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FDA chief admits he knows people injured by COVID shots but defends their approval


(LifeSiteNews) — Trump administration Food & Drug Administration (FDA) Commissioner Dr. Marty Makary pleaded with Americans to “be patient” with its handling of the COVID-19 shots, amid discontent with the agency approving a new mRNA-based shot instead of pulling the existing ones from the market.

On July 19, The Epoch Times released a video interview with Makary covering a broad range of issues, during which senior editor Jan Jekielek relayed the surprise of the “Make America Healthy Again” movement that the FDA authorized Spikevax for “high-risk” children aged six months to 11 years old (Spikevax later received a disclaimer warning of the potential for heart damage).

Makary said they were moving away from “blindly rubber-stamping COVID vaccines each year,” but claimed that simply rejecting the jabs entirely would eliminate the government’s leverage to get the companies to conduct “proper randomized control trials.” He stressed that the vaccine is not approved for healthy children and suggested that the approach they’ve taken will finally result in more comprehensive studies that will provide more conclusive data.

Jekielek then asked about warning signs with mRNA products. Makary said the government’s current adverse event databases were “too clunky to make any inferences about rates” and that they’ve found most people who begin to report adverse events give up before completion because the website is too onerous. On the flip side, they are complicated by people who “report injuries that are not injuries,” the truth of which would require separate investigation to ascertain. 

“We’re committed” to more reliable analysis, Makary said, and are not “blowing off” warning signs. “I personally know of people who have been injured by the vaccine,” he said. “I personally know of friends who have lost a loved one from the mRNA COVID vaccine […] People have a right to be angry. They have been deceived.”

“I would ask people to be patient with us as we do this the proper scientific way,” he added, suggesting that “within the next six months these trials can be done.”

Many viewers were dissatisfied by Makary’s explanation, wondering why the existing vaccines would not be paused for safety’s sake at least until the results of those future studies are in, and noting that he originally supported much of the establishment pandemic response, including the shots, in 2020 and 2021.

There is already large body of evidence against the COVID shots, which were developed in record time by the first Trump administration’s Operation Warp Speed initiative.

The federal Vaccine Adverse Event Reporting System (VAERS) reports 38,709 deaths, 221,030 hospitalizations, 22,331 heart attacks, and 28,966 myocarditis and pericarditis cases as of June 27, among other ailments. The U.S. Centers for Disease Control & Prevention (CDC) researchers have recognized a “high verification rate of reports of myocarditis to VAERS after mRNA-based COVID-19 vaccination,” leading to the conclusion that “under-reporting is more likely” than over-reporting.

An analysis of 99 million people across eight countries published in the journal Vaccine “observed significantly higher risks of myocarditis following the first, second and third doses” of mRNA-based COVID shots, as well as signs of increased risk of “pericarditis, Guillain-Barré syndrome, and cerebral venous sinus thrombosis,” and other “potential safety signals that require further investigation.” In April 2024, the U.S. Centers for Disease Control & Prevention (CDC) was forced to release by court order 780,000 previously undisclosed reports of serious adverse reactions, and a study out of Japan found “statistically significant increases” in cancer deaths after third doses of mRNA-based COVID-19 jabs, and offered several theories for a causal link.

In January, a long-awaited Florida grand jury report on the COVID shot manufacturers found that while only a miniscule percentage of the millions of vaccinations resulted in serious harm based on the data it had access to, such events do occur, and there are “profound and serious issues” in pharmaceutical companies’ review process, including reluctance to share what evidence of adverse events they did find.

In May, Marty Makary and vaccine chief Dr. Vinay Prasad announced that there would no longer be blanket recommendations for all Americans to receive the shot, but the “risk factors” it would still be recommended for include asthma, cancer, cerebrovascular disease, chronic kidney diseases, a handful of chronic liver and lung diseases, diabetes, disabilities such as Down’s syndrome, heart conditions, HIV, dementia, Parkinson’s, obesity, smoking, tuberculosis, and more. Health & Human Services (HHS) Secretary Robert F. Kennedy Jr. subsequently announced COVID shots would not be recommended to healthy children or pregnant women.

However, last month the Trump administration approved a new mRNA-based COVID-19 shot from Moderna, for “individuals who have been previously vaccinated with any COVID-19 vaccine and are: 65 years and older, or 12 through 64 with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.” 




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