Published March 30, 2022
Adverse cardiovascular, thrombotic, and neurologic events related to the Covid vaccine have occurred around the world. As I and others have noted before, the Food and Drug Administration’s (FDA) own vaccine adverse event tracking system (the Vaccine Adverse Event Reporting System, or VAERS) shows substantial and serious risks from the vaccine, even though the FDA only collects an estimated 10 percent of all adverse events.
Still, federal agencies and manufacturers aren’t officially warning American public about these risks, despite having known this information for almost a whole year. The narrative that receiving vaccines and boosters, possibly forever, is a patriotic duty has superseded the traditional and normal standards of public health and safety.
It’s clear today there are both safety and efficacy problems with vaccines and boosters. All of the FDA’s 18,000-plus employees have access to the same drug safety data we have, which raises important concerns about the agency’s failure to act in the more than 14 months since the first adverse events were reported.
It is typical for labeling to reflect changes in vaccine safety as more people are vaccinated and a range of data is collected, even if most adverse events are noted as mild. But there has been no updated Covid-19 labeling reflecting the latest safety and efficacy findings in VAERS. The FDA has not issued “Dear Doctor” letters giving updated safety guidance, nor “Dear Pharmacist” letters to pharmacists, who are still administering thousands of boosters to kids and other young healthy people.
The FDA ought to recommend that physicians continue to track symptoms to avoid further inflammatory neurologic/thrombotic/cardiovascular tragedies, rather than its proposal to expand the dosing interval in hopes that a longer period between jabs will mitigate risk, though there is no concrete clinical evidence that it will do anything.
The FDA is ignoring internal drug safety epidemiologists who have noted, 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. This is standard practice with every other available vaccine.
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? The agency should convene and dedicate a Data Safety Monitoring Board to surveil all these post-marketing effects. Are Americans expected to believe that there is inadequate funding in the $6.5 billion-per-year taxpayer-funded FDA to address these public health issues?
Safety risks
Any physician, pharmacist, and nurse, or anyone else with a clinical professional license, who works at the FDA, the Centers for Disease Control (CDC), or any other public health agency, must have a “current, active, full, and unrestricted license or registration from any state in the U.S.” Not fully warning patients about the potential dangers of any drug before administering potentially dangerous vaccines and boosters places these professionals’ license at risk, regardless of what the CDC, FDA, or White House says.
Physicians, pharmacists and nurses have always been held to a higher standard. They are expected to think for themselves rather than simply take orders.
Mission failure
Separate from that, not speaking out about potential problems with a vaccine appears to be a direct violation of the Federal Public Health Vision, Mission and Values statement. This mission statement is specific about its obligations to provide accountability and clear communication in public health matters. The silence also contradicts the FDA motto, which is to assure that “all food is safe; all medical products are safe and effective; and the public health is advanced and protected.” The CDC motto pledges to “Base all public health decisions on the highest quality scientific data that is derived openly and objectively.”
When even the liberal New York Times expresses outrage at the CDC’s deliberate omission about mRNA efficacy and safety data, then it’s clear that the federal health authorities have gone too far.
FDA and CDC officials are still pushing a potentially unsafe and ineffective Covid-19 vaccine. The original strain of Covid-19 has been replaced by mutations. Continuing to promote the original vaccine for the mutated strain of Covid-19 is akin to promoting last year’s flu vaccine for this year’s flu strain. The original, Wuhan version of Covid-19 doesn’t exist today.
But that hasn’t stopped the FDA or the CDC from continuing to promote the outdated vaccine as though it’s a miracle drug. Both agencies constantly push boosters onto the American public, even showing images of kids and young adults with bandages from their latest shot, despite CDC data saying that there is essentially no benefit in boosting or vaccinating those younger groups.
CDC and FDA accountability
Unfortunately, few officials from either party, with the exception of Wisconsin Senator Ron Johnson, are willing to do anything to hold CDC and FDA officials accountable. It will likely take a combination of courageous whistleblowers, a strong president who actually believes in “following the science,” and an assertive new Congress to uncover the many CDC and FDA civil and executive service malefactors who, along with Anthony Fauci, have taken the American people for fools. The government is now entering its third year of using a virus of questionable lethality as a lever to spread fear and seize power. Regaining our rights as free citizens requires that we end the state of emergency that the public health establishment has permitted our leaders to impose.
David Gortler is a pharmacologist, pharmacist, and an FDA and healthcare policy oversight fellow at the Ethics and Public Policy Center in Washington DC. He was a professor of pharmacology and biotechnology at the Yale University School of Medicine, where he also served at Yale’s Bioethics Center, and was an FDA medical officer who was later appointed by the White House as senior advisor to the FDA commissioner for drug safety, FDA science policy, and FDA regulatory affairs. He is a columnist at Forbes, where he writes on drug safety, health care, and FDA policy.
