The FDA sets aside June for potential vaccine decisions for children under 5

Friday the Food and Drug Administration established a provisional timetable for deciding whether to authorize a coronavirus vaccine for America’s youngest children, announcing that June 8 is the first date she will submit the data to her outside consultants for a recommendation.

The nation’s 18 million children under 5 are the only group not yet eligible for coronavirus vaccination.

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 assessment.”

The FDA set a busy schedule in June, setting aside three days for its external advisory committee to consider Moderna and Pfizer-BioNTech pediatric vaccine applications, and another day to discuss and presumably vote on proposals to update existing vaccines in so that they work best against a number of coronavirus variants. The dates are tentative, the agency said, as the companies have not yet completed their emergency clearance applications.

The release of a schedule by the agency came after some critics expressed concerns that it was delaying action on Moderna’s application to compare it to Pfizer data, which isn’t expected in full until June. FDA commissioner Robert Califf said this was not the case in interviews on Thursday and Friday. “Categorically, there is no reason for the FDA to wait,” he told Andy Slavitt on the “In the Bubble” podcast.

Moderna said Thursday that it had asked the FDA to authorize its vaccine for children ages six months to 6 years. Saying that his clinical trial showed that the vaccine was safe and produced an antibody response comparable to that of adults between the ages of 18 and 25. This met the trial success criterion. He said the vaccine appeared to be 51% effective against symptomatic infections among those under the age of 2 and 37% among those between the ages of 2 and 5.

These efficacy rates are far below those of previous clinical trials conducted by both Moderna and Pfizer before the highly transmissible Omicron variant emerged. Omicron and its sub-variants have been shown to be much more adept at evading protection from antibodies that are the immune system’s first line of defense against infection.

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

Moderna said it will finish submitting its data to the FDA by May 9. Pfizer and BioNTech are expected to complete their application to vaccinate children under 5 in June. Vaccination regimens are different: Moderna offers two doses, using a quarter the strength of an adult dose. Pfizer and BioNTech are working on a three-dose regimen, at one-tenth the adult dose.

Pfizer’s vaccine is already licensed for everyone ages 5 and up, while Moderna shots are limited to adults. Moderna previously requested authorization of its vaccine for children between the ages of 6 and 17. The company said it expects to submit data to support and update those requests in about two weeks.

The FDA appears to want to consider Moderna’s requests to vaccinate multiple age groups at the same time. Dr Peter Marks, who oversees vaccine regulation, testified in a Senate hearing this week that it takes longer to review questions that cover a wider range of the population.

If so, this position could lead to criticism. “That would definitely make the message a little easier: ‘Here is this vaccine. Now it’s available to all kids, ‘”said Dr. Jesse L. Goodman, a former FDA chief scientist, said in an interview Thursday.

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

The agency set June 28 for the advisory committee to consider the question of how best to update existing vaccines. Researchers working for the National Institutes of Health and vaccine manufacturers sought to redesign the vaccines to be more effective against the new virus variants. Federal health officials said they must choose one or more revised versions by June to produce doses by the fall when they expect a resurgence of the coronavirus.

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

These vaccines are based on latest messenger RNA technology, while the Novavax vaccine is protein based. Protein-based vaccines have been around for decades and generally have a solid safety record and mild side effects.

If licensed, it is unclear what role the Novavax vaccine would play in the national vaccination schedule. But some experts suggest that people who hesitate to take Moderna or Pfizer-BioNTech shots may be more willing to accept the more conventional Novavax doses. It’s also possible that a protein-based vaccine might work well as a booster for Pfizer or Moderna shots.

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