The FDA authorized booster shots for people 65 and older, younger adults with underlying health conditions and those in jobs that put them at high-risk for COVID-19.
— The newly-authorized boosters won’t be made available until after the CDC committee meets Thursday and decides exactly who should get them.
— The decision comes after the FDA authorized extra doses of the Pfizer or Moderna COVID-19 vaccine for people who are severely immunocompromised.
The Food and Drug Administration on Wednesday authorized booster doses of the Pfizer-BioNTech vaccine for people 65 and older and those whose jobs put them at high risk for exposure to COVID-19.
Individuals 18 and up who are at high risk for severe COVID-19 were also included in the authorization, which only covers those who are at least six months out from their second dose of the COVID-19 vaccine.
High-risk jobs include “health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others,” said acting FDA Commissioner Dr. Janet Woodcock.
The decision comes almost six weeks after the FDA authorized extra doses of the Pfizer or Moderna COVID-19 vaccine for people who are severely immunocompromised.
“We believe boosters have an important role to play in addressing the continued threat of this disease, alongside efforts to increase global access and uptake among the unvaccinated,” said Albert Bourla, Pfizer chairman and chief executive officer.
The newly-authorized boosters won’t be made available until after a critical Centers for Disease Control and Prevention committee meets Thursday and decides exactly who should get them.
The FDA’s authorization was not what Pfizer and BioNTech had originally asked for. Almost a month ago they submitted an application to the FDA to get boosters approved for everyone 16 and over at least six months after their second dose of the COVID-19 vaccine.
Since then, the FDA has been evaluating the data the companies submitted. It reached a decision Wednesday evening.
On Friday, an outside advisory committee to the FDA decided there wasn’t yet sufficient evidence to show COVID-19 booster shots for people under 65 are necessary.
That was “relatively unusual” said Phyllis Arthur, vice president of infectious diseases and diagnostics policy for the Biotechnology Innovation Organization.
“A lot of their conversation was around whether there was enough ability to parse the data out by population… to ensure the data was clear for multiple populations,” she said.
Data from Israel suggests that COVID-19 vaccine protection begins to fade over time, beginning at around six months, with vaccinated people becoming first more prone to mild disease, and then to increasingly severe disease.
Committee members wanted to wait for more data to become available before issuing blanket approval for a booster shot for everyone 16 and older.
Instead, the Vaccines and Related Biological Products Advisory Committee voted to recommend a third dose of the Pfizer-BioNTech COVID-19 vaccine six months after full vaccination for people aged 65 and older and those at high risk of severe COVID-19.
Now, the FDA has made its decision based on the data the companies submitted and the committee’s recommendations.
“The committee advises FDA, they are not the decision-makers,” said Dr. Kelly Moore, chief executive officer of Immunize.org, which educates health care professionals about U.S. vaccine recommendations.
The boosters can’t be made available to the public until the CDC committee votes. The two agencies have different responsibilities.
The FDA decides if a drug or vaccine is safe and effective and whether it meets the claims made by the manufacturer. The CDC decides who should get that drug or vaccine.
The CDC’s outside committee, called the Advisory Committee on Immunization Practices, met Wednesday and will meet again Thursday. It is expected to vote on who the boosters should be recommended for Thursday afternoon. That recommendation then goes to CDC director Dr. Rochelle Walensky for a signature.
Only when it’s published by the CDC does it become official and health care workers can begin giving booster shots for this group.
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