FDA OKs Pfizer-BioNTech Boosters for Adults 65+, Others at High Risk

• The Food and Drug Administration approved Pfizer-BioNTech boosters for people ages 65 and older.
• The approval also includes people ages 18 through 64 at high risk of severe COVID-19 or at higher risk of infection due to their job or the institution where they live.
• The Pfizer-BioNTech COVID-19 vaccine is currently fully approved in the United States as a two-dose regimen for people 16 years and older under the brand name Comirnaty.

People ages 65 and up and those at high risk of severe COVID-19 or infection will soon be able to get a third dose of the Pfizer-BioNTech COVID-19 vaccine at least 6 months after their second injection.

The Food and Drug Administration (FDA) updated the existing emergency use authorization (EUA) for this vaccine to allow the use of a single booster dose in people:

• ages 65 and older
• ages 18 through 64 who are at high risk of severe COVID-19
• ages 18 through 64 who are at higher risk of contracting an infection due to their occupation or the institution in which they live

The booster can be given at least 6 months after the second dose.

This change only applies to the Pfizer-BioNTech vaccine. The FDA will review booster applications from Moderna and Johnson & Johnson at a later date.

On Monday, the FDA’s vaccine advisory committee voted unanimously to recommend almost identical eligibility criteria for boosters of this vaccine. The one addition made by the FDA was institutional risk of infection.

Acting FDA Commissioner Dr. Janet Woodcock also provided some insight into which subgroups fall under the EUA.

The authorization would allow for booster doses “in certain populations such as healthcare workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others,” she said in a news release.

“This is a really amazing… for people who are at severe risk for COVID: older adults, as well as people who are at risk [of infection] in healthcare settings and other high-risk settings. A third dose will protect them,” FDA committee member Dr. Amanda Cohn, a chief medical officer at the Centers for Disease Control and Prevention (CDC), said on Monday.

She pointed out that many of the people in these high-risk groups were vaccinated in December 2020 or January of this year, so they’re more likely to be at risk of infection due to waning immunity after vaccination.

The Pfizer-BioNTech vaccine is currently fully approved in the United States as a two-dose regimen for people ages 16 and older under the brand name Comirnaty.

Initial doses of the vaccine are also available under an EUA for 12- to 15-year-olds. This group, and 15- and 16-year-olds, would not be eligible for boosters at this time.

People with weakened immune systems are already able to get a third dose of an mRNA vaccine in the United States. This is not considered a booster dose, but a way to help increase people’s initial immune response.

Emergency approval, which was used initially for all COVID-19 vaccines, is a faster regulatory route intended for a public health emergency, such as a pandemic.

As part of the EUA, the FDA will continue to monitor data on the safety and effectiveness of booster doses for these groups.

The CDC’s Advisory Committee on Immunization Practices (ACIP) will meet to discuss whether the CDC should recommend the rollout of Pfizer-BioNTech boosters for these groups.

However, even if the CDC makes a different recommendation on boosters, healthcare professionals can offer booster doses of the Pfizer-BioNTech vaccine to anyone who meets the FDA’s eligibility criteria.