Ex-FDA adviser: Agency ignoring requirement to disclose COVID-shot risks

A former adviser to the FDA commissioner who continues to serve in an oversight role says the agency is ignoring its requirement to disclose clear safety and efficacy problems with the COVID-19 vaccines.

‘It’s pretty clear today there are both safety and efficacy problems’

Art Moore
WND News Center

A former adviser to the FDA commissioner who continues to serve in an oversight role says the agency is ignoring its requirement to disclose clear safety and efficacy problems with the COVID-19 vaccines.

David Gortler wrote in a column Friday for the Federalist that, for example, the FDA, Centers for Disease Control, Pfizer and Moderna have known from the beginning about myocarditis and pericarditis risks from the mRNA vaccines.

And there are many other adverse events reported in the tracking system run by the FDA and the CDC, the Vaccine Adverse Event Reporting System, or VAERS.

Yet no formal warnings have been made to Americans, such as labeling and letters to warn physicians, pharmacists, or the American public.

“Why? One reasonable explanation is because it would counter the narrative that endless vaccines and boosters is your patriotic duty,” Gortler wrote.

He explained that, normally, the responsibility of notifying consumers and prescribers of updates in safety and efficacy would fall upon manufacturers.

“But since Covid-19 vaccinations were mandated by the White House for all workers until the Supreme Court took action (they are still mandated for health-care professionals), and the fact that Pfizer and Moderna still have a federally granted liability shield, the duty of safety monitoring must fall under the auspices of the FDA.”

Gortler is a pharmacologist, pharmacist and FDA and health policy fellow at the Ethics and Public Policy Center in Washington, D.C. He was an FDA medical officer before being appointed by the Donald Trump White House as senior adviser to the FDA commissioner for drug safety, FDA science policy and FDA regulatory affairs. Gortler previously served as a professor of pharmacology and biotechnology at the Yale University School of Medicine, where he also served at Yale’s Bioethicist Center.

He noted that the relatively sparse 107-page FDA review document conspicuously notes “clinically important serious adverse reactions [included] anaphylaxis and myocarditis/pericarditis,” meaning severe allergic reactions and inflammation of the heart and or the sac containing the heart.

Moderna’s review was only 30 pages, but it also presented indications of myocarditis and pericarditis in the initial study.

“It’s pretty clear today there are both safety and efficacy problems with vaccines and boosters,” Gortler wrote. “Because all of the FDA’s 18,000-plus employees had access to the same drug safety data we have, one must ask questions like these: Where is the updated Covid-19 labeling reflecting the latest safety and efficacy findings in VAERS?”

He had more questions:

  • Where are the FDA “Dear Doctor” letters giving updated safety guidance?
  • Where are the “Dear Pharmacist” letters to pharmacists who are still administering thousands of boosters to kids and other young healthy people on a daily basis?
  • Why isn’t the FDA recommending follow-up symptom tracking to avoid further inflammatory neurologic/thrombotic/cardiovascular tragedies instead of its proposal to extend the dosing interval and cross fingers that would mitigate risk (as there is no concrete clinical evidence that will happen)?
  • Why is the FDA ignoring internal drug safety epidemiologists who have stated during official FDA presentations that it only takes a single, well-documented adverse event to justify a safety signal investigation and warning to the American public of the risk?
  • Why isn’t the FDA demanding studies addressing genotoxicity, teratogenicity, oncogenicity, the potential for reduced fertility in men and women, the clinical effects of spike proteins in donated blood, and the bioaccumulation of vaccine in women’s ovaries?
  • Why isn’t the agency convening and dedicating a Data Safety Monitoring Board to surveil all these post-marketing effects and others?

Gortler pointed out that for any physician, pharmacist or other health professional working for the FDA, CDC or another agency, failure to warn patients about the potential dangers of any drug would place their professional licenses at risk.

“Physicians, pharmacists and nurses have always been expected to think for themselves rather than simply take orders.”

Gortler said he believes that “starker evidence of clear malfeasance” will be revealed, most likely under a Republican administration.

“When that happens, the licensed practitioners and scientists responsible for withholding vital health information from the public should be thoroughly investigated by their academic boards and licensing authorities,” he said.

He said FDA officials “are still pushing a potentially risky vaccine by purposely hiding facts from the public.”

The FDA website, he pointed out, shows images of children and young adults pushing boosters, despite the latest CDC data indicating there is no known benefit of COVID vaccination for those low-risk groups.

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christodamas
christodamas
3 months ago

The FDA website, he pointed out, shows images of children and young adults pushing boosters, despite the latest CDC data indicating there is no known benefit of COVID vaccination for those low-risk groups.

The FDA is rotted to the core.

Margaret
Margaret
2 months ago

664 Reports of Myocarditis in 5- to 17-Year-Olds After COVID Shots, VAERS Data ShowVAERS data released Friday by the Centers for Disease Control and Prevention included a total of 1,195,396 reports of adverse events from all age groups following COVID vaccines, including 26,059 deaths and 211,584 serious injuries between Dec. 14, 2020, and March 18, 2022.

Read the article for details about adverse health Impacts after COVID vaccination reported to VAERS including: heart disorders, myocarditis, pericarditis, myocardial infarction, blood clotting, strokes, neurological disorders such as paralysis, hearing and vision impairment, and other serious impacts, premature births and miscarriages, severe or life threatening allergic reactions, amputations and more.

Heart Damage Found in Teens Months After Second Pfizer Shot, Study ShowsA new peer-reviewed study shows more than two-thirds of adolescents with COVID-19 vaccine-related myopericarditis had persistent heart abnormalities months after their initial diagnosis, raising concerns for potential long-term effects and contradicting claims by health officials that the condition is “mild.”

Citizen T.
Citizen T.
2 months ago

This article should be headlines across the country.
People face a dilemma when they must vaccinate or lose their job.
Even from a safety perspective, why take the vaccine when it is not effective against current variants? (does no good and in fact can harm) FDA needs to do the right thing and approve Novavax, which doesn’t suffer from the myocarditis issues and is actually effective against Omicron.