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@usatoday.com.
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Atlantic
15 hours ago
- Atlantic
RFK Jr. Is Globalizing the Anti-Vaccine Agenda
This week, Robert F. Kennedy Jr. used his address to a global vaccine summit to disparage global vaccination. The conference was organized by Gavi, the world's leading immunization program, and in a recorded speech, Kennedy accused the organization of collaborating with social-media companies to stifle dissenting views on immunization during the coronavirus pandemic and said it had 'ignored the science' in its work. He criticized Gavi for recommending COVID-19 shots to pregnant women, and went deep on a discredited study that purported to find safety issues with a tetanus vaccine commonly used in the developing world. 'In its zeal to promote universal vaccination,' Kennedy claimed, Gavi 'has neglected the key issue of vaccine safety.' Kennedy's remarks confirmed what The New York Times first reported in March: that the United States, Gavi's third-largest donor, would stop pledging money to the organization. (Congress, which has always had final say over Gavi funding, has not yet weighed in.) They are also the first indication that the U.S.'s rejection of global vaccine campaigns stems from the Trump administration's opposition not only to foreign aid, but to vaccination itself. For the first time, Kennedy has managed to use the anti-vaccine agenda to guide American foreign policy. Gavi, at its most basic level, is Costco for immunizations, wielding its massive purchasing power to buy vaccines in bulk for cheap. National governments and private philanthropies pledge funding to it every five years. The United Kingdom and the Gates Foundation are its largest donors; the United Nations distributes the shots. The poorest countries pay 20 cents per vaccine, and prices rise along with national income. Since the partnership was launched, in January 2000, 19 countries —including Ukraine, Congo, and Guyana—have gone from relying on Gavi to paying for vaccinations entirely on their own. Indonesia, which accepted donations from Gavi as recently as 2017, pledged $30 million to the organization this funding cycle. Gavi, by its own estimate, has saved about 19 million lives and vaccinated 1 billion children. At the conference this week, the director of the World Health Organization noted that since 2000, the number of children who die each year before they reach the age of 5 has fallen by more than half, largely due to the power of vaccines. By Gavi's estimates, the U.S. canceling its Biden-era pledge to provide $1.2 billion this donation cycle could lead to the deaths of more than 1 million children who otherwise would have lived. (The Department of Health and Human Services did not respond to a request for comment.) In his recorded remarks, Kennedy said America would not send the money until Gavi can 're-earn the public trust' by 'taking vaccine safety seriously.' Cutting off millions of children's only access to routine vaccines is 'the most emphatic globalization of the anti-vaxxer agenda,' Lawrence Gostin, the faculty director of Georgetown's O'Neill Institute for National and Global Health Law, told me. Tom Frieden, the former director of the CDC, told me that after he heard Kennedy's remarks, 'I was literally sick to my stomach,' because 'unscientific, irresponsible statements like this will result in the deaths of children.' (The U.S. has run an international anti-vaccine campaign before: According to an investigation by Reuters, in 2020, the Pentagon unleashed bot accounts on multiple social-media platforms that impersonated Filipinos and discouraged uptake of China's Sinovac vaccine—the first COVID vaccine available in the Philippines—using a hashtag that read, in Tagalog, 'China is the virus.' The goal was not to combat vaccines, but to undermine China's influence.) Kennedy's prerecorded address held back his harshest critiques of Gavi. In his 2021 book, The Real Anthony Fauci, Kennedy paints 'Bill Gates's surrogate group Gavi' (the Gates Foundation co-founded Gavi) as nothing more than a profiteering 'cabal' and a facilitator of 'African Genocide.' To hear Kennedy tell it, 'virtually all of Gates's blockbuster African and Asian vaccines—polio, DTP, hepatitis B, malaria, meningitis, HPV, and Hib—cause far more injuries and deaths than they avert.' Decades' worth of safety and efficacy studies have proved him wrong. In his remarks to Gavi this week, Kennedy focused on the DTP (diphtheria, tetanus, and pertussis) shot, describing at length a 'landmark' 2017 study that found the vaccine increased all-cause mortality among girls in Guinea-Bissau. But as Frieden pointed out, this was in fact a relatively small observational study. In 2022, a randomized, double-blind, placebo-controlled trial of more than 50,000 newborns found that the DTP vaccine significantly decreased infant mortality. Frieden compared the evidence: 'Hundreds of kids versus 50,000 kids. Poorly done; well done.' Kennedy made efforts to take his anti-vaccine advocacy global before he became America's health secretary. In 2021, he delivered a webinar on the importance of expanding an 'international movement' for Children's Health Defense, the anti-vaccine organization he founded. In 2019, when Samoa was experiencing a major dip in measles immunization after an improperly prepared vaccine killed two children, Kennedy visited the prime minister and, on behalf of Children's Health Defense, reportedly offered to build an information system the country could use to track the health effects of vaccines and other medical interventions. When a deadly measles outbreak took hold later that year, Kennedy sent a letter to the prime minister suggesting that widespread vaccination might make unvaccinated Samoan children more likely to die of measles. (In an interview for a 2023 documentary, Kennedy said that 'I had nothing to do with people not vaccinating in Samoa' and that his conversations about vaccines with the prime minister had been 'limited.') Now, it seems, Kennedy has gained the power to realize his ambitions both domestically and abroad. Earlier this month, Kennedy dismissed all 17 members of the CDC's vaccine advisory committee, then replaced them with a group that includes several allies who have spread misinformation about the harms of vaccines. This week, as other countries pledged their support for Gavi, Kennedy's brand-new, handpicked panel convened for a discussion of the dangers of thimerosal, a vaccine ingredient that is a frequent target of anti-vaxxers despite having been found safe. The committee has formed a working group to review the 'cumulative effect' of childhood vaccination in the United States. As Kennedy said in his address to Gavi, 'Business as usual is over.'
The Hill
15 hours ago
- The Hill
RFK Jr. is fighting a two-front war against chronic disease and anti-MAHA partisans
At a certain point, the gruesome reality of war fades into a white noise of fatalism. Hundreds of thousands killed in Iraq; tens of thousands killed in Afghanistan; over 1 million killed or wounded in Ukraine; Israel and Iran at each other's throats, with the fear of the U.S. being dragged into a wider war. Since the end of World War Two, it can be argued that there has been no 'just' war — just needless killing. While most on the left won't want to hear it or acknowledge it, there has been no president more firmly opposed to these 'forever wars' and the slaughter of young soldiers than President Trump. That said, there was one war Trump was anxious to wage — a war that counterintuitively saves lives, while taking none. To command the campaign, Trump selected Robert F. Kennedy Jr. 'Make America Healthy Again.' It's a nice slogan and looks good on the front of a hat, but what is it really about? The reality is that this program has the potential to save more lives than all those lost in the wars since WWII — and then some. As Trump's secretary of Health and Human Services, Kennedy has chosen to dedicate the rest of his working life to this quest. Why? To save lives that should not be lost in the battle against the unchecked and steadily advancing chronic disease epidemic raging in our nation. Tragically, millions of Americans are lost each year to such preventable disease. Depending upon the study, experts say that approximately 1 million Americans die each year from heart disease; over 1,300 per day, or approximately 500,000 per year, from obesity; 1.5 million Americans are newly diagnosed with diabetes each year, with over 100,000 passing away each year from the disease. Many of these deaths overlap; many are preventable; and many are caused by the foods, beverages and food additives we consume each day. But now Kennedy and his team at HHS have illuminated a bright light at the end of this dark and seemingly endless tunnel. On June 19, Kennedy posted, 'Big food brands are listening. From cereals to spices to fast food, artificial dyes and additives are being removed from America's food supply …' Along with that announcement, he attached a video reporting that General Mills was removing artificial food dyes from U.S. cereals and K-12 school foods by summer 2026 and removing all artificial dyes completely by the end of 2027; Kraft-Heinz just announced that they are removing all artificial dyes by the end of 2027; In-N-Out Burger announced that they removed artificial dyes from strawberry shakes and pink lemonade, using beet juice and turmeric instead. Steak 'N Shake will now be using beef tallow instead of vegetable oil to cook French fries, onion rings and chicken tenders; and McCormick spice company announced it is working to remove artificial food dyes and sodium. All of this comes on top of the banning of Red Dye No. 3, which potentially causes cancer. This is huge and truly transformative news for the health of the American people. None of it was really going anywhere until RFK Jr. came on the scene. While great news, little of this progress will hold unless the broken U.S. healthcare bureaucracy is torn down and rebuilt into an aerodynamic, perpetual-motion machine protecting the health of the American people. To this point, as Kennedy pointed out after his testimony before the House Commerce Committee earlier this week, 'We've thrown trillions of dollars at our health agencies — and the American people have only gotten sicker … we're transforming HHS from a bloated sick-care bureaucracy into a streamlined health care agency focused on outcomes—not waste.' He added, 'The path forward is clear: We will restore public trust by restoring public truth.' Unfortunately, while Kennedy was testifying before this committee regarding the president's 2026 Health and Human Services budget, we also got a troubling look at the other war he is forced to wage to 'Make America Healthy Again.' It is a war that Kennedy would like to avoid. Sadly, but quite predictably, a number of the Democratic members used the hearing for partisan purposes to fire loaded trick questions at Kennedy while demanding 'yes' or 'no' answers based on false premises. Most of them pompously went out of their way to prevent Kennedy from getting a word in edgewise in response. Why? Because they didn't care about any of his answers. That was not the point of the exercise. It was all partisan performance art. It was all about fundraising letters and voters back home. Kennedy is a well-known personality, they wanted to badger and harass him into getting the soundbite needed for their next reelection effort. The ironic part is that Kennedy would very much like to work with all the members taking partisan shots at him for self-promotion. He knows many of them and has worked with some in the past. Rather than be at 'war' with them, Kennedy desperately wants to enlist them as allies in the greater war which, as Kennedy has repeatedly stated, has made America 'the sickest nation in the world.' The American people are sick of being sick — and sick of the partisan nonsense that has put them at greater risk. Tens of millions now believe Kennedy is a prayer answered when it comes to combating those issues. They want and need their congressional representatives to join with Kennedy to make them and their children healthier. A 'war' that takes no lives but could potentially save millions. Kennedy is waging it but needs help from every power center to win it. Douglas MacKinnon is a former White House and Pentagon official.
Yahoo
15 hours ago
- Yahoo
Member of RFK Jr's new vaccine panel withdraws over conflict of interest
A member of the health secretary Robert F Kennedy Jr's newly overhauled federal vaccine advisory panel withdrew after a conflict of interest review, a spokesperson has told the Guardian. Dr Michael Ross, who was involved in multiple private healthcare companies, withdrew after review of his financial holdings. Kennedy unilaterally fired all 17 members of the Centers for Disease Control and Prevention's (CDC) advisory committee on immunization practices (ACIP) in June, arguing they had too many conflicts of interest. Related: Who are the eight new vaccine advisers appointed by Robert F Kennedy? Ross was among eight of Kennedy's ideological allies appointed to the committee, after the secretary argued the old members of the committee were subject to too many conflicts of interest. 'Yesterday, Dr Michael Ross decided to withdraw from serving on ACIP during the financial holdings review,' a spokesperson for the Department of Health and Human Services (HHS) said. 'The sacrifice to serve on ACIP varies from member to member, and we appreciate Dr Ross's willingness to go through this rigorous process.' The spokesperson made the comments after Guardian inquiries about conflict of interest disclosures for new members of ACIP. Although the Trump administration and Kennedy developed a conflict of interest tracker specifically for ACIP members, Kennedy's appointees have not been added. The HHS spokesperson did not respond to Guardian inquiries about when and where new, written conflict of interest disclosures would be published. Instead, the spokesperson said the department has, 'comprehensively reviewed all newly appointed ACIP members for conflicts of interests in accordance with federal law, regulations and departmental polices', and that the members were provided 'ethics training prior to discharging their duties'. The new members of the committee were asked to disclose conflicts of interest before the meeting began on Wednesday. The committee chair Dr Martin Kulldorff and committee member Dr Robert Malone omitted widely reported work in vaccine litigation, and nurse Vicky Pebsworth said she was 'asked to read' a statement disclosed ownership of a healthcare stock but said it was below the government ethics office threshold for reporting. Ethics review of the new members was also the subject of Senate testimony on Wednesday. Under questioning by the Democratic senator Patty Murray of Washington, the Trump nominee to head the CDC, Dr Susan Monarez, said she was 'not familiar whether or not the members that are participating in the meeting this week have or have not gone through the ethics review necessary to allow them to participate in those meetings'. 'If it is known that they have not gone through the ethics process and they issue recommendations, would you accept them as valid?' asked Murray. 'If they have not gone through an ethics approval process, they shouldn't be participating in the meetings,' said Monarez.
