The US Food and Drug Administration (FDA) has issued an alert regarding the risk of heart inflammation to fact sheets for Moderna and Pfizer-BioNTech COVID-19 vaccines.
The warning pointed out that reports of adverse effects after vaccination particularly after the second dose suggested an increased likelihood of myocarditis or inflammation of the heart muscle.
Earlier this week, vaccine consultants to the US Centers for Disease Control and Prevention heard that the organization had acquired about 1,200 reports of such heart inflammation after 300 million doses of the two vaccines had been offered.
The CDC has verified about 300 cases, many of those cases seem to be notably higher in males particularly young men and adolescents. The cases seem to stem mostly after the second vaccine dose.
The alert update follows a substantial analysis of information and discussion by the US Centers for Disease Control and Prevention (CDC’s) Advisory Committee on Immunization Practices, the FDA said.
“This is still an unusual event,” Dr Tom Shimabukuro said at the meeting. For both vaccines combined, there were 12.6 heart inflammation cases per million doses. The cases were more steady among Moderna’s vaccine partakers at 19.8 cases per million versus eight outbreaks per million for Pfizer’s.
Men under 30 compose the majority of the cases, the CDC said, and most cases happen to be mild of the 295 people who have acquired the ailment and had been discharged.
The FDA is urging vaccinators to seek timely medical attention if they experience “chest pain, shortness of breath, or feelings of having a fast-beating, fluttering, or pounding heart after vaccination.”
The data presented at FDA’s meeting strengthened the decision to revise the fact sheets and further informed the specific revisions,” the FDA said in a statement.
There has been no comment from Pfizer and Moderna yet.