Jul 30, 2020 • 11:49 am CDT
Ohio Governor Overrules Pharmacy Board
Ohio Governor @GovMikeDeWine issued a Tweet on July 30, 2020, saying 'I agree with Dr. Steven Hahn, Commissioner of the U.S. FDA, that prescribing of hydroxychloroquine to treat COVID-19 disease should be between a doctor and a patient.'
'Therefore, I am asking the @OhioRxBoard to halt their new rule prohibiting the selling or dispensing of hydroxychloroquine (Plaquenil) for the treatment or prevention of COVID-19.'
In response, the Ohio Board published the following statement around noon on July 30th: 'As a result of the feedback received by the medical and patient community and at the request of Governor DeWine, the State of Ohio Board of Pharmacy has withdrawn proposed rule 4729:5-5-21 of the Administrative Code. Therefore, prohibitions on the prescribing of chloroquine and hydroxychloroquine in Ohio for the treatment of COVID-19 will not take effect ... at this time.'
Jul 30, 2020 • 10:23 am CDT
60 Million Flu Shots Now Shipping to the US
Seqirus announced on July 30, 2020, it has begun shipping its portfolio of seasonal influenza vaccines, up to 60 vaccine doses, to customers in the USA for the Northern Hemisphere's 2020-2021 influenza season.
For this flu season, Seqirus will provide FLUAD, the first-and-only adjuvanted seasonal influenza vaccine approved for adults 65 and older, in addition to FLUAD Quadrivalent.
The Seqirus 2020 - 2021 influenza vaccine portfolio also includes FLUCELVAX QUADRIVALENT, a cell-based quadrivalent influenza vaccine approved for use in persons 4-years of age and older, and AFLURIA QUADRIVALENT, an egg-based quadrivalent influenza vaccine approved for use in those 6-months of age and older.
Jul 30, 2020 • 10:11 am CDT
NEJM Study: Nirsevimab for Prevention of RSV in Preterm Infants
Detailed results from a Phase 2b trial for Nirsevimab published by Sanofi on July 30, 2020, showed a significant reduction in medically attended lower respiratory tract infections (LRTI), mainly bronchiolitis and pneumonia, and hospitalizations caused by the Respiratory Syncytial Virus (RSV) in healthy preterm infants.
Published in the NEJM, these positive study results demonstrate for the first time that a single dose monoclonal antibody can significantly reduce medically attended RSV LRTI in infants through the full RSV season.
Jul 30, 2020 • 9:18 am CDT
Vaccine Found Effective Against Coronavirus Mutant Variant D614G
On July 30, 2020, Inovio announced INO-4800 vaccinations generated antibodies neutralizing both the earlier strain of the SARS-CoV-2 betacoronavirus, as well as the mutant variant D614G, that has emerged with greater infectivity in the USA, and now accounts for about 80% of newly circulating coronavirus infections.
Jul 30, 2020 • 8:26 am CDT
Facts About J&J’s COVID-19 Vaccine Candidate
Data published in Nature by J&J on July 30, 2020, showed that Janssen's investigational vaccine elicited an immune response against SARS-CoV-2 in a preclinical, nonhuman study. Based on the positive data from this preclinical study, the first-in-human Phase 1/2a clinical trial is now underway in USA and Belgium, with a Phase 3 study expected to commence in September 2020.
Jul 30, 2020 • 8:08 am CDT
GEN-009 Vaccine Found Effective in Advanced Solid Tumors
Genocea Biosciences announced on July 30, 2020, it will present initial clinical data today on the first 5 patients from Part B of the ongoing Phase 1/2a study, which explores the combination of Genocea’s neoantigen vaccine, GEN-009, and checkpoint inhibitor-based regimens, in advanced solid tumors.
Jul 30, 2020 • 8:02 am CDT
Global Phase 2/3 Study Announced For Opaganib (Yeliva)
RedHill Biopharma Ltd. announced on July 30, 2020, that it has initiated a global Phase 2/3 clinical study across 40 clinical sites evaluating Opaganib (Yeliva®, ABC294640) in patients hospitalized with severe SARS-CoV-2 infection and pneumonia, requiring treatment with supplemental oxygen. The study has been approved in the UK and Russia and is under review in Italy, Brazil, and Mexico.
Enrollment in a parallel U.S. Phase 2 study in patients with severe COVID-19 is expected to be completed in August 2020.
Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with anticancer, anti-inflammatory and anti-viral activities, targeting multiple oncology, viral, inflammatory and gastrointestinal indications. By inhibiting SK2, Opaganib impacts multiple cellular pathways that are associated with cancer growth, viral replication, and pathological inflammation.
Jul 30, 2020 • 5:52 am CDT
Study: Protective Effect of Pneumococcal Vaccination on Cardiovascular Disease
A new meta-analysis published on July 28, 2020, found seniors vaccinated with a PPV23 vaccine would be protection against invasive pneumococcal disease and community-acquired pneumonia due to S.pneumoniae, but also help prevent cardiovascular events, myocardial infarction, and related mortality.
This protection was seen in individuals of all age groups, but particularly in those 65 years of age and older.
Jul 29, 2020 • 1:32 pm CDT
Hydroxychloroquine Administered Without Pennsylvania's Approval
On July 28, 2020, the Pennsylvania Department of Health (DOH) issued a report that stated the Brighton Rehabilitation and Wellness Center provided 205 patients with hydroxychloroquine, without receiving prior approval. Known as Plaquenil in the USA, hydroxychloroquine is FDA-approved to treat certain types of malaria and autoimmune conditions such as chronic discoid lupus erythematosus, systemic lupus erythematosus in adults, and rheumatoid arthritis.
But, Plaquenil is not U.S. FDA approved for treating COVID-19 disease patients.
Additionally, the Pennsylvania DOH reported on July 29th, that Allegheny County (125) and Philadelphia County (111) reported new COVID-19 cases. Furthermore, there have been about 7,200 coronavirus related fatalities reported in PA, with 4,883 reported in residents from nursing or personal care facilities.
Jul 29, 2020 • 10:49 am CDT
Russian COVID-19 Vaccine Could Launch in August 2020
Russian officials said on July 29, 2020, they are working toward a date of August 10th or earlier for approval of the COVID-19 vaccine candidate. This Russian vaccine was developed by the Gamalei National Research Center for Epidemiology and Microbiology.
The Russian COVID-19 vaccine candidate uses a weakened virus to deliver small parts of a pathogen and stimulate an immune response. And, is a vector vaccine based on adenovirus DNA, in which the SARS-CoV-2 coronavirus gene is integrated.
Jul 29, 2020 • 10:29 am CDT
Stanford Medicine Updates Coronavirus Antiviral Phase 2 Study
On July 27, 2020, Stanford Medicine updated its phase 2 clinical study testing favipiravir (Avigan) for treating COVID-19 outpatients. These researchers want to determine whether favipiravir, an oral antiviral medication, is effective in reducing the severity of symptoms and shortening the duration of COVID-19 disease.
According to Reuters, Stanford professor Yvonne Maldonado stated, “We’re moving as fast as we can." If the drug can be shown to reduce symptoms and the viral load among patients, “that would be a big deal”.
Jul 29, 2020 • 9:46 am CDT
Sanofi Pasteur and Translate Bio to Develop mRNA Vaccines
Translate Bio announced on July 20, 2020, the closing of a previously announced expansion of the collaboration and licensing agreement with Sanofi Pasteur to develop mRNA vaccines for all infectious disease pathogens.
Sanofi stated on July 29th, it expects a Phase 1 study to start by the end of 2020, and, and if the data are positive, seek approval at the earliest in the second half of 2021. Translate Bio has established mRNA manufacturing capacity and Sanofi expects to be able to supply an annual capacity of 90 to 360 million coronavirus prevention vaccine doses.
Jul 29, 2020 • 6:57 am CDT
Study: COVID-19 Vaccine Candidate Induced SARS-CoV-2 Neutralizing Activity in Pre-Clinical Study
On July 28, 2020, the NEJM published a study, Evaluation of the mRNA-1273 Vaccine against SARS-CoV-2 in Nonhuman Primates, which found vaccinations with the mRNA-1273 vaccine candidate induced robust SARS-CoV-2 neutralizing activity, rapid protection in the upper and lower airways, and no pathologic changes in the lung, in of nonhuman primates.
Jul 29, 2020 • 6:38 am CDT
World Hepatitis Day Seeks 290 Million People
World Hepatitis Day is celebrated on July 28, 2020, focused on bringing the world together to raise awareness of the global burden of viral hepatitis and to empower disease prevention. Worldwide, 290 million people are living with viral hepatitis unaware. Without finding the undiagnosed and linking them to care, millions will continue to suffer, and lives will be lost during 2020.
As an example, Hepatitis A is a vaccine-preventable liver infection caused by the hepatitis A virus, which is very contagious. It is spread when someone unknowingly ingests the virus — even in microscopic amounts — through close personal contact with an infected person or through eating contaminated food or drink, says the U.S. CDC.
Hepatitis A vaccine news can be found at PrecisionVaccinations.
Jul 28, 2020 • 9:01 pm CDT
50 Million Quadrivalent Flu Shots Begin Shipping
GSK announced on July 28, 2020, it started shipping more than 50 million quadrivalent influenza vaccine doses to US healthcare providers and pharmacies for the 2020-21 flu season. This data indicates about a 9% increase from the last flu season.
Both FLULAVAL QUADRIVALENT and FLUARIX QUADRIVALENT will be available in a 0.5mL, single-dose, pre-filled syringe, and indicated for patients 6 months and older in line with CDC recommendations.
Jul 28, 2020 • 4:03 pm CDT
1 Million COVID-19 Molecular Diagnostic Tests Shipped Each Day
The Advanced Medical Technology Association announced on July 28, 2020, that shipments of COVID-19 molecular diagnostic tests reached 1 million per day for the week ending July 24th, based on the latest data from the association's National Testing Registry. Overall, about 80 million tests have been shipped in the USA during 2020.
Jul 28, 2020 • 1:48 pm CDT
Alzheimer's Vaccine Candidate Advanced to Phase Ib/II Study
AC Immune SA announced on July 16, 2020, the initiation of the 2nd-highest dosing group in the Company’s Phase 1b/2a clinical trial evaluating ACI-35.030 for the treatment of Alzheimer’s disease (AD). The decision to advance to the higher dosing group follows encouraging interim safety, tolerability, and immunogenicity results from the initial dosing group.
The ACI-35.030 vaccine candidate is being developed in collaboration with Janssen Pharmaceuticals and is the first AD vaccine candidate designed to generate a specific antibody response against pathologic phospho-Tau (pTau) proteins in the brain.
Immunization with anti-Tau vaccines has become an important strategy for the treatment of AD characterized by Tau pathology, said the company.
Jul 28, 2020 • 1:25 pm CDT
Coronavirus Mutations Enables the Virus to Elude Antibodies
A non-peer-reviewed study published on July 22, 2020, stated the degree to which SARS-CoV-2 will adapt and evade neutralizing antibodies is unclear. These researchers showed that 'functional SARS-CoV-2 S protein variants with mutations in the receptor-binding domain and N-terminal domain that confer resistance to monoclonal antibodies or convalescent plasma can be readily selected.'
This means SARS-CoV-2 S variants that resist commonly elicited neutralizing antibodies are now present at low frequencies in circulating SARS-CoV-2 populations.
They suggest that COVID-19 treatment ‘cocktails’ of multiple neutralizing antibodies, each recognizing a different part of the spike protein, could stop the virus from evolving resistance.
Jul 28, 2020 • 11:38 am CDT
Dry Powder Inhalation Could Be a Potent Tool in COVID-19 Antiviral Treatment
Scientists at The University of Texas at Austin announced on July 28, 2020, they are hoping to use their novel thin-film-freezing technology to deliver remdesivir through dry powder inhalation, potentially making treatment more potent, easier to administer and more broadly available.
One way to overcome the poor absorption rates of remdesivir is to deliver it directly to the infection site.
The UT Austin research team has developed inhaled forms of remdesivir for protecting and treating the respiratory mode of infection, including an amorphous brittle matrix powder made by thin-film freezing.
Not only would this delivery method allow for wider distribution of an essential antiviral in the fight against COVID-19 disease, it could also make remdesivir more effective.
Jul 28, 2020 • 8:58 am CDT
Pfizer and BioNTech Launch Late-Stage Coronavirus Vaccine Study
Pfizer Inc. and BioNTech SE announced on July 27, 2020, the launching of a Phase 2/3 safety and efficacy clinical study to evaluate a single nucleoside-modified messenger RNA candidate from their BNT162 mRNA-based vaccine program against SARS-CoV-2 coronavirus.
The BNT162b2 vaccine candidate encodes an optimized SARS-CoV-2 full-length spike glycoprotein, at a 30µg dose level, in a 2-dose regimen for this Phase 2/3 study.
BNT162b2 remains under clinical study and is not currently approved for distribution anywhere in the world. However, assuming clinical success, Pfizer and BioNTech may seek regulatory review as early as October 2020, and, if approved, plan to supply up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021, said these companies in a press statement.
Jul 27, 2020 • 10:34 pm CDT
Study: Vaccines Found to be Remarkably Safe
Over a 20-year period, 57 FDA-approved vaccines were found to be remarkably safe, reported a new study published in the Annals of Internal Medicine on July 28, 2020. The most common safety issue triggering label modifications was the expansion of population restrictions (36%), followed by allergies (22%).
Jul 27, 2020 • 10:08 pm CDT
Remdesivir Linked to Significantly Greater Recovery and Lower Fatality Rate
Jul 27, 2020 • 10:00 pm CDT
Status: COVID-19 Disease Prevention Vaccines Remain in Clinical Studies
As of July 27, 2020, the US Food and Drug Administration has not approved any COVID-19 disease prevention vaccines. The SARS-CoV-2 vaccine development landscape includes innovative platforms such as nucleic acid (DNA and RNA), virus-like particle, peptide, viral vector (replicating and non-replicating), recombinant protein, live attenuated virus and inactivated virus approaches.
Jul 27, 2020 • 7:10 pm CDT
$265 Million Vaccine Services Order Issued to Texas A&M University
The US government has issued a new federal task order reserving production capacity at one of Texas A&M University System College Station's facilities to mass manufacture the COVID-19 vaccine candidate of Novavax, Inc., NVX-CoV2373, through the end of 2021.
This task order is valued at about $265 million, announced the university on July 27, 2020.
Jul 27, 2020 • 2:28 pm CDT
Study: It's Time for a 3rd Generation Pneumococcal Conjugate Vaccine
In The Lancet Infectious Diseases on July 2020, researchers describe the effect of pneumococcal conjugate vaccines on the incidence of invasive pneumococcal disease in France over a 17-year period. This study's finding suggests that efforts to reduce invasive pneumococcal disease continue to be compromised by serotype replacement.
Jul 27, 2020 • 7:37 am CDT
AstraZeneca Signs $174 Million Coronavirus Vaccine Services Agreement
Emergent BioSolutions announced on July 27, 2020, that it has signed an agreement to provide contract development and manufacturing services for AstraZeneca’s COVID-19 vaccine candidate, AZD1222, valued at approximately $174 million through 2021. This agreement follows an $87 million contract signed in June 2020.
Jul 27, 2020 • 7:27 am CDT
New Test Differentiates SARS-CoV-2 From Other Coronaviruses
The FluoroType® SARS-CoV-2 plus next-generation 6-plex PCR assay for the highly specific detection of the SARS-CoV-2 coronavirus ... showed 100% sensitivity and 100% specificity, reported Bruker on July 27, 2020. This test differentiates SARS-CoV-2 from 4 other endemic human coronaviruses for specificity.
Jul 27, 2020 • 7:12 am CDT
Phase II Study Launches of LAM-002A for COVID-19 Treatment
AI Therapeutics announced on July 27, 2020, the start of a Phase II clinical trial for the treatment of newly diagnosed COVID-19 patients in collaboration with Yale University. LAM-002A is a first in class, highly selective, PIKfyve kinase inhibitor that has demonstrated potent in vitro antiviral activity against several isolates of SARS-CoV-2.
Jul 27, 2020 • 6:53 am CDT
Seniors Reduce Alzheimer's Risk With Influenza and Pneumococcal Vaccinations
Flu shots and pneumonia vaccinations are associated with reduced risk of Alzheimer’s disease, according to research reported at the Alzheimer’s Association International Conference on July 27, 2020.
This new research reported at least 1 flu shot was associated with a 17% reduction in Alzheimer’s incidence. And, more frequent influenza vaccination was associated with another 13% reduction in Alzheimer’s incidence.
The researchers found the protective association between the flu vaccine and the risk of Alzheimer’s was strongest for those who received their first vaccine at a younger age — for example, the people who received a flu shot at age 60 benefitted more than those who received one at age 70.
And, seniors (65 to 75 yrs old) who received a pneumococcal vaccination had about 40% less risk of Alzheimer's disease depending on their genetic profile. These researchers took into account a known genetic risk factor for Alzheimer’s — the rs2075650 G allele in the TOMM40 gene.
Jul 26, 2020 • 2:06 pm CDT
Smallpox Plagued Eurasia a Long, Long Time Ago
After killing more than 300 million people in the 12th century, smallpox's last victim was confirmed in 1978, said an article published in Nature on July 23, 2020. However, new genetic evidence is starting to uncover when smallpox first started attacking people.
The new analysis implies that the smallpox virus was circulating in humans at least 1,700 years back when many peoples were migrating across Eurasia.
This news indicates genetic research is rewriting the history of diseases.
Jul 26, 2020 • 9:45 am CDT
LabCorp Processing Coronavirus Tests Within 3 Days
Jul 26, 2020 • 8:24 am CDT
Millions More Britons To Receive Free Flu Shots
The UK's Prime Minister Boris Johnson said on July 24, 2020, 'he wants everyone to have a flu jab in the run-up to this winter,' reported the BBC. The most comprehensive flu vaccination program in the UK’s history was announced by the UK's NHS.
'A significant new group of people will be eligible for the free flu vaccine as people aged 50 to 64 will be invited for influenza vaccination.'
The NHS's expanded influenza vaccination program is part of plans to reduce the risk of further coronavirus cases in the UK.
Jul 26, 2020 • 7:27 am CDT
Certain States Don't Embrace Cancer Prevention
Based on survey data from the National Immunization Study published on July 21, 2020, found HPV vaccine hesitancy was more than 65% in the US states of Idaho, Kansas, Michigan, Montana, Nebraska, North Dakota, Oklahoma, and Utah.
"The hesitancy of parents to protect their child against HPV is troubling because improving HPV vaccination coverage is our only option to curb the rising burden of cancers caused by this virus," said Kalyani Sonawane, Ph.D., an assistant professor at UTHealth School of Public Health.
More than 90% of all cervical cancers are caused by HPV, a contagious sexually transmitted infection, says the U.S. CDC.
Jul 25, 2020 • 1:52 pm CDT
Update: COVID-19 Vaccine Candidates
SARS-CoV-2 vaccine candidates include nucleic acid (DNA and RNA), virus-like particle, peptide, viral vector (replicating and non-replicating), recombinant protein, live attenuated virus, and inactivated virus approaches. The vaccine updated listing is as of July 25, 2020.
Jul 25, 2020 • 1:48 pm CDT
CDC Says: “It is Critically Important for Public Health to Open Schools"
The US Centers for Disease Control and Prevention (CDC) released new science-based resources and tools for school administrators, teachers, parents, guardians, and caregivers when schools open for the Fall 2020 academic term.
“It is critically important for our public health to open schools this fall,” said CDC Director Dr. Robert R. Redfield, on July 23, 2020.
Jul 25, 2020 • 1:32 pm CDT
80 Million Polio Vaccinations Missed During 2020
Afghanistan, Pakistan, and Chad have reported new polio cases in early July 2020, according to the Global Polio Eradication Initiative (GPEI). Afghanistan reported 5 more wild poliovirus type 1 (WPV1) cases, with Pakistan reporting 2 new WPV1 cases. And, Chad reported 3 more circulating vaccine-derived poliovirus type 2 (cVDPV2) cases.
“Our early-stage analysis suggests that almost 80 million polio vaccination opportunities have been missed by children in our Region due to COVID-19,” said Dr. Hamid Jafari, Director for GPEI in the Eastern Mediterranean Region on July 20, 2020.
Jul 25, 2020 • 11:08 am CDT
Study: Flu Shots Associated With Reduced Fatality Risks
An influenza study based on registry data from Demark found flu shots were associated with reduced risks for all-cause death, including cardiovascular and stroke among adults with diabetes.
'We have also shown that vaccination is significantly associated with a reduced incidence of acute diabetes complications,' said these researchers on July 24, 2020.
Jul 25, 2020 • 10:55 am CDT
FDA Authorizes COVID-19 Testing For Unwary People
The FDA said on July 24, 2020, it recognizes that organizations may want to conduct virus testing of asymptomatic people to help ensure the safety of their employees, patients, students, and others.
Jul 24, 2020 • 5:22 pm CDT
Russia's 2nd Coronavirus Vaccine Authorized For Human Study
The Vektor State Research Center of Virology and Biotechnology announced on July 24, 2020, it has been granted a Russian health ministry’s permit for clinical tests of its anti-coronavirus vaccine. Russian consumer rights oversight authority’s chief Anna Popova said Vektor had successfully finished pre-clinical tests of an anti-coronavirus vaccine, reported TASS.
Jul 24, 2020 • 2:43 pm CDT
Leronlimab (PRO 140) Reported Very Effective Treating COVID-19 Patients
CytoDyn Inc., a biotechnology company developing leronlimab (PRO 140), announced on July 21, 2020, the results of the patient safety data from the Company’s over-enrolled COVID-19 disease Phase 2 trial for treating mild-to-moderate indications.
Just 5 patients out of 56 (about 9%) reported serious adverse events, none were related to leronlimab.
Leronlimab (PRO 140) is a CCR5 antagonist, with the potential for multiple therapeutic indications, says the company.
Jul 24, 2020 • 12:38 pm CDT
Phase 3 Study: Favipiravir (Avigan) Found Significantly Effective When Treating COVID-19 Patients
Jul 24, 2020 • 2:58 am CDT
NEJM Study: Hydroxychloroquine Use Did Not Improve Hospitalized COVID-19 Patient's Clinical Status
Jul 23, 2020 • 8:40 pm CDT
California Purchases $315 Million Worth of Face Masks
Taking aggressive action to boost the state of California’s long-term supply of life-saving personal protective equipment both now and into the fall months, Governor Gavin Newsom announced on July 22, 2020, he is ready to spend as much as $315 million on face masks. Governor Newsom has directed the Department of Public Health and Office of Emergency Services to further increase the state’s strategic stockpile to 100 million N-95 respirators and 200 million surgical masks by early Fall 2020 in order to account for the potential need given the recent rise in COVID-19 cases.
The contract with BYD can be viewed here.
Jul 23, 2020 • 12:51 pm CDT
Influenza Levels Reported Lower Than Normal
Globally, influenza activity was reported at lower levels than expected for this time of the year, stated the WHO on July 20, 2020. In the temperate zone of the Northern Hemisphere, which includes the USA and Canada, influenza activity returned to interseasonal levels.
And, in the temperate zones of the Southern Hemisphere, the influenza season has not commenced.
Jul 23, 2020 • 12:43 pm CDT
Study: NQAZ Prevented 100% of Infections From Relapsing Malaria
A large phase 3 clinical trial's results published on July 20, 2020, has shown that the antimalarial-antibacterial drug combination naphthoquine-azithromycin (NQAZ) is effective in preventing malarial Plasmodium infections.
These researchers concluded saying 'monthly prophylaxis with NQAZ tablets was well tolerated and highly effective for preventing Plasmodium infections.'
Jul 23, 2020 • 12:16 pm CDT
Australia Defeats Southern Hemisphere Flu Season
According to ABC News reporting on July 23, 2020, Australia has not recorded any flu deaths since April 2020, with only 36 deaths recorded this year, compared to 430 in the same period during 2019. Health experts say school closures, physical distancing, hand hygiene, and border closures all played a part in reducing the number of flu cases.
There was also a substantial increase in flu shots, with 2 million more influenza vaccine doses being administered in 2020.
Jul 23, 2020 • 8:17 am CDT
The HIV Prevention Toolbox: Priorities for Patients and Providers
Top experts discuss in a video the latest research in treating patients that are most at risk for HIV infection, screening, and identifying appropriate candidates PrEP, syndicated by Medscape on July 22, 2020.
Jul 22, 2020 • 6:19 pm CDT
HPV Vaccines That Work in USA ... May Miss the Mark Around the World
A research team at Dartmouth’s and Dartmouth-Hitchcock’s Norris Cotton Cancer Center has found that the same vaccination programs that target human papillomavirus (hrHPV) strains in the USA, may not be as effective in protecting other women, said by Gregory J. Tsongalis, Ph.D.
“The most expensive vaccine would protect the majority of women, however many HPV vaccination programs in low- and middle-income countries use the less costly vaccine[s], and these vaccines are not providing adequate protection,” Tsongalis stated in a JAMA article published on July 21, 2020.
Jul 22, 2020 • 6:08 pm CDT
Special Report: The NIH's RADx Initiative
In the week leading up to July 13, 2020, daily diagnostic testing capacity was fluctuating between 520,000 and 823,000 tests, which is not meeting current demand in the USA, stated a Special Report published by NEJM on July 22, 2020.
To meet this challenge, the U.S. NIH's RADx program will make it possible to rapidly scale-up testing across the country and enhance access to those most in need. While diagnostic testing has long been a mainstay of public health, newer technologies offer patient- and user-friendly designs that work with cellphones, for example, to lower cost and increase accessibility both at home and at the point of care.
RADx offers many groups support to bring the diagnostic technologies that require additional clinical, regulatory, and commercialization assistance from development to deployment.
Jul 22, 2020 • 3:44 pm CDT
Phase 2/3 Study Evaluating opaganib (Yeliva) Launching in Brazil and Mexico
Tel-Aviv and Raleigh based RedHill Biopharma announced on July 22, 2020, that it has submitted a Clinical Trial Application for the Phase 2/3 clinical study evaluating opaganib (Yeliva, ABC294640)1 in patients hospitalized with severe SARS-CoV-2 infection and pneumonia in Brazil and Mexico.
A Phase 2/3 study with opaganib in patients with severe COVID-19 has already been approved in the UK and Russia.
Jul 22, 2020 • 2:58 pm CDT
Update: 186 Coronavirus Tests Authorized in the USA
As of July 21, 2020, the U.S. FDA has authorized 186 coronavirus diagnostic tests under EUAs, which include 153 molecular tests, 31 antibody tests, and 2 antigen tests.
Jul 22, 2020 • 7:21 am CDT
COVID-19 Disease Predictor: Gene Cluster and Blood Type
A new study published by the NEJM on July 17, 2020, found the 3p21.31 gene cluster was a genetic susceptibility locus in patients with COVID-19 disease with respiratory failure.
And, this study confirmed a potential involvement of the ABO blood-group system. This analysis showed a higher risk in blood group A than in other blood groups and a protective effect in blood group O, as compared with other blood groups.
Jul 22, 2020 • 7:04 am CDT
Coronavirus Data Hub Dashboard Opened For Viewing
The US Department of Health and Human Services (HHS) debuted its new COVID-19 dashboard on July 20, 2020, called the Coronavirus Data Hub. On July 10th, the HHS ordered hospitals in the USA to submit related data to HHS, or to their state health department, which would then submit it to HHS for inclusion in the new, real-time dashboard.
Jul 21, 2020 • 3:11 pm CDT
Brazil Launches China's Vaccine Study
Dimas Tadeu Covas, president of the Butantan Institute, who is coordinating a late-stage study, said at a press conference on July 21, 2020, that if the Sinovac vaccine CoronaVac proves safe and effective, Brazil would receive 120 million vaccine doses from China at the beginning of 2021, which will allow 30 million Brazilians to be vaccinated, reported CTV news.
Jul 21, 2020 • 2:50 pm CDT
COVID-19 Vaccine Candidate Receives Singapore's Launch Approval
On July 21, 2020, Arcturus Therapeutics and Duke-NUS Medical School in Singapore announced that the Clinical Trial Application for COVID-19 vaccine candidate LUNAR-COV19 has been approved to proceed by the Singapore Health Sciences Authority. The healthy volunteer study will evaluate several dose levels of LUNAR-COV19 in up to 108 adults, including older adults.
Jul 21, 2020 • 10:52 am CDT
German Biopharmaceutical Company Raises About USD 640 Million
Jul 21, 2020 • 10:37 am CDT
Needed: Tests That Detect & Differentiate Coronavirus and Influenza Viruses
The largest laboratory company in the USA is warning 'it will be impossible to increase coronavirus testing capacity to cope with demand during the autumn flu season, which usually starts October 1st each year, reported the Financial Times on July 20, 2020.
James Davis, executive vice-president at Quest Diagnostics, said “other solutions need to be found” to detect positive patients in addition to the nasal swab tests currently in use."
In preparation for the 2020-2021 flu season, the U.S. FDA has already issued emergency use authorizations for diagnostic tests that detect and differentiate the viruses that cause COVID-19 disease and influenza, such as the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay.
Jul 21, 2020 • 10:21 am CDT
Selva Therapeutics Announces $3M Funding for Infectious Diseases Oral Antiviral, Including COVID-19
Selva Therapeutics, Inc. announced it raised $3 million on July 21, 2020, to advance SLV213 into clinical trials as an oral drug candidate for the treatment of COVID-19. Selva says SLV213 has the potential to be a treatment for multiple infectious diseases caused by other coronaviruses, such as SARS, and also Ebola viruses, Nipah virus, and Chagas disease, a parasitic disease currently spreading into the southern USA.
Jul 21, 2020 • 5:57 am CDT
China's Coronavirus Vaccine Found Safe and Effective
The Lancet published the results of a phase 2 study on July 20, 2020, found CanSino Biologics's Ad5-vectored COVID-19 vaccine at 5 × 1010 viral particles are safe and induced significant immune responses in the majority of recipients after a single immunization. Whether it will prevent infection is unknown.
Jul 21, 2020 • 5:11 am CDT
NIAID Awards $2.2 Million for COVID-19 Vaccine Development
On July 20, 2020, Metaclipse announced it was awarded $2.2 million by the National Institute of Allergy and Infectious Diseases to support its development of a COVID-19 disease preventive vaccine. Metaclipse is developing an influenza vaccine for seniors based on a modified influenza virus-like particle (VLP) vaccine approach that incorporates natural adjuvants, called cytokines, which are attached to the surface of VLPs.
Modified VLPs have been found in pre-clinical animal studies to be more effective than un-modified influenza VLPs at generating an immune response to different influenza strains.
Jul 20, 2020 • 3:08 pm CDT
FDA Warning Letter: Hydroxychloroquine-online.com
The U.S. FDA announced it reviewed the website www.pharmaboosters.com and Hydroxychloroquine-online.com on June 23, 2020. Based on this review, the FDA announced on July 9, 2020, these Hydroxychloroquine (Plaquenil) products are unapproved and sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a).
Jul 20, 2020 • 2:54 pm CDT
Patients Receiving SNG001 Reported a 79% Reduced Risk of Developing Severe COVID-19
Synairgen plc, which originated from research at the University of Southampton, announced on July 20, 2020, positive results from its phase 2 clinical trial of SNG001, its wholly-owned inhaled formulation of interferon beta, in hospitalized COVID-19 patients. The company stated patients who received SNG001 had a 79% lower risk of developing severe COVID-19 disease, compared to placebo.
And, patients who received SNG001 were more than twice as likely to recover from COVID-19 as those on placebo.
In previous clinical trials in asthma and COPD, inhaled SNG001 has been found well-tolerated and shown to upregulate lung antiviral defenses.
Jul 20, 2020 • 11:57 am CDT
AZD1222 Vaccine Showed Robust Immune Responses in Phase I/II Study
Interim results announced by AstraZeneca on July 20, 2020, from the ongoing Phase I/II COV001 trial, led by Oxford University, showed the AZD1222 vaccine candidate was tolerated and generated robust immune responses against the SARS-CoV-2 betacoronavirus in all evaluated participants.
The results published in The Lancet confirmed a single dose of AZD1222 resulted in a 4-fold increase in antibodies to the SARS-CoV-2 virus spike protein in 95% of participants one month after injection. In all participants, a T-cell response was induced, peaking by day 14, and maintained 2-months after vaccination.
Jul 20, 2020 • 6:31 am CDT
The UK Secures Access to 3rd Coronavirus Vaccine Candidate
Jul 20, 2020 • 3:26 am CDT
'I Have Lyme Disease'
'Since I’m not a doctor, I say I have “chronic Lyme. It’s a shorter way for me to say that this disease is still affecting me after more than a decade, said Elena Delle Donne, a player for the WNBA's Wahington Mystics, on July 15, 2020. 'I prefer it to the alternative, which is “Post-Treatment Lyme Disease Syndrome with a current active infection with a different strain of borrelia and bartonella as well as other co-infections.'
'Taking 64 pills a day is the only way to keep my condition under any sort of control and the only way to keep myself healthy enough to play the game that I love and earn the paycheck that supports my family.'
Jul 20, 2020 • 3:16 am CDT
Vaccines Often Take Years to Develop
To gain some perspective on what researchers developing a coronavirus vaccine are up against, here's how long it took to develop vaccines for other infectious diseases throughout history, wrote Business Insider on July 18, 2020.
In the USA, vaccine development undergoes 4 phases of vaccine trials and thorough vetting from the CDC and the FDA.