Pfizer and Moderna boosters approved by FDA for adults

The decision comes after at least 10 states have begun making booster shots eligible to healthy adults.



The Food and Drug Administration approved COVID-19 booster shots for all vaccinated Americans over the age of 18 on Friday, in an effort to combat a coronavirus outbreak that is anticipated to worsen this winter. Adults who completed a two-dose regimen of either Pfizer and BioNTech's or Moderna's vaccines at least six months ago are now eligible for a third shot, significantly increasing the number of people eligible for a booster in the United States. In August, Pfizer requested broad clearance for an extra dose in all adults. However, the FDA issued a narrower authorisation for older adults and those at higher risk of COVID-19 owing to their health or job, with assistance from outside advisers. Last month, Moderna gained a similar limited authorization for its booster shot.


The FDA came to a decision ten days after Pfizer submitted a new request for broad authorization citing findings from a Phase 3 clinical trial involving more than 10,000 people that proved the third dose to be safe and effective. Moderna submitted a request for authorization for a similarly broad clearance . On Friday, the CDC's advisers issued a similar suggestion, which agency director Rochelle Walensky endorsed. "The FDA has determined that the currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines to individuals 18 years of age and older," said Peter Marks, head of the FDA office that reviews vaccines, in a statement. Moderna’s booster is half the strength of what's used for the first two doses.