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FDA To Add Rare Heart Inflammation Warning To Pfizer And Moderna Vaccines By Reuters

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© Reuters. FILE PHOTO: A nurse Cindy Méndez wearing a protective mask holds a syringe with a dose of Pfizer-BioNTech COVID-19 vaccine during the coronavirus disease (COVID-19) pandemic, at NYC Health + Hospitals Harlem Hospital in the New Manhattan district. me

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By Michael Erman and Manojna Maddipatla

(Reuters) -The U.S. Food and Drug Administration said Wednesday it plans to act quickly to add a warning about rare cases of heart inflammation in teens and young adults to Pfizer / BioNTech fact sheets and Modern (NASDAQ 🙂 COVID-19 vaccines.

Advisory groups from the U.S. Centers for Disease Control and Prevention (CDC), meeting to discuss reported cases of heart disease after vaccination, found that inflammation in adolescents and young adults is probably related to vaccines, but that the benefits of the injections seemed to clearly outweigh the risk.

Moderna shares closed 4.2% down, while Pfizer (NYSE 🙂 fell 1.4%.

Health regulators in several countries have been investigating whether Pfizer / BioNTech and Moderna injections using new mRNA technology pose a risk and, if so, how serious.

The CDC said that patients with heart inflammation after vaccination generally recover from symptoms and do well.

The US Department of Health and Human Services, along with leading groups of US physicians and public health officials, issued a statement stressing that the vaccines are safe and effective and that the side effect of the heart is “extremely rare”.

“We strongly encourage all people 12 years of age and older who are eligible to receive the vaccine under the Emergency Use Authorization to get vaccinated,” he said.

The CDC has warned doctors and hospitals to watch out for symptoms of myocarditis or pericarditis, and the FDA’s warning will further raise awareness.

Concerns about the more highly transmissible variant of the Delta coronavirus taking hold in the United States, and its impact on younger people, have added to the urgency to scale up vaccines even as the inoculation effort here has slowed considerably. .

The number of Americans receiving their first dose of the COVID-19 vaccine has decreased by approximately 85% since it peaked in mid-April, and is likely to fall short of President Joe Biden’s goal of having administered at least one. injection to 70% of adults by July 4. .

GUARANTEED WARNING

“Based on the available data, a warning statement on the fact sheets would be warranted for both healthcare providers and vaccine recipients and caregivers,” FDA official Doran Fink said at the advisory committee meeting.

Fink, deputy director of the agency’s vaccine division, said the FDA hopes to act quickly to add the warning after the meeting concludes.

Cases of heart inflammation appear to be markedly higher in the week after the second dose of vaccine and in men. The CDC identified 309 hospitalizations for cardiac inflammation in people under the age of 30, of which 295 were discharged.

Dr. Tom Shimabukuro, deputy director of the CDC’s Office of Immunization Safety, said in a presentation that data from one of the agency’s safety monitoring systems, Vaccine Safety Datalink (VSD), suggests a rate of 12, 6 cases per million in the three weeks after the second injection. in people 12 to 39 years old.

“We are seeing this in younger age groups, mainly people in their teens and 20s, and we are seeing it more in men than women,” Shimabukuro said. “This effect largely disappears once you enter these older age groups: people 50 and older.”

The CDC has been investigating cases of heart inflammation primarily in young men for several months. The Israeli health ministry earlier this month said it saw a possible link between such cases and Pfizer’s COVID-19 vaccine.

The CDC said it was still assessing the risk of the condition and did not specifically confirm a causal relationship between the vaccines and the heart problem.

However, he said that a much larger than expected number of young men between the ages of 12 and 24 have experienced heart inflammation after their second dose of the vaccine.

According to data from the U.S. Vaccine Adverse Event Reporting System (VAERS), 347 cases of cardiac inflammation were observed in the week after the second dose of vaccine in men ages 12 to 24. That compares with expectations of 12 or fewer cases for men in that age range based on history incidence rates for the U.S. population, the CDC said.

Pfizer, whose vaccine has been licensed for use in Americans since age 12, previously said it had not seen a higher rate of heart inflammation than would normally be expected in the general population.

Moderna said she is aware of case reports of cardiac inflammation after administration of mRNA vaccines. He said he is working with regulatory and public health authorities to assess the problem.

So far, more than 138 million Americans have been fully vaccinated with one of the two mRNA vaccines, according to CDC data as of Monday.

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