US Foods and Drug Administration warning about rare cases of heart inflammation
The US Foods and Drug Administration said it will add a warning about rare cases of heart inflammation in adolescents and young adults to fact sheets for the Pfizer/BioNTech and Moderna Covid-19 vaccines.
US Centers for Disease Control and Prevention (CDC) advisory groups, meeting to discuss reported cases of the heart condition after a vaccination, found the risk in adolescents and young adults is likely linked to the vaccines, but that the profits of the shots appeared to clearly outweigh the risk.
Pfizer, whose vaccine has been authorized for use in Americans as young as 12, previously said it had not observed a higher rate of heart inflammation than would normally be expected in the general population.
Moderna said it is aware of reports of heart inflammation cases following the administration of mRNA vaccines. It said it is working with public health and regulatory authorities to assess the issue.