FDA panel unanimously approves Moderna booster shot

BOSTON — BREAKING UPDATE: The US advisory panel endorses Moderna COVID-19 vaccine booster shots for seniors and other high-risk groups.


Happening Thursday, the FDA will meet to determine whether it will give approval for Moderna’s booster shot. Millions of Americans who got a Pfizer COVID-19 shot have now already received their booster shot. But it might not be a done deal for the Cambridge-based company.

Ahead of Thursday’s meeting, scientists with the FDA said that Moderna had not met all of their criteria for booster shots, and part of the reason isn’t so bad. It’s actually because Moderna’s first two doses are so effective, that getting a booster might not produce that much more antibodies to warrant getting another shot. But that will be one of the many issues taken up for debate with the FDA.

Moderna’s booster shot is half the strength of its original vaccine, which was given in two shots about four weeks apart. The company is initially asking for approval for its third shot to be given to adults 65 and older as well as for those who are at high risk. One downfall for Moderna is that it has far less data than Pfizer did when that company asked for approval from the FDA. But a study led by the CDC found that Moderna’s vaccine was slightly more effective than Pfizer’s in keeping people out of the hospital. If a booster is approved, the clinical director at Brigham and Women’s Hospital says they are still researching whether people will need to continually get them.

“What I think we’ll see is that perhaps the optimal initial approach to a COVID-19 vaccine is actually three doses, not two and then we’ll have to follow the amount of disease that’s occurring in vaccinated people and severity and make a decision about how often it may need to be given in the future,” said Dr. Paul Sax.

Whether it will be every year or ten years, he said more research will need to be done to determine that. After the FDA takes up Moderna’s third shot Thursday, they’ll be considering a booster for Johnson and Johnson on Friday.


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