On Friday, the U.S. Food and Drug Administration added a warning to Moderna and Pfizer-BioNTech Covid-19 vaccines regarding a rare risk of heart inflammation.
Pfizer and Moderna’s fact sheets now include a warning about myocarditis and pericarditis after the second dose. The warning stipulates that there have been reports of unfavorable events following vaccination, specifically after the second dose, which point to increased risk of both types of heart inflammation.
Myocarditis is the inflammation of the heart muscle and pericarditis is the inflammation of the tissue surrounding the heart. However, health officials firmly believe that the vaccine benefits outweigh any risk.
“The risk of myocarditis and pericarditis appears to be very low given the number of vaccine doses that have been administered,” Janet Woodcock, acting FDA commissioner, said in a statement.
“The benefits of Covid-19 vaccination continue to outweigh the risks, given the risk of Covid-19 diseases and related, potentially severe, complications,” she said.
There have been approximately 1,200 reports of said heart inflammation after 300 million doses of both vaccines had been administered. The CDC has verified 300 of those cases, which mostly involve young men and teenagers.
The FDA has advised that vaccine recipients get medical attention if they feel any “chest pain, shortness of breath, or feelings of having a fast-beating, fluttering, or pounding heart after vaccination.”
“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.
Moving forward, both the FDA and CDC are monitoring incoming reports of any complications regarding the vaccines and will continue to assess long-term outcomes.