The Food and Drug Administration (FDA) said on Wednesday that it will add a warning of heart inflammation to the fact sheet for the Pfizer and Moderna mRNA COVID-19 vaccines that are given to patients prior to vaccination.
At a meeting of the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP), Dr. Doran Fink, deputy director of the FDA’s vaccines division told the committee that the FDA will “move rapidly to update the fact sheets” to ensure transparency surrounding identified risks, no matter how rare.
“We do agree that, based on the available data, a warning statement in the fact sheets for both healthcare providers and vaccine recipients and caregivers would be warranted in this situation,” Fink said.
Fink added that the warning statements “would likely include information stating that these events have occurred in some vaccine recipients, particularly following dose two of mRNA vaccines, that the onset of symptoms typically have been several days to a week following vaccination.” Symptoms include chest pain and shortness of breath.
ACIP met to discuss the latest data on myocarditis and pericarditis incidents following mRNA vaccination in adolescents and younger adults under 29, particularly after a second dose. The majority of inflammation cases have also been reported in male patients.
A member of the panel who gave a presentation at the meeting suggested that there was a “likely association of myocarditis with mRNA vaccination in adolescents and young adults.”
Dr. Mathew Oster, a pediatric cardiologist at Children’s Healthcare of Atlanta, also told the panel, “It does appear that the mRNA vaccines may be a trigger for myocarditis.”
Dr. Tom Shimabukuro, a CDC official, to the agency’s vaccine advisory committee said that case rates logged in the reporting system are higher than expected in young males.
Pfizer and Moderna have not returned requests for comment from The Epoch Times.
Myocarditis is inflammation of the heart muscle, while pericarditis is inflammation of the sac-like tissue surrounding the heart. Inflammation can also occur due to infection with the CCP (Chinese Communist Party) virus that causes the disease COVID-19. So far, no one has died from inflammation following vaccination although many have been hospitalized.
BY MEILING LEE