(LifeSiteNews) — The Trump administration’s Food and Drug Administration (FDA) announced it will now require updated safety warnings on mRNA COVID-19 shots to include the “extremely high risk” of myocarditis/pericarditis and the likelihood of long-term, irreversible heart damage for teen boys and young men up to age 24.
The required safety updates apply to Comirnaty, the mRNA COVID shot manufactured by Pfizer Inc., and Spikevax, the mRNA COVID shot manufactured ModernaTX, Inc.
According to a press release, the FDA now requires each of those manufacturers to update the warning about the risks of myocarditis and pericarditis to include information about:
- the estimated unadjusted incidence of myocarditis and/or pericarditis following administration of the 2023-2024 Formula of mRNA COVID-19 shots and
- the results of a study that collected information on cardiac magnetic resonance imaging (cardiac MRI) in people who developed myocarditis after receiving an mRNA COVID-19 injection.
The FDA has also required the manufacturers to describe the new safety information in the adverse reactions section of the prescribing information and in the information for recipients and caregivers.
Additionally, the fact sheets for healthcare providers and for recipients and caregivers for Moderna COVID-19 shot and Pfizer-BioNTech COVID-19 shot, which are authorized for emergency use in individuals 6 months through 11 years of age, have also been updated to include the new safety information in alignment with the Comirnaty and Spikevax prescribing information and information for recipients and caregivers.
In a video published on social media, Dr. Vinay Prasad, director of the Center for Biologics Evaluation & Research Chief Medical and Scientific Officer, explained the alarming reasons for the warning updates.
While heart problems arose in approximately 8 out of 1 million persons ages 6 months to 64 years following reception of the cited shots, that number more than triples to 27 per million for males ages 12 to 24.
Prasad noted that multiple studies have arrived at similar findings.
