Panel Advises CDC to Recommend RSV Antibody for Infants
A government advisory panel in a split vote on June 26 advised the Centers for Disease Control and Prevention to recommend an antibody against respiratory syncytial virus (RSV) for many infants younger than 8 months of age.
In the first vote from the Advisory Committee on Immunization Practices (ACIP) since it was remade by Health Secretary Robert F. Kennedy Jr., a majority of members said they favor making an antibody made by Merck called clesrovimab available to all infants, regardless of underlying health.
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Fast Company
30 minutes ago
- Fast Company
Merck's RSV shot for infants gets key approval despite RFK Jr.'s panel shakeup
Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., who has previously made statements skeptical of vaccines, is now recommending the respiratory syncytial virus (RSV) vaccine for infants. On Thursday, RFK's Advisory Committee on Immunization Practices (ACIP) voted to recommend clesrovimab, a new RSV antibody shot made by Merck, for infants 8 months and younger who don't have protection from a maternal vaccine (a vaccine received in pregnancy). A broader vaccine review is underway The decision comes after the panel announced on Wednesday it would be reviewing the current childhood immunization schedule. The committee is set to vote on recommendations for the influenza vaccine, as well. The RSV shot was approved for use in infants earlier this month by the Food and Drug Administration (FDA). 'ENFLONSIA provides an important new preventive option to help protect healthy and at-risk infants born during or entering their first RSV season with the same dose regardless of weight,' said Dr. Dean Y. Li, president, Merck Research Laboratories, said at the time. Li continued, 'We are committed to ensuring availability of ENFLONSIA in the U.S. before the start of the upcoming RSV season to help reduce the significant burden of this widespread seasonal infection on families and health care systems.' According to the CDC, RSV infects nearly everyone by age 2, causing cold symptoms, and sometimes, breathing struggles. In the U.S., around 300 infant deaths are caused by RSV each year. The vote, which passed with five for the vaccine and two against, is the first decision from RFK's committee, made up of members whom RFK handpicked after dismissing the previous panel of 17 members in its entirety. The current panel includes some vaccine skeptics. Retsef Levi, an operations management professor at the Massachusetts Institute of Technology, and Vicki Pebsworth, the research director of a group focused on preventing vaccine injuries and deaths, were the two members who voted against the shot. Kennedy's history of vaccine misinformation Trump's controversial pick for HHS Secretary has frequently made false claims on the topic of vaccines. In regard to COVID, Kennedy once falsely claimed that some race groups have natural immunity to the virus. 'COVID-19 attacks certain races disproportionately,' Kennedy said. 'COVID-19 is targeted to attack Caucasians and Black people. The people who are most immune are Ashkenazi Jews and Chinese.' RFK's critics feel that having a vaccine skeptic at the helm of the HHS is already cause for concern after the CDC began postponing meetings on national vaccine recommendations in February. After the committee also announced that it would start a renewed review of all recommended pediatric vaccines, the American Academy of Pediatrics (AAP) put out a video titled, 'AAP Steps up on Vaccine Recommendations,' which warned that immunization policy through ACIP is 'no longer a credible process' under RFK's leadership. The AAP added that it will continue to publish its own recommendations on vaccines for children. Uncertainty at the CDC's helm Thursday's recommendation from RFK's panel still has to be endorsed by the CDC. However, there is major confusion surrounding who is currently in charge of the organization, as it doesn't seem to have a clear leader. Kennedy, and others, have recently sidestepped questions about the matter. Then, last week, RFK gave the name 'Matt Buzzelli,' who he described as 'a public health expert' when Senator Lisa Blunt Rochester pressed him on who the current acting director was. The CDC's leadership page has Matthew Buzzelli, a trial lawyer with no health-related experience, listed fourth as the agency's chief of staff. Following the exchange, the Senator sent RFK a letter, expressing grave concern.
Gizmodo
41 minutes ago
- Gizmodo
RFK Jr.'s Vaccine Panel Votes Against Thimerosal Flu Shots, Citing Debunked Risks
Robert F. Kennedy's war against vaccines has garnered another victory. This week, an outside advisory panel assembled by RFK Jr. voted to recommend against people using vaccines containing thimerosal, a once-common ingredient that anti-vaccination advocates have wrongly blamed for causing autism and other health problems. The Advisory Committee on Immunization Practices met this week to issue several vaccine-related recommendations. In a majority vote, the ACIP recommended against children, pregnant people, and adults receiving certain flu vaccines with thimerosal, despite decades of data showing no harm. The decision is the strongest indicator yet that the country's public health has been hijacked by anti-vax zealots. The ACIP is a panel of outside experts organized by the Centers for Disease Control and Prevention. Their recommendations greatly influence which vaccines are routinely provided to the public. For example, states often mandate that children receive vaccines universally recommended by the ACIP, such as the measles, mumps, and rubella (MMR) vaccine, before they can enter public school. RFK Jr., who has a long history of spreading vaccine-related misinformation, has been busy stacking the deck against vaccines in several ways, including via the ACIP. In early June, he unilaterally fired all 17 members of the ACIP. He then quickly, without any public review, restocked the panel with new appointees, some of whom have misrepresented the science on vaccine safety or have financially benefited from testifying against vaccine manufacturers. The new ACIP panel met for the first time Wednesday and Thursday. Its members did pass some non-controversial votes, such as recommending the routine use of clesrovimab, a recently approved lab-made antibody treatment to prevent severe respiratory syncytial virus infection in infants not protected by maternal vaccines. And it continued to recommend a yearly seasonal flu shot for Americans aged six and over with no contraindications. But the ACIP was also tasked with reexamining a long-debunked talking point from anti-vaccination proponents concerning the supposed health risks of thimerosal in flu vaccines. Lyn Redwood, a former president of the anti-vaccine group founded by RFK Jr., Children's Health Defense, gave a presentation to the ACIP Thursday morning blaming thimerosal for neurological issues. Thimerosal is a mercury-based preservative once commonly added to many vaccines in the U.S. In the late 1990s, it became a bogeyman of the anti-vaccination movement, who argued it was a possible culprit behind the supposed link between higher rates of autism and vaccines. In 1999, in an abundance of precaution, health agencies and some pediatric groups pushed for the removal of thimerosal from childhood vaccines. These days, in the U.S., it's primarily used in multi-dose formulations of the flu vaccine, which is what the ACIP panel was asked to review. But the vast majority of studies have since failed to find any solid evidence that thimerosal in vaccines causes any health issues, let alone autism. This week, prior to the ACIP meeting, CDC scientists even published a report that supported this conclusion and outlined the methodological flaws of the few studies contrary to it. But the document was soon taken down from the CDC's website, purportedly because it did not go through the 'appropriate process to be posted,' according to the HHS. Meanwhile, Redwood's original ACIP presentation appeared to reference a study that doesn't exist—not the first time something similar has happened recently (the presentation was later reuploaded without the fake citation). None of this stopped Redwood from giving a presentation to the ACIP Thursday that ignored the scientific consensus on thimerosal. Kennedy has also now appointed Redwood, a retired registered nurse, to work in the CDC's vaccine safety office. And despite misgivings from some ACIP members, the majority agreed to recommend against the use of thimerosal-containing flu vaccines. The recommendation will hopefully have little practical effect, since most flu vaccines are single dose. Other available ingredients could replace its preservative effects if vaccine manufacturers so desire. But the decision is frustrating, given the complete lack of evidence behind it, and foreboding. RFK's reshuffling of the ACIP seems to have worked as expected in boosting the voice of the anti-vaccination movement and their nonsensical ideas. Today, it's thimerosal. Tomorrow, it might be many of the most important vaccines we rely on.
Business Wire
44 minutes ago
- Business Wire
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 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 ( Please see Prescribing Information for ENFLONSIA (clesrovimab-cfor) at and Patient Information/Medication Guide for ENFLONSIA at
