FDA decision on COVID-19 shots for younger kids unlikely until June - Politico
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A complicating review process could prompt the U.S. Food and Drug Administration (FDA) to delay its plans to authorize COVID-19 vaccines for the nationâs youngest kids until June, Politico reported on Thursday, citing people familiar with the matter.
The Biden administration expected to clear the shots for young children early this year, but the FDA asked vaccine developers Pfizer (NYSE:PFE)/ BioNTech (NASDAQ:BNTX) to test a three-dose regimen, citing concerns over efficacy.
Having extended the rolling submission for an Emergency Use Authorization (EUA) early this year, Pfizer (PFE) is unlikely to officially seek the clearance until June, Politico said.
Meanwhile, on Wednesday, the rival vaccine maker Moderna (NASDAQ:MRNA) announced its plans to seek the EUA for kids aged six months to five years by end of April, meaning a potential regulatory action on the vaccine by mid-May.
However, the regulators are increasingly in favor of postponing any decision until early summer, arguing that the simultaneous authorization and promotion of two vaccines to the general public could be simpler and less confusing.
The plans are tentative and subject to change, especially in the event of a sharp rise in COVID cases, the people said.
An FDA spokesperson said that the decision is dependent on âwhen the data are provided to FDA and fully support a regulatory action.â
Read why Pfizer (PFE) and BioNTech (BNTX) decided to delay their request to seek FDA clearance for the vaccine in younger kids.