Liesl Eibschutz, a medical student from Dartmouth University, loads a syringe with Pfizer COVID-19 vaccine before giving it to people on the first day that people ages 16 and up can receive the vaccine at Kedren Health on Thursday, April 15, 2021 in Los Angeles, CA.
Allen J. Schaben | Los Angeles Times | Getty Images
The Food and Drug Administration authorized Moderna and Pfizer’s 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.
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.
The FDA’s advisory panel originally met in September to consider recommending Pfizer’s boosters for the general public, but decided against doing so amid concerns from some that there wasn’t enough data. They recommended a scaled back distribution plan instead for the elderly and adults who face a high risk from Covid. The CDC approved Pfizer’s booster shots for those groups in September and Moderna and J&J recipients last month.
“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 Dr. Peter Marks, who is the agency’s top vaccine regulator as head of the FDA’s Center for Biologics Evaluation and Research. “Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses…
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