FDA Plans Fast Approvals of Updated COVID-19 Variant Vaccines

“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. Additionally, I will direct FDA [Food and Drug Administration]CDC [Centers for Disease Control and Prevention]To use the fastest possible process without compromising safety to ensure that vaccines are approved quickly and available for sale if necessary.

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

FDA is known for its slow approvals of new vaccines. However, earlier this year the FDA outlined the procedure it will use to speed up approval for any COVID-19 updated vaccines that are being immunized against the emerging variants. This process mirrors the way that the agency approves seasonal flu vaccine formulas every year without lengthy clinical trials.

Instead of carrying out long-running clinical trials that involved tens to thousands of people, vaccine manufacturers will inject their vaccines into a select group of volunteers. The FDA will authorize the distribution of modified vaccines if they are safe and effective.

Many researchers think that the current COVID-19 vaccinations can be given as booster shots to protect against the Omicron variant.

Disclosure: I inoculated my Moderna shots earlier this month with a Pfizer vaccine.