Warnings About Myocarditis Differ Between Pfizer EUA Vaccine and Fully-Approved Comirnaty

The Pfizer BioNTech COVID-19 vaccine authorized under the Emergency Use Authorization (EUA) has a different label than the FDA-approved Comirnaty label for the vaccine, and Pfizer has said they will continue to distribute the vaccine made under the earlier label until stocks run out.

The EUA was granted before the risk of myocarditis for men under 40, caused by the vaccine, was known, and the Comirnaty package insert found on the FDA website includes warnings about the rare side effect. A fact sheet distributed with the EUA vaccine also includes a warning about the risk.

On Tuesday, an FDA official told The Virginia Star on background that the FDA has to ensure that EUA vaccine recipients are informed of the EUA, the extent and benefits of the vaccine, that the vaccine is optional, and of alternatives to the vaccine. Normally that data is communicated through a fact sheet for EUA vaccines. A package insert is used with fully approved vaccines like Comirnaty.

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Top Cardiologist: Vaccine-Induced Myocarditis in Young People ‘Way More Serious’ Than COVID-Induced Myocarditis

Dr. Peter McCullough, a top cardiologist and leader in the medical response to the COVID pandemic, said in a recent interview that myocarditis in young people post vaccine is far more dangerous than the COVID version of the heart disease.

Cases of myocarditis—inflammation of the heart muscle—have spiked dramatically among previously healthy people in heavily vaccinated countries. Health officials have maintained that vaccine-induced myocarditis is rare, and worth the risk because COVID-induced myocarditis is much more prevalent.

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70 Percent of Adult Virginians Have Received at Least One Dose of COVID-19 Vaccine

Governor Ralph Northam announced Monday that Virginia has reached a key vaccination milestone: 70 percent of adult Virginians have received at least one dose of a COVID-19 vaccine.

“Virginia has reached a significant milestone in the fight against COVID-19,” Northam said in his announcement. “Thanks to the millions of Virginians who have rolled up their sleeves to get vaccinated, the virus is in retreat, our economy is growing, and we are closer to putting this pandemic behind us.”

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