On June 23, 2021, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) determined that there is a “likely association” between reported cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane surrounding the heart) following vaccination with experimental messenger RNA (mRNA) biologics for COVID-19 developed by Pfizer/BioNTech and Moderna/National Institute of Allergy and Infectious Diseases (NIAID).1 2 3 4
According to Grace Lee, MD, who chairs ACIP’s safety group:
Clinical presentation of myocarditis cases following vaccination has been distinct, occurring most often within one week after dose two, with chest pain as the most common presentation.3
Based on CDC data, there have been more than 1,200 cases of myocarditis or pericarditis in the United States in people injected with Pfizer/BioNTech’s BNT162b2 or Moderna/NIAID’s mRNA-1273 biologics as of June 11. Of those cases, 267 of them were reported after getting one dose of these shots and 827 of them after two doses. In another 132 cases, the number of doses given is not known.3
“mRNA vaccines may be a new trigger for myocarditis,” said Matthew Oster, MD, MPH of the CDC’s COVID-19 Vaccine Task Force.5
Overall, 65 percent of the cases were linked to Pfizer’s BNT162b2 product and the remainder to Moderna’s mRNA-1273 product. Most of the cases involved people under 30 years of age—the largest segment consisting of those under 24. Some 434 cases of myocarditis have occurred in males between 12-29 years of age within 21 days after getting the second dose.2 4
No Risk-Benefit Analysis on mRNA Biologics
In an interview on Fox News, Steven Malone, MD, who invented the mRNA technology being used in the BNT162b2 and mRNA-1273 products, expressed concern about the risks of giving mRNA biologics to adolescents and young adults.6 7 He said:
My concern is I know there are risks but we don’t have access to the data. And so, I am of the opinion that people have the right to decide whether to accept vaccines or not, especially since these are experimental vaccines.7
Dr. Malone said that he did not believe the potential benefits the mRNA biologics outweigh their potential risks but that it’s difficult to know for sure because the “risk-benefit analysis is not being done.” He warned that the “government is not being transparent about the risks” of these products.7
ACIP Finding Consistent With Israeli Study
The announcement by ACIP of a likely link between the Pfizer/BioNTech and Moderna/NIAID COVID-19 biologics and cases of heart inflammation follows a similar finding by Israel’s Ministry of Health. On June 2, 2021, the Israeli health officials announced they determined there is a “probable link” between Pfizer/BioNTech’s BNT162b2 product and dozens of cases of myocarditis in Israel—primarily in males between 16-30 years of age. This conclusion was based on a study conducted by public health experts from Israel’s Department of Epidemiology and National Center for Disease Control and representatives from Tel Aviv University, Haifa University and the Technion institute.8
In the Israeli study, researchers observed that most of the cases of myocarditis occurred within one to five days after getting the second dose of vaccine, suggesting that the timing of the symptoms experienced by patients did not appear to be random.8
FDA Will Add Warning to Pfizer and Moderna Biologic Fact Sheets
Given the new finding by ACIP, the U.S. Food and Drug Administration (FDA) plans to “move quickly” to add a warning to the fact sheets of both BNT162b2 and mRNA-1273 about the risk of developing inflammatory heart conditions. Doran Fink, MD, deputy director of FDA’s vaccines division, agrees with this move.9 10 She said:
Based on the available data, a warning statement in the fact sheets for both health care providers and vaccine recipients and caregivers would be warranted in this situation.10
However, despite the finding of an association with heart inflammation, especially in teens and young adults under age 30, it does not appear that FDA and CDC officials will change their recommendation that individuals over age 12 should get two doses of the Pfizer or Moderna mRNA vaccines.11
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1 Advisory Committee on Immunization Practices. COVID-19 Vaccine Safety Technical (VaST) Work Group. U.S. Centers for Disease Control and Prevention June 23, 2021.
2 Brueck H. CDC acknowledges a likely link between COVID-19 vaccines and heart inflammation for young men, but says it’s ‘extremely rare’ and the Delta variant is a bigger threat. Business Insider June 23, 2021.
3 Lovelace B. CDC safety group says there’s a likely link between rare heart inflammation in young people after Covid shot. CNBC June 23, 2021.
4 Villafranca O. Some COVID-19 shots may be linked to rare heart problems in teens, CDC says. CBS News June 24, 2021.
5 Soucheray S. Experts: mRNA COVID-19 vaccines likely tied to heart inflammation. CIDRAP News June 23, 2021.
6 RW Malone MD, LLC. Robert W. Malone, M.D., M.S.
7 Eberhart C. ‘The government is not being transparent about the risks’: Inventor of MRNA vaccines says people should not be forced to take experimental COVID vaccines because risks aren’t known and under 18s and those who’ve had virus shouldn’t take it. Daily Mail June 24, 2021.
8 TVR Staff. Probable Link Found Between Pfizer’s COVID Shot and Heart Inflammation. The Vaccine Reaction June 6, 2021.
9 Erman M, Maddipatla M. FDA to add warning about rare heart inflammation to Pfizer, Moderna vaccines. Reuters June 23, 2021.
10 Gardner L. FDA to add warning about rare heart inflammation to Moderna, Pfizer vaccine fact sheets. Politico June 23, 2021.
11 U.S. Centers for Disease Control and Prevention. COVID-19 Vaccines: Summary Documents for Interim Clinical Considerations. June 1, 2021.