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Economic Times
6 days ago
- 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
6 days ago
- 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.
Mint
7 days ago
- Health
- Mint
FDA expands warning about rare heart side effect in two leading Covid vaccines
The Food and Drug Administration has mandated that Pfizer and Moderna expand warning labels on their mRNA COVID-19 vaccines (Comirnaty and Spikevax) to highlight a rare risk of myocarditis and pericarditis, which are heart inflammation conditions, primarily in males aged 16–25. The updated labels now cite an incidence rate of 38 cases per million doses in this demographic, up from prior warnings focused on ages 12–17 (Pfizer) and 18–24 (Moderna). For all recipients under 65, the overall risk remains low at nearly 8 cases per million doses. This move follows FDA analysis of 2023–2024 vaccine safety data, including insurance claims and a study showing persistent cardiac MRI abnormalities in some patients five months post-diagnosis. The CDC, however, maintains that such cases are rare, typically resolve quickly, and are less severe than those caused by COVID-19 infection itself. Policy clash and political tensions underpin new warnings The FDA's decision conflicts with prior CDC assessments that found no increased myocarditis risk in vaccine injury databases since 2022. It also aligns with broader efforts by Health Secretary Robert F. Kennedy Jr.'s administration to tighten vaccine oversight. Kennedy recently replaced all 17 CDC advisory panel members with appointees, including anti-vaccine advocates, and FDA Commissioner Marty Makary, a critic of COVID-19 booster mandates, has restricted annual shots to high-risk groups (e.g., senior citizens). Also Read | Nestle says it will remove artificial dyes from US foods by 2026 Critics argue the label expansion overlooks context: Studies confirm COVID-19 infection poses a 16-fold higher myocarditis risk than vaccination, and most post-vaccine cases are mild, resolving with anti-inflammatory treatment. Yale researchers note the inflammation is transient, not autoimmune, allowing full recovery. Expert backlash and global safety perspectives Medical experts condemn the FDA's approach as misleading. 'They are right to suggest that we need to consider myocarditis risks associated with the vaccine, but what they propose is exactly the wrong solution,' said Dr. Robert Morris of the University of Washington. 'We should be investigating who is prone to myocarditis to see if we can predict and mitigate that risk," according to a report by AP.
Reuters
04-06-2025
- Business
- Reuters
US appeals court sides with Moderna on COVID patent claims
June 4 (Reuters) - Moderna (MRNA.O), opens new tab convinced a U.S. appeals court on Wednesday to uphold a ruling that undercut patent infringement claims by biotech company Alnylam Pharmaceuticals (ALNY.O), opens new tab over Moderna's blockbuster COVID-19 vaccine Spikevax. The U.S. Court of Appeals for the Federal Circuit upheld, opens new tab a Delaware federal court's decision to interpret Alnylam's two patents in a manner that foreclosed its infringement arguments. Alnylam lost a similar dispute in a related Moderna case last year. It has filed separate, ongoing patent lawsuits over Pfizer's COVID shots. An Alnylam spokesperson said the company is reviewing the Wednesday ruling and considering its options. A Moderna spokesperson said it was pleased with the decision and that its vaccine was "a product of many years of pioneering mRNA platform research and development." Cambridge, Massachusetts-based Alnylam first sued Moderna and Pfizer for patent infringement in 2022 for allegedly using its lipid nanoparticle (LNP) technology in their vaccines to deliver genetic material into the body. The lawsuits are part of a web of patent disputes between biotech companies over COVID shots, which includes a lawsuit filed by Moderna against Pfizer later that year. Moderna and Alnylam jointly agreed to dismiss Alnylam's patent claims in the first case in 2023 after U.S. District Judge Colm Connolly interpreted the patents to cover a type of lipid that Spikevax did not have. A three-judge Federal Circuit panel upheld Connolly's interpretation on Wednesday. The case is Alnylam Pharmaceuticals Inc v. Moderna Inc, U.S. Court of Appeals for the Federal Circuit, No. 23-2357. For Alnylam: Paul Hughes of McDermott Will & Emery For Moderna: Jeffrey Lamken of MoloLamken Read more: Alnylam files patent infringement lawsuits against Pfizer, Moderna Alnylam to appeal ruling on patents related to Moderna's COVID vaccines Moderna fends off Alnylam US patent lawsuit over COVID shots, for now
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First Post
03-06-2025
- Health
- First Post
US okays Moderna's 'next generation' Covid-19 vaccine
The new vaccine, mNexspike (mRNA-1283), is a step toward next-generation coronavirus vaccines. It's made in a way that allows for a lower dose, a fifth of the dose of its current COVID-19 vaccine, Spikevax (mRNA-1273) by refining its immune target read more Moderna logo is seen displayed in this illustration taken, May 3, 2022. REUTERS Moderna, a vaccine manufacturer, said late last week that the FDA has authorised its next-generation COVID-19 vaccine. The new vaccine, mNexspike (mRNA-1283), is a step toward next-generation coronavirus vaccines. It's made in a way that allows for a lower dose, a fifth of the dose of its current COVID-19 vaccine, Spikevax (mRNA-1273) by refining its immune target. Moderna's approval was based on a phase 3 randomised controlled trial involving 11,400 participants ages 12 and older. The trial found that a 10-microgram (μg) dose of mNexspike demonstrated a 9.3% higher relative vaccine efficacy (rVE) compared to a 50-μg dose of Spikevax, with a 13.5% higher rVE in adults ages 65 and older. The two vaccinations have identical safety profiles, according to the manufacturer. STORY CONTINUES BELOW THIS AD The approval 'adds an important new tool to help protect people at high risk of severe disease from COVID-19,' Stephane Bancel, Moderna's CEO, said in a statement Saturday. The Food and Drug Administration approved the new vaccine for use in all adults 65 and older, and for people age 12 to 64 who have a least one health condition that puts them at increased risk from the coronavirus. That's the same limit that the FDA set in licensing another COVID-19 vaccine option from competitor Novavax. Those restrictions are a departure from how the US has handled COVID-19 vaccines until now, reflecting scepticism about vaccines from Health Secretary Robert F. Kennedy Jr. and other Trump officials. Moderna's existing vaccine doesn't face those limits and has long been used for anyone ages 6 months and older. The company said it expected to offer both options this fall. The news came just days after the Trump administration cancelled funding for Moderna to develop a vaccine against potential pandemic flu viruses, including the H5N1 bird flu, despite promising early study results. STORY CONTINUES BELOW THIS AD
