FDA Adds Rare Heart Inflammation Warning to Pfizer and Moderna Vaccines – .

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FDA Adds Rare Heart Inflammation Warning to Pfizer and Moderna Vaccines – .


Vials with labels of Pfizer-BioNTech and Moderna coronavirus (COVID-19) vaccine can be seen in this illustrative photo taken on March 19, 2021.
Given Ruvic | Reuters
The United States Food and Drug Administration on Friday added a warning to patient and supplier information sheets for the Pfizer and Moderna Covid-19 vaccines to indicate a rare risk of heart inflammation.
For each vaccine, the information sheets have been revised to include a warning about myocarditis and pericarditis after the second dose and with the onset of symptoms a few days after receiving the vaccine.

Myocarditis is the inflammation of the heart muscle and pericarditis is the inflammation of the tissues surrounding the heart. Health officials have said the benefits of receiving the vaccine always outweigh any risks.

“The risk of myocarditis and pericarditis appears to be very low given the number of doses of vaccine that have been administered,” Janet Woodcock, acting commissioner of the FDA, said in a statement.

“The benefits of vaccination against Covid-19 continue to outweigh the risks, given the risk of Covid-19-related illnesses and related complications, potentially serious,” she said.
The FDA update follows a review and discussion by the Centers for Disease Control and Prevention’s Immunization Practices Advisory Committee that met on Wednesday.

There have been over 1,200 cases of myocarditis or pericarditis, mostly in people 30 and under who received the injections, according to the CDC meeting presentation slides.

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

– CNBC’s Berkeley Lovelace Jr. contributed reporting

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