Drugmakers Moderna and Pfizer announced Friday morning that the Food and Drug Administration (FDA) has authorized booster doses of their respective COVID-19 vaccine for all adults 18 and older in the United States.
Later Friday, CDC Director Dr. Rochelle Walensky accepted the unanimous recommendation of an influential panel of advisers to the agency, meaing tens of millions of Americans will be able to shore up their protection against the deadly coronavirus ahead of the holidays.
"After critical scientific evaluation, today’s unanimous decision carefully considered the current state of the pandemic, the latest vaccine effectiveness data over time, and review of safety data from people who have already received a COVID-19 primary vaccine series and booster," Dr. Walensky wrote in a statement.
Booster shots have demonstrated the ability to safely increase people’s protection against infection and severe outcomes and are an important public health tool to strengthen our defenses against the virus as we enter the winter holidays," Dr. Walensky added. "Based on the compelling evidence, all adults over 18 should now have equitable access to a COVID-19 booster dose.”
The move follows the actions of a number of states and localities, including New York City, who have already expanded eligibility for booster doses without the go-ahead from federal regulators.
“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,” Stéphane Bancel, Chief Executive Officer of Moderna, said in a statement. “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.”
Shortly after, Pfizer and BioNTech made a similar announcement about expanding access to booster doses of their mRNA vaccine.
“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,” Pfizer CEO Albert Bourla said in a statement.
“With boosters, more adults will now have the opportunity to help preserve a high-level of protection against this disease," Bourla added. "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,” Ugur Sahin, CEO and Co-founder of BioNTech, said. “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 of Friday, more than 33 million booster doses have been administered in the U.S., according to data from the CDC. More than 13 million of those have been boosters of Moderna's mRNA vaccine, and more than 19 million have been Pfizer-BioNTech boosters.
Currently, the FDA has granted emergency use authorization for the Pfizer and Moderna boosters for people who are 65 or older, who have underlying medical conditions, or who work or live in high-risk settings, such as prisons or homeless shelters. The Johnson & Johnson boosters, however, are authorized for all adults.
But with winter approaching and COVID-19 cases climbing again, some state and local governments are applying a broad interpretation to the FDA authorization and CDC guidance.
In Colorado, where the positivity rate is 13.4%, the state Department of Public Health and Environment says COVID-19 is spreading so fast that almost every adult in the state is now considered to be living in a high-risk setting.
In New York City, where health officials on Monday began encouraging all adults who want booster shots to get them, Dr. Mitchell Katz, the head of the city’s public hospitals, pointed to the New York’s population density in making the case for why residents are at higher risk. Cases are up 25% in the city since Halloween.
In Arkansas, the Health Department said that some people found the FDA and CDC rules for booster shots confusing, hampering efforts.
"I think it'll eliminate some confusion, and it'll also encourage everyone across the board that meets this criteria to go get the booster shot,” Arkansas Gov. Asa Hutchinson said Monday. “That's the best protection from the virus and from serious health consequences."
The CDC said in a statement to Spectrum News on Tuesday, “Vaccine providers should administer vaccine in accordance” with the FDA authorizations.
All three authorized COVID-19 shots are highly effective at preventing severe illness, hospitalization and death, but studies have shown that their effectiveness can wear off over time.
Spectrum News' Ryan Chatelain contributed to this report.