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Yahoo
29 minutes ago
- Health
- Yahoo
FDA OKs new COVID-19 vaccine for 65 and older, others with conditions
May 31 (UPI) -- The Food and Drug Administration has approved Moderna's new COVID-19 vaccine, days after the federal government tightened vaccine standards for the virus. The FDA announced Friday that mNEXSPIKE can be given to adults 65 and older and those 12 to 64 with at least one underlying condition that could put them at risk of severe infection. Recipients also must have been previously vaccinated for COVID-19. The company, headquartered in Cambridge, Mass., said Saturday it expects to have the vaccine available for the 2025-2026 respiratory virus season. Moderna also produces Spikevax for COVID-19, and mRESVIA for the respiratory syncytial virus, or RSV. "The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19," Stéphane Bancel, chief executive officer of Moderna, said. "COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone. We appreciate the FDA's timely review and thank the entire Moderna team for their hard work and continued commitment to public health." STAT reported the next-generation COVID-19 vaccine uses a refined target to generate antibodies against the SARS-CoV-2 virus. The dose is one-fifth the doage used in Spikevax, the current vaccine. Moderna conducted a randomized, observer-blind Phase 3 clinical trial of approximately 11,400 participants aged 12 years and older to test the mRNA-1283. The primary efficacy was to demonstrate the vaccine efficacy against COVID-19 starting 14 days after mNEXSPIKE compared with Spikevax, Moderna's updated COVID-19 vaccine approved on Sept. 6, 2024. The new vaccine showed a 9.3% higher relative vaccine efficacy than the mRNA-1273 in individuals aged 12 years and older. It was 13.5% better in adults aged 65 and older. In the Phase 3 trial, the most common side effects were injection site pain, fatigue, headache and myalgia. The company said there is a very small chance that mNEXSPIKE could cause a severe allergic reaction, usually within a few minutes to 1 hour after getting a dose of mNEXSPIKE. Myocarditis, which is inflammation of the heart muscle, and pericarditis, which is inflammation of the lining outside the heart, have occurred in some people who have received mRNA COVID-19 vaccines, Moderna said. Of those with problems, they are among males12 through 24. The FDA has asked Moderna to conduct post-marketing studies to continue to evaluate the safety and effectiveness of the product. This includes a study on the outcomes of pregnant people and their babies when the vaccine was administered during pregnancy. The study is to be submitted by the end of 2032. Pfizer was the first COVID-19 vaccine to receive emergency approval in December 2020 and Moderna was followed one week later. The first COVID-19 cases were reported in the United States in January 2020. The FDA first granted Pfizer-BioNTech full COVID-19 approval for those 12 and older in August 2021 and Moderna in January 2022. They remain available under emergency use authorization for children as young as 6 months. On Friday, the Centers for Disease Control and Prevention said children without underlying health conditions "may receive" a COVID-19 vaccine, contradicting a directive by Health and Human Services Secretary Robert F. Kennedy Jr. earlier in the week. The CDC updated the childhood immunization schedule published late Thursday. Kennedy, who said the agency would stop recommending the shots for healthy children, noted the guidelines would be changed. The new schedule also requires health insurance companies, Medicare and Medicaid plans to continue to cover the vaccines for children. COVID-19 shots during pregnancy are listed as "No Guidance/Not Applicable," where they were previously recommended for all pregnant adults. Earlier this month, the FDA approved Novavax's COVID-19 vaccine with age restrictions after a six-week delay. The agency approved the vaccine only for people 65 and older and those 12 and older with at least one underlying condition at a higher risk of severe illness. This week, HHS notified Moderna that it was canceling contracts worth $766 million to develop, test and license vaccines for flu subtypes that could trigger future pandemics, including the dangerous H5N1 bird flu virus. The first COVID-19 case was reported in the United States on Jan. 20, 2020. About 23% of U.S. adults are estimated to be up to date with the vaccine, according to the CDC through April. For children 6 months and up to 18, it is an estimated 13.%, the CDC reported.
Yahoo
29 minutes ago
- Business
- Yahoo
FDA clears Moderna's new COVID vaccine, but with limits
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. The Food and Drug Administration has granted an approval to Moderna's next-generation COVID-19 vaccine, but with limits that will restrict use to older adults and people with preexisting health conditions. The OK is the first since agency leadership rolled out new guidelines for COVID shot approvals. The new vaccine, which Moderna will sell as mNexspike, is cleared for healthy adults 65 years and older and for individuals aged between 12 years and 64 years with one or more underlying 'risk factors,' the company said Saturday. Moderna CEO Stéphane Bancel called the shot an 'important new tool' to protect people from COVID, noting in a statement that more than 47,000 people in the U.S. died from the disease last year. The FDA based its decision on data from a Phase 3 study that pitted mNexspike against Spikevax, Moderna's original vaccine which is cleared for broad use. Results found mNexspike was 'non-inferior' to Spikevax overall and, in people older than 12 years, slightly more effective on a relative basis. Moderna expects to make mNexspike, which is currently targeted to the JN.1 coronavirus variant, available beginning in the fall. The FDA granted its approval by a May 31 deadline it had set, despite worries that recent moves by Trump administration officials might jeopardize the shot. In May, FDA Commissioner Martin Makary and top vaccine official Vinay Prasad said the agency would require placebo-controlled trials before it cleared any new COVID shots in healthy children and adults. Previously, the FDA has accepted comparative immune data for some decisions, such as for boosters. More recently, Health and Human Services Secretary Robert F. Kennedy Jr. said the Centers for Disease Control and Prevention would remove COVID shots from the recommended immunization schedules for pregnant women and healthy children. The CDC has since confused that messaging with a notice indicating the shots remain an option for children. MNexspike's approval is similar to what the FDA recently granted Novavax's protein-based shot Nuvaxovid. That vaccine is also cleared for older adults and those at high risk, while the company is required to conduct an additional study. Messenger RNA shots like Moderna's and Pfizer's Cominarty have appeared to be under higher scrutiny, however. Kennedy has previous questioned the technology, and HHS recently canceled a lucrative contract with Moderna to develop mRNA vaccines for pandemic-prone influenza like bird flu. MRNA shots can be developed and adapted more quickly, traits that allowed Pfizer and Moderna to quickly deliver safe and effective vaccines early on in the pandemic. In a note to clients, Jefferies analyst Michael Yee said the on-time approval is an 'incremental positive' for Moderna. It shows FDA leaders are 'still rational so long as the data packages show good efficacy and is well conducted.' However, there's still some risk Moderna doesn't hit its sales guidance, he added, as vaccination rates remain low. Advisers to the CDC are set to meet in late June to discuss COVID vaccine use recommendations for the coming fall and winter seasons.
UPI
an hour ago
- Health
- UPI
FDA OKs new COVID-19 vaccine for 65 and older, others with conditions
A vial of the Moderna COVID-19 vaccine in the Meuhedet Clinic in Jerusalem on January 3, 2022. The FDA approved a new version of the vaccine on Friday. File photo by Debbie Hill/UPI | License Photo May 31 (UPI) -- The Food and Drug Administration has approved Moderna's new COVID-19 vaccine, days after the federal government tightened vaccine standards for the virus. The FDA announced Friday that mNEXSPIKE can be given to adults 65 and older and those 12 to 64 with at least one underlying condition that could put them at risk of severe infection. Recipients also must have been previously vaccinated for COVID-19. The company, headquartered in Cambridge, Mass., said Saturday it expects to have the vaccine available for the 2025-2026 respiratory virus season. Moderna also produces Spikevax for COVID-19, and mRESVIA for the respiratory syncytial virus, or RSV. "The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19," Stéphane Bancel, chief executive officer of Moderna, said. "COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone. We appreciate the FDA's timely review and thank the entire Moderna team for their hard work and continued commitment to public health." STAT reported the next-generation COVID-19 vaccine uses a refined target to generate antibodies against the SARS-CoV-2 virus. The dose is one-fifth the doage used in Spikevax, the current vaccine. Moderna conducted a randomized, observer-blind Phase 3 clinical trial of approximately 11,400 participants aged 12 years and older to test the mRNA-1283. The primary efficacy was to demonstrate the vaccine efficacy against COVID-19 starting 14 days after mNEXSPIKE compared with Spikevax, Moderna's updated COVID-19 vaccine approved on Sept. 6, 2024. The new vaccine showed a 9.3% higher relative vaccine efficacy than the mRNA-1273 in individuals aged 12 years and older. It was 13.5% better in adults aged 65 and older. In the Phase 3 trial, the most common side effects were injection site pain, fatigue, headache and myalgia. The company said there is a very small chance that mNEXSPIKE could cause a severe allergic reaction, usually within a few minutes to 1 hour after getting a dose of mNEXSPIKE. Myocarditis, which is inflammation of the heart muscle, and pericarditis, which is inflammation of the lining outside the heart, have occurred in some people who have received mRNA COVID-19 vaccines, Moderna said. Of those with problems, they are among males12 through 24. The FDA has asked Moderna to conduct post-marketing studies to continue to evaluate the safety and effectiveness of the product. This includes a study on the outcomes of pregnant people and their babies when the vaccine was administered during pregnancy. The study is to be submitted by the end of 2032. Pfizer was the first COVID-19 vaccine to receive emergency approval in December 2020 and Moderna was followed one week later. The first COVID-19 cases were reported in the United States in January 2020. The FDA first granted Pfizer-BioNTech full COVID-19 approval for those 12 and older in August 2021 and Moderna in January 2022. They remain available under emergency use authorization for children as young as 6 months. On Friday, the Centers for Disease Control and Prevention said children without underlying health conditions "may receive" a COVID-19 vaccine, contradicting a directive by Health and Human Services Secretary Robert F. Kennedy Jr. earlier in the week. The CDC updated the childhood immunization schedule published late Thursday. Kennedy, who said the agency would stop recommending the shots for healthy children, noted the guidelines would be changed. The new schedule also requires health insurance companies, Medicare and Medicaid plans to continue to cover the vaccines for children. COVID-19 shots during pregnancy are listed as "No Guidance/Not Applicable," where they were previously recommended for all pregnant adults. Earlier this month, the FDA approved Novavax's COVID-19 vaccine with age restrictions after a six-week delay. The agency approved the vaccine only for people 65 and older and those 12 and older with at least one underlying condition at a higher risk of severe illness. This week, HHS notified Moderna that it was canceling contracts worth $766 million to develop, test and license vaccines for flu subtypes that could trigger future pandemics, including the dangerous H5N1 bird flu virus. The first COVID-19 case was reported in the United States on Jan. 20, 2020. About 23% of U.S. adults are estimated to be up to date with the vaccine, according to the CDC through April. For children 6 months and up to 18, it is an estimated 13.%, the CDC reported.
Axios
6 hours ago
- Health
- Axios
FDA approves new Moderna COVID-19 vaccine
The Food and Drug Administration approved Moderna's next-generation COVID-19 vaccine for adults 65 and older and those 12 to 64 years old with at least one underlying condition that could put them at risk of severe infection, the company said Saturday. The big picture: It was the first such approval since FDA tightened COVID vaccine standards and required drugmakers to conduct more studies before approving updated shots for healthy adults under 65. Regulators under HHS Secretary Robert F. Kennedy Jr. are putting new restrictions on COVID vaccines, including no longer recommending them for healthy children and healthy pregnant women. What they're saying: Moderna CEO Stéphane Bancel said in a news release"COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone." He said the approval "adds an important new tool to help protect people at high risk of severe disease from COVID-19." Moderna expects to have the vaccine, called mNEXSPIKE, available for the 2025-2026 respiratory virus season Zoom in: In a Phase 3 trial of approximately 11,400 participants, the new vaccine showed 9.3% higher relative efficacy compared to Moderna's original vaccine Spikevax in people 12 and older, and a 13.5% higher efficacy in those 65 and older.
Time of India
14 hours ago
- Health
- Time of India
New COVID vaccine approved by US FDA: Here's all about it
Just new variants of the coronavirus causing COVID are emerging, the US Food and Drug Administration (US FDA) has approved a new vaccine against COVID. The vaccine has been manufactured by Moderna. "Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mNEXSPIKE (mRNA-1283), a new vaccine against COVID-19, for use in all adults 65 and older, as well as individuals aged 12-64 years with at least one or more underlying risk factor as defined by the Centers for Disease Control and Prevention (CDC)," the pharma maker has said in a press release. COVID killed 47,000 Americans in 2024. "The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19," said Stéphane Bancel, Chief Executive Officer of Moderna. "COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone. We appreciate the FDA's timely review and thank the entire Moderna team for their hard work and continued commitment to public health. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Buy Brass Idols - Handmade Brass Statues for Home & Gifting Luxeartisanship Buy Now Undo " What is mNEXSPIKE? mNEXSPIKE is a COVID-19 vaccine meant for folks who've already had a previous COVID shot. It's mainly for people aged 65 and older, or anyone between 12 and 64 who's at high risk of getting really sick from the virus. Just a heads-up though—like all vaccines, it's not a guaranteed shield for everyone, but it does offer an extra layer of protection for those who need it most. "You should not get mNEXSPIKE if you hada severe allergic reaction after a previous dose of either mNEXSPIKE, SPIKEVAX (COVID-19 Vaccine, mRNA), or any Moderna COVID-19 vaccine or to any ingredient in these vaccines," Moderna has warned. The side effects are trouble breathing, swelling of face and throat, fast heart beat, rashes, dizziness and weakness. Moderna expects to have mNEXSPIKE available for eligible populations in the U.S. for the 2025-2026 respiratory virus season, alongside Spikevax and mRESVIA, the Company's approved respiratory syncytial virus (RSV) vaccine. One step to a healthier you—join Times Health+ Yoga and feel the change
