FDA authorizes messenger RNA COVID-19 boosters for all adults
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Just 8 weeks after it authorized booster doses of the Pfizer-BioNTech COVID-19 vaccine for people at high risk for severe disease, the FDA on Friday announced that any adult is now eligible for an extra shot.
The FDA issued the updated emergency use authorization for both messenger RNA COVID-19 boosters from Moderna and Pfizer-BioNTech. Earlier this month, Pfizer and BioNTech requested that the agency expand eligibility to anyone aged 18 years or older, not just certain groups.
Boosters are available starting 6 months after completion of the two-dose primary series.
"Throughout the course of the COVID-19 pandemic, the FDA has worked to make timely public health decisions as the pandemic evolves," Acting FDA commissioner Janet Woodcock, MD, said in a statement. "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."
The CDC's Advisory Committee on Immunization Practices convened Friday afternoon to update its recommendation for COVID-19 vaccine boosters. The advisory committee voted 11-0, to update its recommendation to expand to all adults aged 18 years and older.
In a second unanimous vote, the committee specified that those aged 50 years and older should receive a booster dose, as well as all immunocompromised, at-risk adults.
The FDA’s own advisory committee, the Vaccines and Related Biological Products Advisory Committee, was not consulted before Friday’s announcement. The committee had met numerous times over the last several months to discuss who should receive a COVID-19 vaccine booster.
In September, in fact, the committee voted 16-2 not to recommend Pfizer’s booster for all Americans aged 16 years or older, settling on a narrower recommendation for older adults and people at high risk for severe COVID-19.
State and local governments are poised to expand access to boosters. Arkansas, California, Colorado and New Mexico have already started the process.
Perspective
Back to TopJeanne M. Marrazzo, MD, MPH, FACP, FIDSA
The FDA’s approval of the Pfizer booster dose is a recognition of the reality that there is, unfortunately, no easy way out of the COVID-19 pandemic.
Perhaps we were fortunate with the eventual disappearance of the original SARS virus that emerged in 2002, because SARS-CoV-2 is following a distinctly different pattern that takes advantage of waning immunity and emergence of new variants.
With periodic boosting of humoral immunity, let’s hope that we can eventually gain some semblance of control, at least for severe illness, as we continue to gain more knowledge about this formidable foe.
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