An advisory panel to the Food and Drug Administration on Friday rejected calls from the White House and drug maker Pzifer to authorize booster shots for all Americans over 16.
The panel instead approved boosters for those over 65 and individuals at high risk of contracting COVID-19, according to CNN.
The decision capped days of high-level jousting over the booster shots, with the Biden administration pushing hard to get them approved while some departing FDA officials pushed back, saying science should lead and not politics. The Biden administration had announced that it wanted to begin offering booster shots on Sept. 20.
After extensive debate, the panel’s bottom line seemed to be that although the vaccine’s protection undeniably fades over time, Pfizer did not make a strong enough case that the decline in protection was severe enough to impact the health of most Americans.
Sara Oliver with the Centers for Disease Control and Prevention offered data at the panel’s meeting that showed time has eroded protection against mild cases more than serious ones, The Washington Post reported.
Through July, according to unpublished figures she presented, adults 75 and older had an 88 percent level of protection against hospitalization.
“It’s unclear that everyone needs to be boosted, other than a subset of the population that clearly would be at high risk for serious disease,” said Dr. Michael G. Kurilla, a committee member and official at the National Institutes of Health, according to The New York Times.
Dr. Luciana Borio, a former acting chief scientist at the FDA, said having the White House lead the push for boosters was “a process foul in how we go about making those decisions.”
“We need an FDA that has people making these decisions and retaining that ability to make those decisions independently and based on science alone. If this changes, we all lose,” she told the Times.
The decision is the first in a string of FDA and CDC actions to come that will determine if the two agencies will abide by the panel’s decision and how they might adapt it.
Paul Offit, a University of Pennsylvania infectious disease expert, told Politico the drive for boosters was “the administration’s booster plan; it wasn’t the FDA’s booster plan.”
“The administration has kind of backed themselves up against the wall a little bit here.”
Helen Talbot, an infectious disease specialist at Vanderbilt University and a member of CDC’s Advisory Committee on Immunization Practices, said it was “very frightening to me that health care providers, trying to do the best job that they can, are taking guidance from HHS and White House, and now have put themselves at risk.”
In an article, authors Marion Gruber and Philip Krause — who have left the FDA — and over a dozen other co-authors wrote that while boosters might provide some additional protection, they would not be dramatically more effective than the current two shots.
They noted that COVID vaccines were not designed to prevent infection or transmission of the virus; rather they are intended to reduce hospitalizations and deaths.
They are, for the most part, succeeding in that, despite the delta variant, the authors said. Only if a future variant threatened to kill or hospitalize vaccinated populations should there be a booster shot, they argued. Otherwise, a booster shot would be a mistake.
“Careful and public scrutiny of the evolving data will be needed to assure that decisions about boosting are informed by reliable science more than by politics,” they wrote.
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