ACIP Recommends Use of Merck's ENFLONSIA™ (clesrovimab-cfor) for Prevention of Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease in Infants Younger than 8 Months of Age Born During or Entering Their First RSV Season
RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend ENFLONSIA™ (clesrovimab-cfor) as an option for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in infants younger than 8 months of age who are born during or entering their first RSV season. The ACIP also voted to include ENFLONSIA in the Vaccines for Children Program—an important step in ensuring broad access to this preventive option for infants.
ENFLONSIA is a preventive, long-acting monoclonal antibody (mAb) designed to provide direct, rapid and durable protection through 5 months, a typical RSV season, with the same dose regardless of weight. A typical RSV season usually spans autumn to spring of the next year.
ENFLONSIA should not be administered to infants with a history of serious hypersensitivity reactions, including anaphylaxis, to any component of ENFLONSIA. See additional Selected Safety Information below.
'Ahead of the 2025-2026 RSV season, we are proud to offer ENFLONSIA as a new preventive option designed to protect healthy and at-risk infants from RSV disease across a spectrum of severity, including worsening disease requiring hospitalization,' said Dr. Richard M. Haupt, vice president, head of global medical & scientific affairs, vaccines and infectious diseases, Merck Research Laboratories. 'The Committee's recommendation is an important step forward in efforts to help reduce the significant burden RSV continues to place on infants, families and health care systems.'
The U.S. Food and Drug Administration (FDA) approved ENFLONSIA earlier this month based on clinical data from the Phase 2b/3 CLEVER and Phase 3 SMART trials. Merck plans to make ENFLONSIA available for ordering by physicians and health care administrators in July 2025, with shipments to be delivered before the start of the 2025-2026 RSV season.
The ACIP's recommendation for ENFLONSIA is provisional and will be official once reviewed and finalized by the CDC Director or the Health and Human Services Secretary (in the absence of a CDC Director).
About ENFLONSIA™ (clesrovimab-cfor)
ENFLONSIA is Merck's extended half-life monoclonal antibody (mAb) indicated for passive immunization for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants who are born during or entering their first RSV season. ENFLONSIA is administered using the same dose regardless of weight (105 mg/0.7 mL in a prefilled syringe) and is designed to provide direct, rapid and durable protection through 5 months, a typical RSV season. For infants born during the RSV season, ENFLONSIA is to be administered within the first week of life. For infants born outside of the RSV season, ENFLONSIA should be administered shortly before the RSV season begins. For infants undergoing cardiac surgery with cardiopulmonary bypass during or entering their first RSV season, an additional 105 mg dose is recommended as soon as the infant is stable after surgery. ENFLONSIA has a 30-month shelf life.
Selected Safety Information for ENFLONSIA™ (clesrovimab-cfor)
Do not administer ENFLONSIA to infants with a history of serious hypersensitivity reactions, including anaphylaxis, to any component of ENFLONSIA.
Serious hypersensitivity reactions, including anaphylaxis, have been observed with other human immunoglobulin G1 (IgG1) monoclonal antibodies. If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, initiate appropriate medications and/or supportive therapy.
The most common adverse reactions were injection-site erythema (3.8%), injection-site swelling (2.7%) and rash (2.3%).
About RSV
Respiratory syncytial virus (RSV) is a contagious virus that causes widespread seasonal infections and can lead to serious respiratory conditions such as bronchiolitis and pneumonia. According to the CDC, two to three out of every 100 infants under 6 months of age are hospitalized with RSV annually. As the leading cause of hospitalization among infants in the U.S., there is persisting unmet need for RSV preventive options for both healthy and high-risk infants born during or entering their first RSV season. RSV season is the time of year when RSV infections are most common, usually occurring fall/autumn through spring of the next year. RSV typically peaks in the winter in most regions of the United States, but timing and severity in a given community or region can vary year to year.
About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA (the 'company') includes 'forward-looking statements' within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2024 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).
Please see Prescribing Information for ENFLONSIA (clesrovimab-cfor) at https://www.merck.com/product/usa/pi_circulars/e/enflonsia/enflonsia_pi.pdf and Patient Information/Medication Guide for ENFLONSIA at https://www.merck.com/product/usa/pi_circulars/e/enflonsia/enflonsia_ppi.pdf.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Politico
34 minutes ago
- Politico
Kennedy's vaccine panel met for the first time. Here's what to know.
ATLANTA — The first meeting of Health Secretary Robert F. Kennedy Jr.'s handpicked vaccine advisers concluded Thursday — setting the stage to change the childhood vaccine schedule and voting to stop recommending flu shots with an additive that has long been a target of the anti-vaccine movement. The meeting offered a glimpse into how the new Advisory Committee on Immunization Practices will operate — and how federal vaccine policy is beginning to reflect Kennedy's personal views. Earlier this month, he fired 17 members of the panel and replaced them with eight members, several of whom have histories of vaccine skepticism. One resigned before the meeting began, leaving seven members. HHS spokesperson Andrew Nixon told reporters that 'the members of the committee are respected experts who take their responsibility to public health seriously' and who 'deliver recommendations rooted in data and medical integrity.' Here are the takeaways from the two-day meeting at CDC headquarters in Atlanta: Its agenda was Kennedy's The panel voted Thursday to stop recommending that anyone get a flu vaccine that contains thimerosal, a preservative that Kennedy has long wanted gone. Kennedy, in 2014, wrote a book about thimerosal, arguing that it likely causes autism and should be banned. But many public health agencies have long considered it to be safe — including the CDC, according to its website. 'Scientists have been studying the use of thimerosal in vaccines for many years. They haven't found any evidence that thimerosal causes harm,' the website reads. The CDC director usually needs to endorse the recommendations before they are official. But Kennedy will likely be the one to endorse these recommendations because there is currently no CDC director or acting director. What it means: If endorsed, the new recommendations will mark one of the most prominent examples of Kennedy's own views reflected in U.S. vaccine policy since becoming HHS secretary. 'Even though this move only affects a small portion of the flu vaccine supply and likely won't impact access in the US this season, the symbolism is powerful. It signals that falsehoods may have a place in shaping vaccine policy in America,' Katelyn Jetelina, an epidemiologist who has consulted for the CDC, told POLITICO. 'The ripple effects could undermine trust in vaccines, vaccine access globally and weaken pandemic preparedness.' Thimerosal continues to be used as a preservative in some multi-dose vaccine vials to inhibit germ growth. But its use in FDA-licensed flu vaccines has declined over the last 25 years as manufacturers reformulated their products and shifted to single-use vials. Most of those contain little or no thimerosal, according to the CDC. That shift was tied to concerns raised in the late 1990s and early 2000s that thimerosal, a mercury-containing compound, could be linked to autism in children. In 1999, the FDA and CDC announced plans to work with manufacturers to reduce or remove thimerosal from vaccines as a precaution. The preservative was largely removed from pediatric vaccines by 2001. One member's pushback The panel's lone pediatrician, Dartmouth's Dr. Cody Meissner, was the only voting member to push back on views presented that contradicted scientific consensus, a development that encouraged some public health experts who were otherwise troubled by the meeting. 'He's dealt with vaccine-preventable diseases. He's talked to parents about vaccines, so I thought he was generally a voice of reason,' said Dr. Paul Offit, a pediatrician who serves on the FDA's external vaccine panel. What it means: It remains to be seen how Meissner will approach controversial topics at future meetings. He's also publicly agreed with Kennedy's move to pull the Covid-19 vaccine recommendation for pregnant women despite ample evidence of its benefits. Meissner told Reuters in May he thought politics had caused officials to overemphasize the importance of Covid vaccination for pregnant women and young children. Offit and former federal health officials applauded his participation and his defense of science. Meissner was critical of the American Academy of Pediatrics for not participating in the meeting. Several professional groups send liaisons to ACIP meetings to weigh in, though they don't have voting privileges. 'It's somewhat childish for them not to appear,' Meissner said near the end of the meeting Thursday. 'It's dialogue that leads to the best recommendations for the use of vaccines.' Dr. Sean O'Leary, the AAP's committee liaison, defended the organization's decision to not participate, saying ACIP 'has drifted so far from its long standing focus on science, evidence, public health.' 'When that focus returns, we will, too,' he said. More scrutiny of vaccines is ahead The committee's agenda items in the months ahead signal that Thursday's thimerosal votes were just the beginning of policy shifts that could affect vaccine access in the U.S. ACIP Chair Martin Kulldorff, an epidemiologist and former Harvard Medical School professor, said Wednesday the panel will review childhood vaccines and shots not studied in more than seven years, opening up the possibility of significant changes to the pediatric schedule. And he said Thursday the panel may consider at its next meeting advising against use of a combination shot known as MMRV against measles and chickenpox to children under 4. The CDC currently recommends that children under 2 get their first measles, mumps and rubella vaccine and varicella vaccine as separate shots because of an elevated risk with the MMRV shot of febrile seizure, which is common in young children but doesn't cause permanent harm. Why it matters: The thimerosal vote and the potential MMRV recommendation change wouldn't affect a wide swath of the population, given ample supply of alternatives. But those shifts could disproportionately impact vulnerable groups that already face issues accessing health care, like rural state residents and low-income families because they are more likely to get flu shots from wide-scale vaccination drives, public health experts say — not to mention plant the seeds for distrust in other vaccines. Anti-vaccine activists have long alleged links between vaccines and autism. They've theorized that thimerosal, the number of vaccines given to young children and post-immunization fevers could all contribute to the rise in diagnoses, despite peer-reviewed science finding no connections. While the CDC says just 4 percent of the U.S. flu vaccine supply last season contained thimerosal, scientists worry that the ACIP votes will reinvigorate unfounded worries about the ingredient that could generally suppress vaccine confidence — not to mention create access issues for the sliver of the population served by those multi-dose vials. The MMRV vaccine is also not widely used in children under 4. 'The goal was to scare people … the goal was to say, 'Here, look, these companies are putting things in vaccines that are dangerous,'' Offit said.
Yahoo
35 minutes ago
- Yahoo
Robert F. Kennedy Jr. Tells Fox News The Rotten Truth About His Anti-Fluoride Crusade
Robert F. Kennedy Jr. admitted on Thursday there are some potentially big holes in his decision to stop recommending water fluoridation nationwide ― as in cavities. During an interview on Fox News, host Harris Faulkner asked the conspiracy theory-peddling health and human services secretary to address concerns from America's dental community about lower-income children who might not be getting preventative dental care. Kennedy admitted there would be trade-offs for getting rid of fluoride in water. 'It's a balance,' he said. 'You're gonna see probably slightly more cavities. Although in Europe, where they banned fluoride, they did not see an uptick in cavities. The issue is, parents need to decide, because science is very clear on fluoride.' Many years of research show that water fluoridation can significantly reduce cavities in both children and adults, and the U.S. Centers for Disease Control and Prevention has hailed it as one of the country's 10 greatest health achievements of the 20th century. Kennedy, however, has railed against it. He said in April that when it comes to fluoride, 'the more you get, the stupider you are,' referencing a 2025 journal article that suggested fluoride might lower IQs in children. The authors of that study have said themselves that their findings should not be used to evaluate the use of fluoride in water in the U.S., for a variety of reasons. Kennedy was also wrong when he suggested that Europe as a whole had banned fluoride in water. While it's true that many European countries do not add it to their water, the region has a patchwork of practices, as outlined by a 2018 report. Some parts of the U.K. and Ireland fluoridate their tap water, while Greece adds it to bottled water. And in some areas, fluoride occurs naturally in the water supply. Thus far in the U.S., Kennedy's push has led Florida and Utah to ban water fluoridation. Here's a clip of the exchange: FOX: On the issue of fluoride, what has been the response from dentists who may be concerned that some children in lower incomes may not get preventative care?RFK JR: It is an issue. It's a balance. You're gonna see probably slightly more cavities. — Aaron Rupar (@atrupar) June 26, 2025 Because the science is very clear that water fluoridation can prevent cavities, and because oral hygiene affects overall health, many people mocked Kennedy for minimizing the potential effects of his anti-fluoride crusade, which is expected to harm low-income children the most. If only they looked at other places that removed fluoride and see what right. They did. It DID cause harm. And they put it back. Look at Calgary, Juno, Alass (Saudi Arabia). And it DOES disportionately affect the poor, causing an increase in Medicaid costsA JAMA… — Challenge Your Beliefs (@ChallengeBelief) June 26, 2025 Fluoride is safe and effective. RFK has no medical or Dental background that makes him an expert on Fluoride. — Denison Barb (@DenisonBarbs) June 26, 2025 YOU CAN'T MAKE THIS UP: RFK Jr. really said the quiet part out loud; he'd rather let poor kids get cavities than fund basic public health.'It's a balance,' he says, between science and pseudoscience. Between dental care and isn't some fringe experiment.… — Brian Allen (@allenanalysis) June 26, 2025 'You may lose a few molars, but think of the liberty!' - RFK Jr., probably — 𝕊𝕦𝕟𝕕𝕒𝕖_𝔾𝕦𝕣𝕝 (@SundaeDivine) June 26, 2025 On the downside there will be more cavities but on the upside there will be… um actually there is no upside 🙃 — Politics Sloth 🧦🌐🇬🇷🇺🇸 (#1 reply guy) (@SockDemFan) June 26, 2025 More cavities for kids in families who can't afford dental neglected cavities can cause other health issues with infections etc, not to mention leading to the need for more serious and expensive dental work... — Janice Hough (@leftcoastbabe) June 26, 2025 So they admit that taking out fluoride is bad, yet they'll still do it. Morons — Sycamore's Source (@sycamoressource) June 26, 2025 One person snarkily saw an upside to RFK Jr.'s anti-fluoride push. Some dentists are excited. They will have a lot more business soon. — Anthony M. Hopper (@elander777) June 26, 2025 DeSantis Signs Bill Banning Fluoride From Florida's Water System FDA, RFK Jr. Begin Effort To Remove Ingestible Fluoride Products From Market RFK Jr. On Fluoride: 'The More You Get, The Stupider You Are' Republicans Are Lending Support To 1 Of RFK Jr.'s False Claims
Business Wire
an hour ago
- Business Wire
Concentra Announces the Appointment Of Vipin Gopal and Brigid Bonner To Its Board Of Directors
ADDISON, Texas--(BUSINESS WIRE)--Concentra ® Group Holdings Parent, Inc. ('Concentra') (NYSE: CON), today announced the appointment of Vipin Gopal and Brigid Bonner to the Concentra Board of Directors, marking a strategic milestone for the occupational health services company. 'We are pleased to welcome Vipin Gopal and Brigid Bonner to the Concentra Board,' said Bob Ortenzio, Concentra's board chair. 'As Concentra navigates growth and the opportunity to increase shareholder value, expanding the Board with two prominent health care leaders with data, technology, and business transformation expertise will prove to be a mobilizing force for the company.' Vipin Gopal, PhD, brings over 25 years of experience successfully leading data, AI, and digital transformation of Fortune 100 companies. He is a recognized thought leader in leveraging technology to maximize business value, with broad health care industry experience gained through roles across payor, provider, pharmaceutical, and retail pharmacy organizations. Gopal has served as the Chief Data and Analytics Officer at two major companies: Eli Lilly and Company and Walgreens Boots Alliance. In these roles, he was the enterprise executive leader responsible for driving next-generation data and AI strategy and operations across various lines of business. Previously, he was the senior vice president of analytics at Humana and held leadership roles at Cigna, United Technologies Corporation, and Honeywell. Gopal obtained his doctorate from Carnegie Mellon University and from the Indian Institute of Technology (IIT), Bombay, both in engineering, and holds an MBA from the NYU Stern School of Business. 'Concentra analyzes vast amounts of health care data, empowering our clinicians by providing them with valuable insights for superior clinical decision making,' said Keith Newton, Concentra's chief executive officer. 'And, with AI expected to revolutionize numerous aspects of care, Vipin will apply his deep knowledge to help provide guidance to the Concentra organization moving forward.' Brigid Bonner is the president of Bonner Consulting, a firm focused on strategy and digital and personal transformation. She leverages her expertise to help leaders chart their course, whether in pursuit of personal life planning or organizational strategy. Her specialties include strategic planning, business development, digital transformation, consumer experience, and strategic coaching. Bonner has over 35 years of experience as a senior executive traversing nonprofit, for-profit, start-up, and Fortune 100 organizations. Her industry expertise includes retail, technology, e-commerce, and health care. She has held senior leadership roles with CaringBridge, UnitedHealth Group, IBM, Target Corporation, The Schwan Food Company, and Bonner earned her Bachelor of Science degree from Iowa State University, with a double major in journalism/advertising and industrial administration, and her Master of Business Administration degree from Harvard Business School. 'Brigid has made significant contributions to the success of many innovative, high-growth businesses in the health care industry,' continued Newton. 'As the health care landscape continues to become more complex with broad trends in technology innovation at the forefront, Brigid joins the board at a most opportune time, and we welcome her contributions.' Founded in 1979, Concentra has played a significant role in creating the workplace health industry model that exists today. Our national presence enables us to provide access to high-quality care that supports our mission to improve the health of America's workforce. With these two new appointments, the Concentra Board of Directors expands to seven members, composed of outstanding leaders in medicine, finance, and health care organizational management. To learn more, visit About Concentra Concentra is the largest provider of occupational health services in the United States by number of locations, with the mission of improving the health of America's workforce, one patient at a time. Our approximately 12,000 colleagues and affiliated physicians and clinicians support the delivery of an extensive suite of services, including occupational and consumer health services and other direct-to-employer care. We support the care of approximately 50,000 patients each day on average across 45 states at our 627 occupational health centers, 160 onsite health clinics at employer worksites, and Concentra Telemed as of March 31, 2025.
