FDA approves Moderna, Pfizer COVID-19 boosters for all US adults

The Food and Drug Administration authorized Moderna and Pfizer’s Covid booster shots for all U.S. adults on Friday, the booster had already been available to people 65 and older and to anyone 18 years and older who was at elevated risk of contracting 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, M.D., Ph.D., 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.”

“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.

“As we near the two-year mark in our fight against COVID-19, we have reached another critical milestone with the expanded authorization of a booster dose of our COVID-19 vaccine in individuals 18 years and older,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “With boosters, more adults will now have the opportunity to help preserve a high-level of protection against this disease. We are grateful to the FDA for their rigorous review, and the action taken today that we hope will help accelerate our path out of this pandemic.”

“Today’s FDA decision is supported by clinical data showing robust immune responses following a booster dose of our vaccine, exceeding what has been seen even after the completion of the highly-effective two-dose primary schedule,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “These data suggest a booster dose of our vaccine has the potential to maintain a high-level of protection against tested variants, including Delta.”

As a next step, the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to discuss a potential recommendation for rollout of COVID-19 boosters to Americans.

CDC data shows that more than 32 million Americans have already received a booster dose.


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