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The U.S. Food and Drug Administration (FDA) added a warning about the risk of developing heart inflammation to information about the Moderna and Pfizer COVID-19 vaccines.
The FDA announced earlier this month that it would add the warning after the Centers for Disease Control and Prevention (CDC) had reported that more cases of heart inflammation—either myocarditis or pericarditis—were found in young adults and children after they received the vaccines, which use mRNA technology.
On June 25, the agency said that it would add revisions to its patient and provider fact sheets about the “increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination” using the Pfizer or Moderna COVID-19 shots. The Pfizer or Moderna vaccines use mRNA technology and require two doses, whereas the vaccine made by Johnson & Johnson uses an adenovirus and requires a single dose.
FDA Revises Vaccine Fact Sheets to Add Warning on Heart Risks
Dear twitter time to ban the FDA
— zerohedge (@zerohedge) June 26, 2021
Still, health officials have said that the risks of developing heart inflammation are outweighed by the vaccine’s benefits.
“The risk of myocarditis and pericarditis appears to be very low given the number of vaccine doses that have been administered,” Janet Woodcock, the acting FDA commissioner, said in a statement last week. “The benefits of COVID-19 vaccination continue to outweigh the risks, given the risk of COVID-19 diseases and related, potentially severe, complications.”