The CDC’s Advisory Committee on Immunization Practices will hold an emergency meeting on June 18 to discuss a potential link between heart inflammation and mRNA COVID-19 vaccines.
According to Becker’s Hospital Review, at a June 10 presentation to the FDA’s advisory panel, the CDC committee said it has received 275 reported cases of myocarditis, heart muscle inflammation, or pericarditis, inflammation of the heart muscle lining, in people ages 16-24 after getting their second dose of the Pfizer or Moderna COVID-19 vaccine.
The CDC advisory panel said the number of cases is higher than the 10 to 102 cases of the conditions scientists had anticipated in that age group. “We clearly have an imbalance here,” Tom Shimabukuro, MD, who works in the CDC’s Immunization Safety Office, said during the June 10 meeting.
The CDC revealed on Thursday the agency has received a total of 475 cases of myocarditis and pericarditis in people younger than 30 years old, according to The Hill, although preliminary data suggests the vast majority of such patients had fully recovered from their symptoms.
Dr. Shimabukuro pointed out that not all the reported cases may be actually true cases. “It’s a bit of an apples-to-oranges comparison because, again, these are preliminary reports. Not all these will turn out to be true myocarditis or pericarditis reports.”
Shimabukuro also said that the cases are consistent with reports of rare cases of heart inflammation that had been studied in Israel and reported from the U.S. Department of Defense earlier this year.
“Risk-benefit considerations to determine whether to issue an emergency use authorization for use of a COVID-19 vaccine into healthy pediatric individuals will need to account for this information, and risk-benefit consideration will likely be different, not only compared to those for adults, but also they may be different for younger versus older pediatric groups,” Dr. Marion Gruber, director of the FDA’s vaccine office, said at the meeting.
