Vax policy changes Kennedy could make

Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.
Jan 24, 2025 View in browser
 
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By Lauren Gardner and David Lim

With Robert King

Driving The Day

Robert F. Kennedy Jr. walking between meetings on Capitol Hill

If confirmed as HHS secretary, Robert F. Kennedy Jr. could wield plenty of authority when it comes to vaccine policy. | Chip Somodevilla/Getty Images

VACCINE WATCH — How could Robert F. Kennedy Jr. possibly use his authority as HHS secretary to alter U.S. vaccine policy?

In many ways, as Lauren found. Several policy areas, including some that have flown under the radar, could see major changes if the longtime vaccine skeptic is confirmed. They include:

Liability and injury: Changes to the existing liability protections for certain vaccine makers and modifications to the list of vaccine-related conditions eligible for federal compensation to patients could be the most consequential, according to vaccine law experts.

Kennedy could pull back declarations made under a 2005 law that allowed the Trump and Biden administrations to shield the manufacturers of Covid-19 vaccines and other pandemic-related measures from liability. Such an unprecedented move would surely prompt lawsuits from the drug industry — as well as scores of people who believe they were injured by Covid shots.

Kennedy — who has continued to promote the debunked link between vaccines and autism — also could propose adding new conditions to the vaccine injury table.

Routine childhood vaccines: Kennedy could have sweeping influence over the federal government’s vaccine messaging. One way would be to shape how the CDC recommends shots for children.

Sixteen vaccines are recommended for routine use in kids, meaning the default medical decision is to vaccinate. But that could soften to “shared clinical decision-making,” which promotes discussions between providers and patients about whether to take a given shot.

Advisory committees: Kennedy could also try to reshape the makeup and charge of the Advisory Committee on Immunization Practices, the expert panel that advises the CDC on which vaccines to recommend. Disbanding the panel is among the options he’s weighing with allies, POLITICO’s Adam Cancryn reports.

But other advisory panels weigh in on vaccine policy and could come under scrutiny, such as those focused on vaccine injuries and safety and effectiveness research.

Did we miss anything? Let us know.

IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. We’re reachable by Signal. Send your tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).

 

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In Congress

Sen. Bernie Sanders (I-Vt.) arrives for a late-night vote series at the U.S. Capitol.

Sen. Bernie Sanders hosted a roundtable on routine childhood vaccinations this week. | Francis Chung/POLITICO

THE VACCINE COMMUNICATIONS WAR — Four public health experts came to Capitol Hill this week to advocate for routine childhood vaccinations as Senate committees prepare to consider Kennedy’s nomination next week.

During a roundtable Wednesday hosted by Sen. Bernie Sanders (I-Vt.), ranking member of the Health, Education, Labor and Pensions Committee, Democratic panel members heard from two pediatricians, a nurse and an epidemiologist who reflected on how diseases widely feared by their parents or themselves early in their careers have been largely eradicated by vaccines. Many doctors currently in training haven’t seen many of the formerly common childhood illnesses, they said.

Now, “measles land is what I fear we’re about to see,” said Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia.

Democrats pressed the speakers about how best to communicate the benefits of vaccines while acknowledging the public’s fears about serious side effects. They reiterated that the FDA and the CDC track adverse events closely but admitted assuaging parents’ fears remains difficult.

“How do you get that information out there? Because, frankly, once you scare people, it’s hard to unscare, it’s hard to unring the bell. And I think that’s been the challenge,” Offit said. “Part of the challenge is there’s not a clear cause or causes for autism.”

Split screen: On Tuesday, one of Kennedy’s boosters appeared on a popular podcast to talk about the Make America Healthy Again movement’s rise — and her own skepticism around the childhood immunization schedule.

Dr. Casey Means, a former surgeon who’s now a wellness influencer close to Kennedy, noted that vaccine science isn’t her area of expertise. But she questioned the practice of vaccinating infants against hepatitis B within their first 24 hours of life — as is recommended — when mothers can be tested for the virus.

“To me, that’s just, like, dystopian,” Means told Kristin Cavallari, a reality TV star who has said she didn’t plan to vaccinate at least two of her children.

Hepatitis B can be spread through sex and intravenous drug use, as well as from mother to baby. But it’s also easily transmitted through casual contact with infected blood or saliva, and young children who catch it are at greater risk of developing cirrhosis and liver cancer later.

Eye on the FDA

MEETINGS DELAYED — The Trump administration’s effort to pause health department public-speaking engagements until a presidential appointee approves them is already impacting the FDA.

A public webinar on how the agency reviews biologic license applications for blood and source plasma initially scheduled for Feb. 19 has been postponed, and a rescheduled date has not been determined, according to an email obtained by POLITICO.

“Once we have further information concerning the date of the event, you will be informed,” FDA consumer safety officer Stacey Rivette wrote in the email.

Another canceled meeting is a monthly CDC call for laboratory and testing professionals held by the Laboratory Outreach Communication System to provide a venue to ask questions and get information about diagnostic testing issues.

An email obtained by POLITICO indicates the next call — typically held on the third Monday of every month — will be on Feb. 24 due to President’s Day.

PENDING PDUFA DATES — Wall Street is closely watching the Trump administration’s communication pause and its potential impact on the FDA’s deadlines to respond to drug applications — known as a Prescription Drug User Fee Act date.

“We believe it is reasonably possible that the pace of the transition process and desire to freeze many decisions could impact some companies with forthcoming PDUFA dates,” Raymond James analyst Chris Meekins wrote on Thursday in a research note. “We do not believe outcomes will change, just timing.”

Biogen and Eisai have a Jan. 25 PDUFA date for Eisai’s supplemental biologics license application for Leqembi IV maintenance dosing for treatment of early Alzheimer’s disease — a date Meekins says will be a signal of how the agency will approach the issue.

“HHS has issued a pause on mass communications and public appearances that are not directly related to emergencies or critical to preserving health,” HHS’ press shop said in an email. “This is a short pause to allow the new team to set up a process for review and prioritization. There are exceptions for announcements that HHS divisions believe are mission critical, but they will be made on a case by case basis.”

Pharma Moves

Dr. Sara Brenner is listed as “Principal Deputy Commissioner and First Assistant to the Commissioner of Food and Drugs” on the FDA’s leadership webpage as of Thursday evening. FDA’s press office did not immediately respond to an inquiry about who the agency’s acting commissioner is.

Susan Monarez, deputy director for the Advanced Research Projects Agency for Health since January 2023, has been tapped as acting director of the CDC.

Document Drawer

Johnny Copper filed at the Supreme Court asking for an emergency order against the FDA that aims to keep their flavored open-system vaping products on the market while litigation over the agency’s marketing denial order resolves. The manufacturer also argues its lawsuit is different from other similar lawsuits and should be heard by the Eleventh Circuit.

A number of documents related to diversity, equity, and inclusion efforts were removed from government websites this week — but one unexpected casualty appears to be the FDA’s Center for Devices and Radiological Health 2022-2025 Strategic Priorities.

WHAT WE'RE READING

Purdue Pharma and the Sackler family have struck a new $7.4 billion settlement deal in principle with 15 states aimed at resolving lawsuits alleging they played a role in the opioid crisis, STAT’s Ed Silverman reports.

Susan Wood, a former FDA official who resigned in 2005 over the agency’s handling of Plan B access, died at her home in London of brain cancer, The Washington Post’s Emily Langer reports.

 

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