Topline

The Food and Drug Administration approved new COVID-19 vaccines from Pfizer and Moderna on Thursday, with both drugmakers saying their shots will be available within the coming days ahead of the fall and winter respiratory virus surge.

Key Facts

Both shots target the KP.2 COVID-19 variant—a descendant of the omicron subvariant—that was the dominant strain circulating in the U.S. earlier this year.

The FDA granted accelerated use authorization to Moderna and Pfizer’s updated jabs to “more closely target currently circulating variants and provide better protection against serious consequences of COVID-19,” the FDA said in its announcement.

Moderna told Forbes it expects its vaccine to be available “within the coming days,” while Pfizer previously said its shot will be available immediately following approval.

The FDA in June asked vaccine makers to create shots that target the coronavirus’ JN.1 variant, but later changed this recommendation to advise manufacturers to focus on the KP.2 strain of the JN line after reviewing updated case data.

Novavax—which filed for approval for a vaccine that targets the JN.1 variant—did not receive approval from the FDA on Thursday, and said in a statement it’s “working productively” with the FDA as it completes its review, and expects authorization to happen “in time for peak vaccination season.”

This is a developing story.

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