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On April 28, Moderna submitted a request to the U.S. Food and Drug Administration (FDA) for emergency use authorization for its COVID-19 vaccine in children between six months and six years old.
The Cambridge, Mass.-based company is now the second to request permission for an mRNA vaccine against COVID-19 for use in that age group. Pfizer-BioNTech, the other mRNA vaccine maker, requested the same authorization for its shot in February, under a rolling submission process in which the company would provide additional data for the agency to review. The FDA initially planned to review Pfizer-BioNTech’s request at that time, but decided to postpone a scheduled meeting of its independent panel of experts until the company provided additional data. The studies on younger kids, completed in December 2021, showed underwhelming protection in children two to four years old, although the vaccine did generate good immunity among those six months to two years old, and the company has since tested an additional, third dose of the vaccine to produce a stronger immune response. The FDA will likely compare those data from Pfizer-BioNTech against those from Moderna in these youngest children, which are now available.
Moderna’s recent studies show that vaccinated children from six months to six years old were able to generate antibodies that could neutralize SARS-CoV-2 at levels similar to those produced in vaccinated adults. One difference: the children in Moderna’s study were given a quarter of the dose given to adults—which still produced a robust immune response, which could be due to the fact that children’s still-developing immune systems might respond more aggressively to vaccines. That’s a positive, since lower doses have been linked to fewer side effects.
As with the Pfizer-BioNTech shot, Moderna’s…
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Source : time
