confounding factors. Moderate chocolate intake also correlated with a slight reduction in the risk of all-cause, CVD, and dementia mortality.

Further research is needed to investigate the potential link between high chocolate intake and all-cause and cause-specific deaths.

Journal reference:

  • Sun, Y., Liu, B., Snetselaar, L. G., et al. (2023). Chocolate Consumption in Relation to All-Cause and Cause-Specific Mortality in Women: The Women’s Health Initiative. Journal of the Academy of Nutrition and Dietetics 123(6); 902-911. doi:10.1016/j.jand.2022.12.007



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