Latest news with #mNEXSPIKE
Yahoo
a day ago
- Health
- Yahoo
What you need to know about Moderna's new COVID vaccine, just approved by the FDA
Moderna, over the weekend, announced that the U.S. Food and Drug Administration had approved its second-generation COVID vaccine, but only for specific populations: all adults 65 and over and those between 12 and 64 with at least one underlying risk factor as defined by the Centers for Disease Control and Prevention. Moderna's COVID shot had previously been approved for everyone 12 and older. The narrower approval follows the FDA announcing it was likely to limit access to immunizations among healthy children and adults under 65 this fall—as well as an announcement by Health Secretary Robert F. Kennedy Jr. (who, in 2021, called mRNA shots the 'deadliest vaccine ever made') about how COVID shots would be removed from the federal vaccine schedule for children and pregnant women. Still, days later, the CDC issued its own updated advice, going against Kennedy's announcement by keeping the shots on the schedule for healthy children 6 months and older. The mNEXSPIKE vaccine, which is meant to be a booster but will not immediately replace the Moderna's original COVID shot, was found through a Phase 3 clinical trial of 11,400 participants to be superior to the original; it showed a 9.3% higher relative vaccine efficacy (rVE) in individuals 12 and older and a 13.5% higher rVE in adults 65 and older. It will be available to those in the eligible populations—including those with risk factors such as asthma, chronic lung or kidney disease, or diabetes, according to the CDC—in the 2025–2026 respiratory virus season. The limits worry some physicians, including Dr. Jennifer Nayak, associate professor of pediatrics, microbiotics, and immunology at the University of Rochester, who told Rochester First, 'We know that [of] children who are hospitalized with COVID-19, about 41% of them don't have a known preexisting condition,' Nayak said. 'When you limit vaccination to only children who have preexisting conditions, you're going to miss some of the children who will get more seriously ill with this virus.' This updated mRNA shot still works by teaching the body to make a specific protein that helps your immune system ward off certain diseases. But instead of targeting the entire spike protein on the virus's surface, reports Medical Xpress, the new vaccine focuses on just two segments. This helps it last longer when refrigerated, making it easier to distribute in certain parts of the world, and more effective at lower doses. In the clinical trial, the new vaccine was found 'to have a similar safety profile' to the original, with 'fewer local reactions and comparable systemic reactions,' the most common being injection site pain, fatigue, headache, and myalgia. Still, other possible risks listed by Moderna, which 'may not be all the possible side effects,' include: Severe allergic reaction (which would occur within one hour) that could cause trouble breathing, face or throat swelling, body rash, fast heartbeat, or dizziness Myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the heart's outside lining, especially in males age 12–24; symptoms include chest pain, shortness of breath, and feelings of a fluttering or pounding heart) Such reactions, Moderna suggests, can be reported to the Vaccine Adverse Event Reporting System (VAERS). '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, in a company news release. 'COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone.' More on vaccines: The new COVID strain, NB 1.8.1, is an Omicron variant. Here's all you need to know Researchers uncover a link to autism—and it isn't vaccines The shingles vaccine could be the next best tool to prevent dementia, new study finds This story was originally featured on
Yahoo
a day ago
- Automotive
- Yahoo
Top Stock Movers Now: Ford, Cleveland-Cliffs, Moderna, and More
U.S. equities were mixed at midday after China accused the U.S. of violating a trade deal the two countries reached last month. Shares of the "Big Three" U.S. automakers tumbled after President Donald Trump said late Friday he planned to double tariffs on steel imports to 50%. Shares of Moderna climbed after the FDA approved the drugmaker's new COVID-19 vaccine, mNEXSPIKE, "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."U.S. equities were mixed at midday after China hit back at the U.S. and accused Washington of violating a trade deal the two countries reached last month. President Donald Trump said on Friday that China had "totally violated" the truce they struck in Geneva. The Dow Jones Industrial Average was down 0.5% and the S&P 500 slipped 0.1%. The Nasdaq was up 0.2%. Science Applications International Corp. (SAIC), or SAIC, shares dropped after the technology firm reported fiscal 2026 first-quarter profit and free cash flow below analysts' expectations. Shares of "Big Three" U.S. automakers General Motors (GM), Ford (F), and Chrysler parent Stellantis (STLA) tumbled after Trump said he planned to double tariffs on steel imports to 50%. By contrast, Cleveland-Cliffs (CLF), Steel Dynamics (STLD), and Nucor (NUE) were among U.S. steelmakers whose stocks jumped on Trump's plan to lift steel tariffs. Shares of Moderna (MRNA) gained after the Food and Drug Administration (FDA) approved the drugmaker's new COVID-19 vaccine, mNEXSPIKE, "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." Blueprint Medicines (BPMC) shares jumped after French drugmaker Sanofi (SNY) agreed to buy the Cambridge, Mass.-based biopharma firm for up to $9.5 billion. Oil and gold futures surged. The yield on the 10-year Treasury note gained. The U.S. dollar lost ground to the euro, pound, and yen. Major cryptocurrencies were mixed. Read the original article on Investopedia
Gulf Insider
a day ago
- Health
- Gulf Insider
Moderna Disables Comments On X Post Announcing New Covid Shot Amid Backlash
Moderna shares rose in premarket trading after the company announced FDA approval of its new lower-dose Covid-19 vaccine, mNEXSPIKE, for adults aged 65 and older, as well as individuals 12–64 with underlying health conditions. However, the approval sparked backlash on X, with many questioning the Trump administration and Health Secretary Robert F. Kennedy Jr.'s 'MAHA' (Make America Healthy Again) agenda. Moderna said in a Saturday morning X post that the mNEXSPIKE (mRNA-1283) vaccine should be available in the U.S. in time for the 2025-26 respiratory virus season, which starts later this year. '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 Stéphane Bancel stated in a press release. Bancel noted, '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.' Last month, the FDA announced that Covid vaccines would not be offered this fall to healthy children and adults. At the same time, the Trump administration stated that any new Covid vaccines must undergo clinical trials using an inert placebo—such as saline—rather than being tested against existing approved vaccines. Moderna's X post was met with heavy backlash, as many users voiced outrage over the FDA's approval, under Health Secretary RFK Jr., of yet another round of Covid vaccines. Moderna's social media team disabled comments on the post. Bottom line: people are furious: X user KAS14599753: ' When your products are so safe and effective, you turn off the comments.' X user Dr Aseem Malhotra: ' Complete and total madness. This company ( like Pfizer ) should be under investigation.' X user Gadsden2020: ' Gee, I wonder why they don't let everyone comment on this? Could it be that they know people aren't buying their bullshit anymore? We know it's only about the $$$.' X user DocAhmadMalik: ' Thank you, Donald Trump, Bobby, Jay, and Aseem, for proving that you are in on the game or totally hopeless.' Click here to read more…
Yahoo
2 days 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
Miami Herald
2 days ago
- Health
- Miami Herald
Moderna Receives U.S. FDA Approval for COVID-19 Vaccine mNEXSPIKE
mNEXSPIKE becomes Moderna's third FDA-approved product CAMBRIDGE, MA / ACCESS Newswire / May 31, 2025 / 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).[1] "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." The FDA's approval of mNEXSPIKE is based on results from a randomized, observer-blind, active-controlled Phase 3 clinical trial ( Identifier: NCT05815498), which enrolled approximately 11,400 participants aged 12 years and older. The primary efficacy objective in this study 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. mRNA-1283 is under review with regulators in multiple markets around the world. About ModernaModerna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines. Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. mNEXSPIKE®, mRESVIA® and Spikevax®are registered trademarks of Moderna. INDICATION mNEXSPIKE is a vaccine to protect against COVID-19. mNEXSPIKE is for people who have received a COVID-19 vaccine before and are: • 65 years of age and older, or • 12 years through 64 years of age at high risk for severe COVID-19. Vaccination with mNEXSPIKE may not protect all people who receive the vaccine. IMPORTANT SAFETY INFORMATION 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. What are the risks of mNEXSPIKE?There is a very small chance that mNEXSPIKE could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of mNEXSPIKE. For this reason, your healthcare provider may ask you to stay for a short time at the place where you received your vaccine. Signs of a severe allergic reaction can include: Trouble breathingSwelling of your face and throatA fast heartbeatA rash all over your bodyDizziness and weakness Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received mRNA COVID-19 vaccines. Myocarditis and pericarditis following mRNA COVID-19 vaccines have occurred most commonly in males 12 years through 24 years of age. You should seek medical attention right away if you or your child has any of the following symptoms after receiving the vaccine, particularly during the 2 weeks after receiving a dose of the vaccine: Chest painShortness of breathFeelings of having a fast-beating, fluttering, or pounding heart Side effects that have been reported in clinical trials with mNEXSPIKE include: Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm of the injection, swelling (hardness), and side effects: fatigue, headache, muscle pain, joint pain, chills, nausea, vomiting, and fever Tell your vaccination provider about all of your medical conditions, including if you: have any allergieshad a severe allergic reaction after receiving a previous dose of any COVID-19 vaccinehave had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)have a feverhave a bleeding disorder or are on a blood thinnerare immunocompromised or are on a medicine that affects your immune systemare pregnant or plan to become pregnantare breastfeedinghave received any other COVID-19 vaccinehave ever fainted in association with an injection These may not be all the possible side effects of mNEXSPIKE. Ask your healthcare provider about any side effects that concern you. You may report side effects to Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or Please click for mNEXSPIKE Full Prescribing Information. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the efficacy, safety and tolerability of mNEXSPIKE; and the availability of Moderna's respiratory vaccines for the 2025-2026 season. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, which are available on the SEC's website at Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release. Moderna ContactsMedia:Chris RidleyHead of Global Media Relations+1 Investors:Lavina TalukdarSenior Vice President & Head of Investor Relations+1
