Dr. Marty Makary blasts FDA for bypassing expert panel to approve 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.

‘There is no greater slap in the face of science’

Art Moore
WND News Center

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
Dr. Marty Makary

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.

“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.

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Sylvia
Sylvia
4 months ago

Thanks, Art, for sharing a great article.
Prof Marty Makary deserves our sincere gratitude for having the courage to state that:
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“.
The mRNA vaccines for Covid-19 have been mandated by many governments around the world. Humans are being used as experimental objects, with zero regard to freedom of choice – is this democracy?
Since the FDA released the initial 55,000 pages of the Pfizer mRNA vaccine data, as ordered by Judge Mark Pittman, many have read the contents. Shocking and eye-opening indeed!
This data comes directly from Pfizer, the manufacturer of the mRNA vaccine.
It is undeniably obvious that the adverse reactions were known from the very start. Yet, authorities ceaselessly state that “the benefits far outweigh the risks”; reports of injury or death post-vaccination are callously dismissed as “rare and statistically insignificant”.
Who are the real conspirationists?
Who is touting dis-/mis-information?
Who is covering up the truth?
Greed is indeed addictive.
Mandating lifelong dependency on vaccines is sheer absurdity.
Most shockingly, natural immunity is treated as non-existent. 
There is zero scientific data as to:

  1. What the short and long-term effects are, particularly on children whose immune system is still in development;
  2. What the vaccine does to the immune system (innate & adaptive) – does it reprogram, sterilize, or take over its role?
  3. What the vaccine does to each organ, eg liver, heart, brain, etc.

Since scientific understanding of the immune system is currently, at best, in its infancy, it is more responsible to err on the side of caution rather than rush headlong into the ‘little known’?
These mandates have destroyed the economy and people’s livelihood. Fear is being used to subjugate people.
Let’s take stock and stop the damage before it is too late.
It is time to restore our Constitution, our Democracy, and have authorities respect our Rights.

Margaret
Margaret
4 months ago

People need to learn about the adverse events after COVID vaccination that are being reported by so many, among children, teens, young adults, and many in those 50-years old and up.Exclusive Interview: Woman Dies From Rare Brain Disorder After Second Pfizer Shot, Husband Says We’re ‘Guinea Pigs’
10 Lives Changed Forever by COVID Shots

Sylvia
Sylvia
4 months ago

I agree with Margaret that people need to learn about adverse events of Covid-19 vaccines. It is equally imperative that people understand risks associated to any medication. No medication is free from adverse, or side, effects. These may not happen to you – but they may!
It is unwise to simply ‘hand over’ control of your health to medical practitioners. They provide a service, just like any service provider in any other field.
You are 100% responsible, and accountable, for your own body and your health. Consulting a health practitioner is prrfectly fine, as long as you remain an active partner in the discussions and decision making.
Please remember that, although a healthy body is incredibly resilient, some damage cannot be undone.
Vaccine makers have 100% Federal exemption from any and all liability. In other words:

  1. Authorities mandate vaccination;
  2. You could be jobless or have your licence revoked if you disobey;
  3. You and you alone are responsible if you suffer any injuries or die as a direct or indirect effect of a vaccine,

Does that make any logical or rational sense? Is it fair and equitable? Does it show any consideration or respect for basic human rights?
Or is it merely a blatant grab for power to feed the Hungry Ghost of GREED?

Doctor X
Doctor X
4 months ago

Approve novovax already. Data is spectacular. Approved around the world. Safest vaccine made so far and the most effective against the omicron lineage!

PrimaryCareDr
4 months ago
Reply to  Doctor X

Patients ask me about getting a vaccine. I used to recommend it. Now with the 2nd booster there is minimal data to support it. Not that effective against Omicron and immunity apparently lasts about a month. Furthermore risk with mRNA vaccines appears to go up the more you get. And why no vote by the FDA panel. Why is the safest and most effective vaccine, Novavax, still being slow walked through the FDA approval process. This all smells of big Pharma making money at the risk of the health of patients. I have lost a LOT of faith in the FDA and CDC. I have had little faith in our government as the almighty dollar rules most of our representatives decisions; not what is right!

Denis Constant
Denis Constant
4 months ago

The corrupt behaviour exhibited by the FDA in the approval process of vaccine will undoubtedly have a very negative impact on the science industry in the future when confronted with an additional virus. For those who continue to muster support for MRNA and BIoNTech and discounting their inefficacy with Omicron, have chosen their personal financial benefits at the expense of saving life in America. The proof is in the pudding.

HonestRep
HonestRep
4 months ago

Has anyone evaluated Novavax efficacy yet?

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