Dr. David Gortler: Manufacturers, FDA Culpable for Ignoring COVID-19 Vaccine Risks

By David Gortler

From day one, the U.S. Food and Drug Administration knew the Covid-19 vaccine was linked to serious heart trouble in recipients.

The FDA medical officer review of Pfizer’s original Covid-19 application notes “clinically important serious adverse reactions [included] anaphylaxis and myocarditis/pericarditis”—that is, severe allergic reactions and inflammation of the heart and or the sac containing the heart, respectively.

As of this writing, FDA has not released its review of the Moderna “Spikevax” mRNA vaccine application despite having granted emergency use authorization well more than a year ago and full approval late last month. (Editors note: The document was released after this publication and is currently being reviewed).

What is Known

The Vaccine Adverse Event Reporting System (VAERS), jointly run by FDA and the Centers for Disease Control, lists a long and impersonal number of cardiovascular-related events in young, healthy people. Without reading the underlying narratives submitted with the reports, it’s hard to establish the precise causal links regarding these adverse events. Still, there are thousands of reports of heart attacks, myocarditis, and pericarditis in the United States alone, which should have spurred manufacturers and the FDA into full investigation mode.

Studies acknowledged by FDA officials show that the FDA’s various safety databases only collect an estimated 1 to 13 percent of all adverse events that occur. Multiple FDA drug safety epidemiologists have stated during official FDA presentations that it only takes a single well-documented adverse event to justify a safety signal investigation and in turn to warn the American public of the potential risk.

Historically, the FDA has sought safety warnings on labels, up to and including a “black boxed warning” and a prescribing restriction known as a Risk Evaluation and Mitigation Strategy (REMS) for much less. For instance, in 2008, after fewer than 200 spontaneous VAERS reports of tendon rupture following administration of the class of antibiotics known as fluoroquinolones, FDA added a “black box warning” and REMS prescribing restrictions.

Yet thousands of serious, debilitating, and deadly safety VAERS reports following COVID-19 vaccines and boosters are not being held to the same regulatory standards. If approximately 1 to 13 percent of adverse events are reported, extrapolating those numbers means the actual number of adverse health events could easily be in the hundreds of thousands in the United States and many millions worldwide.

In addition to VAERS, the CDC’s Vaccine Safety Datalink indicates an excess risk of myocarditis and pericarditis in recipients following the Pfizer and Moderna vaccines. The cardiovascular risk after any mRNA vaccine is high, but with Moderna, it’s approximately four times higher than Pfizer’s.

International Action

Other public health agencies with much tinier budgets and staff compared to our FDA’s took action on this months ago. In October, Denmark, Finland, Norway, and Sweden suspended the use of the Moderna vaccine for young people, but it’s still full speed ahead here in the United States.

Since then, more data has been released affirming the same: On Jan. 25, 2022, a CDC and FDA study published in JAMA shows the risk of myocarditis following any kind of mRNA Covid vaccination is greater than the background risk in the population, with the largest proportions of cases of myocarditis occurring among white males.

A comprehensive study out of Britain from December 2021 examined data from more than 42 million people who have taken a Covid-19 shot found a noteworthy increase in myocarditis with mRNA vaccines that persisted and increased with every dose and booster. “An association between Covid-19 infection and myocarditis was observed in all ages for both sexes,” the study’s abstract states. “These findings have important implications for public health and vaccination policy.” Indeed they do—especially in light of the questionable way the FDA approved vaccines in kids from 5 to 13 years old, and the pending FDA applications to approve vaccination in babies starting at 6 months old.

Losing Trust

The FDA, CDC, and manufacturers have access to VAERS and additional high-quality denominator-based vaccine safety systems including the Biologics Effectiveness and Safety Initiative (BEST) and the Vaccine Safety Datalink (VSD), respectively.

Have manufacturers and our health agencies used these tools and others to fully investigate the cardiovascular health risks of the vaccine? There is reason to doubt, given the political pressure the Biden administration has put on the agencies to advocate for taking the vaccine while almost never mentioning safety.

Myocarditis and pericarditis have historically been rare. They are defined as inflammation of the heart muscle or layers of the pericardial sac, respectively. Both conditions cause easily recognizable ECG changes and have ambiguous symptoms that include shortness of breath and chest pain. Myocarditis and pericarditis can easily be diagnosed clinically with echocardiograms and can be treated by inexpensive pharmacology and bedrest, but for that to happen, people need to know to seek medical diagnosis and care.

Therein is the problem: providers and patients are not being adequately warned to monitor for cardiovascular symptoms despite the increased incidence. Since there is a failure of manufacturers and the FDA to address this and other untoward effects of mRNA utility and mandates, outside drug safety experts need to publicly address mRNA Covid vaccine safety immediately.

The failure to adequately monitor and warn for Covid vaccine adverse events has served to harden not only Covid vaccine hesitancy but has shredded the credibility of public health authorities. The failure to openly talk about known adverse reactions erodes trust.

David Gortler (dgortler@eppc.org) is a pharmacologist, FDA, and health policy fellow at the Ethics and Public Policy Center, a former senior advisor to the FDA commissioner for drug safety, and a policy advisor to The Heartland Policy. A version of this article appeared in The Federalist on February 10. Reprinted with permission.