With Daniel Payne
— Pfizer and BioNTech soon plan to seek FDA authorization for a Covid-19 booster shot for kids ages 5 to 11.
— Congress wants to send an FDA user fee reauthorization package to Biden’s desk before the August recess.
— FDA authorized the first Covid-19 test to detect chemical compounds in a breath sample associated with an infection.
It’s Friday! Welcome back to Prescription Pulse. Inquiring minds want to know more about the time a bear allegedly showed up at the FDA’s campus.
Send tips and feedback to David Lim ([email protected] or @davidalim), Lauren Gardner ([email protected] or @Gardner_LM) or Katherine Ellen Foley ([email protected] or @katherineefoley).
More than 10,000 kids under 12 have participated in trials for the Pfizer-BioNTech vaccine, and no new safety signals were detected among the 401 booster recipients analyzed, they said.
But there’s a lack of strong evidence that young, healthy people need booster shots to remain protected against severe disease, hospitalization and death, which has given some vaccine advisers to federal regulators pause when mulling over booster recommendations. Agencies ultimately opted to allow boosters down to age 12 over the winter as the Omicron variant surged across the U.S.
Reminder: CDC’s Advisory Committee on Immunization Practices will meet on Wednesday to discuss Covid boosters and how to approach them moving forward.
Related reading: The Wall Street Journal breaks down a key issue behind the mystery of how long people who are fully vaccinated are protected from Covid by looking at the role T cells — a type of white blood cell that are part of the immune system — might play in preventing infection.
FDA AUTHORIZES FIRST COVID BREATH TEST — FDA on Thursday granted emergency use authorization to a test that can detect chemical compounds in breath samples associated with a Covid-19 infection in less than three minutes.
The diagnostic, manufactured by InspectIR, must be administered by a trained individual overseen by a health care provider. In a clinical study, the test had a sensitivity of 91.2 percent and a specificity of 99.3 percent, but presumptive positive results “should be confirmed with a molecular test,” said FDA.
“InspectIR expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day,” the FDA said in a press release. “At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month.”
Despite increasing Covid caseloads in 31 states, the administration believes there’s little evidence the uptick, driven by the more contagious BA.2 subvariant, will reach the heights of the Omicron and Delta waves that preceded it. More encouragingly, Covid hospitalizations have remained largely flat — a sign that vaccines and treatments ensure far fewer people suffer serious symptoms and a boon to the theory that the U.S. can more safely live with the virus.
But Biden officials and others close to the federal response privately acknowledged that the next few weeks will determine whether the White House has truly entered a new era — or managed to misread the moment.
Feds continue certain Covid precautions: Health and Human Services Secretary Xavier Becerra extended the Covid-19 public health emergency another 90 days as cases of the Omicron subvariant BA.2 climb. The Transportation Security Administration also extended the mask mandate for planes and other forms of public transportation through May 3, as recommended by the Center for Disease Control and Prevention.
WHAT DID WE LEARN? — POLITICO’s Alice Miranda Ollstein sat down with Rep. Raul Ruiz (D-Calif.) to discuss the lessons learned and missed from the Covid-19 pandemic and steps the government should take to address a range of public health issues going forward, especially for people of color and other marginalized populations.
These “View from the Hill” interviews with the POLITICO health care team are part of a broader series at the Harvard T.H. Chan School of Public Health, Public Health on the Brink. The series explores why and how our public health system has become so frayed — and how to strengthen it before the next crisis hits.
E&C LIKELY HOLDING USER FEE MARKUP IN EARLY MAY — The House Energy and Commerce Committee will likely hold a markup of legislation to reauthorize FDA’s user fee programs in early May as part of an effort to square away one of the last must-pass vehicles before Congress leaves for its summer recess.
“Early May was what we are hearing, and we’re hopeful that timeline holds, first, second week of May,” AdvaMed CEO Scott Whitaker told POLITICO. “The indication we’re getting from the Hill is that they want to make sure that things are fairly worked out and bipartisan in the rider space.”
A spokesperson for E&C Democrats did not provide a date for the markup, which has not yet been formally announced.
“FDA user fee reauthorizations are a top priority. The Committee will continue to work in a timely manner in order for Congress to pass and send user fee reauthorizations to President Biden’s desk for signature before the August Recess,” the spokesperson told POLITICO.
PFIZER WORKING ON A LONGER-LASTING COVID VACCINE — Albert Bourla, chief executive officer at Pfizer, said the company is developing a version of their Covid-19 vaccine that should last about a year, POLITICO’s Daniel Payne reports.
An annual shot would help vaccine uptake around the world, he said on a panel hosted by the International Federation of Pharmaceutical Manufacturers & Associations on Wednesday, suggesting that fewer people are getting boosters because they need several vaccines within such a short period.
And pharma execs talked patent waivers: At the same panel, which included heads of Eli Lilly and Roche, executives railed against a proposed intellectual properties waiver for some medicines — long discussed in the World Trade Organization.
They argued waivers would be counterproductive to increasing the vaccine and drug supply worldwide. They blamed governments for not preparing to receive the vaccine supply when it became available — leading to a situation where the supply of shots is larger than the country’s ability to absorb them.
HHS ADVISERS RECOMMEND MENTAL HEALTH SCREENING FOR KIDS AS YOUNG AS 8 — Health care providers should screen children and teens between 8 and 18 for anxiety and depression and suicide risk regardless of whether they exhibit symptoms, according to draft recommendations from the U.S. Preventive Services Task Force. Comments on the proposed guidance are open through May 9.
MONDAY: Industry executives and government officials gather at the World Vaccine Congress, held in Washington through Thursday. (Lauren and Katherine will be there — come say hi!)
TUESDAY: Johnson & Johnson holds a Q1 earnings call at 8:30 a.m. EDT.
Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA.
FDA unveils new draft policy on research diversity — The FDA this week issued a long-awaited draft guidance document on plans that pharmaceutical and medical device developers can submit as part of their clinical trial applications to enhance diversity in their research programs. The goal of the plans, known as Race and Ethnicity Diversity Plans, is to establish a proactive strategy for enrolling diverse populations in the clinical study, including strategies to engage with, enroll and retain these participants. In addition, companies are asked to assess whether the product might perform differently in certain populations (for example, genetic factors can occasionally result in differences in drug metabolization). FDA writes that if there is an indication of potential differential performance, sponsors may need “increased (i.e., greater than proportional) enrollment of certain populations” to allow for adequate data on those differences, and how they can be mitigated.
DCist’s Rachel Kurzius explores the financial costs associated with seeking medical treatment to prevent rabies after an animal encounter.
The Atlantic’s Katherine Wu scrutinizes the rollout of the U.S. Covid-19 booster shot campaign.
FDA issued guidance outlining performance criteria for denture base resins and facet screw systems for companies seeking 510(k) clearance through the agency’s safety and performance-based pathway.
FDA published guidance on Thursday that provides recommendations for companies sending in bioavailability information to seek approval for drug products.
On Wednesday, FDA released draft guidance outlining how companies should submit a waiver request regarding pH adjusters for generic drugs.
