The Food and Drug Administration of the United States will now require COVVI-19 vaccines from PFIZER / BIONTech and MODERNA to use extended warning labels with more information on the risk of a rare heart disease after vaccination.
Previous labels of vaccines have warned of the risk of a heart disease called myocarditis, inflammation of the heart muscle and pericarditis, inflammation of the lining outside the heart, which, according to the website of the control and prevention of American diseases, is rare but possible after vaccination. The new labels will expand this warning to certain age groups.
Research has always shown that COVVI-19 mRNM vaccines are safe and effective, and millions of people have obtained them without serious incident. Some studies have shown that COVVI-19 infection itself has a higher risk of myocarditis or pericarditis than the vaccine.
The CDC last month told its independent vaccination advisers that research had shown that COVVI-19 vaccinations from 2020 to 2022 have shown a significantly significant increase in myocarditis. The incidents were rare, however, and “there is no increased risk observed with the doses administered in the following years,” said the agency.
In the same case as someone has developed cardiac inflammation after vaccination, the CDC told advisers, acute myocarditis generally resolves quickly.
Vaccines have already warned that the highest risk of these heart problems has been observed in men aged 18 to 24 for the modern vaccine and from 12 to 17 for Pfizer; The new warnings for the two vaccines will be for men aged 16 to 25.
In letters to Pfizer and Moderna which were dated April 17 and which are now published online, the agency indicates that the analysis of data insurance complaints shows that there were eight cases of myocarditis and / or pericarditis per million doses of vaccine given to people aged 6 months to 64 years.
The cases were more frequent in men aged 16 to 25 within seven days of vaccination, but they were still rare, with around 38 cases of myocarditis and / or pericarditis per million doses among this group.
A spokesman for the United States Ministry of Health and Social Services said on Wednesday that this decision was aimed at increasing “radical transparency”. Neither pfizer nor moderna responded to requests for comment.
Vaccines were developed during the first Trump administration and suffered what the CDC said was “the most intensive security analysis in the history of the United States”, and the agency continues to monitor data from the administration of vaccines for efficiency and any potential problem.
The United States Secretary for Health and Social Services, Robert F. Kennedy Jr., a long-standing anti-vaccine activist, falsely said that the COVVI-19 vaccine was “the deadliest vaccine ever made”.
On Wednesday, in an audience of the US Senate in internal security and government affairs, Senator Ron Johnson, R-Wisconsin, said that the Biden administration had minimized the risk of the vaccine and delayed information on these risks for the public.
A witness, Hawaii Governor Josh Green, a family doctor, said in his testimony that American vaccine safety surveillance systems operated “exactly as expected” by detecting rare cases of myocarditis.
“The data has been made public, the warnings have been updated and the clinical guidelines have been revised accordingly,” said Green. “Despite this, some continue to promote misleading interpretations, complaints or anecdotes not verified to suggest that vaccines are largely dangerous.”
The FDA has taken recent measures to limit COVVI-19 vaccines for certain groups.
On Tuesday, the FDA said that it would modify the type of evidence it would accept from vaccine manufacturers to approve update cocovid shots, which can limit that is eligible for updated shots. Vaccines should be available in the fall, but only for adults 65 and over and people with underlying conditions that count them at a higher risk of severe COVVI-19 infection.
In an editorial published in the New England Journal of Medicine, the FDA commissioner, Dr. Marty Makary, and Dr. Vinay Prasad, the new director of the FDA biology center for evaluation and research, said that there was not enough evidence that healthy children and adults clinically benefit from COVVI-19 shooting, in particular in adults Control tests.
On Thursday, advisers against FDA vaccines – the Vaccines Advisory Committee and Biological Products – will meet to discuss the selection of the coronavirus strain for COVVI -19 vaccines this fall.
Brenda Goodman of CNN contributed to this report.
