FDA sets aside June for potential decisions on vaccines for children under 5

The Food and Drug Administration on Friday established a tentative schedule for deciding whether or not to allow a coronavirus vaccine...


The Food and Drug Administration on Friday established a tentative schedule for deciding whether or not to allow a coronavirus vaccine for America’s youngest children, announcing that June 8 is the earliest date he will present data to his outside advisers for a recommendation.

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

The agency said it understood the urgency of protecting this group and would act quickly “if the data clearly points the way forward after our assessment.”

The FDA has set a busy schedule in June, setting aside three days for its external advisory committee to review pediatric vaccine applications from Moderna and Pfizer-BioNTech, and another day to debate and likely vote on proposed vaccine updates. existing ones so that they work better against a range of coronavirus variants. The dates are tentative, the agency said, as companies have not yet completed their applications for emergency clearance.

The agency’s release of a timeline came after some critics raised concerns that it was delaying action on Moderna’s app in order to compare it to Pfizer’s data, which is not available. not expected in full until June. FDA Commissioner Robert Califf said that was not the case in interviews Thursday and Friday. “Categorically, there’s no reason for the FDA to wait,” he told Andy Slavitt on the podcast “In the bubble”.

Moderna said on Thursday it asked the FDA to clear its vaccine for children six months to 6 years old, saying his clinical trial showed the vaccine was safe and produced an antibody response comparable to adults aged 18 to 25. This met the pass criterion for the trial. He said the vaccine appeared to be 51% effective against symptomatic infection in children under 2 and 37% effective in 2-5 year olds.

These efficacy rates are far lower than previous clinical trials conducted by both Moderna and Pfizer prior to the emergence of the highly transmissible variant of Omicron. Omicron and its subvariants have been shown to be much more adept at evading protection against antibodies which are the immune system’s first line of defense against infection.

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

Moderna said it will finish submitting its data to the FDA by May 9. Pfizer and BioNTech are expected to complete their application for vaccination of children under 5 in June. The vaccine schedules are different: Moderna offers two doses, using a quarter of 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 5 years and older, while Moderna’s vaccines are restricted to adults. Moderna previously applied for authorization of its vaccine for children aged 6 to 17. The company said it plans to submit supporting data and update those claims in about two weeks.

The FDA seems willing to consider Moderna’s requests to vaccinate multiple age groups at the same time. Dr. Peter Marks, who oversees vaccine regulation, told a Senate hearing this week that applications that cover a wider swath of the population take longer to review.

If so, this position could trigger criticism. “It would certainly make it a little easier to get the message, ‘Here’s that vaccine. It’s now available to all children,” former FDA chief scientist Dr. Jesse L. Goodman said in an interview Thursday.

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

The agency has set June 28 for the advisory committee to consider how best to update existing vaccines. Researchers working for the National Institutes of Health and vaccine makers have raced to try and redesign vaccines to be more effective against new virus variants. Federal health officials said they must choose one or more revised versions by June in order to manufacture doses by the fall, when they expect the coronavirus to reappear.

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

These vaccines are based on new 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.

If licensed, it is unclear what role the Novavax vaccine would play in the country’s immunization program. But some experts suggest that people who are reluctant to take Moderna or Pfizer-BioNTech injections may be more willing to accept the more conventional doses of Novavax. It’s also possible that a protein-based vaccine would work well as a booster for Pfizer or Moderna injections.

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Newsrust - US Top News: FDA sets aside June for potential decisions on vaccines for children under 5
FDA sets aside June for potential decisions on vaccines for children under 5
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