Latest news with #RSV
Yahoo
8 hours ago
- Health
- Yahoo
RFK Jr's vaccine panel recommends new RSV treatment for infants
Robert F Kennedy Jr's reconstituted vaccine advisory panel recommended a new treatment to prevent respiratory syncytial virus (RSV) in infants. The treatment, a new monoclonal antibody called clesrovimab, which will be sold under the brand name Enflonsia by Merck, was recommended by the powerful committee after being approved by the Food and Drug Administration (FDA) roughly two weeks ago. The tortured vote took place a day late and after rounds of questions from the panel's seven new members – all ideological allies of Trump health secretary, who views 'overmedicalization' as one of the greatest threats to American children. Related: US pediatricians criticize RFK Jr's new vaccine panel: 'Truly an embarrassment' 'I think we need to ask ourselves what the parent would say given this data,' said Dr Retsef Levi, a Massachusetts Institute of Technology professor of operations management, who over hours of hearings has proven to be an outspoken skeptic of the medications under review. He said he would be 'concerned' and ultimately voted against recommending the monoclonal antibody. The panel, formally called the Centers for Disease Control and Prevention's advisory committee on immunization practices (ACIP), is a critical federal advisory board that recommends how the agency should distribute vaccines and other interventions, such as monoclonal antibodies, to the American public. Kennedy's decision to remove its 17 serving members and replace them with hand-picked appointments has been roundly condemned by the medical establishment. The meetings are must-watch in scientific and medical circles. The vote is just one order of business for the panel, which is set to consider a much more controversial issue this afternoon – thimerosal in influenza vaccines. The ethylmercury-based preservative was removed from routine childhood vaccines in the early 2000s, but its use is considered an issue of settled science. Thimerosal use has remained a talking point for anti-vaccine advocates for decades. The preservative is contained in multi-dose vials of influenza vaccines. Experts have argued that removing the ingredient would force manufacturers to ship only single-use vials, which would be more expensive. Curtailing vaccine access has been a goal of anti-vaccine advocates. Kennedy unilaterally fired all 17 members of the ACIP in June citing conflicts of interest, and replaced the group with eight ideological allies. One of those appointees, Dr Michael Ross, dropped out of the panel on Tuesday after a government financial review, and after it was publicly reported that he was not employed by two universities where Kennedy said he held appointments. That has left seven members – far less than the panel's typical 19 voting members. The vote for members was whether to recommend clesrovimab, a monoclonal antibody, for all infants younger than eight months old born during or entering RSV season. They also voted on whether to include that drug in an important program called Vaccines for Children, through which about half of all American children access vaccines. Although five members ultimately voted yes, it was only after lengthy discussion, a no vote from Levi, and a second no from nurse Vicky Pebsworth, who served as the volunteer research director for one of the nation's oldest prominent anti-vaccine groups. RSV is the leading cause of hospitalization among US infants, and most infants are infected in the first year of life. Between 2% and 3% are hospitalized, a majority of whom have no underlying health conditions. Before 2023, there was no long-acting prevention for RSV. The efficacy of monoclonal antibodies wanes over time. Although some ACIP members asked whether it was problematic to push the likely transmission of the disease to toddlerhood, CDC career scientists said that was the point – the most dangerous time for a child to contract RSV is in the first months of life. 'Part of what we want to do is protect them when they're most vulnerable,' said Adam McNeil, CDC deputy branch chief for epidemiology in respiratory viruses. 'The biggest impact among those newborns is getting those [ages] zero to two months [old] – and getting them through that vulnerable period.' In the 2024-2025 respiratory disease season, 57% of infants were either born to a vaccinated mother or received monoclonal antibodies at birth. As a result, hospitalizations from RSV were reduced by 30%-40%, according to CDC data.
eNCA
9 hours ago
- Health
- eNCA
US panel replaced under Trump backs new shot for kids
WASHINGTON - A medical panel appointed by Health Secretary Robert F. Kennedy Jr. voted Thursday to recommend a new antibody treatment against RSV, a common respiratory illness that is the leading cause of hospitalization for infants in the United States. The vote marked the first by the Advisory Committee on Immunization Practices (ACIP) since Kennedy dismissed all members of the influential group of independent experts and replaced them with his own nominees, a move that made this decision a test of the new panel's intentions. Clesrovimab was recently approved by the Food and Drug Administration as a shot for newborns and young babies experiencing their first respiratory syncytial virus (RSV) season. Marketed under the name Enflonsia by its manufacturer Merck, it was shown in clinical trials to be safe and effective at significantly reducing RSV infections and hospitalizations among infants. The ACIP panel was asked to adjudicate the next step after approval -- namely, whether it should now be recommended for infants under eight months old entering their first RSV season who are not already protected by an RSV vaccine administered to their mother during pregnancy. They voted 5-2 in favor. The two dissenters were Retsef Levi, a professor of operations management at MIT who has questioned the safety of Covid-19 vaccines, and Vicky Pebsworth, a nurse and member of the anti-vaccine National Vaccine Information Center (NVIC). "I don't feel this is ready to be administered to all healthy babies. I think we should take a more precautionary approach," said Levi, explaining his "no" vote. Pebsworth did not offer comments, but the NVIC previously opposed the earlier-approved RSV antibody, nirsevimab.
The Herald Scotland
18 hours ago
- Health
- The Herald Scotland
Obamacare Supreme Court decision: What it means for RFK Jr.
The suit started in Texas where two Christian owned business and individuals argued that health insurance plans they buy shouldn't have to cover medical tests and drugs they object to on religious grounds, such as the HIV-prevention drug PrEP. But the legal issue at the heart of the Supreme Court case was whether USPSTF is so powerful that, under the Constitution, its members must be appointed by the president and confirmed by the Senate. Justice Brett Kavanaugh wrote for the 6-3 majority that Health and Human Services Secretary Robert F. Kennedy Jr. can remove task force members at will and can review their recommendations before they take effect. "The Task Force members are removable at will by the Secretary of HHS, and their recommendations are reviewable by the Secretary before they take effect," he wrote. "So Task Force members are supervised and directed by the Secretary, who in turn answers to the President preserving the chain of command." The Health and Human Services Secretary has always appointed USPSTF members and ratified their recommendations, said MaryBeth Musumeci, teaching associate professor of health policy and management at George Washington University's Milken Institute School of Public Health. But the ruling expanded on that authority by clarifying that the secretary could also remove members and block recommendations, she said. Given that Kennedy had recently fired all 17 original members of the Advisory Committee on Immunization Practices, another expert panel that issues health recommendations, Musumeci said "there is reason to be worried." The secretary has never removed access to preventive services that have been proven to help people stay healthy nor have they "sought to shape the membership of our expert panel in any way," USPSTF chair Dr. Michael Silverstein said in a statement emailed to USA TODAY. "While the HHS Secretary has long had authority over the USPSTF, historically they have only acted to increase access to preventive care, occasionally going beyond the evidence to secure enhanced coverage for preventive services," he said. "Given our shared focus on preventing cancer and chronic disease, we certainly hope that the Secretary will allow our current work to continue unimpeded, as it has thus far." Surprise move? RFK Jr.'s vaccine committee votes to recommend RSV shot for infants Katherine Hempstead, senior policy officer at the Robert Wood Johnson Foundation, a health nonprofit, praised the SCOTUS decision because it meant that millions of Americans still have access to preventive care such as mental health screenings, cancer screenings, STI testing and important medications. But she also called the ruling both an "ending and a beginning." "It's the ending of the challenge but now it's the beginning of something that's going to unfold where we're going to see someone exercise control over this expert panel that has very strong opinions about... many aspects of medical care," she said. More details: Supreme Court rejects conservative challenge to Obamacare health coverage If Kennedy plans to target USPSTF, it's unclear what preventive services could be at risk, Musumeci said. But insurance companies ultimately have the final decision. Even if the secretary vetoes a new recommendation or revokes an existing one, insurance companies can still decide to cover the preventive service. America's Health Insurance Plans, a trade association representing health insurance companies, plans to closely monitor the ongoing legal process but affirms that the SCOTUS ruling will not impact any existing coverage, according to an emailed statement sent to USA TODAY. Contributing: Maureen Groppe and Bart Jansen, USA TODAY; Reuters. Adrianna Rodriguez can be reached at adrodriguez@
Gulf Today
a day ago
- Health
- Gulf Today
Many older people are really eager to be vaccinated
Paula Span, Tribune News Service Kim Beckham, an insurance agent in Victoria, Texas, had seen friends suffer so badly from shingles that she wanted to receive the first approved shingles vaccine as soon as it became available, even if she had to pay for it out-of-pocket. Her doctor and several pharmacies turned her down because she was below the recommended age at the time, which was 60. So, in 2016, she celebrated her 60th birthday at her local CVS. 'I was there when they opened,' Beckham recalled. After getting her Zostavax shot, she said, 'I felt really relieved.' She has since received the newer, more effective shingles vaccine, as well as a pneumonia shot, an RSV vaccine to guard against respiratory syncytial virus, annual flu shots and all recommended COVID-19 vaccinations. Some older people are really eager to be vaccinated. Robin Wolaner, 71, a retired publisher in Sausalito, California, has been known to badger friends who delay getting recommended shots, sending them relevant medical studies. 'I'm sort of hectoring,' she acknowledged. Deana Hendrickson, 66, who provides daily care for three young grandsons in Los Angeles, sought an additional MMR shot, though she was vaccinated against measles, mumps, and rubella as a child, in case her immunity to measles had waned. For older adults who express more confidence in vaccine safety than younger groups, the past few months have brought welcome research. Studies have found important benefits from a newer vaccine and enhanced versions of older ones, and one vaccine may confer a major bonus that nobody foresaw. The new studies are coming at a fraught political moment. The nation's health secretary, Robert F. Kennedy Jr., has long disparaged certain vaccines, calling them unsafe and saying that the government officials who regulate them are compromised and corrupt. On June 9, Kennedy fired a panel of scientific advisers to the Centers for Disease Control and Prevention, and later replaced them with some who have been skeptical of vaccines. But so far, Kennedy has not tried to curb access to the shots for older Americans. The evidence that vaccines are beneficial remains overwhelming. The phrase 'Vaccines are not just for kids anymore' has become a favorite for William Schaffner, an infectious diseases specialist at Vanderbilt University Medical Center. 'The population over 65, which often suffers the worst impact of respiratory viruses and others, now has the benefit of vaccines that can prevent much of that serious illness,' he said. Take influenza, which annually sends from 140,000 to 710,000 people to hospitals, most of them seniors, and is fatal to 10% of hospitalized older adults. For about 15 years, the CDC has approved several enhanced flu vaccines for people 65 and older. More effective than the standard formulation, they either contain higher levels of the antigen that builds protection against the virus or incorporate an adjuvant that creates a stronger immune response. Or they're recombinant vaccines, developed through a different method, with higher antigen levels. In a meta-analysis in the Journal of the American Geriatrics Society, 'all the enhanced vaccine products were superior to the standard dose for preventing hospitalisations,' said Rebecca Morgan, a health research methodologist at Case Western Reserve University and an author of the study. Compared with the standard flu shot, the enhanced vaccines reduced the risk of hospitalization from the flu in older adults, by at least 11% and up to 18%. The CDC advises adults 65 and older to receive the enhanced vaccines, as many already do. More good news: Vaccines to prevent respiratory syncytial virus in people 60 and older are performing admirably. RSV is the most common cause of hospitalization for infants, and it also poses significant risks to older people. 'Season in and season out,' Schaffner said, 'it produces outbreaks of serious respiratory illness that rivals influenza.' Because the FDA first approved an RSV vaccine in 2023, the 2023-24 season provided 'the first opportunity to see it in a real-world context,' said Pauline Terebuh, an epidemiologist at Case Western Reserve School of Medicine and an author of a recent study in the journal JAMA Network Open. In analysing electronic health records for almost 800,000 patients, the researchers found the vaccines to be 75% effective against acute infection, meaning illness that was serious enough to send a patient to a health care provider. The vaccines were 75% effective in preventing emergency room or urgent care visits, and 75% effective against hospitalisation, both among those ages 60 to 74 and those older. Immunocompromised patients, despite having a somewhat lower level of protection from the vaccine, will also benefit from it, Terebuh said. As for adverse effects, the study found a very low risk for Guillain-Barré syndrome, a rare condition that causes muscle weakness and that typically follows an infection, in about 11 cases per 1 million doses of vaccine. That, she said, 'shouldn't dissuade people.' The CDC now recommends RSV vaccination for people 75 and older, and for those 60 to 74 if they're at higher risk of severe illness (from, say, heart disease). As data from the 2024-25 season becomes available, researchers hope to determine whether the vaccine will remain a one-and-done, or whether immunity will require repeated vaccination. People 65 and up express the greatest confidence in vaccine safety of any adult group, a KFF survey found in April. More than 80% said they were 'very 'or 'somewhat confident' about MMR, shingles, pneumonia, and flu shots. Although the COVID vaccine drew lower support among all adults, more than two-thirds of older adults expressed confidence in its safety. Even skeptics might become excited about one possible benefit of the shingles vaccine: This spring, Stanford researchers reported that over seven years, vaccination against shingles reduced the risk of dementia by 20%, a finding that made headlines. Biases often undermine observational studies that compare vaccinated with unvaccinated groups. 'People who are healthier and more health-motivated are the ones who get vaccinated,' said Pascal Geldsetzer, an epidemiologist at the Knight Initiative for Brain Resilience at Stanford and lead author of the study. 'It's hard to know whether this is cause and effect,' he said, 'or whether they're less likely to develop dementia anyway.' So the Stanford team took advantage of a 'natural experiment' when the first shingles vaccine, Zostavax, was introduced in Wales. Health officials set a strict age cutoff: People who turned 80 on or before Sept. 1, 2013, weren't eligible for vaccination, but those even slightly younger were eligible. In the sample of nearly 300,000 adults whose birthdays fell close to either side of that date, almost half of the eligible group received the vaccine, but virtually nobody in the older group did. 'Just as in a randomized trial, these comparison groups should be similar in every way,' Geldsetzer explained. A substantial reduction in dementia diagnoses in the vaccine-eligible group, with a much stronger protective effect in women, therefore constitutes 'more powerful and convincing evidence,' he said. The team also found reduced rates of dementia after shingles vaccines were introduced in Australia and other countries. 'We keep seeing this in one dataset after another,' Geldsetzer said. In the United States, where a more potent vaccine, Shingrix, became available in 2017 and supplanted Zostavax, Oxford investigators found an even stronger effect.
Politico
a day ago
- Health
- Politico
Vaccine panel's new path raises concerns
Driving the Day THE VIEW FROM ATLANTA — The CDC's revamped Advisory Committee on Immunization Practices wrapped up its first meeting Thursday, recommending use of a new monoclonal antibody for respiratory syncytial virus in infants and flu shots for everyone 6 months and older beginning this fall. But public health experts and former government officials said they were troubled by the tenor of the panel's vaccine discussions, as well as its move to recommend pulling a little-used preservative from the seasonal flu shot supply. Thimerosal's fate: ACIP voted to recommend against anyone — adult, child and pregnant person — receiving a seasonal flu vaccine with the mercury-containing compound, despite scientific consensus that it's not linked to severe adverse events or conditions like autism. Before the meeting, HHS Secretary Robert F. Kennedy Jr. questioned the safety of thimerosal on X, calling it a 'treadworn lie of the vaccine industry' that the compound is safe. In 2014, he wrote a book about thimerosal, arguing that it likely causes autism and should be banned. The real-world impact in the U.S. is minimal — just 4 percent of the supply last season contained thimerosal — but public health officials warn that even small percentages of a population-wide campaign matter. The multidose vials containing thimerosal are most likely purchased by state and local health departments or other entities that hold community-wide vaccination drives, potentially threatening access in low-income or rural areas. And beyond access, the suggestion that thimerosal is worth eliminating from the domestic seasonal vaccine supply could stoke vaccine hesitancy in low-income nations reliant on those products to reach as many citizens as possible. Multidose vials are also typically used in pandemics for the same access reason, and even though pandemic influenza vaccines weren't considered, a record of ACIP discouraging use of products containing thimerosal could hamper future immunization campaigns during health emergencies. Another RSV antibody: The committee's 5-2 vote recommending Merck's clesrovimab followed a tense debate among members about its benefits for otherwise healthy babies — despite ample data showing the virus can readily land those children in the hospital. Retsef Levi, an MIT business professor who voted against recommending it, focused on a nonstatistically significant increase in deaths among infants who got the immunization and questioned whether parents of healthy children would want to use it. But Dr. Cody Meissner, a Dartmouth pediatrics professor who's previously served on the ACIP and the FDA's vaccine panel, pushed back, noting it's impossible to predict which healthy children will avoid RSV's most severe consequences. 'If I were your pediatrician, I would strongly recommend that your wife either receive the RSV vaccine or a monoclonal antibody at birth,' Meissner said to Levi. Looking ahead: Lauren and POLITICO's Sophie Gardner, who was in the room at CDC headquarters, broke down the main takeaways from this week's meeting. IT'S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. How about those Washington Wizards draft picks? Send your NBA thoughts and news tips to David Lim (dlim@ @davidalim or davidalim.49 on Signal) and Lauren Gardner (lgardner@ @Gardner_LM or gardnerlm.01 on Signal). Eye on the FDA FDA LAYS OUT MDUFA PROCESS — The FDA announced Thursday In the Federal Register it will start the reauthorization process for its medical device user fee program by holding a public meeting on Aug. 4. People can 'present their views' on reupping the program through which industry pays fees to the agency to speed medical device reviews. Soon after, the agency says it will continue to meet with patient and consumer advocacy groups at least once a month while it negotiates with the medical device industry — with the first meeting to start by October. The FDA requests that people interested in participating in the meetings to notify the agency within 30 days. Why it matters: The notice is the latest sign the FDA will move to reauthorize its user fee programs despite HHS Secretary Robert F. Kennedy Jr.'s distaste for what he says are programs that allow industries to have a cozy relationship with the agency that regulates drugs and medical devices. Coronavirus UPDATED LABELING — The FDA formally posted a safety communication on Wednesday noting required updates to prescribing information for Pfizer's Comirnaty and Moderna's Spikevax Covid-19 vaccines to include the estimated unadjusted incidence of myocarditis and pericarditis following administration of the 2023-2024 shot. The agency also required the vaccine makers to add the results of a study that examined cardiac MRI findings in people who had developed myocarditis —an inflammation of the heart muscle — after receiving an mRNA Covid vaccine. Industry Intel NOVO'S NEXT MOVE — Fresh off a breakup with telehealth platform Hims, Danish drugmaker Novo Nordisk said Thursday it is partnering with WeightWatchers to distribute Wegovy via online mail orders at CenterWell Pharmacy. 'We will continue to pursue and build on agreements with companies that share our values and refine initiatives that help improve access to our FDA-approved medicines for patients,' Dave Moore, executive vice president of U.S. operations for Novo, said in a press release. In Congress THUNE: NO PARLIAMENTARIAN OVERRIDE — Senate Majority Leader John Thune said Thursday the Senate would not move to overrule its parliamentarian after she advised that including key provisions in the GOP's domestic-policy megabill would expose it to a fatal Democratic filibuster, POLITICO's Jordain Carney and Benjamin Guggenheim report. After the decisions — including provisions that would crack down on provider taxes states used to fund their Medicaid programs as well as measures meant to exclude undocumented residents from public benefits — were publicized Thursday, multiple conservative Republicans called on the Senate to sideline Parliamentarian Elizabeth MacDonough. But when asked by POLITICO about overruling her, Thune said, 'No, that would not be a good option for getting a bill done.' Republicans are expected to try to rewrite the provisions in hopes of winning MacDonough's blessing. The FDA announced import alerts on certain Olympus medical devices, including specific models of ureterorenoscopes, bronchoscopes, laparoscopes and automated endoscope reprocessors, tied to concerns over quality system regulation violations. The FDA's Center for Drug Evaluation and Research released its annual drug trials snapshots summary report. The center approved 50 novel drugs in 2024. The FDA published guidance outlining how medical device manufacturers can submit cybersecurity information as part of premarket applications. It also published draft guidance on unique device identifier requirements for combination products. Eli Lilly is scheduled to meet with the White House Office of Information and Regulatory Affairs on Monday to discuss the Health Resources and Services Administration's 340B rebate guidance. WHAT WE'RE READING Eric Green, who led the National Human Genome Research Institute before being forced out of the NIH, still does not know who pushed him out, STAT's Anil Oza reports. The Supreme Court cleared the way for states to exclude Planned Parenthood from their Medicaid programs, Lauren and POLITICO's Alice Miranda Ollstein and Josh Gerstein write.
