FDA adds warning of rare heart inflammation in Pfizer, Moderna vaccines

vials with See Pfizer-BioNTech and Modern Coronavirus (COVID-19) vaccine labels in this illustration image taken March 19, 2021.

Dado Ruvic | Reuters

The United States Food and Drug Administration on Friday added a warning for patient and supplier fact sheets for Pfizer and Moderna Covid-19 vaccines to indicate a rare risk of inflammation of the heart.

For each vaccine, the fact sheets have been revised to include a warning on myocarditis and pericarditis after the second dose e with the beginning of symptoms within a few days after receiving the shot.

Myocarditis is inflammation of the heart muscle and pericarditis is inflammation of the tissue surrounding the heart. Health officials said the benefits of receiving the vaccine still surpasses any risk.

“The risk of myocarditis and pericarditis appear to be very low given the number of doses of the vaccine that were administered, “said Janet Woodcock, interim commissioner of the FDA in a declaration.

“The benefits of Vaccination against Covid-19 continues to outweigh the risks, given the risk of Covid-19 diseases and related, potentially serious complications, “he said.

The FDA update follows a review and discussion of the Centers for Disease Control and Prevention Advisory Committee on Meeting on immunization practices on Wednesday.

There have been more of 1,200 cases of a myocarditis or pericarditis mainly in people 30 and less who received the shots, according to the presentation slides of the CDC meeting.

About 300 million shots had been administered as of June 11, according to the CDC. There have been just 12.6 cases of cardiac inflammation per million doses for both vaccines combined.

– CNBC’s Berkeley Lovelace Jr. contributed to the report

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