The Food and Drug Administration authorized Moderna’s and Pfizer’s Covid booster shots for all U.S. adults Friday — two months later than the Biden administration had wanted to begin giving the extra doses — as growing data shows the efficacy of vaccines wanes over time.
The emergency use authorization comes after the companies in the last week submitted new data supporting the third doses. Scientists advising the FDA had rejected the administration’s original plans to start distributing boosters to all adults the week of Sept. 20, citing a lack of supporting data. Moderna resubmitted its application just two days ago.
FDA Acting Commissioner Janet Woodcock cleared the doses without the usual public meeting to review the new data. 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 Stephane Bancel said in a statement.
Woodcock said the agency has acted swiftly to protect the public as the pandemic evolves. She said booster shots are the best way to keep people from ending up hospitalized or dying from Covid.
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.
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