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11/19/2021

FDA, CDC advisers approve Moderna, Pfizer COVID-19 booster shots for all adults

The CDC Advisory Committee on Immunization Practices has voted unanimously to recommend booster doses of Pfizer/BioNTech's and Moderna's COVID-19 vaccine for all adults six months after they finish their first two doses.
Sandra Levy
Senior Editor
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Several hours after The Food and Drug Administration authorized Moderna and Pfizer’s Covid booster shots for all U.S. adults, the CDC's Advisory Committee on Immunization Practices late Friday voted unanimously, 11-0, to recommend booster doses of Pfizer/BioNTech's and Moderna's COVID-19 vaccine for all adults in the United States six months after they finish their first two doses.

Members of the Advisory Committee on Immunization Practices also voted on a second question, strengthening the recommendation for boosters for people 50 and older.

Moderna's booster can be used in all individuals age 18 years old and older who have completed a primary vaccination with any other authorized or approved COVID-19 vaccine.

Throughout the course of the COVID-19 pandemic, the FDA has worked to make timely public health decisions as the pandemic evolves. COVID-19 vaccines have proven to be the best and highly effective defense against COVID-19. Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death, said acting FDA commissioner Janet Woodcock.

[Read more: Moderna asks FDA to OK COVID-19 booster shots for all adults

“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,” said Stéphane Bancel, Moderna CEO. “We thank the FDA for their review, and are confident in the robust clinical evidence that a 50 µg booster dose of mRNA-1273 induces a strong immune response against COVID-19.”

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 Peter Marks, director 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 are available to all who may need one.

Read more: Retailers begin offering Moderna , J&J COVID-19 booster shots]

CDC director Rochelle Walensky previously said the public health agency would “act swiftly” after the FDA OKs the shots, according to a CNBC report.

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