FDA Adds Heart Inflammation Warning to Moderna, Pfizer Vaccines
But the condition is very rare and patients are recovering quickly.
The US Food and Drug Administration added a warning about the potential risk for heart inflammation to the Moderna and Pfizer-BioNTech vaccine on Friday.
The respective vaccines’ fact sheets now say that they carry a slight risk for myocarditis and pericarditis amongst vaccine recipients, according to CNN. The addition of the warnings come on the heels of a CDC announcement that it received around 1,200 reports of heart inflammation after 300 million doses of the vaccines had been administered. The CDC confirmed just 300 of those cases. The cases seem to primarily occur in adolescents and young men in particular.
“This update follows an extensive review of information and the discussion by CDC’s Advisory Committee on Immunization Practices meeting on Wednesday,” the FDA said in a press release. “The data presented at this meeting reinforced the FDA’s decision to revise the fact sheets and further informed the specific revisions.”
While it seems disconcerting, cases of heart inflammation amongst those receiving the vaccine are still incredibly rare. There have only been 12.6 heart inflammation cases for every million doses of both vaccines combined, reports CNBC. On top of that, the patients afflicted by the issue are quickly recovering.
“The risk of myocarditis and pericarditis appears to be very low given the number of vaccine doses that have been administered,” acting FDA commissioner Janet Woodcock said in a statement attained by CNBC. “The benefits of Covid-19 vaccination continue to outweigh the risks, given the risk of Covid-19 diseases and related, potentially severe, complications.”
So if you haven’t gotten your vaccine yet, you should not let the tiny risk of heart inflammation stop you. It’s still a better alternative to catching the coronavirus — and potentially suffering from its long-term effects.