(Republican Insider) – The FDA has now approved a fourth COVID-19 booster and a fifth for those who are considered immunocompromised. The FDA did this without even so much as consulting with its expert panel.
As you may recall, two top FDA scientists resigned last year after claiming that the agency’s vaccine-approval process had been compromised by politics. Now it looks like the FDA isn’t even interested in getting a vote from the expert panel before moving forward with approving even more shots.
The shots, by the way, are the very same formula as they’ve always been, designed for the long gone original strain out of Wuhan.
Nonetheless, the US is now leading the world and has become the first country to recommend a fifth shot.
The agency said this especially fragile group also can get an additional booster, a fifth shot. https://t.co/CgEcNpJfer
— ABC7 Sarasota (@mysuncoast) March 29, 2022
The FDA took plenty of heat over their latest announcements including from Dr. Marty Makary, professor at Johns Hopkins University, who 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.”
Mercury News noted that the FDA’s announcement on Tuesday was not a recommendation but rather just the expansion of emergency use authorization for the Pfizer and Moderna shots as second boosters. Apparently, we are still under a state of emergency, which is outright ridiculous in its own right.
The agency’s outside panel of vaccine experts is scheduled to meet April 6 to discuss boosters but no vote is planned.
WND reports: “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.”
The director of the FDA’s Center for Biologics Evaluation and Research, Dr. Peter Marks, 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 therefore 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.
Never mind the risks of getting even just one of these shots let alone four of them. The so-called scientists at the FDA aren’t very concerned about the potentially dangerous side effects.
Marks was at the center of the resignations last summer at the FDA of top scientists Marion Gruber and Philip Krause. Politico cited a former FDA official who said the two officials quit because they were angry about the agency’s lack of autonomy when it came to its approval of the vaccines.
A current FDA official told Politico that the resignations came due to differences with Marks who appears to be motivated by politics rather than science.
On Tuesday, Dr. Makary pointed out that “political interference over boosters” from the Biden regime was the issue that resulted in the resignations.
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.
Makary further noted that editor of the New England Journal of Medicine and member of the FDA’s expert vaccine panel, Dr. Eric Rubin, 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.”
Rubin famously argued during a vaccine panel hearing last fall regarding giving the vaccines to children under 12, “We’re never going to learn about how safe the vaccine is unless we start giving it,” adding, “That’s just the way it goes.”
This was after he acknowledged that myocarditis is “a side effect that we can’t measure yet.” As we all know, he went on to approve the vaccines anyway.
Makary asserted that Biden and his new FDA commissioner 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,” he wrote.
Science, he further argued, should not be compromised by politics. During an appearance on Fox News Tuesday, Makary stated he would not be getting a booster shot.
During the interview, he was asked about Washington DC’s threat to revoke the medical license of any physician who doesn’t get a booster shot by Thursday.
Makary stated that he was “unboosted” and if DC makes good on their threat, he will lose his 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.
No one should get jabbed with anymore COVID shots simply because the federal government says we should. There is no scientific data to back up the need for additional shots. There isn’t even any data to back up the need for one shot, especially for healthy young people.
This is absolute lunacy.
Isn’t COVID supposed to be over?
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