FDA Plans Fast Approvals of Updated COVID-19 Variant Vaccines

Vaccine makers are already targeting the omicron variant.


"In the event, hopefully unlikely, that updated vaccinations or boosters are needed to respond to this new variant, we will accelerate their development and deployment with every available tool," said President Joe Biden at a White House press conference today. "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 [Food and Drug Administration] and CDC [Centers for Disease Control and Prevention] to use the fastest process possible without cutting any corners for safekeeping to get vaccines approved and on the market as soon as possible if needed."

Vaccine makers Pfizer/BioNTechModerna, and Johnson & Johnson have all announced that they are already working on updated vaccines aimed specifically at the omicron coronavirus variant identified last week.

The FDA is infamous for dawdling over the authorization of new vaccines. But earlier this year, the agency outlined the process it would adopt for speeding up the evaluation and approval of any COVID-19 vaccines updated to immunize against emerging variants. That process is similar to how the agency annually approves seasonal influenza vaccine formulations without requiring lengthy clinical trials.

Instead of conducting months-long clinical trials involving tens of thousands of participants, vaccine makers will test their modified coronavirus vaccines by injecting them into a small cohort of a several hundred volunteers. If the modified vaccines are safe and effective, that is, they generate a robust immune response to the variant coronavirus similar to the earlier versions of the vaccines; the FDA will then authorize their distribution.

In the meantime, many researchers believe that booster shots of the current COVID-19 vaccines will offer some protection against the omicron variant.

Disclosure: Earlier this month, I boosted my Moderna shots with a Pfizer inoculation.