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The CDC meeting follows the Food and Drug Administration’s advisory committee discussion earlier this month about cases of myocarditis and pericarditis seen in a small number of patients who received either of the two available mRNA shots. Health officials are particularly focused on cases seen in people age 30 or younger.
Fink said the FDA wanted to hear the CDC committee before finalizing the wording. The FDA warning likely says there may be a risk of developing myocarditis or pericarditis within a week after receiving a second dose of Pfizer or Moderna shots, and most cases seem to resolve themselves. The long-term effects, however, remain unclear.
Scope of the problem: Cases are rare, with more than 1,200 cases under investigation as of June 11 among the more than 150 million people who have received the Pfizer or Moderna vaccines. The CDC discovered more cases occurring after the second shot of the mRNA vaccine. More cases have been reported among recipients of the Pfizer vaccine, which may be due to the fact that the injection is allowed for people 12 years of age and older, while the Moderna dose is only allowed for adults.
“mRNA vaccines may be a new trigger for myocarditis,” said CDC’s Matthew Oster, “and the condition can also occur after viral infection, including Covid-19.”
Despite the potential risks, the benefit of immunization against the Covid-19 virus is enormous, a group of public health officials in the federal and private sectors said in a statement released during the Centers for Disease Control and Prevention meeting. They urged Americans 12 and older to get vaccinated because the risks of vaccine rejection are “far greater than any rare side effects from vaccines,” especially as the highly contagious delta variant continues to spread widely and sicken young adults.
“The facts are clear: This is an extremely rare side effect, and very few people will experience it after vaccination,” officials including CDC Director Rochelle Walinsky and Assistant Secretary of Health Rachel Levine said in the statement. For young people who experience it, most cases are mild, and individuals usually recover on their own or with minimal treatment. In addition, we know that myocarditis and pericarditis are more common if you become infected with COVID-19, and the risks to the heart from COVID-19 infection can be more severe.”
Follow-up surveillance: If a link between mRNA vaccines and heart disease is established, especially among young adults, the number of reported cases will likely rise. Almost every syringe given in the United States is either Pfizer or Moderna, and only children ages 12 to 15 were eligible for Pfizer vaccines as of May 10, when the Food and Drug Administration (FDA) expanded its emergency authorization to include the category age.
The CDC plans to recommend that patients who develop myocarditis after the first mRNA dose of Covid postpone their second dose until more data is collected on the condition’s association with Covid-19 vaccines, Sarah Oliver of the agency’s National Center for Immunization and Respiratory Diseases said. But, she added, a person can receive their second dose after consulting with a doctor if their heart has recovered.
The next step: Despite lingering questions about cases of post-vaccination myocarditis, federal health officials and advisory committee members agreed that the benefits of immunizing teens and young adults outweighed the risks. With the makers of the Covid-19 vaccine now studying their shots on babies as young as six months old, regulators will be watching for any signs of an increased risk of heart infection.
Health officials are considering physiological differences between adolescents and younger children, as well as disease severity in this population, in relation to the benefits of giving injections to different age groups of children. Children are less likely than adults to develop severe Covid, but federal data shows that children under 5 and teens have higher rates of hospitalization from 5 to 11 years old. Children are also at risk of developing a serious inflammatory syndrome known as MIS-C.
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