FDA adds possible risk of heart inflammation to Moderna, Pfizer COVID-19 vaccines
Warning update follows an extensive review of information and discussion by CDC’s Advisory Committee.
FollowThe US Food and Drug Administration (FDA) has added a warning about the risk of heart inflammation to fact sheets for Moderna and Pfizer-BioNTech Covid-19 vaccines.
The warning on Friday noted that reports of adverse events following vaccination – particularly after the second dose – suggest increased risks of myocarditis, or inflammation of the heart muscle, and pericarditis, or inflammation of the tissue surrounding the heart.
For each vaccine, the fact sheets for healthcare providers have been revised to include a warning that reports of adverse events suggest increased risks of myocarditis and pericarditis, particularly after the second dose and with onset of symptoms within a few days after vaccination, the FDA said.
FDA update comes after following an extensive review of information and the discussion by CDC’s Advisory Committee on Immunization Practices meeting on Wednesday.
A panel comprising of expert advisors to the Centers for Disease Control and Prevention (CDC) on Wednesday (Jun 23) acknowledged that there was a “likely association” between mRNA Covid-19 vaccines and an elevated risk of heart issues in adolescents and young adults.
"Clinical presentation of myocarditis cases following vaccination has been distinct, occurring most often within 1 week after dose two, with chest pain as the most common presentation, " said Grace Lee, MD, chair of safety subcommittee of Advisory Committee on Immunization Practices (ACIP) that advices CDC.
"mRNA vaccines may be a new trigger for myocarditis, yet it does have some different characteristics," said Matthew Oster, MD, MPH, from the CDC's Covid-19 Vaccine Task Force.
The most common symptoms reported by patients were chest pain, shortness of breath, and difficulty sleeping.
At the end of the second week of June, more than 1,200 cases of myocarditis or pericarditis have been reported to the US Vaccine Adverse Event Reporting System.
The cases reportedly appear to be notably higher in males and in the week after the second vaccine dose.
There has been no comment from Pfizer and Moderna yet.
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