The US Food and Drug Administration will now require that the Covid-199 vaccines of the PFIZER/BionTech and Moderna will be used with detailed information about rare heart risks after vaccination.
The previous label of the vaccine warns of cardinomyitis, inflammation and pericardial inflammation of the heart muscles, lining outside the heart, and the disease control website center. Say It is possible after vaccination. The new label expands the warning into a specific age group.
research MRNA COVID-199 The vaccine continued to show that safe, effective and millions of people have obtained them without serious events. Some studies are covid-19 infections higher Risk of cardinomyitis or pericarditis than vaccine.
Last month CDC I told independent vaccine advisors According to the study, covid-19 vaccinations between 2020 and 2022 have statistically increased risk of myocarditis. But the incident was rare, and “the dose administered over the years did not increase the risk,” the agency said.
CDC if it is rare when someone causes heart inflammation after vaccination Telled tortureAcute myocarditis is usually solved quickly.
The vaccine has already been warned that the highest risk of this heart problem has been observed in men between 18 and 24 years of age in Hyundai vaccine, and in the case of Pfizer, 12-17 years old; A new warning for both vaccines is for men between 16 and 25 years old.
By letter Pfizer and Modern The agency is currently posted online and analyzed the commercial health insurance billing data that there are millions of cardalitis and/or cardinomyitis for 6 months to 64 years of age from 6 months to 64 years old.
The case was more common among men between 16 and 25 years of age within seven days after vaccination, but about 38 of these groups were still rare.
The US Department of Health and Welfare said that this measure is to increase “radical transparency” on Wednesday. Pfizer Moderna did not respond to the request. For opinions.
The vaccine was developed by the first Trump administration CDC says It was “the most intensive safety analysis in American history,” and the institution continues to monitor vaccine management data for efficiency and potential problems.
For a long time, Robert F. Kennedy Jr., a US Minister of Health and Welfare, has falsely claimed that the Covid-19 vaccine is “the most deadly vaccine.”
US Senate Security and Subcommittee of Government Agency hearing On Wednesday, Senator R-Cornly, Ron Johnson, insisted that the Biden administration delayed the risk of vaccines and gaining information about the risks.
Josh Green, a family doctor, Hawaii Governor Josh Green confession The US vaccine safety monitoring system detects rare myocarditis cases and worked “as intended.”
“The data has been released, a warning has been updated, and the clinical guidelines have been revised.” Nevertheless, some people suggest that the vaccine is not extensively safe, with the interpretation, proven claims or anecdotes that are misunderstood. ”
The FDA recently took measures to limit the Covid-19 vaccine of a specific group.
tuesday, The FDA said the vaccine manufacturer will change the type of evidence to accommodate to approve the updated coved shot. The vaccine is expected to be available in autumn, but adults aged 65 or older and those with basic status are increasing the risk of serious Covid-19 infections.
at Editorial has been posted Dr. MARTY MAKARY and Dr. Vinay Prasad, a new FDA commissioner of the FDA’s biological evaluation and research center, are not sufficient to get a clinically significant benefit from a regular Covid-19 shot of healthy children and adults in New England Medicine, especially adults. There is not enough evidence that he wants to recommend from 50 to 64 to 64.
~ thursday, The FDA’s vaccine advisor (vaccine and related biological advisory committee) will gather to discuss the selection of corona virus variations of Covid-199 vaccines this fall.
CNN’s Brenda Goodman contributed to this report.
