FDA Approval of Second COVID Booster May Be Near, Report Says

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March 21, 2023 -- The FDA might be preparing to OK a second round of COVID-19 booster shots that target the original virus as well as the Omicron variant to protect people over 65 and others who are particularly vulnerable.

That’s the message from The Wall Street Journal, which published an article Monday citing unnamed sources familiar with discussions.

“The officials are moving toward authorizing the second jabs of the Omicron-targeted shots for people who are 65 years and older or who have weakened immune systems, though the officials haven’t reached a final decision and could change their mind, one of the people said,” The Journal wrote.

The boosters would need to be approved by the CDC for wide distribution.

The FDA approved using the so-called bivalent booster in August. The CDC granted approval in September, but a second round of approval would be needed.

Only 16% of Americans have received the bivalent booster, Yahoo News reported March 8.

Still, some people who are elderly or in other high-risk populations want another booster shot.

The FDA has said that might be needed. But some health officials say there isn’t enough evidence showing that a six-month booster is effective. 

Canada and the United Kingdom plan to offer spring boosters to people at highest risk of severe COVID-19 illness.

But U.S. officials have said they want an annual vaccination schedule, “partly because many people have tired of frequent boostings,” The Journal reported.

Lack of FDA progress is frustrating “a small but determined group of people who are keen not to have to wait until the autumn to get another dose of COVID vaccine,” STAT reported earlier this month.