FDA reserves June for potential vaccine decisions for children under 5

WASHINGTON — The Food and Drug Administration on Friday set a tentative timetable for deciding whether to approve a coronavirus vaccine for America’s youngest children, announcing that June 8 is the earliest date it will present data to its outside advisors for a recommendation. .

The country’s 18 million children under the age of 5 are the only group not yet eligible for vaccination against the coronavirus.

The agency said it understood the urgency of protecting that group and would act quickly “if the data supports a clear path forward after our review.”

The FDA has set a packed schedule for June, allocating three days to its external advisory committee to consider Moderna and Pfizer-BioNTech’s pediatric vaccine applications, and another day to debate and presumably vote on proposals to update existing vaccines. work so that they work better against a range of coronavirus variants. The dates are preliminary, the agency said, as the companies have not yet finalized their emergency permit applications.

The agency’s release of a schedule came after some critics expressed concerns it was delaying action on Moderna’s application to compare it with data from Pfizer, which isn’t expected to be in full until June. FDA Commissioner Robert M. Califf said this was not the case in interviews on Thursday and Friday.

“Categorically, there’s no reason for the FDA to wait,” he told Andy Slavitt on the “In the Bubble” podcast. In an email response to questions, Dr. Peter Marks, who oversees the agency’s vaccine regulations, said that regulators “will not hold back from moving forward on any request just to synchronize things.”

Moderna said Thursday it had asked the FDA to approve its vaccine for children under 6, saying the clinical trial showed the vaccine was safe and produced an antibody response comparable to that seen in adults ages 18 to 25. . That met the criterion for success of the trial. It said the vaccine appeared to be 51 percent effective against symptomatic infection in those under age 2 and 37 percent effective in those 2 to 5.

Those efficacy rates are well below previous clinical trials conducted by both Moderna and Pfizer before the highly transmissible Omicron variant emerged. Omicron and its subvariants have proven to be much more adept at evading protection against antibodies that are the immune system’s first line of defense against infection.

Because there were no cases of serious illness or hospitalization among any of the study participants, it was not possible to assess how well the vaccine protects against the worst outcomes of Covid.

Moderna said it will be ready to submit the data to the FDA by May 9. Pfizer and BioNTech are expected to complete their application to vaccinate children under 5 years of age in June. Vaccine regimens are different: Moderna suggests two doses, using one-fourth the strength of an adult dose. Pfizer and BioNTech are working on a three-dose regimen, one-tenth the strength of the adult dose.

Pfizer’s vaccine is already approved for everyone 5 years and older, while Moderna’s injections are limited to adults. Moderna has previously requested approval for its vaccine for children between the ages of 6 and 17. The company said it plans to submit data supporting and updating these requests in about two weeks.

The FDA appears to be considering Moderna’s requests to vaccinate multiple age groups at once. dr. Marks testified at a Senate hearing this week that it takes more time to review applications that cover a larger segment of the population.

If so, that attitude can provoke criticism. “That would certainly make reporting a bit easier: ‘Here’s this vaccine. It’s now available to all kids,” Dr. Jesse L. Goodman, a former chief scientist at the FDA, said in an interview on Thursday.

But he added: “The Pfizer vaccine is available for the older children. This younger group is currently the greatest unmet need. I don’t think there would be anything wrong with authorizing the vaccine for the youngster first, if they were ready.”

The agency set aside June 28 for the advisory committee to consider how best to update existing vaccines. Researchers working for the National Institutes of Health and vaccine manufacturers have raced to try and redesign the vaccines so that they are more effective against newer virus variants. Federal health officials have said they must pick one or more revised versions by June to produce doses by the fall, when they expect the coronavirus to rise again.

The agency also said it plans to present vaccine data on June 7 from Novavax, which has developed a vaccine using a more conventional approach than the Pfizer-BioNTech and Moderna injections that have now been used to inoculate hundreds of millions of Americans.

Those vaccines are based on newer messenger RNA technology, while Novavax’s vaccine is protein-based. Protein-based vaccines have been used for decades and generally have a strong track record of safety and mild side effects.

It’s not clear what role the Novavax vaccine, if approved, would play in the country’s vaccination program. But some experts suggest that people who are hesitant to take the Moderna or Pfizer-BioNTech injections may be more willing to accept the more conventional Novavax doses. It is also possible that a protein-based vaccine will work well as a booster for Pfizer or Moderna injections.

This post FDA reserves June for potential vaccine decisions for children under 5

was original published at “https://www.nytimes.com/2022/04/29/us/politics/fda-covid-vaccine-under-5.html”