The U.S. Food and Drug Administration authorized Moderna (NASDAQ:MRNA) and Pfizer’s (NYSE:PFE) COVID booster shots for all U.S. adults on Friday, belatedly fulfilling a critical part of the Biden administration’s plan to administer extra doses to the general public as growing data demonstrates the efficacy of vaccines wanes over time.
The approval comes about two months late — after scientists advising the FDA rejected the administration’s original plans to start distributing boosters to all adults the week of Sept. 20, citing a lack of data supporting the third doses.
FDA Acting Commissioner Janet Woodcock also cleared the doses without the usual public meeting to review new data submitted by the companies in the last week. Moderna resubmitted its application just two days ago. The companies announced the decision Friday morning.
"This emergency use authorization comes at a critical time as we enter the winter months and face increasing COVID-19 case counts and hospitalizations across the country," Moderna CEO Stéphane Bancel said in a statement.
The Centers for Disease Control and Prevention still has to authorize distribution of the booster doses before people can start receiving the shots, which could start this weekend. The CDC’s independent panel of vaccine experts is scheduled to meet Friday to review the new data and is expected to quickly approve the third doses.
CDC Director Rochelle Walensky on Wednesday said the public health agency would “act swiftly” after the FDA OKs the shots.
Shares in Moderna shot higher $18.97, or 7.6%, to $270.38, while those for Pfizer improved $1.13, or 2.2%, to $52.53.
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