Powered by Topple

FDA panel disapproves of COVID booster vaccines citing a lack of safety data

Powered by Topple

A Food and Drug Administration panel voted to reject an effort by the Biden administration to begin rolling out COVID-19 booster vaccines next week, citing a lack of safety data.

The rejection by the independent advisory committee came after reviewing a 23-page briefing report issued by the FDA citing recent studies, leading the panel to recommend a third dose of the coronavirus vaccine only for Americans over 65 as well as those who are more at risk of contracting COVID.

The committee members said that more information will be required before it approves the vaccine for Americans 16 and older.

In addition, the panel noted that the current two-dose regime of the Pfizer vaccine is very effective at preventing the spread of the highly contagious Delta variant of COVID-19 for a majority of people, the New York Post reported.

(Video: Fox News)

“[O]overall, data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States. There are many potentially relevant studies, but FDA has not independently reviewed or verified the underlying data or their conclusions,” the panel’s report states.

“For a licensed vaccine, a change in dosing regimen, such as inclusion of a booster dose, requires the approval of a supplemental BLA. This supplemental BLA must include data demonstrating the safety and effectiveness of the additional dose,” it continues. “The benefit of a booster dose must be weighed against potential risk.”

Dr. Michael Carome, director of Public Citizen’s Health Research Group, said during Friday’s meeting of the panel that “there is a lack of data on effectiveness and duration” of the original COVID vaccines, making approval of a booster unnecessary for the time being.

“Current evidence does not appear to show a need for boosting,” he added.

It should be noted that the FDA does not have to follow the guidance or recommendations of the independent advisory panel, but thus far in relation to COVID-19 vaccines, the agency has done so.

The panel voted overwhelmingly — 16-2 — to reject booster vaccines after analyzing data from several studies, the findings of which were included in the report.

In particular, panel members cited research published in the July issue of the New England Journal of Medicine which showed people who took both Pfizer doses remain 88 percent protected against the Delta variant of the virus.

Approval of the third dose was thrown into doubt last week when Dr. Paul A. Offit, head of the Vaccine Education Center at Children’s Hospital of Philadelphia, declared that they were “premature.” In an interview with The New York Times, Offit said, “There is no compelling reason to get a third dose now.”

The advisory panel also reviewed on Friday a Pfizer study involving 306 people who demonstrated that following a booster shot, virus-combatting antibodies increased by a factor of three when the shot was administered six to eight months after the second dose.

However, Dr. Meg Seymour of the National Center for Health Research said that increase was not enough to justify a third dose for the majority of the population.

“The total safety sample is very small. The data provided did not allow us to draw concrete conclusions,” she said.

During his Friday program, Fox News host Tucker Carlson commented on the panel’s vote and suggested that the rejection of the boosters by the panel is not going to be well received by the White House.

“Go and pull up the conversation that’s online and ask yourself, [had] this had taken place anywhere else but the FDA, would Twitter have banned it immediately? Yes,” he said, noting that the panel cited a lack of “safety information” in rejecting Pfizer’s proposal.

“The Biden administration has known for weeks that FDA staff — actual scientists, not politicians — thought booster shots were ‘premature and unnecessary.’ By the way, why are we pushing for boosters if the vaccines are so effective?” he said. “Ooh, we’re not allowed to ask that, either.

“Turns out there was nearly a mutiny within the FDA, but the Biden administration pressed ahead anyway because they have a political objective, not a scientific one, not a public health objective, but a political objective,” he added.

“It turns out they’re only going to stop pushing their politics, these mandates if they are forced to stop, and today, for once, they were forced to stop.”

Jon Dougherty

Comments

Latest Articles