Manufacturers, FDA, Others Not Adequately Addressing Cardiovascular COVID-19 Vaccine Risks

By David Gortler, PharmD — Feb 11, 2022
From the very beginning, the FDA knew that the COVID-19 vaccine was linked to serious heart trouble in recipients. The FDA medical officer review [1] of Pfizer’s original COVID-19 application notes “clinically important serious adverse reactions [included] anaphylaxis and myocarditis/pericarditis.” There is an urgent need for the FDA, CDC, and manufacturers to thoroughly investigate serious heart-related adverse events after the Pfizer and Moderna COVID vaccines.
Image courtesy of torstensimon on Pixabay

“Mitigation of the observed risks of myocarditis/pericarditis and associated uncertainties will be accomplished through labeling (including warning statements about the risks of vaccine-associated myocarditis/pericarditis) and through continued safety surveillance and postmarketing studies to be conducted by the Applicant, US government agencies (including FDA and CDC), and other healthcare stakeholders.” [Emphasis added]

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 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. 

The Vaccine Adverse Event Reporting System (VAERS), jointly run by FDA and CDC, lists a long and impersonal number of cardiovascular-related events in young, healthy people, but without reading the underlying narratives submitted with the reports, it’s hard to establish the precise causal links regarding these adverse events.  Studies acknowledged by FDA officials show that the FDA's various safety databases only collect somewhere between 1 to 13% of all adverse events that actually occur.  During official FDA presentations, multiple FDA drug safety epidemiologists have stated that it only takes a single, well-documented adverse event to justify a safety signal investigation and, in turn, warn the American public of the 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 instance, in 2008, after less than 200 spontaneous F/AERS reports of tendon rupture following administration of the class of antibiotics known as fluoroquinolones, FDA added a “black boxed warning” and the REMS prescribing restrictions.  Yet serious, debilitating, and deadly safety VAERS reports following COVID vaccines/boosters are not being held to the same regulatory standards.  If only 1-13% of adverse events are reported, extrapolating those numbers means the actual number of adverse health events could easily be underreported. 

In addition to VAERS, the CDC’s Vaccine Safety Datalink shows 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.  For context, The CDC Vaccine Safety Datalink placed the “excess” cases of myocarditis and pericarditis at 13.1 cases/million doses administered to those age 18-39. (Roughly 300 excess cases overall).

Other public health agencies with much tinier budgets and staff compared to our FDA’s, took action on this 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 USA. 

Since then, more data has been released affirming the same:  A recent 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 from Britain from December 2021 examined data from over 42 million people who have taken a COVID-19 shot found a noteworthy increase in myocarditis with mRNA vaccines which persisted and increased with every dose and booster. 

“These findings have important implications for public health and vaccination policy.” 

Indeed they do -- especially in light of the highly questionable manner in which the FDA approved vaccines in kids from 5 to 13 years old, and the currently pending FDA applications to approve vaccination in babies from 6 months and up. 

Knowing that the Pfizer and Moderna vaccines can cause myocarditis, vaccine safety scientists need to look at other cardiovascular-related adverse effects. The FDA, CDC, and manufacturers have access to VAERS and other high-quality denominator-based vaccine safety systems, including the Biologics Effectiveness and Safety Initiative (BEST), Defense Medical Epidemiology Database (DMED), and the Vaccine Safety Datalink (VSD), respectively.

Have manufacturers and our health agencies used these tools and others to thoroughly investigate the cardiovascular health risks of the vaccine?

Therein is the problem: providers and patients are not being adequately warned to monitor for cardiovascular symptoms despite the increased incidence.  Pfizer and Moderna should use their considerable resources to research, publish and inform young people about the risk of myocarditis and pericarditis after taking their vaccines. Additionally, pharmacists should educate patients about adverse reactions such as myocarditis and pericarditis.

Going forward, Americans need safety warnings and transparency….from someone…

On February 4th, 2022, a CDC advisory committee proposed extending the gap between COVID-19 shots to mitigate the cardiovascular damage of the vaccine.  This details the fact that the federal government is aware of the serious risk, but rather than actually addressing the risk head-on and loudly communicating the risk to the public; they are taking the "half-measure" of just changing the interval and hoping to mitigate risk without evidence that it will have any effect on the outcome.  

Since manufacturers and the FDA fail to address this and other untoward effects of mRNA utility and mandates, additional drug safety experts need to publicly address mRNA COVID vaccine safety. 

Vaccines are one of the most important inventions in human history, saving millions of lives. That does not mean that every person should get every vaccine, and like every drug out there, it is critically important to detect and report safety problems quickly.

The failure to adequately monitor and warn for COVID vaccine adverse events has not only served to harden COVID vaccine hesitancy but has shredded the credibility of America’s public health authorities. The failure to encourage open conversation about known adverse reactions erodes trust. We are long past the day when hiding information from the public is considered suitable for public health. It never is.

It is not only unethical and disrespectful to patients; it’s dangerous.  

[1] Clinical Review Memorandum of Pfizer vaccine

Dr. David Gortler is a pharmacologist, pharmacist, and an FDA and health care policy 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 served at Yale’s Bioethicist Center and was an FDA Medical Officer who was later appointed by the White House to serve on the FDA’s Senior Executive Leadership Team as senior advisor to the FDA Commissioner for drug safety, FDA science policy, and FDA regulatory affairs.   He is a regular columnist at Forbes, where he writes on drug safety, healthcare, and FDA policy.