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Omicron-Specific COVID Boosters Are Coming

Posted: Monday, August 29, 2022. 9:18 am CST.

By Zoila Palma Gonzalez: The United States Food and Drug Administration (FDA) could authorize a new COVID-19 booster shot this week, Market Watch reports.

The booster shot could be approved without going through its normal decision-making process including a study that would have shown if the shots were safe and worked in humans.

According to the report, the vaccine that was modified to target the Omicron variant, won’t have finished testing in humans when the FDA makes its decisions.

The FDA reportedly plans to assess the shots using data from research on mice.

“Real-world evidence from the current mRNA COVID-19 vaccines, which have been administered to millions of individuals, show us that the vaccines are safe,” FDA Commissioner Robert Califf said.

The clearance of the shots without data from clinical trials would be similar to the approach the FDA takes with flu shots.

 

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