Authored by Zachary Stieber & Jan Jekielek via The Epoch Times (emphasis ours),
The commissioner of the Food and Drug Administration is responding to critics of the agency’s recent approvals of COVID-19 vaccines, saying the FDA is involved in a process that takes time.
Dr. Marty Makary urged patience after disclosing that he was aware of research indicating COVID-19 vaccines may cause immune system deregulation and described databases with self-reported adverse events as inadequate to determine harms from vaccines.
“I don’t want people to think that we’re blowing off the safety signal[s] that many people have described,” said Makary, who was speaking on July 14 on EpochTV’s “American Thought Leaders” in an interview that will be released soon.
“I personally know of people who have been injured by the vaccine. I personally know of friends who have lost a loved one from the mRNA COVID vaccine. So I think it is reasonable at this time to say we want good, solid, definitive data, and the conditional, limited approval of the COVID vaccines is in that framework that we want to see a proper dataset come to us so we can take a good look at that data.”
The Moderna and Pfizer-BioNTech vaccines utilize messenger ribonucleic acid (mRNA) technology.
The FDA has, for years, cleared updated COVID-19 vaccines on an annual basis despite there being scant or no clinical trial data demonstrating the effectiveness of the shots. Makary and another top FDA official, Dr. Vinay Prasad, announced in May that regulators would not be issuing new licenses for the vaccines for many Americans unless manufacturers ran trials based on clinical endpoints, such as the prevention of symptomatic COVID-19.
They also said that testing showing the vaccines trigger antibodies would be sufficient for the elderly, as well as young people with at least one condition the government says places them at higher risk of severe COVID-19 outcomes.
The FDA subsequently approved, in addition to Novavax’s vaccine, a new next-generation vaccine from Moderna and an updated version of Moderna’s existing vaccine, Spikevax, for the elderly and people with at least one risk factor. The latter approval also came for those at least 6 months of age who have at least one risk factor; previously, the vaccine was available under emergency authorization for younger children.
A spokesperson for the Department of Health and Human Services, the FDA’s parent agency, told The Epoch Times in an email that the approval was based on “a targeted review of the vaccine’s data, focused specifically on protecting children at highest risk” and that the approval “reflects a careful evaluation of the scientific evidence.” Moderna officials said the vaccines provide an important tool to protect people against severe disease and hospitalization. Critics said the FDA should not have cleared the vaccines.
“This move puts America’s children at high risk and is a giant step backward for science-based healthcare,” Dr. Joseph Varon, president and chief medical officer of the Independent Medical Alliance, said in a statement, citing concerns about side effects such as heart inflammation, or myocarditis.
Makary said in the EpochTV interview that “we have a situation whereby we would love these companies to run a proper randomized, controlled trial. And so if you do nothing—if you reject the COVID vaccines as they come to you for approval—then you have no leverage to be able to ask the company to do that, and those studies may never be done.”
The FDA does not itself run trials, and trials are large and expensive, the commissioner said. He noted that the original trials ran several years ago and said new ones should be done to show parents whether their children really need an annual COVID-19 vaccine.
Makary and Prasad wrote in a recent viewpoint that “the burden of proof must be high to vaccinate healthy people at low risk of severe disease” and that the FDA “authorizes specific indications for use only when there is substantial confidence that benefits outweigh risks.”
While doctors can administer COVID-19 vaccines and other drugs for unapproved purposes, or off-label, they urged doctors who choose to vaccinate young males—the population at highest risk of myocarditis—to consider factors such as recent COVID-19 infection and the risk of myocarditis before administering the shots.
Makary also said on EpochTV that there’s one stance for healthy people and another when it comes to people with a risk factor, such as people with cancer.
“We are going to be OK with the COVID vaccines in high-risk Americans, which is a much more limited indication,” he said.
He added later: “For people who think that we approved a COVID vaccine for, say, healthy children, that’s incorrect. That’s not true.”
Makary also highlighted how the FDA just expanded the warnings for myocarditis for the Moderna and Pfizer vaccines, both of which utilize mRNA technology, based on a safety study the FDA completed.
The updated labels state that the highest risk for myocarditis is in males aged 12 to 24, with 27 cases per million doses recorded within seven days of a vaccination.
The FDA commissioner then turned to how he knows people who were injured by the COVID-19 vaccine, and knows of deaths among others.
The Centers for Disease Control and Prevention says on its website that several factors explain reports of death after COVID-19 vaccination, including requirements that doctors report any deaths after vaccination to the Vaccine Adverse Event Reporting System (VAERS) database, regardless of the cause.
The CDC has also said that the only post-vaccination deaths caused by the vaccines were from the now-discontinued Johnson & Johnson vaccine. According to an Epoch Times investigation, the CDC found evidence, such as autopsies, that the available vaccines caused other deaths while looking into deaths reported to VAERS.
The CDC also says that certain side effects, such as myocarditis, are caused by the vaccines but that most side effects reported after COVID-19 vaccination are rare, and until recently, it recommended that all people aged 6 months and older receive an annual shot. The agency removed recommendations for healthy children and pregnant women to get a COVID-19 vaccine under orders from Health Secretary Robert F. Kennedy Jr.
Makary said he believes vaccine injuries are real and that some cases designated as long COVID, or lingering effects from a COVID-19 infection, were actually caused by vaccination.
“I’m not saying that’s all of them. I don’t want people to read too much into that. But I would like people to be patient with us as we try to approach this methodologically, collecting the proper data,” he said. “It is easy to react. I was very angry when I learned that a friend’s father had died from the COVID vaccine. And look, we’re convinced it was causal until proven otherwise. You can always nitpick and say, ‘Well, this could have been a random event,’ but no, there are many reasons why we are confident that it was causal. Now, when I say we are not the FDA, but me and my circle of friends and loved ones who know this individual who lost their father.
“So people have a right to be angry. They have been deceived on different aspects of the COVID pandemic. They have been ordered to march into a vaccine line even if they were healthy and low-risk and already had circulating antibodies. People have a right to be upset, but I would ask people to be patient with us as we do this the proper scientific way.”
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