FDA Authorizes Booster Dose of Pfizer Inc for 65 and Older and Some Others

The U.S. Food and Drug Administration announced this week that it has authorized a booster dose of the Pfizer Inc. and BioNTech COVID-19 vaccine for individuals who are 65 and older.

The booster is also for people who are at high risk of severe disease, and others who are regularly exposed to the virus.

This change to the vaccine’s emergency use authorization will allow boosters for groups such as health-care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, FDA acting Commissioner Janet Woodcock stated.

Pfizer had requested the FDA to expand its vaccine approval to include boosters for people aged 16 and older and had presented data last week to an outside FDA panel of advisors.

The FDA panel voted against the proposition that boosters were needed by everyone but said evidence showed they were helpful to older people and those at high risk.

Dr. William Schaffner, medical director of the National Foundation for Infectious Diseases (NFID), said the FDA’s statement was more expansive in who is included as eligible for boosters when compared to the panel’s recommendation.

“Very broad indeed, especially that ‘among others.’ That could essentially give the green light for giving boosters to a very substantial proportion of the previously vaccinated adult population,” said Schaffner.

Schaffner also serves as the NFID’s liaison to the Advisory Committee on Immunization Practices (ACIP) at the U.S. Centers for Disease Control and Prevention (CDC).

The FDA authorization was “generally in line” with the advisory panel vote, said Dr. Jesse Goodman, an infectious disease expert at Georgetown University in Washington.

“These are pretty broad categories that give a fair amount of latitude to the judgment of healthcare providers and people providing immunizations,” he added.

The agency could revisit the issue for a broader authorization in the future.

“This first FDA authorization of a COVID-19 vaccine booster is a critical milestone in the ongoing fight against this disease,” said Pfizer chief Albert Bourla.

Disclaimer: We have no position in any of the companies mentioned and have not been compensated for this article.