Former FDA senior adviser warns the public: FDA is purposely hiding facts about COVID-19 vaccine health problems By Zoey Sky for Heart
Countless reports and many studies have shown that the Wuhan coronavirus (COVID-19) vaccines are linked to adverse effects, from minor ones like pain at the site of injection to more serious side effects like heart inflammation.
David Gortler, a former senior adviser to the Food and Drug Administration(FDA) commissioner, warned that the agency is ignoring its requirement to “disclose clear safety and efficacy problems with the COVID-19 vaccines.”
Gortler is a pharmacologist, pharmacist and an FDA and health policy fellow at the Ethics and Public Policy Center (EPPC). He was an FDA medical officer before being appointed by former president Donald Trump’s White House as senior adviser to the FDA commissioner for drug safety, FDA science policy and FDA regulatory affairs.
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Americans remain uninformed about COVID vaccine side effects
Late in March, Gortler wrote a column where he warned that the FDA, the Centers for Disease Control and Prevention(CDC), Pfizer and Moderna have all known from the beginning about myocarditis and pericarditis risks from the COVID-19 mRNA vaccines.
Throughout the coronavirus pandemic, many adverse events have been reported using the Vaccine Adverse Event Reporting System (VAERS), the tracking system run by the FDA and the CDC. But Gortler pointed out that Americans have received no formal warnings, such as labeling and letters to warn physicians, pharmacists or the public.
He thinks that it is because it would dispel the narrative that getting vaccines and boosters is the “patriotic duty” of Americans. Usually, notifying consumers and prescribers of updates in safety and efficacy is the responsibility of manufacturers.
Gortler also noted that the meager 107-page FDA review document obviously excluded “clinically important serious adverse reactions” like anaphylaxis (severe allergic reactions), myocarditis and pericarditis.
Myocarditis and pericarditis involve inflammation of the heart and the sac containing the heart, respectively. (Related: Pfizer sweeps in to control the FDA and facilitate sweeping redactions of the court-ordered disclosure of their vaccine injury data.)
Meanwhile, Moderna’s review only had 30 pages but presented reports of myocarditis and pericarditis in the initial study. There’s no denying that there are many safety and efficacy issues with coronavirus vaccines and boosters, warned Gortler.
Since the FDA’s 18,000-plus employees had access to the same drug safety data, this emphasizes the fact that there is still no updated COVID-19 labeling reflecting the latest safety and efficacy findings in VAERS.
Scrutinizing the COVID-19 vaccine
Gortler has these questions for the FDA:
- Where are the FDA “Dear Doctor” letters with updated safety guidance?
- Where are the “Dear Pharmacist” letters to pharmacists who are still inoculating and giving boosters to thousands of kids and other young healthy people daily?
- Why isn’t the FDA recommending follow-up symptom tracking to avoid further inflammatory cardiovascular, neurologic or thrombotic events?
- Why isn’t the FDA convening and dedicating a Data Safety Monitoring Board to monitor all post-marketing effects and others?
Gortler also advised that for any physician, pharmacist or other health professional working for the FDA, CDC or another agency, the failure to warn patients about the potential dangers of any drug would place their professional licenses at risk. He added that more evidence of “clear malfeasance” will be revealed, but probably under a Republican administration.
If that happens, all the licensed practitioners and scientists who withheld crucial information about the side effects of the COVID-19 vaccines from the public should be thoroughly investigated by their academic boards and licensing authorities.
Despite the many reported cases of adverse reactions, FDA officials are still pushing the “potentially risky vaccine” by hiding data from the public. Even the FDA website shows images of children and young adults getting boosters. However, the latest CDC data has revealed that there is no known benefit of coronavirus vaccination for those low-risk groups.
