Complicated reality of RSV shots

Dec 13, 2024

Presented by PBM Accountability Project

Driving The Day

Moderna sign

Moderna's RSV vaccine safety monitoring system identified safety concerns in a clinical study of the effects of the vaccine on infants.

RSV SHOTS IN FOCUS — The respiratory syncytial virus continues to confound scientists in their quest to develop vaccines protecting young babies from severe illness.

The FDA’s independent vaccine advisers applauded RSV vaccine developers and the agency on Thursday for creating a clinical study environment that allowed testing to move forward while installing guardrails that would halt the program if significant safety issues arose.

The system worked as intended, they said, when Moderna detected severe lower respiratory tract infections in at least two vaccinated study participants, which required the trial’s pause in July (five vaccinated infants ages 5 to 8 months developed severe RSV cases). The FDA has since put a hold on enrolling children under 2 years old and those ages 2 through 5 who have never been exposed to the virus in most RSV vaccine trials.

Lingering questions: But the Moderna experience raises questions around why the company’s messenger RNA candidates may have provoked those children to develop severe cases of the disease. A 1960s-era vaccine in testing spurred more severe disease in vaccinated children once they were naturally exposed to RSV, leading to two deaths that halted pediatric immunization development for the virus for decades.

The safety signal in the Moderna vaccines is “not final but likely true,” said Dr. Hana El Sahly, a Baylor College of Medicine professor and advisory committee chair.

It’s unclear whether the messenger RNA platform contributed to the events, but some committee members said the FDA should consider continuing studies for other vaccine technologies.

“This needs to be done on a vaccine-platform-by-vaccine-platform basis and continue with the very careful age de-escalation and pre-infection approach,” said Dr. Arnold Monto, a University of Michigan epidemiologist.

Don’t we have RSV shots? Yes, but it’s complicated.

The CDC recommends that pregnant people between 32 and 36 weeks’ gestation receive Pfizer’s adult RSV vaccine during respiratory virus season, generally from September to January, to help protect babies during their first months of life. But the CDC doesn’t recommend that those individuals get another dose during subsequent pregnancies as scientists continue studying whether revaccination is beneficial.

Babies born to mothers who already received the shot, or to those who didn’t get a maternal vaccine, may receive a monoclonal antibody shot that provides passive immunity to RSV. But that type of immunization can be expensive, and one panel member cautioned that the virus could mutate to evade the prophylactic treatment.

RSV is the leading cause of hospitalization in infants and disproportionately affects kids 2 and under who are otherwise healthy. Older children typically develop milder disease with subsequent infections, creating a gap between the youngest babies and older toddlers who could benefit from vaccination.

IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Are you President-elect Donald Trump’s FDA pick, Marty Makary? Let’s grab coffee.

Send your favorite coffee shop to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).

A message from PBM Accountability Project:

Pharmacy benefit managers (PBMs) are taking advantage of Medicare and America’s seniors. It's time for Congress to act. Rein in PBMs by requiring them to increase transparency, share discounts with seniors, and delink PBM profits from the cost of medicines in Medicare. Congress must pass S. 2973 and S. 3430 this year. Learn more.

In Congress

President-elect Donald Trump is pictured on the floor of the New York Stock Exchange.

Donald Trump told Time magazine that he would consider stopping use of some vaccines if they were "dangerous." | Alex Brandon/AP

TRUMP FLOATS PULLING VACCINES HE FINDS ‘DANGEROUS’ — President-elect Donald Trump said in an interview with Time magazine released Thursday that he’s open to eliminating vaccines depending on Robert F. Kennedy Jr.’s review of their safety and if Trump thinks they are “dangerous” or “not beneficial.”

“I’m going to be listening to Bobby, who I’ve really gotten along with great and I have a lot of respect for having to do with food, having to do with vaccinations,” Trump said. “I don’t think it’s going to be very controversial in the end.”

Public health and medical experts have heralded widespread vaccinations as lifesaving for a huge number of Americans who would have otherwise died of infectious diseases, POLITICO’s Daniel Payne reports.

Kennedy is headed to Capitol Hill next week to meet with senators about his confirmation as HHS secretary.

END-OF-YEAR HEALTH PACKAGE TALKS — Republican and Democrat lawmakers on Capitol Hill continued to hash out an end-of-year health care package both sides could agree to as of Thursday evening, two people familiar with the talks granted anonymity told POLITICO.

House Republicans were weighing a three-month extension Thursday of key health programs set to expire at the end of the year — but talks over a larger package remain in play. One major issue is whether the health care provisions are offset.

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Eye on the FDA

REAL-WORLD DATA CENTER LAUNCH — The Center for Drug Evaluation and Research is opening a Center for Real-World Evidence Innovation tasked with coordinating how the FDA’s drug center uses real-world evidence and data in regulatory decisions.

“We are creating a focal point within CDER to identify ways in which we can utilize RWE to streamline the development of effective and safe medicines for conditions with unmet need,” CDER Director Patrizia Cavazzoni said in a statement.

The agency seeks a new leader to replace Dr. John Concato, who is retiring from the FDA after heading up the drug center’s real-world evidence program for four years.

SERIOUS LIVER INJURY SAFETY SIGNAL — On Thursday, the FDA flagged that postmarket study data showed that some patients without liver cirrhosis who used Ocaliva to treat primary biliary cholangitis — a chronic autoimmune condition that causes scarring of the liver bile ducts — had serious liver injury.

The agency had cautioned in 2021 that patients with advanced cirrhosis were at risk of liver injury when taking Ocaliva — which was approved in 2016.

“FDA’s review of this required clinical trial found that some cases of liver injury in patients without cirrhosis resulted in liver transplant,” the FDA said in a safety communication. “This risk was notably higher for patients taking Ocaliva compared with a placebo.”

Document Drawer

The Plum Book — a list of presidentially appointed positions in the U.S. government — was updated on Thursday.

The Office of Special Counsel released a report this week that partially substantiated BARDA Director Rick Bright’s allegations of wrongdoing within HHS’ Office of the Assistant Secretary for Preparedness and Response during the early days of the Covid pandemic. Investigators agreed that the distribution of hydroxychloroquine posed a public safety risk, but they didn’t find evidence of improprieties in other aspects of the office’s response.

The FDA’s proposed rule seeking to establish maximum nicotine levels for cigarettes and certain other combustible products is under review at the White House Office of Information and Regulatory Affairs.

WHAT WE'RE READING

Eli Lilly CEO David Ricks hinted that the incoming Trump administration will want companies to raise prices in other nations to help lower what people pay in the U.S., Fierce Pharma's Kevin Dunleavy reports.

A message from PBM Accountability Project:

There’s consensus in Congress – real PBM reform is needed NOW.

Both sides agree we need to: improve transparency, break the link that allows PBMs to tie their profits to the price of the drug, and force PBMs to share discounts with seniors.

Congress: It is time to finish the job and pass bipartisan senate bills 2973 and 3430. America’s seniors are counting on it. Learn more.