Latest news with #MartinKulldorff
USA Today
2 days ago
- Health
- USA Today
In surprise move, RFK Jr.'s vaccine committee votes to recommend RSV shot for infants
In their first vote since appointed by Health and Human Services Secretary Robert F. Kennedy Jr., the eight members of a vaccine committee voted to recommend a shot that protects infants against respiratory syncytial virus, or RSV. Clesrovimab, a monoclonal antibody created by pharmaceutical giant Merck, is recommended for use in infants younger than eight months born during or entering their first RSV season. Martin Kulldorff, who led the June 26 meeting, recently served as an expert witness for plaintiffs who accused Merck of concealing the risks of Gardasil, a vaccine used to prevent cancer from human papillomavirus, or HPV. The eight new ACIP members met for the first time on June 25. Kennedy fired all 17 original members of the committee on June 9 and appointed its new members a few days later. Given the inclusion of vaccine skeptics, the approval comes as a surprise to close watchers of the panel. Experts from the Centers for Disease Control and Prevention's workgroup that presented data on the drug universally supported the drug. However, two panel members still voted against it. RSV infects nearly everyone by the time they're 2. It causes cold symptoms, affecting the breathing passages and lungs, according to the CDC. In the U.S., about 58,000 children younger than 5 are hospitalized for RSV each year, and several hundred die. ACIP's first meeting: Inside the unusual, RFK-appointed panel that's deciding on childhood vaccines Merck's shot is the second RSV monoclonal antibody on the market. The first, a shot from Sanofi and AstraZeneca called Beyfortus, was approved by the Food and Drug Administration in July 2023 and prevents RSV lower respiratory tract disease in infants entering or during their first RSV season. It was the first of its kind to be widely available to everyone beyond a small population of immunocompromised children. Data presented during the June 25 ACIP meeting found the shot reduced hospitalizations by about 47% in newborns up to two months old, the population at highest risk of hospitalization. Dr. Cody Meissner, who voted to recommend the Merck shot, said on June 25 that the result data from Beyfortus in the last RSV season was an 'astonishing accomplishment.' The Beyfortus shot was recommended by ACIP in 2023 for babies under 9 months old who are entering their first RSV season. It's also recommended for babies 8 to 19 months who are at increased risk of severe disease if they're entering their second season of RSV. Parents will have the choice between the two shots. If they receive Beyfortus, they're not recommended to get the new monoclonal antibody by Merck. Pregnant patients also have access to Pfizer's RSV vaccine Abrysvo, which is recommended for pregnant people to protect newborns from lower respiratory infections. The shot is approved for use during the 32nd and 26th weeks of pregnancy during the RSV season, which typically starts in September and runs through January in the U.S. Adrianna can be reached at adrodriguez@
Yahoo
2 days ago
- Health
- Yahoo
In surprise move, RFK Jr.'s vaccine committee votes to recommend RSV shot for infants
In their first vote since appointed by Health and Human Services Secretary Robert F. Kennedy, the eight members of a vaccine committee voted to recommend a shot that protects infants against respiratory syncytial virus, or RSV. Clesrovimab, a monoclonal antibody created by pharmaceutical giant Merck, is recommended for use in infants younger than eight months born during or entering their first RSV season. Martin Kulldorff, who led the June 26 meeting, recently served as an expert witness for plaintiffs who accused Merck of concealing the risks of Gardasil, a vaccine used to prevent cancer from human papillomavirus, or HPV. The eight new ACIP members met for the first time on June 25. Kennedy fired all 17 original members of the committee on June 9 and appointed its new members a few days later. Given the inclusion of vaccine skeptics, the approval comes as a surprise to close watchers of the panel. Experts from the Centers for Disease Control and Prevention's workgroup that presented data on the drug universally supported the drug. However, two panel members still voted against it. RSV infects nearly everyone by the time they're 2. It causes cold symptoms, affecting the breathing passages and lungs, according to the CDC. In the U.S., about 58,000 children younger than 5 are hospitalized for RSV each year, and several hundred die. ACIP's first meeting: Inside the unusual, RFK-appointed panel that's deciding on childhood vaccines Merck's shot is the second RSV monoclonal antibody on the market. The first, a shot from Sanofi and AstraZeneca called Beyfortus, was approved by the Food and Drug Administration in July 2023 and prevents RSV lower respiratory tract disease in infants entering or during their first RSV season. It was the first of its kind to be widely available to everyone beyond a small population of immunocompromised children. Data presented during the June 25 ACIP meeting found the shot reduced hospitalizations by about 47% in newborns up to two months old, the population at highest risk of hospitalization. Dr. Cody Meissner, who voted to recommend the Merck shot, said on June 25 that the result data from Beyfortus in the last RSV season was an 'astonishing accomplishment.' Beyfortus shot that was recommended by ACIP in 2023 for babies under 9 months old who are entering their first RSV season. It's also recommended for babies 8 to 19 months who are at increased risk of severe disease if they're entering their second season of RSV. Parents will have the choice between the two shots. If they receive Beyfortus, they're not recommended to get the new monoclonal antibody by Merck. Pregnant patients also have access to Pfizer's RSV vaccine Abrysvo, which is recommended for pregnant people to protect newborns from lower respiratory infections. The shot is approved for use during the 32nd and 26th weeks of pregnancy during the RSV season, which typically starts in September and runs through January in the U.S. Adrianna can be reached at adrodriguez@ This article originally appeared on USA TODAY: RFK Jr.'s new ACIP votes to recommend RSV shot for infants
Washington Post
3 days ago
- Health
- Washington Post
Kennedy's new vaccine panel alarms pediatricians with inquiries into long-settled questions
ATLANTA — U.S. Health Secretary Robert F. Kennedy Jr.'s new vaccine advisers alarmed pediatricians Wednesday by announcing inquiries into some long-settled questions about children's shots. Opening the first meeting of Kennedy's handpicked seven-member panel, committee chairman Martin Kulldorff said he was appointing a work group to evaluate the 'cumulative effect' of the children's vaccine schedule — the list of immunizations given at different times throughout childhood.
Yahoo
3 days ago
- Health
- Yahoo
CDC vaccine advisory panel to study childhood schedule, delays RSV shot vote
The Centers for Disease Control and Prevention's vaccine advisory committee wrapped up the first day of its meeting since Health and Human Services Secretary Robert F. Kennedy Jr. dismissed the entire panel and appointed his own hand-selected members. The Advisory Committee for Immunization Practices (ACIP) met on Wednesday to discuss possible recommendations for respiratory syncytial virus (RSV) vaccines and antibody shots, as well as COVID-19 vaccine recommendations to be further reviewed at a later date. Martin Kulldorff, the ACIP's new chair, said two new work groups would be established, one focusing on the cumulative effects of children and adolescents receiving all recommended vaccines on the childhood immunization schedule and another reviewing vaccines that haven't been examined for more than seven years. MORE: What to expect from the upcoming CDC vaccine advisory committee meeting with RFK Jr.'s new members The latter group may discuss whether the hepatitis B vaccine is necessary at birth before a baby leaves the hospital, according to Kulldorff. "The number of vaccines that our children and adolescents receive today exceeds what children in most other developed nations receive and what most of us in this room received when we were children," Kulldorff said. The American Academy of Pediatrics put out a video on Wednesday, saying immunization policy through ACIP is "no longer a credible process" and that it will continue to publish its own vaccine recommendations for children. In the morning, CDC staff presented data on COVID-19 vaccines, showing safety and efficacy as well as a reduction in hospitalizations and deaths. For the 2024-25 updated COVID vaccine against emergency department and urgent care encounters, the CDC found 79% effectiveness for children between nine months and 4 years old, 57% effectiveness among children between five and 17 years old and 34% effectiveness for those aged 18 and older. Kulldorff asked where the data shows COVID-19 vaccine effectiveness from placebo-controlled trials. Dr. Adam MacNeil, from the CDC's National Center for Immunization and Respiratory Diseases (NCIRD), said the CDC's evaluation of effectiveness came from real-world data. "Randomized clinical control trials are not necessarily comparable to what we're currently seeing with the vaccine," MacNeil said. "Where we're trying to now monitor is the real-world impacts of these vaccines as opposed to clinical trial data, which was certainly extensively documented." The ACIP members also discussed questions about potential safety signals surrounding the COVID vaccine, with the CDC determining that myocarditis and pericarditis -- inflammation of the heart muscle and the sac around the heart, respectively -- are still risks, but no other risks have been found. MORE: Experts warn RFK Jr. is unraveling the system that kept vaccines safe The group also discussed RSV vaccines and antibody shots, but the committee delayed its vote on recommendations until Thursday. Currently, RSV vaccines are recommended for pregnant people between 32 and 36 weeks of pregnancy to pass on protection to a fetus, which should last throughout their first RSV season. For babies eight months and younger born to mothers who did not receive a maternal RSV vaccine, monoclonal antibody shots are available. Monoclonal antibodies are proteins manufactured in a lab and mimic the antibodies the body naturally creates when fighting an infection. They do not activate the immune system as would occur with vaccination. The shot is also recommended for a small group of children from 8 months old through 19 months old who are at increased risk for severe RSV. During the meeting, Dr. Georgina Peacock, director of the Immunization Services Division in the CDC's NCRID, shared CDC data showing 57% of infants born between April 2024 and March 2025 were protected from RSV by maternal vaccination or receipt of nirsevimab, one of the antibody shots. Dr. Cody Meissner, one of the new ACIP members, described the vaccine and antibody data, showing its real-world impacts as a "truly spectacular accomplishment." "People should understand this is a truly spectacular accomplishment and will have enormous impact on public health," he said. Another ACIP member, Retsef Levi, expressed some skepticism, saying he wanted to see more data on how efficacy for the maternal vaccine changes over time, adding that RSV is a "tricky" virus that "fools interventions in unexpected ways." In response, MacNeil of the NCRID said vaccine efficacy does wane over time, but the maternal RSV vaccine protects newborns and infants when they're at their most vulnerable, before they develop more robust immune systems. The group will vote on Thursday on whether to recommend a newer monoclonal antibody shot for babies eight months and younger and to update the resolution for the federal Vaccines for Children program to include details about the new, potentially approved antibody shot.
Deccan Herald
3 days ago
- Health
- Deccan Herald
Kennedy's vaccine panel breaks norms, plans to review immunisation schedule
Committee chair Dr. Martin Kulldorff - a biostatistician and epidemiologist who publicly criticised Covid-19 lockdowns and was fired from Harvard for refusing to take a Covid-19 vaccine - said the panel will review the total number of vaccines U.S. children and adolescents receive, which he said exceeds those given to children in other developed nations.
