Latest news with #mRESVIA
a day ago
- Health
FDA expands approval of Moderna's RSV vaccine to some adults under age 60
The U.S. Food and Drug Administration expanded its approval of Moderna's respiratory syncytial virus (RSV) vaccine on Thursday to include adults under the age of 60 at increased risk of the disease. Previously, the vaccine, known as mRESVIA, had been licensed for use for those aged 60 and older. Approval for mRESVIA came after Moderna conducted a late-stage clinical trial showing the vaccine helped boost immune responses in younger adults. More than one-third of adults between ages 18 and 59 have at least one underlying condition that puts them at increased risk of RSV, according to Moderna. "RSV poses a serious health risk to adults with certain chronic conditions, and today's approval marks an important step forward in our ability to protect additional populations from severe illness from RSV," Stéphane Bancel, CEO of Moderna, said in a press release. "We appreciate the FDA's review and thank all the participants in our clinical trial as well as the Moderna team for their dedication to protecting people against RSV." Although the FDA approves vaccines and may expand approvals for certain age groups, the Centers for Disease Control and Prevention sets recommendations regarding who should get vaccines and when. Currently, the CDC recommends RSV vaccination only for those aged 75 and older and for those aged 60 and over at increased risk. The CDC's independent vaccine advisory committee will need to vote to recommend that the new age group be eligible for the shot, followed by a final recommendation from the director of the CDC. Earlier this week, Kennedy removed all 17 sitting members of the committee and replaced them with eight new members. It remains unclear how the new members of the panel will decide to approach recommendations for the RSV vaccine. As of Friday, the CDC director role remains vacant and Health and Human Services Secretary Robert F. Kennedy Jr. has been making final recommendations. In an April meeting, the prior advisory committee voted to recommend RSV vaccination for those aged 50 to 59 with increased risk of disease, but Kennedy did not adopt the recommendations. meeting scheduled to be held between June 25 and June 27 Moderna's RSV vaccine is based on mRNA technology, which some of the new members have expressed skepticism about, especially in relation to COVID-19 vaccines. Despite availability, RSV vaccination has been lagging. As of April 26, the latest date for which CDC data is available, an estimated 47.5% of adults aged 75 and older and 38.1% of adults aged 60 to 74 with a high-risk condition reported ever having received an RSV vaccine.
Yahoo
a day ago
- Health
- Yahoo
FDA expands approval of Moderna's RSV vaccine to some adults under age 60
The U.S. Food and Drug Administration expanded its approval of Moderna's respiratory syncytial virus (RSV) vaccine on Thursday to include adults under the age of 60 at increased risk of the disease. Previously, the vaccine, known as mRESVIA, had been licensed for use for those aged 60 and older. Approval for mRESVIA came after Moderna conducted a late-stage clinical trial showing the vaccine helped boost immune responses in younger adults. MORE: Despite 'game-changing' new RSV shots, uptake lagged among infants, adults: Experts More than one-third of adults between ages 18 and 59 have at least one underlying condition that puts them at increased risk of RSV, according to Moderna. "RSV poses a serious health risk to adults with certain chronic conditions, and today's approval marks an important step forward in our ability to protect additional populations from severe illness from RSV," Stéphane Bancel, CEO of Moderna, said in a press release. "We appreciate the FDA's review and thank all the participants in our clinical trial as well as the Moderna team for their dedication to protecting people against RSV." Although the FDA approves vaccines and may expand approvals for certain age groups, the Centers for Disease Control and Prevention sets recommendations regarding who should get vaccines and when. Currently, the CDC recommends RSV vaccination only for those aged 75 and older and for those aged 60 and over at increased risk. The CDC's independent vaccine advisory committee will need to vote to recommend that the new age group be eligible for the shot, followed by a final recommendation from the director of the CDC. Earlier this week, Kennedy removed all 17 sitting members of the committee and replaced them with eight new members. It remains unclear how the new members of the panel will decide to approach recommendations for the RSV vaccine. MORE: Respiratory virus activity remains 'high' in US and will 'continue for several more weeks': CDC As of Friday, the CDC director role remains vacant and Health and Human Services Secretary Robert F. Kennedy Jr. has been making final recommendations. In an April meeting, the prior advisory committee voted to recommend RSV vaccination for those aged 50 to 59 with increased risk of disease, but Kennedy did not adopt the recommendations. Instead, it appears Kennedy plans to have the new committee re-discuss the recommendations for RSV vaccination as well as discuss HPV and COVID vaccinations in their meeting scheduled to be held between June 25 and June 27 Moderna's RSV vaccine is based on mRNA technology, which some of the new members have expressed skepticism about, especially in relation to COVID-19 vaccines. Despite availability, RSV vaccination has been lagging. As of April 26, the latest date for which CDC data is available, an estimated 47.5% of adults aged 75 and older and 38.1% of adults aged 60 to 74 with a high-risk condition reported ever having received an RSV vaccine. FDA expands approval of Moderna's RSV vaccine to some adults under age 60 originally appeared on
Indianapolis Star
a day ago
- Health
- Indianapolis Star
Moderna Receives U.S. FDA Approval for RSV Vaccine, mRESVIA, in Adults Aged 18–59 at Increased Risk for RSV Disease
Expanded indication builds on existing U.S. FDA approval of mRESVIA for adults aged 60 and older CAMBRIDGE, MA / ACCESS Newswire Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA® (mRNA-1345), the Company's respiratory syncytial virus (RSV) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18-59 years of age who are at increased risk for disease. This approval expands the previous indication of mRESVIA, which was approved in May 2024 for adults aged 60 years and older. 'RSV poses a serious health risk to adults with certain chronic conditions, and today's approval marks an important step forward in our ability to protect additional populations from severe illness from RSV,' said Stéphane Bancel, Chief Executive Officer of Moderna. 'We appreciate the FDA's review and thank all the participants in our clinical trial as well as the Moderna team for their dedication to protecting people against RSV.' While the risk of RSV is well recognized in infants and older adult populations, adults aged 18-59 years with chronic conditions are also vulnerable. 1 Over one-third of adults aged 18-59 years have at least one underlying condition that puts them at increased risk of severe RSV disease, 2 with disease burden and hospitalization rates in this population being comparable, or even exceeding, that observed in older adults. 3 This approval was supported by results from Moderna's Phase 3 study (NCT06067230), which evaluated the safety and immunogenicity of mRESVIA in adults aged 18-59 with underlying health conditions. The immune responses against both RSV-A and RSV-B met prespecified non-inferiority immunobridging criteria when compared to those observed in adults aged 60 years and older in the pivotal Phase 3, placebo-controlled safety and efficacy study. Comparable levels of neutralizing antibodies were observed across both the 18-49 and 50-59 age subgroups, supporting the vaccine's consistent immunogenicity profile in this at-risk, younger adult population. These findings were presented at the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) meeting in April 2025 and have been published in Clinical Infectious Diseases. The vaccine was generally well-tolerated, and the most commonly reported solicited adverse reactions were injection site pain, fatigue, headache, myalgia and arthralgia. Moderna intends to have mRESVIA available for both younger adults at increased risk (ages 18-59) and older adults (ages 60+) in the U.S. for the 2025-2026 respiratory virus season. About mRESVIA® (Respiratory Syncytial Virus Vaccine) mRESVIA® is an RSV vaccine that consists of an mRNA sequence encoding a stabilized prefusion F glycoprotein. The F glycoprotein is expressed on the surface of the virus and is required for infection by helping the virus to enter host cells. The prefusion conformation of the F protein is a significant target of potent neutralizing antibodies and is highly conserved across both RSV-A and RSV-B subtypes. The vaccine uses the same lipid nanoparticles (LNPs) as the Moderna COVID-19 vaccines. About Moderna Moderna 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. mRESVIA® is a registered trademark of Moderna. INDICATION mRESVIA is a vaccine to protect you against lower respiratory tract disease caused by Respiratory Syncytial Virus (RSV). mRESVIA is for people 60 years of age and older and also for people 18 through 59 years of age who are at increased risk for RSV (people with medical conditions such as diabetes or with diseases affecting the lungs and heart). Vaccination with mRESVIA may not protect all people who receive the vaccine. mRESVIA does not contain RSV. mRESVIA cannot give you lower respiratory tract disease caused by RSV. IMPORTANT SAFETY INFORMATION Who should not get mRESVIA? You should not get mRESVIA if you had a severe allergic reaction to any ingredient in mRESVIA. What should you tell your healthcare provider? Tell your healthcare provider about all of your medical conditions, including if you: Have any allergies Had a severe allergic reaction after receiving a previous dose of any other vaccine Have a fever Have a bleeding disorder or are on a blood thinner Are immunocompromised or are on a medicine that affects your immune system Have received any other RSV vaccine Have ever fainted in association with an injection How is mRESVIA given? mRESVIA is given as an injection into the muscle. What are the risks of mRESVIA? There is a very small chance that mRESVIA could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of mRESVIA. 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 may include: Trouble breathing Swelling of your face and throat A fast heartbeat A rash all over your body Dizziness and weakness Side effects that have been reported in clinical trials with mRESVIA include: Injection-site reactions: pain, underarm swelling or tenderness in the same arm of the injection, swelling (hardness), and redness Fatigue, headache, muscle pain, joint pain, chills, nausea or vomiting, fever and hives These may not be all of the possible side effects of mRESVIA. Ask your healthcare provider about any side effects that concern you. You may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or Please click for mRESVIA Full Prescribing Information. Moderna Forward-Looking Statements This 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 mRESVIA; the disease burden associated with RSV, particularly in adults with certain risk factors; and the availability of mRESVIA 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 Contacts Media: Chris Ridley Head of Global Media Relations +1 617-800-3651 Investors: Lavina Talukdar Senior Vice President & Head of Investor Relations +1 617-209-5834 1 Prasad N, Walker TA, Waite B, et al. Respiratory syncytial virus-associated hospitalizations among adults with chronic medical conditions. Clin Infect Dis 2021; 73(1): e158-e63. 2 Wilker E, Jiang M, Francis B, et al. Burden of chronic medical conditions that are risk factors for severe RSV among adults aged 18-59 years in the United States. Poster presented at: ESCMID; April 2025; Vienna, Austria. 3 Weycker D, Averin A, Houde L, et al. Rates of Lower Respiratory Tract Illness in US Adults by Age and Comorbidity Profile. Infect Dis Ther 2024; 13(1): 207-20. SOURCE: Moderna, Inc.
Yahoo
a day ago
- Health
- Yahoo
Moderna's mRNA RSV vaccine wins expanded FDA approval for younger adults
The US Food and Drug Administration (FDA) has expanded approval of Moderna's respiratory syncytial virus (RSV) vaccine to include younger adults at risk, though its still uncertain whether the shot will be recommended for broader use in the national immunisation schedule. Moderna's vaccine, known under the brand name mRESVIA, became the first non-Covid-19 messenger RNA-based (mRNA) vaccine to be approved in the US in May 2024. Until now, the vaccine was licensed for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older. The expanded approval now includes individuals aged 18 to 59 who are at risk of RSV. This approval was supported by results from Moderna's Phase III study (NCT06067230), which demonstrated the vaccine's immune response worked just as well in this age group compared to the existing approved age group of 60 years and older. Infants and older adults remain the most vulnerable age groups to RSV, though over one-third of adults between 18 and 59 years of age have at least one underlying condition that puts them at increased risk of developing a severe form of the disease. "RSV poses a serious health risk to adults with certain chronic conditions, and today's approval marks an important step forward in our ability to protect additional populations from severe illness from RSV," said Stéphane Bancel, Chief Executive Officer of Moderna. Moderna said it plans to have mRESVIA available for both both younger adults and older adults in the US in time for the 2025-2026 respiratory virus season. This usually begins around November and peaks in the mid-Winter months. mRESVIA is the second approved product in the US for Moderna, along with its Covid-19 vaccine Spikevax. The pharma company has been seeking outside investment to fund late-stage trials for further infectious disease vaccine candidates, amid a strategy to diversify its portfolio. Whilst the label expansion reflects an easing in regulatory tension surrounding mRNA vaccines under the Trump administration, FDA approval does not automatically mean shots enter national immunisation schedules. That is instead decided by the US Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP). The CDC currently recommends the vaccine for adults aged 75 and older, as well as for adults aged 60 to 74 who are at increased risk of infection. In April, the CDC's ACIP recommended the use of approved RSV vaccines in at-risk adults aged 50 to 59. This week, US health secretary Robert F Kennedy (RFK) Jr axed the entire ACIP panel of experts, replacing members with vaccine sceptics and individuals with no prior public health strategy experience. The reshuffle has raised concerns about the future of the US immunisation schedule and the scope of vaccine recommendations. 'Investor focus will likely shift to the CDC's ACIP's next meeting, which is scheduled to proceed on June 25-27,' said William Blair analyst Miles Minter in a research note. 'This will be the first time for investors to see the refreshed ACIP in action and will be important for sentiment in the vaccine sector, which continues to decline in our view. Ultimately, we see the biggest headwind to the RSV vaccination market as restrictive ACIP recommendations that do not include re-dosing potential,' Minter added. The label expansion sees Moderna catch up with Pfizer, which already has an RSV vaccine approved for adults aged 18 years and over. Like mRESVIA, Pfizer's Abrysvo has the requirement of increased disease risk for those between 18 and 59, whilst anyone above the age of 60 is eligible for the jab. Pfizer still has a market advantage, however, with Abrysvo the only vaccine product approved for infants. It also gained FDA approval a year before mRESVIA, giving it first to market advantage. GSK also has an FDA-approved vaccine in the form of Arexvy, though its label only covers those at risk in individuals aged between 50 through 59 years, along with the standard indication of ages 60 and over. "Moderna's mRNA RSV vaccine wins expanded FDA approval for younger adults" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. 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
- Health
- Yahoo
Moderna falls on fears new CDC vaccine advisory panel could cloud RSV shot prospects
(Reuters) -Moderna's shares fell 2.5% before the bell on Friday, on concerns whether a new CDC advisory panel would back the use of the company's respiratory syncytial virus vaccine in a broader age group. The RSV shot, mRESVIA, secured U.S. approval on Thursday for expanded use in at-risk adults aged 18 to 59 years, but needs the U.S. Centers for Disease Control and Prevention's recommendation before it is made available for the age group. It is already approved for use in adults aged 60 or older. The biotech's stock extended its decline into the second session, following the appointment of the new panel late Wednesday. Some of the new appointees have openly expressed anti-vaccine views, including against the mRNA vaccine technology on which Moderna's shots are based. Earlier this week, Health Secretary Robert F. Kennedy Jr. fired all 17 members of the panel, known as the Advisory Committee on Immunization Practices (ACIP), saying it would "re-establish public confidence in vaccine science" - a move health experts warn could undermine public confidence in available vaccines. The ACIP advises the CDC on who should get the shots after they are approved by the U.S. Food and Drug Administration. The panel meeting for Moderna's RSV shot, scheduled for later this month, will be the "first time for investors to see the refreshed ACIP in action and will be important for sentiment in the vaccine sector, which continues to decline in our view," said William Blair analyst Myles Minter. U.S.-listed shares of GSK and Pfizer fell marginally and those of smaller Novavax were down 1.7% at $7.03 in premarket trade. The CDC currently recommends Moderna's vaccine for adults aged 75 and older, as well as for at-risk adults aged 60 to 74. In April, the ACIP recommended the use of approved RSV vaccines in at-risk adults aged 50 to 59. However, the CDC is yet to sign off on the recommendation.
