Latest news with #Spikevax
&w=3840&q=100)
First Post
an hour ago
- 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
Yahoo
a day ago
- Business
- Yahoo
Moderna Stock Climbs as FDA Approves New COVID-19 Vaccine
Moderna said the FDA approved its new COVID-19 vaccine "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." Shares of the pharmaceutical giant rose Monday morning but are still down by nearly 35% this year. Moderna's original COVID-19 vaccine generated $3.1 billion in sales last of Moderna (MRNA) climbed Monday after the Food and Drug Administration (FDA) approved the drugmaker's new COVID-19 vaccine. Moderna said its new vaccine, mNEXSPIKE, showed a higher relative efficacy in a clinical trial than its first FDA-approved COVID-19 vaccine and was approved "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 Cambridge, Mass.-based company said it "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." Moderna's original COVID-19 vaccine, Spikevax, generated $3.1 billion in sales last year. Moderna shares rose 2% soon after markets opened but have lost nearly 35% of their value in 2025. Read the original article on Investopedia Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
a day ago
- Business
- Yahoo
Moderna's New COVID Vaccine Secures FDA-Clearance For Seniors, At-Risk Individuals
The U.S. Food and Drug Administration (FDA) on Saturday approved Moderna, Inc.'s (NASDAQ:MRNA) mNexspike (mRNA-1283), a new vaccine against COVID-19, for all adults 65 and older and 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 FDA approval of our third product, mNEXSPIKE...,' said Stéphane Bancel, Chief Executive Officer of Moderna. The FDA's approval of mNEXSPIKE is based on results from a randomized, observer-blind, active-controlled Phase 3 trial, which enrolled approximately 11,400 participants aged 12 years and primary efficacy objective was to demonstrate the non-inferior vaccine efficacy against COVID-19 starting 14 days after mNexspike compared to that after the comparator vaccine, mRNA-1273 (Spikevax), Moderna's original COVID-19 vaccine. Participants received either a 10 μg dose of mRNA-1283 or a 50 μg dose of mRNA-1273. mRNA-1283 showed a 9.3% higher relative vaccine efficacy (rVE) compared to mRNA-1273 in individuals aged 12 years and older, and in a descriptive sub-group analysis, a 13.5% higher rVE in adults aged 65 and older. In the Phase 3 trial, mRNA-1283 was found to have a similar safety profile to mRNA-1273, with fewer local reactions and comparable systemic reactions. The most commonly solicited side effects were injection site pain, fatigue, headache and myalgia. 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. William Blair writes, 'Approval of mRNA-1283 is an incremental win for Moderna, especially considering HHS Secretary Robert F. Kennedy Jr.'s negative public opinion on mRNA COVID-19 vaccines, and we continue to see autonomy and data-driven decisions at the FDA.' 'We do not see approval of mRNA-1283 as a massive boost to Moderna's COVID-19 vaccine sales, which we believe are primarily driven by sentiment surrounding the vaccination market in general, but this is a critical step in the regulatory path for the combo flu/COVID vaccine product, mRNA-1083, which uses mRNA-1283 as the COVID-19 component of its formulation,' analyst Myles Minter writes. Analyst Minter says Moderna is still facing challenges from new government policies, including losing about $700 million in funding from the Department of Health and Human Services for its bird flu vaccine project. In addition, William Blair writes that the company's goal to break even by 2028 is overly optimistic since it would need to more than double its revenue—based on cash costs—to reach that target. In May, the FDA approved Novavax, Inc.'s (NASDAQ:NVAX) Nuvaxovid for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older and individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 (e.g. asthma, cancer, diabetes, obesity, smoking). Achievement of the U.S. license approval has triggered a $175 million milestone payment from Sanofi SA (NASDAQ:SNY). Price Action: MRNA stock is up 4.82% at $27.84 during the premarket session at the last check on Monday. Read Next:Photo by Wolfilser via Shutterstock Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? MODERNA (MRNA): Free Stock Analysis Report This article Moderna's New COVID Vaccine Secures FDA-Clearance For Seniors, At-Risk Individuals originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved.
CNBC
a day ago
- 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.
NBC News
2 days ago
- Health
- NBC News
FDA grants limited approval to new Covid vaccine from Moderna
Moderna announced this weekend that the Food and Drug Administration approved its lower-dose Covid-19 vaccine for adults 65 and older, as well as people ages 12 to 64 with at least one medical condition that increases their risk for severe Covid. The approval, which is limited to individuals who have previously received a Covid vaccine, was granted by the FDA on Friday. Moderna said in a Saturday press release that the new vaccine should be available in the U.S. in time for the 2025-26 respiratory virus season, which starts in the fall. Moderna is also updating its original vaccine to target the LP.8.1 variant this fall. The company submitted an application in May for the FDA to approve the updated formula. The newly approved vaccine, mNEXSPIKE, contains one-fifth of of Moderna's original Covid vaccine dose, Spikevax. It is intended as an alternative for individuals who prefer a lower-dose option, not as a replacement for existing Covid vaccines. But young, healthy adults won't be eligible to receive it, despite their inclusion in Moderna's clinical trial. The FDA imposed similar limitations on Novavax's Covid vaccine when it approved the shot last month. But Friday marks the first time the FDA has greenlit a vaccine since the Trump administration's call for tighter restrictions on vaccine eligibility and approvals. The FDA said last month that it would limit its approval of updated Covid shots moving forward to older adults and younger people with underlying medical conditions. Health and Human Services Secretary Robert F. Kennedy Jr. also announced last week that the Centers for Disease Control and Prevention would no longer recommend Covid vaccines for healthy children and pregnant women. The CDC website appears to soften that recommendation, suggesting that parents can speak with a doctor about vaccinating children 6 months and older. The Trump administration has also said new Covid vaccines must undergo clinical trials with an inert placebo — meaning some participants would receive the new vaccine while others would receive an inactive substance like saline, to compare results. Many new vaccines are tested against older, approved versions, a method considered to be more ethical since using an inert placebo would mean withholding the benefit of a vaccine from study participants. Moderna's new vaccine was tested this way, using what's known as an 'active comparator.' In a trial of around 11,400 participants ages 12 and up, the new vaccine generated higher antibody levels than the company's original Covid shot, according to Moderna. The company also said the new vaccine had fewer local reactions, which typically include redness or swelling at the injection site. Systemic reactions, which may include fever, headaches or chills, were comparable between the shots. The main side effects of mNEXSPIKE were injection site pain, fatigue, headache and muscle pain, Moderna said in its press release.
