Latest news with #mNexspike
Medscape
4 hours ago
- Health
- Medscape
FDA Approves Moderna's New COVID Vaccine With Restricted Use
The FDA has approved Moderna's new COVID-19 shot, an mRNA vaccine, with some limits on who can get it. The vaccine, called mNexspike, is for people who've previously received a COVID-19 shot and is mainly intended for adults ages 65 and older. People ages 12 to 64 may also get the shot if they have at least one medical condition that increases their risk for serious illness from COVID as defined by the CDC. COVID is caused by SARS-CoV-2 virus, which spreads from person to person and infects the airways. While some people may only have mild symptoms, older adults, or those with certain underlying health conditions such as heart disease, diabetes, obesity, cancer, or COPD, among other conditions, are at a higher risk for severe illness. Overall, COVID remains a serious health risk that caused over 47,000 deaths in the United States last year alone. Getting vaccinated is still one of the best ways to lower this risk, especially for those who are more likely to get seriously sick. Moderna said the FDA approved mNexspike based on results of a large study involving about 11,400 people ages 12 and older that showed it worked equally well and sometimes better than Spikevax, the original Moderna vaccine. The new shot showed about 9.3% better protection than Spikevax in people 12 and older and 13.5% better results in adults 65 and older. The mNexspike vaccine contains special genetic material (mRNA) that teaches the body to recognize parts of a key protein that helps the virus infect human cells. The new vaccine is based on the Omicron JN.1 COVID variant and helps your immune system make antibodies to protect you. Common side effects include pain, redness, or swelling from the injection, painfully swollen lymph nodes in the same arm, tiredness, headache, muscle or joint pain, chills, nausea, vomiting, and fever.
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First Post
9 hours 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'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
2 days 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.
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Business Standard
3 days ago
- Health
- Business Standard
US FDA approves Moderna's new lower-dose Covid-19 vaccine 'mNexspike'
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 AP Washington The US 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 US 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 cancelled funding for Moderna to develop a vaccine against potential pandemic flu viruses, including the H5N1 bird flu, despite promising early study results. (Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
