The Centers for Disease Control and Prevention (CDC) announced this week that they will be holding an emergency meeting on June 18th to discuss reports of heart inflammation following doses of both the Pfizer and Moderna Covid-19 vaccines. While the CDC claims that these reports have been rare, they’re still higher than initially expected, hence the meeting.
The CDC has identified 226 cases that could meet the agency’s definition of myocarditis and pericarditis following the injections. A majority of those who experienced inflammation have recovered while 41 experienced ongoing symptoms, 15 are still currently hospitalized, and 3 are in the intensive care unit.
“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.”
Dr. Tom Shimabukuro, a CDC vaccine safety official, stated that so far their findings were mostly “consistent with reports of rare cases of heart inflammation that had been studied in Israel and reported from the US Department of Defense earlier this year.”
A panel of independent advisers for the Food and Drug Administration (FDA0 will be meeting this upcoming Thursday to review the new details regarding myocarditis and pericarditis. The meeting will also serve to discuss how the FDA should approach giving an emergency use authorization for using these vaccines in younger children; the next phase of reaching herd immunity in America.
Pfizer already received an emergency use authorization for their vaccine in Americans 12 and up last month, and announced that they were already going through trials to make sure it’s safe for children as young as 6 months old. Moderna is also in the process of seeking a EUA for their vaccine in adolescents.
Pfizer believes they can finish their children’s trials by the beginning of September, while FDA officials have warned that authorizing vaccines for younger age groups, especially babies and toddlers, could take longer due to how much their bodies are still developing. The FDA believes children will likely be able to receive their vaccines by mid to late fall at the earliest.
“We recognize that some adverse reactions, for example myocarditis or pericarditis as discussed earlier today, may be too infrequent to detect in a safety database of typical size for pre-licensure clinical trials,” said Dr. Doran Fink, a top official in the FDA’s vaccine office.
“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.
Eric Mastrota is a Contributing Editor at The National Digest based in New York. A graduate of SUNY New Paltz, he reports on world news, culture, and lifestyle. You can reach him at firstname.lastname@example.org.