Updated COVID-19 vaccines may cause heart inflammation and severe allergic shock, according to a new study from the U.S. Food and Drug Administration.
Researchers with the FDA, the U.S. National Institutes of Health, and companies like CVS looked at health care databases to try to figure out if there were signs the Moderna and Pfizer bivalent COVID-19 vaccines might be linked to any health issues.
The bivalent shots were replaced soon after by updated vaccines because their effects, which already started low, were shown to wane in observational studies.
Patricia Lloyd, an FDA researcher, and her co-authors said the study "Supports the safety of these vaccines" and "Supports the conclusion that the benefits of vaccination outweigh the risks."
Asked for evidence to support those conclusions, Ms. Lloyd referred a request for comment to the FDA. "With over a billion doses of the mRNA vaccines administered, available scientific evidence supports the conclusion that the vaccines are safe and effective. The FDA stands behind its findings of quality, safety, and efficacy for the mRNA vaccines. Additionally, it is simply a fact that millions of lives have been saved because of the COVID-19 mRNA vaccines, which most Americans undergoing vaccination have received," an FDA spokesperson claimed.
"We found the number of myocarditis reports in VAERS after COVID-19 vaccination in 2021 was 223 times higher than the average of all vaccines combined for the past 30 years," the researchers said.
Federal officials have said that the COVID-19 vaccines cause myocarditis, pericarditis, and anaphylaxis, but that the vaccines also provide protection against infection and severe illness, tilting the risk-benefit balance in their favor.
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