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Food and Drug Administration on Friday set a tentative timetable He announced that June 8 is the earliest date he will submit data to his outside advisors for a recommendation to decide whether a coronavirus vaccine should be allowed for America’s youngest children.
The country’s 18 million children under the age of 5 are the only group not yet eligible for the coronavirus vaccine.
The agency said it understands the urgency of protecting this group and will act quickly “if the data supports a clear path forward following our assessment.”
The FDA has set up a packed June schedule, with the external advisory committee taking three days to evaluate Moderna and Pfizer-BioNTech’s pediatric vaccine applications, and another day to discuss and possibly vote on recommendations to update existing vaccines to make them work better. a number of coronavirus variants. The agency said the dates are uncertain as companies have yet to complete their emergency permit applications.
A program announcement by the agency came after some critics expressed concerns that it was delaying action on Moderna’s application to compare with data from Pfizer, which wasn’t fully expected until June. That’s not the case, FDA commissioner Robert Califf said in talks 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 on Thursday it has asked the FDA to authorize the vaccine for children aged six months to six years. He said its clinical trial has shown the vaccine is safe and produces an antibody response comparable to adults aged 18 to 25. This met the success criteria of the experiment. The vaccine was found to be 51% effective against symptomatic infection among those younger than 2 years old, and 37% effective between 2 and 5 years old.
These efficacy rates are well below previous clinical trials conducted by both Moderna and Pfizer before the highly infectious Omicron variant emerged. Omicron and its subvariants have proven far more adept at protecting themselves from antibodies, which are the immune system’s first line of defense against infection.
As none of the study participants had serious illness or hospitalization, it was not possible to assess how well the vaccine protected against the worst consequences of Covid.
Moderna said it will finish submitting its data to the FDA by May 9. Pfizer and BioNTech are expected to complete applications to vaccinate children under the age of 5 in June. Vaccination regimens are different: Moderna recommends two doses, using one-quarter the adult dose. Pfizer and BioNTech are working on a three-dose regimen that is one-tenth the adult dose.
Pfizer’s vaccine is already approved for anyone aged 5 years and older, while Moderna’s vaccines are limited to adults. Moderna had previously requested vaccination authorization for children aged 6 to 17. The company said it plans to provide data that supports and updates these claims in about two weeks.
The FDA seems to want to evaluate Moderna’s practices in vaccinating several age groups at once. Overseeing the vaccine regulation, Dr. Peter Marks said at a Senate session this week that it’s taking more time to review applications that cover a wider segment of the population.
If so, this stance may trigger criticism. “This will definitely make texting a little bit easier: ‘Here’s the vaccine. Former FDA chief scientist Dr. It’s now available to all kids,’ Jesse L. Goodman said in an interview Thursday.
But he added: “The Pfizer vaccine is available for older children. This group of young people is currently the greatest unmet need. If they do, I don’t think there’s anything wrong with letting young people get the vaccine first.”
The agency designated 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 are racing to try to redesign vaccines to be more effective against newer virus variants. Federal health officials have said they must select one or more revised versions by June to produce doses in the fall when they expect a resurgence of the coronavirus.
The agency also said it plans to submit vaccine data from Novavax on June 7. He developed a vaccine using a more traditional approach than the Pfizer-BioNTech and Moderna vaccines currently used to vaccinate hundreds of millions of Americans.
The basis of these vaccines newer messenger RNA technologyNovavax’s vaccine is protein-based. Protein-based vaccines have been in use for decades and generally have a strong track record of safety and mild side effects.
If approved, it’s not clear what role the Novavax vaccine will play in the country’s vaccine program. But some experts suggest that people who are hesitant to get Moderna or Pfizer-BioNTech shots may be more willing to accept more traditional Novavax doses. It is also possible that a protein-based vaccine would work well as a supplement to the Pfizer or Moderna vaccines.
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