FDA authorizes Pfizer, Moderna's omicron boosters

In the first step toward the national rollout of omicron-updated COVID-19 vaccines, the FDA authorized Pfizer's and Moderna's candidates for emergency use Aug. 31. The CDC will meet for the next two days, and pending the agency's OK, the boosters could be ready after Labor Day weekend

Pfizer's candidate, which showed a 9.1-times better response than its predecessor, is authorized for people 12 and older. Moderna's new booster, which is nearly twice as effective as its original formula, is authorized for adults 19 and older. 

"As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants," FDA Commissioner Robert Califf, MD, said in a statement. 

The release date for the bivalent vaccines, which target the original strain and the omicron variant, have been hiked up twice. In June, when the federal government instructed vaccine makers to tweak their product to better protect against omicron subvariants BA.4 and BA.5, the proposed deadline was October. When not long after, BA.5 dominated more than 90 percent of COVID-19 cases, the deadline then shifted up to mid-September.

 

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