San Francisco Chronicle
Federal health regulators anticipate adding warnings for the Pfizer and Moderna COVID-19 vaccines in light of reports of heart inflammation in a small number of adolescents and young adults after vaccination.
The Food and Drug Administration will “move rapidly” to include the warnings of possible vaccine-induced heart inflammation on fact sheets for health care providers and recipients, the FDA’s Dr. Doran Fink said Wednesday during a public meeting of the Advisory Committee for Immunization Practices. The committee advises the federal Centers for Disease Control and Prevention on vaccine policy.
Regulators did not indicate any plans to change federal rules allowing the vaccines to be given to children as young as 12, saying the dangers of heart inflammation were small compared with the risks from contracting COVID-19.
“The facts are clear: This is an extremely rare side effect, and only an exceedingly small number of people will experience it after vaccination,” CDC Director Dr. Rochelle Walensky and Assistant Secretary for Health Dr. Rachel Levine said in a joint statement with several medical associations. “Importantly, for the young people who do, most cases are mild, and individuals recover often on their own or with minimal treatment.”
They added that myocarditis and pericarditis, inflammation of the heart and heart lining, “are much more common if you get COVID-19, and the risks to the heart from COVID-19 infection can be more severe.”
The warnings on vaccine fact sheets are meant to alert health care professionals and the public of the possible post-vaccination risk of heart inflammation. Cases of myocarditis have been reported mostly in young males within a week of getting their second shot of mRNA vaccine, the type produced by Pfizer and Moderna. Most often the cases were mild and people recovered quickly.
The issue has not been reported among people who have received the Johnson & Johnson COVID vaccine.
The latest data suggests a likely association between heart inflammation with the Pfizer and Moderna vaccines in adolescents and young adults, an analysis by the CDC committee’s vaccine safety work group found.
Fink said the FDA warning “would likely include information stating these events have occurred in some vaccine recipients following dose 2 of mRNA vaccines.” Inflammation typically has occurred “within several days to a week following vaccination,” he said.
Although the committee did not suggest changing vaccination age rules, two CDC researchers who presented new data said providers should consider a procedural change when vaccinating people with a history of myocarditis. If someone with a history of myocarditis develops symptoms after the first dose, they recommend delaying the second dose until more information is known. If the heart has recovered, the second dose can be given “under certain circumstances,” they said.
Many members of the CDC committee, which includes infectious disease and pediatric experts, said they agreed that the benefits of vaccinating young people against COVID outweigh the risks of myocarditis, which typically is treatable.
“This is still a very rare event,” said Dr. Tom Shimabukuro of the CDC’s COVID-19 Vaccine Task Force.
About 600 cases of myocarditis have been reported out of 133 million second-dose shots administered, according to new data presented by the CDC on Wednesday.
For people ages 12 to 39, myocarditis occurred at a rate of 12.6 cases per million second-dose shots in the 21 days after vaccination, according to CDC data.
“We’re talking about a handful of cases per million doses,” said Stanford infectious disease specialist Dr. Yvonne Maldonado, who added that she “absolutely” still recommends that people get vaccinated.
“The vaccine is still highly beneficial when you compare it to the risk of getting COVID disease,” Maldonado said. “The risk of COVID in an individual child or adult is still much higher than any complication from the vaccine.”
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