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Economic Times
26-06-2025
- Health
- Economic Times
FDA issues new heart risk warnings for Pfizer, Moderna COVID vaccines - should you be worried?
What's Behind the FDA's New Warning? Who Faces the Highest Risk? Live Events What's Changing in the Vaccine Labels? What's the FDA Doing Next? FAQs (You can now subscribe to our (You can now subscribe to our Economic Times WhatsApp channel The US Food and Drug Administration (FDA) has warned that COVID-19 vaccines, which are manufactured by Pfizer and Moderna, have the potential for cardiac risks, as per a warnings were first proposed in letters, which were sent to both companies in April, providing additional information about the potential risks of myocarditis and/or pericarditis associated with the two vaccines, as reported by the Cardiovascular Business report. Myocarditis and pericarditis have the possibility of leading to long-term heart damage, according to the READ: Meet Trapit Bansal, Meta's new AI superintelligence team hire - Is Meta poaching top talent from OpenAI? FDA's latest update covers Pfizer's Comirnaty vaccine and Moderna's Spikevax vaccine, while both companies had mentioned text about myocarditis and pericarditis in the labelling for these vaccines since 2021, but the FDA wanted more information added to these warnings that specifically mentions the increased risks for young men, as per the Cardiovascular Business READ: After Canada, now US: College graduates face the toughest job market in decades – what's gone wrong? According to the Cardiovascular Business report, the new labeling for both the vaccines is now required to include the following text, as per FDA's latest update:"Based on analyses of commercial health insurance claims data from inpatient and outpatient settings, the estimated unadjusted incidence of myocarditis and/or pericarditis during the period 1 through 7 days following administration of the 2023-2024 Formula of mRNA COVID-19 vaccines was approximately 8 cases per million doses in individuals 6 months through 64 years of age and approximately 27 cases per million doses in males 12 through 24 years of age," as quoted in the label should also include, "Follow-up information on cardiovascular outcomes in hospitalized patients who had been diagnosed with COVID-19 vaccine-associated myocarditis is available from a longitudinal retrospective observational study. Most of these patients had received a two-dose primary series of an mRNA COVID-19 vaccine prior to their diagnosis. In this study, at a median follow-up of approximately 5 months post-vaccination, persistence of abnormal cardiac magnetic resonance imaging (CMR) findings that are a marker for myocardial injury was common. The clinical and prognostic significance of these CMR findings is not known," as quoted by the Cardiovascular Business READ: Top economist warns: US faces a crisis worse than recession — here's what could be coming While, FDA has also emphasised that it plans to keep tracking the safety of COVID-19 vaccines from now on, as per the agency said, 'Continuous monitoring and assessment of the safety of all vaccines, including the mRNA COVID-19 vaccines, is an FDA priority and we remain committed to informing the public when we learn new information about these vaccines,' adding, 'In addition, as part of the approvals of Comirnaty and Spikevax, each manufacturer is required by FDA to conduct a study to assess if there are long-term heart effects in people who have had myocarditis after receiving an mRNA COVID-19 vaccine. These studies are underway,' quoted by the Cardiovascular Business FDA wants the public to have clearer information about rare heart-related risks linked to COVID-19 mRNA vaccines, especially for young men, as per the Cardiovascular Business the FDA continues to support their use, but these warnings are about rare side effects, as per the Cardiovascular Business report.
Time of India
26-06-2025
- Health
- Time of India
FDA issues new heart risk warnings for Pfizer, Moderna COVID vaccines - should you be worried?
The US Food and Drug Administration (FDA) has warned that COVID-19 vaccines, which are manufactured by Pfizer and Moderna, have the potential for cardiac risks, as per a report. What's Behind the FDA's New Warning? These warnings were first proposed in letters, which were sent to both companies in April, providing additional information about the potential risks of myocarditis and/or pericarditis associated with the two vaccines, as reported by the Cardiovascular Business report. Myocarditis and pericarditis have the possibility of leading to long-term heart damage, according to the report. ALSO READ: Meet Trapit Bansal, Meta's new AI superintelligence team hire - Is Meta poaching top talent from OpenAI? by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Play War Thunder now for free War Thunder Play Now Undo Who Faces the Highest Risk? FDA's latest update covers Pfizer's Comirnaty vaccine and Moderna's Spikevax vaccine, while both companies had mentioned text about myocarditis and pericarditis in the labelling for these vaccines since 2021, but the FDA wanted more information added to these warnings that specifically mentions the increased risks for young men, as per the Cardiovascular Business report. ALSO READ: After Canada, now US: College graduates face the toughest job market in decades – what's gone wrong? Live Events What's Changing in the Vaccine Labels? According to the Cardiovascular Business report, the new labeling for both the vaccines is now required to include the following text, as per FDA's latest update: "Based on analyses of commercial health insurance claims data from inpatient and outpatient settings, the estimated unadjusted incidence of myocarditis and/or pericarditis during the period 1 through 7 days following administration of the 2023-2024 Formula of mRNA COVID-19 vaccines was approximately 8 cases per million doses in individuals 6 months through 64 years of age and approximately 27 cases per million doses in males 12 through 24 years of age," as quoted in the report. The label should also include, "Follow-up information on cardiovascular outcomes in hospitalized patients who had been diagnosed with COVID-19 vaccine-associated myocarditis is available from a longitudinal retrospective observational study. Most of these patients had received a two-dose primary series of an mRNA COVID-19 vaccine prior to their diagnosis. In this study, at a median follow-up of approximately 5 months post-vaccination, persistence of abnormal cardiac magnetic resonance imaging (CMR) findings that are a marker for myocardial injury was common. The clinical and prognostic significance of these CMR findings is not known," as quoted by the Cardiovascular Business report. ALSO READ: Top economist warns: US faces a crisis worse than recession — here's what could be coming What's the FDA Doing Next? While, FDA has also emphasised that it plans to keep tracking the safety of COVID-19 vaccines from now on, as per the report. The agency said, 'Continuous monitoring and assessment of the safety of all vaccines, including the mRNA COVID-19 vaccines, is an FDA priority and we remain committed to informing the public when we learn new information about these vaccines,' adding, 'In addition, as part of the approvals of Comirnaty and Spikevax, each manufacturer is required by FDA to conduct a study to assess if there are long-term heart effects in people who have had myocarditis after receiving an mRNA COVID-19 vaccine. These studies are underway,' quoted by the Cardiovascular Business report. FAQs Why is the FDA updating warnings now? The FDA wants the public to have clearer information about rare heart-related risks linked to COVID-19 mRNA vaccines, especially for young men, as per the Cardiovascular Business report. Are Moderna and Pfizer vaccines still considered safe? Yes, the FDA continues to support their use, but these warnings are about rare side effects, as per the Cardiovascular Business report.
Medscape
02-06-2025
- Business
- Medscape
ACURATE Heart Valves Halted After Consequential Study
Boston Scientific has discontinued production of its ACURATE neo2 heart valves following the release of data showing the devices were linked to higher rates of all-cause death, stroke, and rehospitalization than were other commercially available valves. The company reported the decision in a May 28 regulatory filing. 'While data continue to support the performance of the ACURATE valve system when the product's optimized instructions for use are followed, this decision was made based on recent discussions with regulators, which resulted in increased clinical and regulatory requirements to maintain approvals in global markets and to obtain approval in new markets,' Boston Scientific told Cardiovascular Business . 'Therefore, related commercial, clinical, research and development, and manufacturing activities will cease.' The company said it also would be halting production of its ACURATE PRIME valves, although the reason for that move was not clear. Disappointing Results The decision on the neo2 follows the publication May 21 of two articles from the study, one in the Lancet on the outcomes for patients and the other in the Journal of the American College of Cardiology on a relatively high rate of under-expansion of the valves. Despite its use in 50 other countries, ACURATE neo2 had not yet been approved by the US Food and Drug Administration. The Lancet study, which the company funded, involved 1469 patients undergoing transcatheter aortic valve replacement (TAVR). Its aim was to determine whether ACURATE neo2 was not inferior to its competitors. The randomized, controlled trial found ACURATE neo2 was associated with a 6.6% higher rate of a combined outcome of all-cause death, stroke, and rehospitalization after 1 year than was observed in a control group who received SAPIEN 3 or 3 Ultra or Evolut valves. The rates were also higher for each outcome (hazard ratio: 1.30 for all-cause death, 1.68 for stroke, and 1.57 for rehospitalization). Rates of cardiovascular mortality and myocardial infarction also were significantly higher at the same time point, according to the researchers. ACURATE neo2 was developed after its predecessor, ACURATE neo, a self-expanding valve for TAVR, did not achieve outcomes similar to those of SAPIEN and Evolut valves in randomized controlled trials. A problem with paravalvular leakage was found with ACURATE neo, prompting the development of neo2, which included a sealing skirt to prevent leakage, said Raj Makkar, MD, professor and associate director of the Smidt Heart Institute at Cedars-Sinai Medical Center in Los Angeles, and lead author of both papers. 'The sealing skirt worked, and the valvular regurgitation rates were lower than in ACURATE neo, but they were nonetheless still higher than in the control valves,' said, who receives research support from Boston Scientific as well as other manufacturers of heart valves. In addition to poor results on the longer-term outcomes, the ACURATE neo2 was associated with a lower rate of success, determined by whether the device was installed and operated successfully, did not require further interventions, and was not linked to complications within 30 days. One result was positive for ACURATE neo2. 'The hemodynamics were actually quite good,' Makkar said. 'This trial also highlights that, when it comes to clinical outcomes, it's not just the hemodynamics. A lot of other things come into play.' 'The ACURATE neo2 valve is an easy-to-use valve, and smaller, observational studies had suggested that outcomes were good,' Makkar added. 'But you need the rigor of a randomized controlled trial. In a randomized setting, the clinical outcomes were not as robust as they were with the other valve platforms.' Valve Expansion a Concern In a post-study analysis, the researchers went back to see if they could find any contributing factors to the ACURATE neo2's poorer outcomes. When they reviewed angiograms taken during TAVR procedures, they noticed many of the valves had not fully expanded. 'We found that under-expansion was associated with more frequent primary endpoints in contrast to valves that were properly expanded,' Makkar said. 'If you modified the device such that the radial strength were better, and we did more aggressive pre- and post-dilation, we could perhaps improve the expansion of the valve,' Makkar said. 'But whether that would lead to better clinical outcomes remains to be investigated and proven…. Dilation might increase the risk of some complications, such as stroke and aortic root injury. It is reasonable to try to safely expand the valve, but we should not expand the valve at any cost.' Makkar reported research support from Boston Scientific, Edwards Lifesciences, Medtronic, Abbott, and JenaValve.
