FDA Pushes To Authorize Novavax’s Covid-19 Vaccine Despite Serious Cardiovascular Safety Issues

David GortlerJune 9, 2022

Earlier this week, the U.S. Food and Drug Administration (FDA) had a public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss an emergency-use authorization (EUA) request by Novavax for its vaccine to prevent Covid-19 in individuals 18 years of age and older. The committee voted to approve it.

It is clear that there is a noteworthy adverse event signal, especially cardiovascular-related events, following existing Covid vaccines and boosters. Based on available evidence, there is no reason to think the Novavax vaccine will be any different. Indeed, the FDA review of the Novavax “protein subunit” vaccine acknowledged the vaccine carried the possible risk of causing heart inflammation, particularly in young males, similar to the Pfizer, Moderna, and AstraZeneca mRNA vaccines.

In addition to the medical review, the FDA’s Vaccine Adverse Event Reporting System (VAERS) database for Covid-19 vaccines shows a significant number of cardiovascular-related events in young healthy people in particular. To date, there are tens of thousands of reports of heart attack, myocarditis, or pericarditis in the United States alone.

The United States alone has accumulated a list of more than 800,000 reports of adverse events associated with these vaccines, with even more adverse events reported worldwide. Moreover, reported cases are well known to represent only 1–10 percent of the adverse events that occur in actuality. In short, the sheer number of cases — something we’ve never seen before — is cause for alarm to drug safety experts like myself.

Myocarditis and pericarditis used to be considered rare conditions. They are defined as inflammation of the heart muscle or layers of the pericardial sac, respectively. Both conditions cause easily recognizable echocardiogram (ECG) changes and have nonspecific symptoms that include shortness of breath and chest pain.

They can easily be diagnosed clinically with ECGs and treated by pharmacology, but in order for physicians to do that, the FDA label must recommend physicians look for certain symptoms immediately following Covid-19 vaccination. Failing to immediately diagnose myocarditis or pericarditis could have fatal consequences.

These cardiovascular adverse events were warned about in the FDA medical review of the Pfizer application, and the FDA receives new reports on cardiovascular adverse events on a daily basis. The FDA’s medical officer review, which was the basis for approving the Pfizer vaccine, notes that “clinically important serious adverse reactions [were] anaphylaxis and myocarditis/pericarditis.”

Patients Not Warned of Risks

But the problem is patients were — and are still — not being adequately warned or monitored for cardiovascular symptoms on existing Covid-19 vaccines. Pfizer should already have placed a warning on the label.

Pfizer, Moderna, and AstraZeneca should have already volunteered to warn all their patients about potentially deadly cardiovascular adverse events, as well as other adverse events trending upward in VAERS that are associated with Covid vaccine and booster administration. At a minimum, any Novavax vaccine should have a prominent warning informing the public about the risk of potential serious and deadly cardiovascular adverse events, but since Pfizer and Moderna aren’t doing so, neither is Novavax.

Adverse events from drugs were already the fourth leading cause of death prior to the Covid-19 pandemic, according to the FDA. Because Pfizer and Moderna’s cardiovascular and other adverse events were not taken seriously enough by the FDA to warrant more substantial labeling warnings, Covid-19 vaccine adverse events have become a major source of morbidity and mortality, per the FDA’s VAERS reporting system.

VRBPAC granted an EUA to the Novavax vaccine, prior to its full clinical review, even though it appeared to have at least the same cardiovascular risk as other Covid-19 vaccines. In its meeting, the FDA’s vaccine advisory committee members voted “yes” on the question “Based on the totality of scientific evidence available, do the benefits of the Novavax COVID-19 Vaccine when administered as a two-dose series outweigh its risks for use in individuals 18 years of age and older?”

The Answer to the Question Should Have Been ‘No’

The FDA described events of myocarditis and pericarditis associated with the Novavax vaccine. This is in spite of the fact that Novavax, along with all drug manufacturers, made their best effort to only recruit healthy volunteers to enter their vaccine trials.

While the number of reports were few in the Novavax briefing document, the real-world incidence of cardiovascular risk and all other adverse events presented is likely substantially greater. Novavax’s Covid-19 vaccine does not appear to offer any safety advantage over existing mRNA vaccines.

Like the Pfizer, Moderna, and AstraZeneca vaccines, the risk for myocarditis is greatest with young, healthy males. Despite the rather implicating pattern, Novavax officials stated that “we believe there is insufficient evidence to establish a causal relationship.”

Other adverse events reported (not including minor adverse event reports such as pain at the injection site, fatigue, headache, and muscle ache) with Novavax appear to follow the same unacceptable safety profile associated with other vaccines. Despite that, Novavax officials have stated that “We believe our vaccine offers a differentiated option.”

But that differentiation, while certainly applying to a mechanistic effect, does not appear to translate to a safety effect. While there seems to be a benefit from an efficacy standpoint with Novavax’s vaccine for now, that didn’t end well with any of the mRNA vaccines.

FDA Ignores Vital Questions

Two fundamental questions seem to have been ignored by the FDA in advancing this to an advisory committee meeting. The first question is whether a vaccination, especially approved through the EUA process, is needed at all.

We are no longer deeply embedded in the throes of the pandemic. In addition, there is a well-established low risk of serious Covid complications with the existing dominant variants and the availability of therapeutics with known safety records, with mask-wearing and social distancing as alternate protective measures.

On top of that, we have seen a crumbling efficacy plus clear problems with safety from all other Covid-19 vaccines. If the Novavax vaccine is somehow better, the manufacturer ought to take the time to scientifically prove it via clinical trials before widely advocating for administering it to patients nationwide.

The second question is regarding vaccination for anyone (and everyone) as we are approaching herd immunity from the wild-type Covid-19 strain. Giving the original vaccine for Covid-19 is akin to giving the flu vaccine from 2020 for the new strain of flu in 2022.

On top of that, most people around the world have already acquired natural immunity through previous infections, and therefore do not need any Covid-19 vaccinations. This is especially true in light of the findings of the recent 30,000-person study sponsored by Moderna and Anthony Fauci’s National Institute of Allergy and Infectious Disease (NIAID), which shows that natural immunity is superior to immunity given by any Covid-19 vaccines.

The Novavax vaccine should not have been granted an EUA because there is no actual Covid-19 emergency necessitating the emergency approval process, and the vaccine trials show evidence of a serious risk of heart inflammation.

Our FDA seems to have lost its historically sacrosanct high standard for drug safety and efficacy. It is the American public who will suffer from the agency’s failure to take the time to adequately test its hypothesis before making its decision. Unfortunately, this is far from being an isolated or “one-off” incident.

Dr. David Gortler is a pharmacologist, pharmacist, and an FDA and health policy fellow at the Ethics and Public Policy Center. He was a professor of pharmacology and biotechnology at the Yale University School of Medicine, where he also served at Yale’s Bioethicist 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.