Pfizer-BioNTech asked the Food and Drug Administration (FDA) on Tuesday for emergency use authorization for its Covid-19 booster shot for all adults ages 18 and up, a move the company has been working towards over the past several months.
The formal request will now be considered by the FDA, which will make a final decision in the coming weeks. It’s unclear whether the agency will ask its independent advisory group, called the Vaccines and Related Biological Products Advisory Committee, to offer guidance on authorizing the booster.
In its first request for booster authorization, Pfizer asked the FDA to authorize the additional shots for everyone ages 16 and up. The FDA advisory panel, however, rejected that request, limiting the shots to certain groups, in part due to safety concerns in younger people. Pfizer’s booster shot is currently authorized for certain subsets of adults in the United States: people ages 65 and up, people living in long-term care facilities, and people ages 18 to 64 at high risk of Covid because of either underlying medical conditions or their jobs. It’s given six months after completion of the initial two-dose vaccination series.
Is this going to make a difference? Probably not.
Here's why: pic.twitter.com/nkvmYBWrVd
— Céline Gounder, MD, ScM, FIDSA (@celinegounder) November 9, 2021
People aged 18 and over who received the one-shot Johnson & Johnson vaccine may currently opt for the “mix and match” approach and receive the Pfizer booster, as long as it has been more than two months since they received their single vaccination. Johnson & Johnson’s own booster is also currently approved, with its own guidelines and limitations.
JUST IN: Pfizer is asking the FDA to amend its booster authorization to include all adults 18 and older. https://t.co/MX3jv8e7dT
— ABC News (@ABC) November 9, 2021
In Pfizer’s latest request, the company says that results from a Phase 3 clinical trial with more than 10,000 participants found that the third dose was safe and effective.
Great news — with boosters, vaccines for children 5-11, and now a potential antiviral this effective…we have real tools to end this pandemic. https://t.co/nVWv6tT0U6
— Gavin Newsom (@GavinNewsom) November 5, 2021
If the FDA authorizes the booster for the younger age group, the Centers for Disease Control and Prevention (CDC) must officially recommend the shot before it can be administered.