FDA to Add Heart Warning for Pfizer and Moderna mRNA Vaccines

Empty vials of different vaccines by Moderna, Pfizer-BioNTech and AstraZeneca against Covid-19 caused by the novel coronavirus are pictured at the vaccination center in Rosenheim, southern Germany, on April 20, 2021, amid the novel coronavirus / COVID-19 pandemic. (Photo by Christof STACHE / AFP) (Photo by CHRISTOF STACHE/AFP via Getty …
CHRISTOF STACHE/AFP via Getty Images

The Food and Drug Administration (FDA) is expected to “move rapidly” to add warning labels to Pfizer and Moderna vaccines, following the emergence of heart inflammation cases — myocarditis and pericarditis — after receiving the non-traditional mRNA jabs, the agency’s Dr. Doran Fink said Wednesday.

The move follows the Centers for Disease Control and Prevention (CDC) reporting roughly 1,200 cases of heart inflammation conditions occurring primarily in young men after receiving the mRNA jabs. The advisory panel said there is a “likely association” between the condition and the mRNA vaccines, which teach cells to make a protein that triggers an immune response.

The warning “would likely include information stating these events have occurred in some vaccine recipients following dose 2 of mRNA vaccines,” according to the San Francisco Chronicle.

The heart inflammation condition typically occurs “within several days to a week following vaccination,” and symptoms include shortness of breath, chest pain, and a pounding or fluttering heart.

Despite this, the CDC is continuing to urge everyone 12 and older to get vaccinated.

“The facts are clear: This is an extremely rare side effect, and only an exceedingly small number of people will experience it after vaccination,” CDC Director Dr. Rochelle Walensky and Assistant Secretary for Health Dr. Rachel Levine said in a joint statement.

“Importantly, for the young people who do, most cases are mild, and individuals recover often on their own or with minimal treatment,” the statement said, adding the conditions are “much more common if you get COVID-19, and the risks to the heart from COVID-19 infection can be more severe.”

“We strongly encourage everyone age 12 and older who are eligible to receive the vaccine under Emergency Use Authorization to get vaccinated,” the statement, signed by medical associations in addition to Walensky and Levine, continued:

Especially with the troubling Delta variant increasingly circulating, and more readily impacting younger people, the risks of being unvaccinated are far greater than any rare side effects from the vaccines. If you get COVID-19, you could get severely ill and be hospitalized or even die. Even if your infection is mild, you or your child could face long-term symptoms following COVID-19 infection such as neurological problems or diminished lung function.

Of the over 150 million people in the U.S. who are considered “fully vaccinated,” over 79 million opted for the two-dose Pfizer vaccine, and over 59 million received the Moderna jab. Nearly 12 million have received the more traditional J&J vaccine.

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