Heart Inflammation Warning to Be Added to mRNA Vaccine Fact Sheet: FDA
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.
However, the higher-than-expected reports of heart inflammation in adolescents and young adults following the second dose of the mRNA vaccine prompted the CDC to further investigate the issue.
As of June 11, more than 1,200 cases of post-vaccine myocarditis or pericarditis were reported to federal health authorities among more than 300 million mRNA vaccine doses administered.
Most of the cases were reported after individuals got the Pfizer-BioNTech shot. Some have been reported by patients receiving the Moderna vaccine. Pfizer-BioNTech’s vaccine is authorized for children as young as 12, while Moderna’s is for adults 18 and older.
Despite the “likely association” of heart inflammation and mRNA vaccines, the vaccine advisory committee says that the risk of myocarditis or pericarditis in adolescents and younger adults following inoculation with an mRNA vaccine did not outweigh the vaccine’s benefits.
The panel said the current vaccine policy would not change but risks of heart inflammation should be disclosed to patients.
The advisory committee plans to make four recommendations:
1. For individuals who had pericarditis before their first mRNA vaccine, they may “receive any FDA-authorized COVID-19 vaccine.”
2. For individuals who develop pericarditis after their first mRNA shot, they can get the second dose “after resolution of symptoms.”
3. For persons with myocarditis before their first COVID-19 vaccine, they can go ahead and get vaccinated if their “heart has recovered.”
4. For persons who developed myocarditis after their first mRNA injection, they should “defer [the second] dose of mRNA COVID-19 vaccine until more information is known.” However, they may proceed with the second dose if their heart has recovered and they’ve consulted with their physician.
The CDC’s current vaccine policy states that “COVID-19 vaccines are recommended for persons 12 years of age and older in the United States under FDA’s Emergency Use Authorization.”
The U.S. Department of Health and Human Services (HHS), the CDC, the American Academy of Family Physicians, and 14 other health organizations have published a joint statement seeking to reassure Americans that myocarditis and pericarditis are rare adverse effects that should not discourage people from getting vaccinated.
“The facts are clear: this is an extremely rare side effect, and only an exceedingly small number of people will experience it after vaccination. Importantly, for the young people who do, most cases are mild, and individuals recover often on their own or with minimal treatment. In addition, we know that myocarditis and pericarditis are much more common if you get COVID-19, and the risks to the heart from COVID-19 infection can be more severe,” the HHS said.
“We strongly encourage everyone age 12 and older who are eligible to receive the vaccine under Emergency Use Authorization to get vaccinated, as the benefits of vaccination far outweigh any harm.”
Zachary Stieber contributed to this report.