Health
FDA sets up June meeting on COVID vaccine for youngest children
The Food and Drug Administration on Friday set a tentative date in June to publicly review the COVID-19 vaccine for the youngest children in the United States. This is usually the final step before approving a shot.
The Conference announcement Months of frustration from families longing for the opportunity to vaccinate infants, toddlers and preschoolers, and complaints from politicians lamenting the slow pace of the process continue.
The FDA announced on June 8, 21 and 22 that it would convene an external panel of vaccine experts to consider applying for a pediatric COVID-19 vaccine from Moderna and Pfizer. The date is not final and the FDA said that each company will provide additional details when completing the application.
Currently, only children over the age of 5 can be vaccinated with Pfizer and BioNTech in the United States, and 18 million young children are unprotected.
Thursday, Moderna submitted data to FDA We hope to prove that the two low-dose shots can protect children under the age of six. Moderna has submitted FDA applications for older children, but the FDA has not decided on them. It is not clear if data on older children will be considered at the June meeting.
Pfizer is expected to soon announce whether three of its even smaller shots will work for the youngest children. The two doses were not strong enough..
Questions about what takes so long are swirling, but FDA regulators emphasize that manufacturers cannot evaluate their products until they complete their application. The FDA said Thursday that Moderna would need to submit additional data to complete the process.
On Monday, Top House Democrats are considering postponing work on Moderna’s application for a later joint review with Pfizer, after media reports on the FDA’s status of vaccines for children. Asked for an explanation.
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