FDA to add warning on Pfizer and Moderna mRNA vaccines about link to heart inflammation
The Centers for Disease Control and Prevention (CDC) announced Wednesday, June 23, that the Food and Drug Administration (FDA) will add a warning to the Pfizer and Moderna coronavirus (COVID-19) vaccines about possible link to cases of myocarditis and pericarditis in teenagers and young adults.
Myocarditis is a condition that involves inflammation of the heart muscle. Symptoms can include fever and fatigue, as well as shortness of breath and a very specific type of chest pain. Patients tend to say their chest hurts more when they lean forward. The pain tends to subside when they lean back. Pericarditis, on the other hand, is the swelling and irritation of the thin, sac-like tissue surrounding the heart.
The Advisory Committee on Immunization Practices (ACIP), CDC’s vaccine advisory group, met Wednesday to discuss instances of myocarditis and pericarditis in people aged 30 and younger who have received an mRNA COVID-19 vaccine. Pfizer and Moderna use mRNA technology in their COVID-19 vaccines, while Johnson & Johnson uses the more traditional virus-based technology.
There have been 484 combined preliminary reports of myocarditis and pericarditis in young people under age 30 as of June 11.
So far, 323 cases have been confirmed by CDC. A total of 309 patients were hospitalized, of which 295 were discharged and 79 percent have since recovered. Nine patients are still in hospital, including two in intensive care units. Males were much more likely to report heart inflammation after receiving a second dose than women.
ACIP sees link between mRNA vaccines and heart inflammation
The COVID-19 Vaccine Safety Technical (VaST) Work Group, which is part of ACIP, assessed the reported cases and noted that the risk of myocarditis or pericarditis following vaccination with the mRNA-based vaccines in adolescents and young adults is notably higher after the second dose and in males.
According to VaST, the data suggests a likely association of myocarditis and pericarditis with mRNA vaccination in adolescents and young adults. The group will continue to review the data on myocarditis and pericarditis from available surveillance systems and ongoing safety evaluations.
The ACIP makes recommendations on how to use vaccines to control diseases in the U.S. The recommendations are nonbinding but the CDC often takes the recommended action. (Related: CDC to hold emergency meeting following reports linking mRNA vaccines to heart inflammation.)
Following the meeting, ACIP’s recommendations were as follows:
- Those with pericarditis prior to vaccination can receive any FDA authorized COVID-19 vaccine.
- Those with pericarditis after the first dose of an mRNA COVID-19 vaccine but prior to a second dose should proceed with a second dose of mRNA COVID-19 vaccine after resolution of symptoms.
- Those with myocarditis prior to a COVID-19 vaccination can receive any FDA-authorized COVID-19 vaccine if their heart has recovered.
- Those with myocarditis after the first dose of an mRNA COVID-19 vaccine but prior to a second dose should defer a second dose of mRNA COVID-19 vaccine until more information is known. However, if their heart has recovered, they should consider proceeding with a second dose under certain circumstances.
CDC alarmed by higher-than-expected cases of heart inflammation following COVID-19 vaccination
Earlier this month, the CDC said a higher-than-expected number of young men have experienced heart inflammation after their second dose of the mRNA COVID-19 vaccines, with more than half the cases reported in people between the ages of 12 and 24.
Dr. Tom Shimabukuro, deputy director of the CDC’s Immunization Safety Office, said in a presentation that data from the Vaccine Safety Datalink (VSD) suggests a rate of 12.6 cases per million in the three weeks after the second shot in people between the ages of 12 and 30.
The higher-than-expected rate of the myocarditis and pericarditis cases among Americans below 30 is consistent with the data from Israel.
Israel’s Ministry of Health identified over 200 cases in men between 16 and 30 years old, a vast majority of those happening at the younger end of that range. That equates to a risk of between 1 in 3,000 and 1 in 6,000 of suffering from heart inflammation.
Pfizer, whose vaccine has been authorized for use in Americans as young as 12, previously said it had not observed a higher rate of heart inflammation than would normally be expected in the general population.
Moderna had said it could not identify a causal association with the heart inflammation cases and its vaccine.
HHS releases statement downplaying link of mRNA vaccines to heart inflammation
Despite the ACIP’s findings linking the mRNA vaccines to heart inflammation, the Department of Health and Human Services (HHS) on Wednesday issued a statement from some of the country’s leading doctors, nurses and public health leaders urging all Americans 12 and older to get vaccinated.
“We strongly encourage everyone eligible to receive the vaccine under emergency use authorization to get vaccinated,” they said. “With the troubling Delta variant increasingly circulating, and more readily impacting younger people, the risks of being unvaccinated are far greater than any rare side effects from the vaccines.”
They also downplayed the cases of heart inflammation linked to the mRNA vaccines.
“The facts are clear. This is an extremely rare side effect, and only an exceedingly small number of people will experience it after vaccination. Importantly, for the young people who do, most cases are mild, and individuals recover often on their own or with minimal treatment,” they said.
Without giving facts, they added: “We know that myocarditis and pericarditis are much more common if you get COVID-19, and the risks to the heart from COVID-19 infection can be more severe.”
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