Washington – The US Food and Drug Administration on Wednesday has cleared a booster dose of the Pfizer Inc (PFE.N) and BioNTech COVID-19 vaccine for people who are 65 and older, all people at high risk of severe disease, and others who are regularly exposed to the virus.
This decision starts a quick rollout of the booster shots as soon as this week for millions of people who had their second dose of the vaccine at least six months ago.
According to FDA acting Commissioner Janet Woodcock said in a statement, the change to the vaccine’s emergency use authorization will allow boosters for groups such as healthcare workers, teachers, and daycare staff, grocery workers, and those in homeless shelters or prisons.
Pfizer had asked the FDA to expand its vaccine approval to include boosters for all people aged 16 and older and presented data last week to an outside FDA panel of advisers that it said showed waning immunity over time.
The 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.
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“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, who 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).
“Tomorrow’s ACIP meeting at the CDC will be focused on turning this into an official recommendation for implementation,” said Dr. Amesh Adalja, senior scholar at the Johns Hopkins University Center for Health Security.
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 and former chief scientist at the FDA.
“These are pretty broad categories that give a fair amount of latitude to the judgment of healthcare providers and people providing immunizations,” he added.
President Joe Biden and eight top health officials including Woodcock announced in August the government’s intention to roll out booster shots for people aged 16 and older this week, pending approval by the FDA and CDC.