FDA plans fast approvals for Omicron-targeting vaccines

pharmafile | November 30, 2021 | News story | Manufacturing and Production  

Joe Biden has directed the FDA and CDC to respond quickly to applications for vaccines or boosters to shield against the Omicron coronavirus variant. In May 2021, the FDA outlined the process it would adopt for speeding up the evaluation and approval of COVID-19 vaccines, updated to immunise against emerging variants.

The FDA’s accelerated approval process for updated COVID-19 vaccines accounting for and targeting new variants is similar to the agency’s existing process for annual approval of seasonal influenza vaccine formulations. This process does not require lengthy clinical trials, but rather vaccine makers will test their modified coronavirus vaccines in several hundred volunteers.

Many researchers believe that booster shots of the current COVID-19 vaccines will offer some protection against Omicron.  “Dr Fauci believes that the current vaccines provide at least some protection against the new variant, and the boosters strengthen that protection significantly,” shared Biden in a speech given at the White House. “We do not yet believe that additional measures will be needed.”

Vaccine makers Pfizer/BioNTech, Moderna, and Johnson & Johnson have announced that they are already working on updated vaccines aimed to specifically target the Omicron variant.

“In the event, hopefully unlikely, that updated vaccinations or booster are needed to respond to this new variant, we will accelerate their development and deployment with every available tool,” shared Biden. “My team is already working with officials at Pfizer and Moderna and Johnson & Johnson to develop contingency plans for vaccines and boosters if needed. I will also direct the FDA and CDC to use the fastest process possible without cutting any corners for safekeeping, to get vaccines approved and on the market as soon as possible.”

Ana Ovey

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