The Biden administration‘s approval of a fourth mRNA COVID-19 shot for those 50 and older has raised eyebrows in political and medical circles.
The Food and Drug Administration authorized a second booster shot of the Pfizer-BioNTech and Moderna vaccines for older adults and people as young as 12 with certain immune deficiencies but did so without convening a meeting of its panel of vaccine experts first, a move that angered healthcare experts skeptical of a fourth shot’s utility.
“When last asked about boosters, the FDA’s advisory committee on vaccines voted 16-2 against authorizing a third COVID-19 shot for people under 65,” Heritage Foundation senior fellow Doug Badger wrote in an email to the Washington Examiner. “The FDA hasn’t sought their advice ever since.”
Badger also questioned FDA’s rationale for authorizing the shots, saying the agency doesn’t cite any randomized controlled trials concluding that a fourth dose reduces the risk of severe illness, and pointed out that the shots were designed to fight the original strain of COVID-19, which has not been in circulation for nearly two years.
FDA AUTHORIZES SECOND BOOSTERS OF MRNA COVID-19 VACCINES FOR ADULTS OVER 50
Some public health experts raised similar concerns. Monica Gandhi, a professor of medicine at the University of California, San Francisco, said ignoring input from the Vaccines and Related Biological Products Advisory Committee “led to distrust and confusion in the American public” when the third shot was authorized and could do so again this time.
FDA press officer Abigail Capobianco said the agency didn’t consult the committee because the fourth shot did not raise “new scientific questions.”
“The FDA did not hold a meeting of the Vaccines and Related Biological Products Advisory Committee on Tuesday’s action,” she wrote in an email to the Washington Examiner. “The agency concluded that the request does not raise new scientific questions that would benefit from additional discussion by committee members. The FDA will post documents regarding the authorizations on its website.”
Gandhi noted that many European countries have only approved fourth shots for seniors at least 70 years old and is worried that additional boosters not only won’t help younger people but that the decision to allow them for such a large group could lead to a supply crunch.
The authorization comes as the White House and congressional Democrats spar with Republicans over a new $15 billion round of COVID-19 funding. Democrats caution that the money is needed for testing, vaccines, treatments, and research and development, while Republicans counter the money can be redirected from other sources, including previously approved COVID-19 spending. The White House says it has enough money to provide fourth shots for those 50 and over but would need more funding if shots were approved for all age groups.
A final concern for Gandhi is that the FDA’s criteria could lead to continual booster approvals that may not be warranted.
“All of these discussions seem to not incorporate cellular immunity in our decisions, only antibody levels, which last around four months after a booster,” Gandhi said. “Without a knowledge of the immune system, this discussion of antibodies alone will lead us to want to boost every four months, which is not logistically feasible.”
Not all public health experts questioned the move. University of California, Irvine, professor Andrew Noymer said he wasn’t sure why the FDA may have bypassed the panel but added that it wasn’t a “red flag” for him.
“I think it makes sense to authorize a fourth dose,” he said. “It means that anyone who wants to get one can get one without breaking the rules, and it means insurance companies can cover it.”
It’s possible that the Biden administration will eventually authorize a fourth shot for everyone, Noymer said, noting that the virus is still relatively new and that efforts to combat it are evolving.
“We’re getting an understanding from data that unfolds in real time,” he said. “It’s a thorny problem, and I think the FDA’s decision makes sense.”
The shots will be made available to those who want them, but the FDA is not updating its vaccination recommendation to include a second booster dose yet.
CLICK HERE TO READ MORE FROM THE WASHINGTON EXAMINER
Cases are down sharply from January highs, but the latest variant of concern is an omicron offshoot, BA.2, which now represents nearly 86% of all sequenced cases globally, according to the World Health Organization.
In the United States, BA.2 has not overtaken its sister subvariant, BA.1, which drove the devastating omicron surge over the winter months. But it already accounts for more than 54% of sequenced cases nationally. In the Northeast, BA.2 has already overtaken BA.1 as the most dominant variant.
