Latest news with #myocarditis
Daily Mail
22-05-2025
- Health
- Daily Mail
Trump's FDA drops Covid vaccine bombshell as Pfizer and Moderna admit heart damage risk
The FDA is forcing Pfizer and Moderna to use expanded warning labels about the risks of heart damage tied to Covid vaccines. The shots previously included warning labels about the rare risks of myocarditis, inflammation of the heart muscle, and pericarditis, inflammation of the sac-like lining surrounding the heart. The new labels will expand that warning to certain age groups — specifically males aged 16 to 25 who appear to be at the highest risk of the rare complication. The new guidance comes as an FDA analysis of insurance claims found myocarditis and pericarditis occurred in one in 125,000 doses of the 2023-2024 shots for children and adults under 65. For men under 25, the risk was 19 per 500,000, or the equivalent of one in 250. Experts caution there have been no US deaths directly tied to Covid vaccine-triggered myocarditis and that the Covid virus itself is linked to heart damage, meaning the benefits of vaccination might still outweigh the small risk. The CDC previously acknowledged both conditions were known side effects of the vaccines but did not provide a number of cases. It's unclear exactly when the new labels will go into effect or if Pfizer or Moderna disputed the order. The news comes after a Congressional investigation accused Biden White House officials of purposely covering up warnings about myocarditis in young people. The report suggested a planned Health Alert Network (HAN) message from the CDC on myocarditis was not released, and drafts of the alert downplayed risks. The order is also the latest in the Trump administration's crackdown on Covid vaccines. Last week, reports from Department of Health and Human Services suggested the shots would no longer be routinely recommended for pregnant women, children and teens in the US. And the FDA announced earlier this week that updated Covid vaccines would no longer be automatically approved for use without clinical safety trials. With myocarditis, it's thought that the immune system may register mRNA in Covid vaccines as a threat, leading the immune system to attack itself and cause inflammation of the myocardium, the heart's muscle. This same mechanism has been linked to pericarditis, which leads to inflammation of the pericardium, the sac surrounding the heart. Both conditions have been linked to viruses like the common cold and hepatitis, as well as Covid. While most cases are mild, in rare instances, myocarditis can damage the heart and make it difficult for it to pump blood, eventually leading to heart failure, heart attack, and stroke. CDC officials told the FDA's vaccine advisors last month that acute myocarditis ' tends to resolve quickly' after vaccination. The CDC's voluntary side effect reporting database VAERS, has logged over 1,600 cases of myocarditis in the US, primarily in young men 12 to 29 after they received a Pfizer or Moderna vaccine. The FDA said the call for new warnings was spurred by data from the agency's safety surveillance system and results from an October study of people who developed Covid vaccine-associated myocarditis. Scientists followed up with people who suffered chest pain and elevated levels of troponin in their blood, a protein that signals heart damage. Most of the participants were adolescent males. The researchers wrote in the study, which was co-authored by FDA officials: 'While their clinical course was nearly always mild with a low prevalence and extent of cardiac dysfunction, myocardial injury was common.' Currently, there is no conclusive evidence of deaths in the US directly caused by myocarditis from Covid vaccines. For example, a 2023 Oregon study reviewing death certificates found no fatalities linked to vaccine-induced myocarditis in individuals aged 16–30. However, some researchers caution that underreporting is possible due to gaps in America's healthcare system, where mild or atypical cases may go unrecorded. Still, the consensus among health authorities is that fatal outcomes from vaccine-related myocarditis—if they occur—are extremely rare, while the risks of severe Covid, including heart damage, remain well-documented.
CNN
22-05-2025
- Health
- CNN
FDA requires Covid vaccine makers to expand warning about risk of rare heart inflammation
The US Food and Drug Administration will now require Covid-19 vaccines from Pfizer/BioNTech and Moderna to use expanded warning labels with more information about the risk of a rare heart condition after vaccination. The vaccines' previous labels warned about the risk of a heart condition called myocarditis, inflammation of the heart muscle, and pericarditis, inflammation of the lining outside the heart, which the US Centers for Disease Control and Prevention website says is rare but possible after vaccination. The new labels will expand that warning to certain age groups. Research has consistently shown that the mRNA Covid-19 vaccines are safe and effective, and millions of people have gotten them without serious incident. Some studies have found that Covid-19 infection itself carries a higher risk of myocarditis or pericarditis than the vaccine does. The CDC last month told its independent vaccine advisers that research showed Covid-19 vaccinations from 2020 through 2022 showed a statistically significant increased risk of myocarditis. The incidents were rare, however, and 'there is no increased risk observed with the doses administered in subsequent years,' the agency said. In the rare case that someone did develop heart inflammation after vaccination, the CDC told the advisers, acute myocarditis typically resolves quickly. The vaccines already carried warnings that the highest risk of these heart problems was observed in males between ages 18 and 24 for the Moderna vaccine and 12 to 17 for Pfizer's; the new warnings for both vaccines will be for males age 16 to 25. In letters to Pfizer and Moderna that were dated April 17 and are now posted online, the agency says analysis of commercial health insurance claims data shows that there were eight cases of myocarditis and/or pericarditis per million vaccine doses given to people ages 6 months through 64 years. Cases were more common among males ages 16 through 25 within seven days of vaccination, but they were still rare, with about 38 cases of myocarditis and/or pericarditis per million doses among this group. A spokesperson for the US Department of Health and Human Services said Wednesday that the move was intended to increase 'radical transparency.' Neither Pfizer nor Moderna responded to requests for comment. The vaccines were developed during the first Trump administration and underwent what the CDC says was 'the most intensive safety analysis in US history,' and the agency continues to monitor vaccine administration data for effectiveness and any potential problems. US Health and Human Services Secretary Robert F. Kennedy Jr., a longtime anti-vaccine activist, has falsely claimed that the Covid-19 vaccine was 'the deadliest vaccine ever made.' In a US Senate Homeland Security and Governmental Affairs subcommittee hearing on Wednesday, Sen. Ron Johnson, R-Wisconsin, claimed that the Biden administration downplayed the risks of the vaccine and delayed getting information about those risks to the public. One witness, Hawaii Gov. Josh Green, a family physician, said in his testimony the US vaccine safety monitoring systems worked 'exactly as intended' by detecting rare cases of myocarditis. 'The data were made public, warnings were updated, and clinical guidance was revised accordingly,' Green said. 'Despite this, some continue to promote misleading interpretations, unverified claims or anecdotes to suggest that vaccines are broadly unsafe.' The FDA has taken recent steps to limit Covid-19 vaccines for certain groups. On Tuesday, the FDA said it would change the type of evidence it will accept from vaccine manufacturers to approve updated Covid shots, which may limit who is eligible for updated shots. The vaccines are expected to be be available in the fall, but only for adults 65 and older and people with underlying conditions that put them at a higher risk for severe Covid-19 infection. In an editorial published in the New England Journal of Medicine, FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, the new director of the FDA's Center for Biologics Evaluation and Research, said there's not enough evidence that healthy children and adults get clinically meaningful benefit from regular Covid-19 shots, and officials want to see more placebo-controlled trials, particularly in adults 50 to 64, before recommending the shots for other groups. On Thursday, the FDA's vaccine advisers – the Vaccines and Related Biological Products Advisory Committee – will meet to discuss the coronavirus strain selection for this fall's Covid-19 vaccines. CNN's Brenda Goodman contributed to this report.
CNN
22-05-2025
- Health
- CNN
FDA requires Covid vaccine makers to expand warning about risk of rare heart inflammation
The US Food and Drug Administration will now require Covid-19 vaccines from Pfizer/BioNTech and Moderna to use expanded warning labels with more information about the risk of a rare heart condition after vaccination. The vaccines' previous labels warned about the risk of a heart condition called myocarditis, inflammation of the heart muscle, and pericarditis, inflammation of the lining outside the heart, which the US Centers for Disease Control and Prevention website says is rare but possible after vaccination. The new labels will expand that warning to certain age groups. Research has consistently shown that the mRNA Covid-19 vaccines are safe and effective, and millions of people have gotten them without serious incident. Some studies have found that Covid-19 infection itself carries a higher risk of myocarditis or pericarditis than the vaccine does. The CDC last month told its independent vaccine advisers that research showed Covid-19 vaccinations from 2020 through 2022 showed a statistically significant increased risk of myocarditis. The incidents were rare, however, and 'there is no increased risk observed with the doses administered in subsequent years,' the agency said. In the rare case that someone did develop heart inflammation after vaccination, the CDC told the advisers, acute myocarditis typically resolves quickly. The vaccines already carried warnings that the highest risk of these heart problems was observed in males between ages 18 and 24 for the Moderna vaccine and 12 to 17 for Pfizer's; the new warnings for both vaccines will be for males age 16 to 25. In letters to Pfizer and Moderna that were dated April 17 and are now posted online, the agency says analysis of commercial health insurance claims data shows that there were eight cases of myocarditis and/or pericarditis per million vaccine doses given to people ages 6 months through 64 years. Cases were more common among males ages 16 through 25 within seven days of vaccination, but they were still rare, with about 38 cases of myocarditis and/or pericarditis per million doses among this group. A spokesperson for the US Department of Health and Human Services said Wednesday that the move was intended to increase 'radical transparency.' Neither Pfizer nor Moderna responded to requests for comment. The vaccines were developed during the first Trump administration and underwent what the CDC says was 'the most intensive safety analysis in US history,' and the agency continues to monitor vaccine administration data for effectiveness and any potential problems. US Health and Human Services Secretary Robert F. Kennedy Jr., a longtime anti-vaccine activist, has falsely claimed that the Covid-19 vaccine was 'the deadliest vaccine ever made.' In a US Senate Homeland Security and Governmental Affairs subcommittee hearing on Wednesday, Sen. Ron Johnson, R-Wisconsin, claimed that the Biden administration downplayed the risks of the vaccine and delayed getting information about those risks to the public. One witness, Hawaii Gov. Josh Green, a family physician, said in his testimony the US vaccine safety monitoring systems worked 'exactly as intended' by detecting rare cases of myocarditis. 'The data were made public, warnings were updated, and clinical guidance was revised accordingly,' Green said. 'Despite this, some continue to promote misleading interpretations, unverified claims or anecdotes to suggest that vaccines are broadly unsafe.' The FDA has taken recent steps to limit Covid-19 vaccines for certain groups. On Tuesday, the FDA said it would change the type of evidence it will accept from vaccine manufacturers to approve updated Covid shots, which may limit who is eligible for updated shots. The vaccines are expected to be be available in the fall, but only for adults 65 and older and people with underlying conditions that put them at a higher risk for severe Covid-19 infection. In an editorial published in the New England Journal of Medicine, FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, the new director of the FDA's Center for Biologics Evaluation and Research, said there's not enough evidence that healthy children and adults get clinically meaningful benefit from regular Covid-19 shots, and officials want to see more placebo-controlled trials, particularly in adults 50 to 64, before recommending the shots for other groups. On Thursday, the FDA's vaccine advisers – the Vaccines and Related Biological Products Advisory Committee – will meet to discuss the coronavirus strain selection for this fall's Covid-19 vaccines. CNN's Brenda Goodman contributed to this report.
CNN
22-05-2025
- Health
- CNN
FDA requires Covid vaccine makers to expand warning about risk of rare heart inflammation
The US Food and Drug Administration will now require Covid-19 vaccines from Pfizer/BioNTech and Moderna to use expanded warning labels with more information about the risk of a rare heart condition after vaccination. The vaccines' previous labels warned about the risk of a heart condition called myocarditis, inflammation of the heart muscle, and pericarditis, inflammation of the lining outside the heart, which the US Centers for Disease Control and Prevention website says is rare but possible after vaccination. The new labels will expand that warning to certain age groups. Research has consistently shown that the mRNA Covid-19 vaccines are safe and effective, and millions of people have gotten them without serious incident. Some studies have found that Covid-19 infection itself carries a higher risk of myocarditis or pericarditis than the vaccine does. The CDC last month told its independent vaccine advisers that research showed Covid-19 vaccinations from 2020 through 2022 showed a statistically significant increased risk of myocarditis. The incidents were rare, however, and 'there is no increased risk observed with the doses administered in subsequent years,' the agency said. In the rare case that someone did develop heart inflammation after vaccination, the CDC told the advisers, acute myocarditis typically resolves quickly. The vaccines already carried warnings that the highest risk of these heart problems was observed in males between ages 18 and 24 for the Moderna vaccine and 12 to 17 for Pfizer's; the new warnings for both vaccines will be for males age 16 to 25. In letters to Pfizer and Moderna that were dated April 17 and are now posted online, the agency says analysis of commercial health insurance claims data shows that there were eight cases of myocarditis and/or pericarditis per million vaccine doses given to people ages 6 months through 64 years. Cases were more common among males ages 16 through 25 within seven days of vaccination, but they were still rare, with about 38 cases of myocarditis and/or pericarditis per million doses among this group. A spokesperson for the US Department of Health and Human Services said Wednesday that the move was intended to increase 'radical transparency.' Neither Pfizer nor Moderna responded to requests for comment. The vaccines were developed during the first Trump administration and underwent what the CDC says was 'the most intensive safety analysis in US history,' and the agency continues to monitor vaccine administration data for effectiveness and any potential problems. US Health and Human Services Secretary Robert F. Kennedy Jr., a longtime anti-vaccine activist, has falsely claimed that the Covid-19 vaccine was 'the deadliest vaccine ever made.' In a US Senate Homeland Security and Governmental Affairs subcommittee hearing on Wednesday, Sen. Ron Johnson, R-Wisconsin, claimed that the Biden administration downplayed the risks of the vaccine and delayed getting information about those risks to the public. One witness, Hawaii Gov. Josh Green, a family physician, said in his testimony the US vaccine safety monitoring systems worked 'exactly as intended' by detecting rare cases of myocarditis. 'The data were made public, warnings were updated, and clinical guidance was revised accordingly,' Green said. 'Despite this, some continue to promote misleading interpretations, unverified claims or anecdotes to suggest that vaccines are broadly unsafe.' The FDA has taken recent steps to limit Covid-19 vaccines for certain groups. On Tuesday, the FDA said it would change the type of evidence it will accept from vaccine manufacturers to approve updated Covid shots, which may limit who is eligible for updated shots. The vaccines are expected to be be available in the fall, but only for adults 65 and older and people with underlying conditions that put them at a higher risk for severe Covid-19 infection. In an editorial published in the New England Journal of Medicine, FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, the new director of the FDA's Center for Biologics Evaluation and Research, said there's not enough evidence that healthy children and adults get clinically meaningful benefit from regular Covid-19 shots, and officials want to see more placebo-controlled trials, particularly in adults 50 to 64, before recommending the shots for other groups. On Thursday, the FDA's vaccine advisers – the Vaccines and Related Biological Products Advisory Committee – will meet to discuss the coronavirus strain selection for this fall's Covid-19 vaccines. CNN's Brenda Goodman contributed to this report.
CNN
22-05-2025
- Health
- CNN
FDA requires Covid vaccine makers to expand warning about risk of rare heart inflammation
The US Food and Drug Administration will now require Covid-19 vaccines from Pfizer/BioNTech and Moderna to use expanded warning labels with more information about the risk of a rare heart condition after vaccination. The vaccines' previous labels warned about the risk of a heart condition called myocarditis, inflammation of the heart muscle, and pericarditis, inflammation of the lining outside the heart, which the US Centers for Disease Control and Prevention website says is rare but possible after vaccination. The new labels will expand that warning to certain age groups. Research has consistently shown that the mRNA Covid-19 vaccines are safe and effective, and millions of people have gotten them without serious incident. Some studies have found that Covid-19 infection itself carries a higher risk of myocarditis or pericarditis than the vaccine does. The CDC last month told its independent vaccine advisers that research showed Covid-19 vaccinations from 2020 through 2022 showed a statistically significant increased risk of myocarditis. The incidents were rare, however, and 'there is no increased risk observed with the doses administered in subsequent years,' the agency said. In the rare case that someone did develop heart inflammation after vaccination, the CDC told the advisers, acute myocarditis typically resolves quickly. The vaccines already carried warnings that the highest risk of these heart problems was observed in males between ages 18 and 24 for the Moderna vaccine and 12 to 17 for Pfizer's; the new warnings for both vaccines will be for males age 16 to 25. In letters to Pfizer and Moderna that were dated April 17 and are now posted online, the agency says analysis of commercial health insurance claims data shows that there were eight cases of myocarditis and/or pericarditis per million vaccine doses given to people ages 6 months through 64 years. Cases were more common among males ages 16 through 25 within seven days of vaccination, but they were still rare, with about 38 cases of myocarditis and/or pericarditis per million doses among this group. A spokesperson for the US Department of Health and Human Services said Wednesday that the move was intended to increase 'radical transparency.' Neither Pfizer nor Moderna responded to requests for comment. The vaccines were developed during the first Trump administration and underwent what the CDC says was 'the most intensive safety analysis in US history,' and the agency continues to monitor vaccine administration data for effectiveness and any potential problems. US Health and Human Services Secretary Robert F. Kennedy Jr., a longtime anti-vaccine activist, has falsely claimed that the Covid-19 vaccine was 'the deadliest vaccine ever made.' In a US Senate Homeland Security and Governmental Affairs subcommittee hearing on Wednesday, Sen. Ron Johnson, R-Wisconsin, claimed that the Biden administration downplayed the risks of the vaccine and delayed getting information about those risks to the public. One witness, Hawaii Gov. Josh Green, a family physician, said in his testimony the US vaccine safety monitoring systems worked 'exactly as intended' by detecting rare cases of myocarditis. 'The data were made public, warnings were updated, and clinical guidance was revised accordingly,' Green said. 'Despite this, some continue to promote misleading interpretations, unverified claims or anecdotes to suggest that vaccines are broadly unsafe.' The FDA has taken recent steps to limit Covid-19 vaccines for certain groups. On Tuesday, the FDA said it would change the type of evidence it will accept from vaccine manufacturers to approve updated Covid shots, which may limit who is eligible for updated shots. The vaccines are expected to be be available in the fall, but only for adults 65 and older and people with underlying conditions that put them at a higher risk for severe Covid-19 infection. In an editorial published in the New England Journal of Medicine, FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, the new director of the FDA's Center for Biologics Evaluation and Research, said there's not enough evidence that healthy children and adults get clinically meaningful benefit from regular Covid-19 shots, and officials want to see more placebo-controlled trials, particularly in adults 50 to 64, before recommending the shots for other groups. On Thursday, the FDA's vaccine advisers – the Vaccines and Related Biological Products Advisory Committee – will meet to discuss the coronavirus strain selection for this fall's Covid-19 vaccines. CNN's Brenda Goodman contributed to this report.
