Health
FDA sets up June meeting on COVID vaccine for youngest children
The Food and Drug Administration has set a tentative date in June to publicly review the COVID-19 vaccine for the youngest children in the United States.
Washington-Friday’s Food and Drug Administration has 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 announcement of the meeting follows months of frustration from families longing for the opportunity to vaccinate their little children, along with complaints from politicians lamenting the slow pace of the process.
The FDA said it would convene an external panel of vaccine experts on June 8, 21 and 22 to consider applying for vaccines for children from Moderna and Pfizer. The date is not final and the FDA said each company will provide details when completing the application.
Questions about what takes so long are swirling, but FDA Commissioner Robert Caliph emphasized on Friday that authorities would not be able to evaluate the vaccine until all data were submitted.
“There will be no delay,” Caliph told reporters. health Journalism conference. “We will review the data, meet an advisory board, and make a decision as soon as we receive the application.”
Currently, only children over the age of 5 can be vaccinated against Pfizer in the United States, and 18 million young children are unprotected.
On Thursday, Moderna hopes to submit some of that data to the FDA to prove that two low-dose shots can protect children under the age of six. It is not clear if the child of that data will be considered at the June meeting.
Pfizer will soon announce whether three of the smaller shots will work for the youngest child, months after the disappointing discovery that the two doses were not strong enough.
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.
The FDA has also set up a June 7 meeting to consider the Novavax COVID-19 vaccine for adults. Shots from Maryland-based companies are allowed in Europe and elsewhere, but are delayed due to production issues.
The advisory group will also be convened on June 28 to discuss whether the current USCOVID-19 vaccine needs to be updated to better target coronavirus variants.
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AP Medical Writer Lauran Neergaard contributed to this story
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The Associated Press’s Department of Health Sciences is supported by the Science Education Department of the Howard Hughes Medical Institute. AP is solely responsible for all content.
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