Latest news with #StephaneBancel
Bloomberg
11-06-2025
- Business
- Bloomberg
Moderna Seeks Outside Investors to Fund Select Vaccine Trials
Moderna Inc. is in discussions with large drugmakers and financial firms to get funding for some late-stage vaccine trials as it works to develop its product portfolio while cutting costs. 'We are very actively talking to potential partners right now,' Chief Executive Officer Stephane Bancel said Wednesday at the Goldman Sachs Annual Global Healthcare Conference. The discussions are with pharmaceutical companies and other types of financial partners, he said.
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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
Reuters
02-06-2025
- Business
- Reuters
US FDA approves Moderna's next-generation COVID vaccine for adults 65 or older
May 31 (Reuters) - The U.S. Food and Drug Administration has approved Moderna's (MRNA.O), opens new tab next-generation COVID-19 vaccine for everyone aged 65 and above, the company said on Saturday, the first endorsement since the regulator tightened requirements. The vaccine has also been approved for people aged 12 to 64 with at least one or more underlying risk factors defined by the Centers for Disease Control and Prevention, Moderna said in a statement. The company said it expects to have the vaccine, called mNEXSPIKE, available for the 2025-2026 respiratory virus season. "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," CEO Stephane Bancel said in the statement. The Department of Health and Human Services, under the leadership of long-time vaccine skeptic Robert F. Kennedy Jr., is tightening regulatory scrutiny on vaccines. The FDA said on May 20 it planned to require drugmakers to test their COVID booster shots against an inert placebo in healthy adults under 65 for approval, effectively limiting them to older adults and those at risk of developing severe illness. The Moderna vaccine can be stored in refrigerators rather than freezers, to offer longer shelf life and make distribution easier, especially in developing countries where supply-chain issues could hamper vaccination drives. The Centers for Disease Control and Prevention, which Kennedy also oversees, said on Thursday that COVID vaccines remain an option for healthy children when parents and doctors agree that it is needed, stopping short of Kennedy's announcement days earlier that the agency would remove the shots from its immunization schedule. The CDC announcement eases investor concern to some extent, analysts say, as it keeps the existing framework for older adults and at-risk people who generally seek out the shots. FDA leaders have said 100 million to 200 million Americans would still be eligible for annual shots. Moderna is betting on its newer messenger RNA vaccines as it grapples with waning demand for its original COVID vaccine Spikevax and lower-than-expected uptake of its respiratory syncytial virus vaccine. The approval for mNEXSPIKE was based on late-stage trial data, which showed the shot was not inferior in efficacy compared to Spikevax in individuals aged 12 years and older. The shot also showed superior efficacy compared to Spikevax in adults 18 years of age and older in the study. Kennedy has kickstarted a major overhaul of health departments, laying off thousands of employees to align with President Donald Trump's goal of dramatically shrinking the federal government. This has further ignited worries about potential disruptions to the regulatory review of treatments and vaccines. The CDC's outside panel of vaccine experts in April discussed recommending the booster shots only for populations at risk of severe COVID-19 for the upcoming immunization campaign. The FDA approved Novavax's COVID vaccine Nuvaxovid this month, limiting its use to older adults and people over the age of 12 with conditions that put them at risk due to the illness. Conditions that constitute additional risk range from illnesses such as diabetes and heart disease to behaviors like physical inactivity and substance abuse, according to the CDC. While Moderna's shots, as well as Pfizer-BioNTech's Comirnaty, are mRNA-based, Novavax's vaccine is protein-based and takes longer to manufacture. Moderna this month withdrew an application seeking approval for its flu-and-COVID combination vaccine candidate to wait for efficacy data from a late-stage trial of its influenza shot.
Business Insider
02-06-2025
- Health
- Business Insider
Moderna announces FDA approved mNEXSPIKE, new vaccine against COVID-19
Moderna (MRNA) announced that the U.S. Food and Drug Administration, FDA, has approved mNEXSPIKE, 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. '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 Stephane 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.' Confident Investing Starts Here:
CNBC
02-06-2025
- Health
- CNBC
FDA approves Moderna's new lower-dose Covid-19 vaccine
The U.S. approved a new Covid-19 vaccine made by Moderna late Friday but with limits on who can use it — not a replacement for the company's existing shot, but a second option. The new vaccine, mNexspike, 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 — by refining its immune target. 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 U.S. has handled Covid-19 vaccines until now, reflecting skepticism 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 FDA's approval was based on a study of 11,400 people age 12 and older that compared the new low-dose vaccine with Moderna's existing vaccine. It found the new vaccine was safe and was at least as effective — and more by some measures — than the original shot, the company said. The news came just days after the Trump administration canceled funding for Moderna to develop a vaccine against potential pandemic flu viruses, including the H5N1 bird flu, despite promising early study results.
