FDA hammered for bypassing expert panel to approve FOURTH booster shot

Two top FDA scientists resigned last year after charging the agency was allowing politics to compromise its vaccine-approval process, and now the FDA has expanded emergency use authorization for a fourth booster shot without a vote of its expert panel.

The FDA on Tuesday said people age 50 and older are allowed to get a second Pfizer or Moderna COVID-19 booster – a fourth shot – four months after their first booster.

Dr. Marty Makary, a professor at Johns Hopkins University, condemned the move in a series of tweets Tuesday.

“There is no greater slap in the face of science than bypassing the customary FDA external expert voting process over an authorization with insufficient supporting clinical data,” Makary wrote.

Dr. Marty Makary

“It’s like a judge issuing a verdict and then having lawyers make their arguments.”

The FDA’s announcement Tuesday of the expansion of emergency use authorization for the Pfizer and Moderna shots as second boosters was not a recommendation, the Mercury News noted. The agency’s outside panel of vaccine experts is scheduled to meet April 6 to discuss boosters, but no vote is planned.

The FDA also has authorized a fourth shot for younger people who have had compromised immunity, such as those who have had organ transplants. A second Pfizer booster is allowed for those age 12 or older and a Moderna shot for those age 18 or older.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement that current evidence “suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals.”

Marks said a second booster “could help increase protection levels for these higher-risk individuals.”

“Additionally, the data show that an initial booster dose is critical in helping to protect all adults from the potentially severe outcomes of COVID-19. So, those who have not received their initial booster dose are strongly encouraged to do so,” said Marks.

Marks was at the center of the resignations of the two top FDA scientists last summer, Marion Gruber and Philip Krause, Politico reported. The news site cited a former FDA official who said the two officials quit because they were angered by the agency’s lack of autonomy regarding its approval of the vaccines.

A current official told Politico at the time that the resignations were due to differences with Marks.

On Tuesday, Makary recalled that “political interference over boosters” by the White House was the issue behind the resignations of two the high-level FDA officials.

He argued there is “zero clinical data that a 4th dose reduces hospitalization risk.”

“There isn’t even any evidence that a 3rd dose reduces hospitalization risk in young people,” he said.

Erosion of public confidence Makary noted that the editor of the New England Journal of Medicine, Dr. Eric Rubin, a member of the FDA’s vaccine panel, has said he “hadn’t yet seen enough data on fourth doses to make a determination about whether they are needed for anyone beyond those who are already recommended to get them – adults who are severely immune deficient.”

During an FDA vaccine panel hearing last fall, Rubin reflected the reluctance of members to recommend the Pfizer vaccine for children 5-11, citing the lack of safety data. Rubin said that, for example, myocarditis is “a side effect that we can’t measure yet.” But he concluded the shots should be given to children anyway.

“We’re never going to learn about how safe the vaccine is unless we start giving it,” he argued. “That’s just the way it goes.”

Makary said that President Biden and his new FDA commissioner – with pressure from pharmaceutical companies – should insist on a vote by the FDA’s external experts before authorizing fourth doses.

“Public health confidence has been significantly eroded. Bypassing the expert vote to push 4th doses will make it worse,” the Johns Hopkins professor wrote.

Science, he argued, should not be compromised by politics.

‘I’m not going to get a booster’ In an interview with Fox News on Tuesday, Makary was asked about the District of Columbia’s threat to revoke the medical license of any physician who doesn’t get a booster shot by Thursday.

Makary confirmed that he is “unboosted,” and if D.C. follows through, he will lose his D.C. license and his patients in Washington will need to drive an hour to see him in Maryland.

“Look, we’ve seen this before, this posturing,” he said. “D.C. is the most vigilant about this.”

But he noted that when New York state imposed a mandate on health care workers, 25% of them resisted, arguing there is no supportive data.

“And New York backed off and just didn’t enforce it,” Makary recalled. “We’ll see what D.C. does come Thursday.”

Co-host John Roberts asked: “But you’re not getting a booster between now and Thursday?”

“I’m not going to get a booster just because they say I need one,” Makary replied.

via unsilencednews

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