Latest news with #mRNACovid
NDTV
12-06-2025
- Health
- NDTV
RFK Jr.s New Vaccine Panel Includes Self-Proclaimed Anti-Vaxxer
Health and Human Services Secretary Robert F. Kennedy Jr. announced eight new members of an expert panel that advises the federal government on immunization policy, including several vocal vaccine critics and one who identifies as an "anti-vaxxer." The newly reconstituted panel includes numerous scientists with less conventional views. Several weren't aware of their appointments when contacted by Bloomberg. The moves come as Mr Kennedy makes major changes to how immunizations are studied and administered in the US and paves the way for a more skeptical approach to the use of shots that prevent deadly infections. In just the first few months of his tenure,Mr Kennedy's already taken steps to restrict vaccine approvals and access. On Monday, I took a major step towards restoring public trust in vaccines by reconstituting the Advisory Committee for Immunization Practices (ACIP). I retired the 17 current members of the committee. I'm now repopulating ACIP with the eight new members who will attend ACIP's… — Secretary Kennedy (@SecKennedy) June 11, 2025 Mr Kennedy removed all 17 former members of the panel on Monday, saying "a clean sweep is needed to reestablish public confidence in vaccine science." It was an unprecedented dismantling of the Advisory Committee on Immunization Practices, or ACIP, which reviews the latest data and makes recommendations to the Centers for Disease Control and Prevention, which typically implements them. The new members, including one who claimed Covid shots were causing AIDS and a nurse who became an advocate after saying her child suffered long-term health damage from immunizations, are in a position to revamp vaccine use in the US. The group's positions are used to help determine what shots are given and whether insurers pay for them, among other things. Vaccine Skeptics Robert Malone, a scientist who studied messenger RNA, has spent years espousing debunked theories about the safety of Covid vaccines, at one point claiming the shots were "causing a form of AIDS." While Mr Kennedy said Tuesday afternoon that he would not appoint "anti-vaxxers" to the panel, Malone said in a post on X that he embraced the title two days before his appointment was announced. "The term 'anti-vaxer' it is not a slur, but a compliment. Embrace it. Own it. and be proud to be a part of this fight," Mr Malone wrote. The post didn't indicate Malone is saying he is an anti-vaxxer, according to an HHS official. Instead, it says he opposes vaccine mandates, the official said. Vicky Pebsworth, the nurse who became involved in vaccine safety research because of her child, is listed as the head of research and patient safety for the National Vaccine Information Center, an advocacy group that questions the safety of vaccines. Retsef Levi, an operations professor at Massachusetts Institute of Technology business school, has called into question the safety of mRNA Covid vaccines, including in a post on X. "The evidence is mounting and indisputable that MRNA vaccines cause serious harm including death, especially among young people. We have to stop giving them immediately!" Mr Levi posted in January 2023. Mr Levi also co-authored a study in April about people dying after getting mRNA Covid shots. He wrote that with Joseph Ladapo, the controversial surgeon general of Florida who gained prominence during the Covid pandemic for contradicting federal public health guidance. The study was a preprint, which means it has not been subject to rigorous, peer-reviewed vetting. Martin Kulldorff, a biostatistician and epidemiologist who formerly worked at Harvard Medical School, was a co-author of the Great Barrington Declaration alongside National Institutes of Health Director Jay Bhattacharya. The manifesto called for an alternative to Covid lockdowns focused on protecting the elderly and others at high risk of infection while opening up the rest of society to return to normal early in the outbreak. Another of the appointees, Dartmouth College professor of pediatrics Cody Meissner, signed the declaration. The health secretary, at a showing of Les Miserables at the Kennedy Center in DC on Wednesday, said he changed the makeup of the panel "because the American people deserve it" and because of financial entanglements among the members. "How America responds to outbreaks, pandemics, and preventable deaths are now in the hands of a small group of 'experts' who are loyal to" Mr Kennedy, said Shaughnessy Naughton, president of 314 Action, a nonprofit that works to get Democratic scientists elected. Ms Naughton called on Louisiana Senator Bill Cassidy to investigate why the original panel was dismissed. Mr Kennedy previously promised Cassidy he would not touch the vaccine committee to secure the Republican's vote for the top health job. Member List The list also includes: James Pagano, an emergency room doctor from California Joseph Hibbeln, a psychiatrist and visiting professor at University of Bristol Michael Ross, an obstetrician and gynecologist and the chief medical officer of the generics company Mantra Pharma "I am grateful for the honor to be selected, and will do my best to serve without bias and with rigor," Malone said in a brief phone interview with Bloomberg. "I am honored with this opportunity and humbled by the responsibility," Levi said Wednesday in a post on
Straits Times
12-06-2025
- Health
- Straits Times
Kennedy replaces fired US CDC panel members, includes anti-vaccine proponents
US Health Secretary Robert Kennedy Jr alleged that the prior panel members had conflicts of interest. PHOTO: REUTERS WASHINGTON - US Health Secretary Robert Kennedy Jr named eight members to serve on a key panel of vaccine advisers on June 11, including several who have advocated against vaccines, after abruptly firing all 17 members of the independent committee of experts. They will sit on the US Centres for Disease Control and Prevention's Advisory Committee for Immunisation Practices, which advises the agency on who should get the shots after they are approved by the US Food and Drug Administration. The group of eight - the minimum number allowed by the ACIP founding charter - includes four who have previously worked on committees associated with either the CDC, the Food and Drug Administration, or both. Others have published papers, posted on social media, or written online biographies with anti-vaccine views, including against the mRNA vaccine technology used in some of the newest immunizations such as the Covid-19 vaccine. Among them is Mr Robert Malone, one of the most prominent voices opposing mRNA vaccines. He is aligned with Mr Kennedy's Make America Healthy Again movement. The group also includes Mr Joseph Hibbeln, Mr Martin Kulldorff, Mr Retsef Levi, Mr Cody Meissner, Mr James Pagano, Mr Vicky Pebsworth and Mr Michael Ross. Mr Kennedy, who has long questioned the safety of vaccines contrary to scientific evidence, alleged that the prior panel members, many of whom were appointed by President Joe Biden, had conflicts of interest, without providing evidence of specific members' conflicts. He said the move was necessary 'to re-establish public confidence in vaccine science'. Committee members said their ACIP work follows rigorous vetting of their financial ties and that they must abstain from votes on any vaccine for which they have a conflict. Mr Kennedy said on X that the panel would attend the committee's June 25 meeting. Advisers had been expected to deliberate and vote on who should receive a number of vaccines, including the flu shot and 2025-26 Covid-19 vaccine boosters, and the meeting had been slated for June 25-27. No agenda has been published yet. Shares of vaccine makers Moderna and Pfizer, which both produced mRNA Covid vaccines, fell marginally while those of Novavax, which did not utilise mRNA in its vaccine, rose marginally in after-hours trading. New members It is unclear how new members of the panel have been vetted for conflicts of interest, or when the vetting process began. Mr Meissner and Mr Pebsworth have served on the FDA's Vaccines and Related Biological Products Advisory Committee, and Mr Meissner also previously served on ACIP. Mr Pebsworth is now associated with the National Vaccine Information Centre, a group that advocates for vaccine exemptions and educates about vaccine injury. Mr Kulldorff is an architect of the Great Barrington Declaration, which called for a lighter public health response to Covid-19 in October 2020, and previously served on an ACIP vaccine safety subgroup. Mr Levi has in the past said mRNA vaccines can cause serious harm and death, especially among children, and called for their immediate withdrawal. Mr Ross, a professor at George Washington University, is an operating partner of Havencrest Capital Management, a firm focused on healthcare investments, according to its website. The FDA has found that the mRNA Covid-19 vaccines are generally safe and effective, but Commissioner Marty Makary has questioned the benefit of repeated annual shots for healthy, younger Americans. REUTERS Join ST's Telegram channel and get the latest breaking news delivered to you.
Yahoo
29-05-2025
- Business
- Yahoo
Trump administration cancels multi-million dollar bird flu vaccine contract with Moderna
The Trump administration has cancelled a $766 million contract with Moderna for the development of its human bird flu vaccine, the company has announced. The pharmaceutical giant was awarded the multi-million dollar contract by the Biden administration last year, as the H5N1 virus began to ravage US dairy and poultry farms. It has since infected more than 70 people in America, killing one, and experts say it is only a matter of time before it starts to spread between humans – an event that could trigger a new pandemic. Just yesterday, an 11 year old boy died in Cambodia after becoming infected, the fifth H5N1 death in the region this year. A spokesperson for the US Department of Health and Human Services (HHS) said that after an internal review, the agency had decided to cancel the Moderna contact. Health secretary Robert F. Kennedy Jr, a long time vaccine sceptic, has repeatedly expressed concern over the safety of mRNA vaccines despite them having saved millions of lives during the Covid-19 pandemic. This week Mr Kennedy also announced that mRNA Covid vaccines would no longer be recommended for healthy children or healthy pregnant women. Currently, the US lacks sufficient bird flu vaccine stockpiles, with only 0.82 doses available per person, according to disease analytics firm Airfinity. The agreement with Moderna was intended to strengthen the country's pandemic preparedness by diversifying its emergency H5N1 vaccine stocks. It is thought mRNA vaccines can be developed and produced more rapidly than traditional flu vaccines which are grown in chicken eggs – a method that is both slow and difficult to scale. The cancellation of the contract came on the same day Moderna announced positive results for the jab from its first preliminarily clinical trials: testing of 300 people found the H5N1 vaccines to be 98 per cent efficacy, and 'generally well tolerated.' 'The cancellation [of the contract] means that the government is discarding what could be one of the most effective and rapid tools to combat an avian influenza outbreak,' Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security told Reuters. The European Union has secured 450 million doses of bird flu vaccines – enough for one dose per EU resident – from multiple manufacturers, including CSL Seqirus, GSK, and Pfizer. Moderna, founded just 11 years ago and based in Massachusetts, received over $30 billion in US government funding during the Covid-19 pandemic under the leadership Dr Anthony Fauci, which allowed it to quickly develop and deploy millions of doses of its vaccines. Protect yourself and your family by learning more about Global Health Security Broaden your horizons with award-winning British journalism. Try The Telegraph free for 1 month with unlimited access to our award-winning website, exclusive app, money-saving offers and more.
Epoch Times
20-05-2025
- Health
- Epoch Times
FDA to Unveil New COVID-19 Vaccine Policy
The Food and Drug Administration (FDA) is going to provide an update on COVID-19 policy this week. Dr. Marty Makary, the FDA's commissioner, and Dr. Vinay Prasad, who heads the FDA center that regulates vaccines, are slated to hold a discussion on May 20 about 'an evidence based approach to COVID vaccination.' The FDA has been directing requests for comment to its parent agency, the Department of Health and Human Services (HHS), which did not respond to a request for more details. The Prasad said during a video released by the FDA on May 8 that vaccines save lives 'when given at the right time and the right moment to the right person.' He also Makary told an event later in May that the FDA would be releasing a new framework for vaccines in the near future. Related Stories 5/18/2025 5/16/2025 'We want to be very transparent, and we want to create a framework for vaccine makers that they can use so they have a predictable FDA where they don't have to worry,' Makary said at the Food and Drug Law Institute conference, news outlets reported. Makary and Prasad, before joining the FDA, had criticized the government's clearance and promotion of COVID-19 vaccine boosters, particularly for young people. 'The FDA is now trying to get the public to accept the idea of an annual mRNA Covid vaccine, with no good data,' Makary 'FDA must demand good RCTs for fall of 2025 and companies can go to hell if they don't like it,' Prasad HHS While all individuals aged 65 and older can receive the Novavax vaccine, the FDA said people aged 12 to 64 can only receive the shot if they have at least one underlying health issue that places them at high risk for severe outcomes from COVID-19. The agency
Yahoo
02-05-2025
- Health
- Yahoo
Updated Covid vaccines for the fall may be in jeopardy under Kennedy's new rules
The anticipated rollout of updated Covid vaccines this fall might be at risk after a change by Health and Human Services Secretary Robert F. Kennedy Jr. in how vaccines are tested, experts say. Under the change by Kennedy, according to an HHS spokesperson, all new vaccines will need to go through placebo-controlled clinical trials — where some people get the actual shot and others get something inactive, like a saline shot — to compare the results. Running trials that include a placebo group is already routine for most new vaccines. The original Covid vaccines, from Pfizer and Moderna, approved in late 2020, went through placebo-controlled trials. But as the virus continued to mutate and the vaccines needed to be updated to match the circulating strain, drugmakers moved to a flu vaccine-like model — using smaller studies to test how well the updated shots triggered an immune response against the variant in question. Like the annual flu shot, the updated Covid vaccines weren't treated as entirely new products, since they still used the same formula, with just a tweak to what strain the vaccine would be targeting. The mRNA Covid vaccines were designed so that this change would be particularly easy to make, in the event the shots needed to be quickly updated. Quickly, in this case, turns out to be several months. In order to have enough Covid doses ready to go for the fall, vaccine-makers are told what strain to target in the spring. The Food and Drug Administration's vaccine advisory committee is expected to meet in May or June to make a recommendation on which strains should be included in the next round of shots. A person familiar with the matter, who was not authorized to speak publicly, said the FDA had planned to schedule a meeting for May 22. An HHS spokesperson declined to comment on the meeting date. If the FDA deems Pfizer's and Moderna's updated vaccines 'new' products, requiring fresh trials, it's extremely unlikely the doses would be ready for the fall, experts said. Dr. Paul Offit, the director of the Vaccine Education Center at Children's Hospital of Philadelphia and a member of the FDA's vaccine advisory committee, said the change would almost certainly delay the rollout of the updated shots from Pfizer and Moderna by 'months,' as it would take time for the drugmakers to design the new trials and enroll participants. That would only be the start — the drugmakers would then have to run the actual trial, which would take several months on its own, at minimum, and analyze the results. Even the Covid vaccines — which were hailed as 'the most successful government science program' because of how quickly they were developed, according to Dr. Alex Greninger, a professor of laboratory medicine and pathology at UW Medicine in Seattle — still took at least about six months to run their Phase 3 trials. The HHS spokesperson didn't directly respond to a question about whether the Pfizer and Moderna vaccines would require new clinical trials. However, the spokesperson said in a statement that 'FDA Commissioner Dr. Marty Makary has indicated that significant updates to existing vaccines — such as those addressing seasonal strain changes or antigenic drift — may be considered 'new products' requiring additional clinical evaluation.' 'As we've said before, trials from four years ago conducted in people without natural immunity no longer suffice,' the spokesperson said. 'A four-year-old trial is also not a blank check for new vaccines each year without clinical trial data,' they said, adding that the flu shot would be exempt from the new rule, because it 'has been tried and tested for more than 80 years.' The FDA has already delayed the approval of Novavax's updated Covid vaccine, requiring the company to carry out a new clinical trial because the strain included in the shot differs from what was originally authorized. Vaccine experts panned the new requirements. It's 'unethical,' Offit said, noting that it's generally frowned upon in the scientific community to give someone a placebo when an approved product already exists that can protect them. Dr. Stanley Plotkin, a pediatrician who played a key role in developing the rubella vaccine, said the move would make 'no sense.' 'What would be reasonable is to compare the old vaccine with the new vaccine to see whether the new vaccine gives better immunologic responses,' Plotkin said. 'We have vaccines against Covid, where we have pretty concrete ideas as to what works and what doesn't work. We know they're not perfect, but we have vaccines we know work.' Spokespeople for Pfizer and Moderna did not immediately respond to requests for comment. Former government officials have said HHS, under Kennedy, was moving to slow-walk vaccine approvals, including by imposing new regulatory hurdles on drugmakers, such as changing the requirements for approval or seeking additional clinical trial data. Vaccine experts also fear the rule change is part of a broader effort by Kennedy to sow distrust in vaccines and limit public access to them. 'The goal is to make vaccines more onerous to make, more onerous to test by bringing up these sort of false safety concerns or false efficacy concerns,' Offit said. Dr. Sean O'Leary, chair of the American Academy of Pediatrics Committee on Infectious Diseases, said the change is unlikely to affect brand-new vaccines. But it could have major implications for vaccines that may require updates besides Covid — like those for RSV — since placebo trials are costly and take significantly more time to conduct. 'It's really not feasible, and would lead to lots of hospitalizations and deaths,' O'Leary said. Plotkin added that vaccines being developed for infections that are incurable, like HIV, may also be at risk. 'Suppose you wanted to develop a new HIV vaccine?' he asked. 'Would you do a placebo-controlled trial in that situation? I mean exposing children to a disease which is very serious without offering them anything.' This article was originally published on
