Latest news with #mRNACovid
Yahoo
5 days ago
- 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
NBC News
01-05-2025
- Health
- NBC News
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.'
Yahoo
29-04-2025
- Health
- Yahoo
FDA appears to be slow-walking vaccine approvals
Former government health officials fear the Trump administration is 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. The Food and Drug Administration confirmed Monday it was requiring drugmaker Novavax to run another clinical trial as part of the approval process for its Covid vaccine, which has been available under emergency use authorization since 2022. Dr. Marty Makary, the FDA's commissioner, said the company is asking the agency to approve 'a new product' based on old data. Novavax's shot uses traditional protein-based vaccine technology and is the only alternative to the mRNA shots from Pfizer and Moderna. The drugmaker's application to the FDA was based on a 30,000-person randomized clinical trial conducted in 2021 in the U.S. and Mexico. The agency missed an April 1 deadline decision, prompting concerns among investors that it wouldn't be approved. On Saturday, Makary suggested in a post on X that Novavax was seeking approval for a 'new' vaccine because the strain used in its trial has since been updated to target a more recent Covid variant called JN.1. 'Under this administration, we are prioritizing the Gold Standard of Science--not what saves pharma companies 'tens of millions of dollars,'' Makary said. Novavax declined to comment on Makary's remark. In a release issued Monday, Novavax said it responded to an earlier FDA request to commit to providing more data on the vaccine if approved — a standard practice. Dr. Paul Offit, the director of the Vaccine Education Center at Children's Hospital of Philadelphia, criticized the administration's move, pointing out that the seasonal flu vaccines are updated each year with new strains without the need for new clinical trials. The mRNA Covid vaccines have been similarly updated each year to target the most current strain. 'I mean, how exactly does he propose they do this?' said Offit, who also serves on an independent vaccine advisory committee for the FDA. 'It just worries me that it's part of an overall general strategy to weaken vaccine efforts.' The FDA directs all media inquiries to the Department of Health and Human Services. In a written statement, an HHS spokesperson said the Biden administration waived clinical trial requirements for new Covid vaccines 'using the COVID pandemic as an eternal justification for blanket approvals.' Under Makary, the spokesperson said, trials from four years ago 'no longer suffice.' 'With Novavax seeking authorization for a new formulation targeting the JN.1 variant, the public deserves clear answers about its efficacy and if its benefits outweigh the risks,' the spokesperson said. The Wall Street Journal first reported the FDA's request for a new clinical trial. Novavax's shot isn't the only Covid vaccine that officials say may be at risk. Dr. Tracy Beth Høeg, who was announced as a special adviser to Makary earlier this month, has called for more scrutiny of vaccines, telling FDA staff and high-ranking officials in a meeting outlining priorities that the agency would be doing fewer vaccine approvals going forward, according to three former government officials familiar with the matter, who spoke on the condition of anonymity for fear of retribution. Høeg, a sports medicine physician, rose to prominence during the pandemic as a vocal critic of the Covid vaccines, particularly for children. Her appointment added another anti-Covid-vaccine voice to the Trump administration. In 2021, HHS secretary Robert F. Kennedy Jr. described the Covid vaccine as the 'deadliest vaccine ever made.' In 2023, Makary and Høeg co-wrote an editorial for the New York Post criticizing the Biden administration's recommendation of the Covid shot in children. It's unclear what role — if any — Høeg played in the FDA imposing an additional requirement for Novavax's Covid vaccine approval. Høeg did not respond to multiple requests for comment. There are also concerns about several upcoming FDA deadlines related to Pfizer's mRNA Covid vaccine, including a decision for the full approval for the shot in children under 11, according to two of the former officials. The vaccine currently has an emergency use authorization for ages 11 and under. The mRNA vaccines are a particular target among anti-vaccine activists. The vaccines from Pfizer and Moderna are the first-ever approved using mRNA technology, which has led some to claim they pose a unique threat. Florida Surgeon General Joseph Ladapo has railed against mRNA vaccines, alleging they could possibly alter a person's DNA. Several states have introduced legislation that would ban mRNA vaccines. The CDC says the mRNA Covid vaccines are safe and do not alter DNA; the technology had been studied for decades before its first approval in the U.S. in late 2020. Last week, Politico reported, citing two people familiar with the discussions, that Kennedy is considering pulling the Covid vaccine from the Centers for Disease Control and Prevention's list of recommended immunizations for children, a move that could affect insurance coverage and influence some pediatricians' consideration of whether to administer them. NBC News has not independently confirmed the reporting. Dorit Reiss, a vaccine policy expert at the University of California Law San Francisco, said that while Covid vaccine uptake in children is low, it's important for parents to have the option available. That's especially true for children with underlying health conditions that make them more vulnerable to severe illness and death from the virus, she said. Experts also worry that a possible bird flu vaccine for people could be at risk. One of the former officials said the FDA previously planned to use an emergency use authorization pathway in case health officials needed to quickly greenlight a shot, but it's now unclear whether the Trump administration would do the same. Dr. Ofer Levy, director of the precision vaccines program at Boston Children's Hospital, who has advised the FDA, said it'll be important for public health experts to advocate for vaccines, including the Covid shots. 'It'll be important to have some sort of updated antiviral and Covid vaccine this fall available, and that's particularly important for the most vulnerable individuals,' Levy said. Levy — who said he would not prejudge the administration's potential examination of vaccines — also said common respiratory viruses like the flu and Covid still spread widely, and the public will need vaccines. 'Winter viruses, respiratory viruses, are killing tens of thousands of Americans a year, still,' he said. 'I'm hoping the FDA will continue to consider the mRNA vaccines as one of the platforms.' This article was originally published on
