The U.S. Food and Drug Administration authorized a booster of the Pfizer Inc and BioNTech COVID-19 vaccine for those 65 and older, all people at high risk of severe disease, et al. who are regularly exposed to the virus.
The decision paves the way for a fast rollout of the booster shots as soon as in the week for many people that had their second dose of the vaccine a minimum of six months ago.
The change to the vaccine’s emergency use authorization will allow boosters for groups like health-care workers, teachers and day care staff, grocery workers and people in homeless shelters or prisons, FDA acting Commissioner Janet Woodcock said during a statement.
Pfizer had asked the FDA to expand its vaccine approval to incorporate boosters for all people aged 16 and older and presented data last week to an outdoor 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 people 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 it included as eligible for boosters in comparison to the panel’s recommendation.
“Very broad indeed, especially that ‘among others.’ that would essentially give the green light for giving boosters to a really substantial proportion of the previously vaccinated adult population,” said Schaffner, who is the NFID’s liaison to the Advisory Committee on Immunization Practices (ACIP) at the U.S. Centers for Disease Control and Prevention (CDC).
ACIP could vote Thursday on the utilization of a 3rd shot of the vaccine, workplace official said at a public meeting of the panel on Wednesday.
“Tomorrow’s ACIP meeting at the CDC are going to be focused on turning this into a politician 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 communicable disease expert at Georgetown University in Washington and former chief scientist at the FDA.
“These are pretty broad categories that provides a fair amount of latitude to the judgment of healthcare providers and other 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 in the week , pending approval by the FDA and CDC.
But the advisory panel said there wasn’t enough evidence to support booster shots for that population and also sought more safety data. The FDA doesn’t need to follow the advisory panel’s recommendation, but often does.
The agency could revisit the difficulty for a broader authorization within the future.
“This first FDA authorization of a COVID-19 vaccine booster may be a critical milestone within the ongoing fight against this disease,” said Pfizer chief Albert Bourla. the corporate had argued that boosters are needed for the overall population.
Top FDA members are split on the necessity for boosters for the overall population, with Woodcock backing them while a number of the agency’s senior scientists argued that current evidence doesn’t support them.