FDA Adds Warning About Rare Carditis To Corona Vaccines From Pfizer And Moderna
The US Food and Drug Administration said it will add a warning about rare cases of carditis in adolescents and young adults to the Pfizer / BioNTech, Moderna and Moderna coronavirus vaccines.
The US Centers for Disease Control and Prevention (CDC) advisory groups , which met to discuss reported cases of heart disease after vaccination, found that the risk in teens and young adults was more likely to be associated with the vaccines, but that the benefits of the injections seemed clear, and outweighed the risks .
Health regulators in several countries are investigating whether doses of Pfizer, PfizeBioNTech and Moderna using the new mRNA technology pose a risk, and if so, how dangerous.
The Centers for Disease Control and Prevention said that patients who develop inflammation in the heart after vaccination generally recover from symptoms and improve .
The US Department of Health and Human Services, along with US medical groups and public health officials, issued a statement stressing that vaccines are safe and effective and that cardiac side effects are "extremely rare".
"We strongly encourage everyone 12 years of age or older who is eligible to receive the vaccine under an emergency use permit to obtain the vaccination," the statement read.
The agency said increased concerns about the delta viral variant most transmissible, which is rooted in the United States, and its impact on young people, to the urgent need to increase immunizations, have been warned doctors and hospitals by the Centers for Disease Control and Prevention (CDC) to monitor the symptoms of inflammation of the heart muscle or pericarditis And the US Food and Drug Administration's warning will increase awareness .
"Based on the available data, a warning statement would be warranted in fact sheets for health care providers, vaccine recipients and caregivers," FDA official Doran Fink said at the advisory committee meeting.
Fink, deputy director of the agency's Department of Vaccines, added that the Food and Drug Administration expects to move quickly to add the warning after the meeting ends, and cases of carditis appear to rise significantly in the week following the second vaccine dose and in males, the CDC identified 309 hospital admissions due to Carditis in people under 30 years of age, 295 of whom have been discharged from hospital .
Data from one of the agency's safety monitoring systems suggests a rate of 12.6 cases per million in the next three weeks, with the second dose in the age group of 12, Dr. Tom Shimabukuro, deputy director of the CDC's Office of Immunization Safety, said in a presentation. to 39 years old .
"We see this in younger age groups, especially in teens and early twenties, and we see it more in males, compared to females," Shimabukuro said. above .
The CDC has been investigating cases of carditis mainly in young adults for several months, adding, it is still evaluating the risks of the condition and has not specifically confirmed a causal relationship between vaccines and the heart problem .
However it did report that a much higher number of young adults aged 12-24 years than expected experienced a heart infection after the second dose of the vaccine .
According to data from the US Adverse Event Reporting System, 347 cases of carditis were observed in the week after the second vaccine dose in males aged 12 to 24 years.
Pfizer, whose vaccine is licensed for use in Americans younger than 12, earlier said it had not observed a higher rate of heart inflammation than would normally be expected in the general population .
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