Latest news with #GenerationGoldStandard
Yahoo
29-05-2025
- Health
- Yahoo
HHS terminates Moderna contract to develop bird flu vaccine
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. The U.S. The Department of Health and Human Services has canceled a contract with Moderna to develop messenger RNA vaccines against influenza strains seen as potential pandemic risks, leaving the future of the underlying research uncertain. Moderna revealed in a statement Wednesday that the HHS had terminated the contract, which could have handed the company more than $700 million in total funding. Moderna also reported that an experimental H5 avian influenza vaccine it's developed showed promising results in an early-stage clinical trial. But without the government's help, it will now be forced to 'explore alternatives for late-stage development and manufacturing.' "While the termination of funding from HHS adds uncertainty, we are pleased by the robust immune response and safety profile observed in this interim analysis," said CEO Stéphane Bancel, in a statement. "These clinical data in pandemic influenza underscore the critical role mRNA technology has played as a countermeasure to emerging health threats." In January, the Biden administration awarded Moderna $590 million via the Biomedical Advanced Research and Development Authority, or BARDA, as one of its final acts. The grant expanded on a $176 million award from last year to develop, manufacture and license mRNA vaccines against flu subtypes that could trigger pandemics. The initiative came amidst an outbreak of avian influenza in animals, and was the latest attempt to deploy mRNA technology — which created, in record time, safe and effective shots to battle the COVID-19 pandemic — to prepare for a potential spillover in humans. Since then, however, Robert F. Kennedy Jr., a prominent skeptic of mRNA vaccines, has been put in charge of the HHS. The agency has also directed $500 million in federal funding toward another vaccine initiative called Generation Gold Standard, whose goal is to use a different technology to develop universal shots against 'pandemic-prone' viruses. In an emailed statement, Andrew Nixon, the HHS' director of communications, said that after a 'rigorous review,' the agency has 'concluded that continued investment in Moderna's H5N1 mRNA vaccine was not scientifically or ethically justifiable.' 'The reality is that mRNA technology remains under-tested, and we are not going to spend taxpayer dollars repeating the mistakes of the last administration, which concealed legitimate safety concerns from the public,' Nixon wrote. Moderna and Pfizer's mRNA vaccines for COVID-19 were evaluated in tens of thousands of clinical trial participants in randomized, placebo-controlled studies before their initial authorizations were granted by the Food and Drug Administration. They've since been administered to millions of people across the globe and closely monitored via surveillance systems, with few side effects — most notably the risk in young males of a type of heart inflammation called myocarditis — linked to vaccination. Myocarditis is also associated with COVID-19. The FDA has recently asked Moderna and Pfizer to expand the safety warnings for myocarditis on their shots' prescribing information. The cancellation of Moderna's contract comes days after FDA officials outlined stricter approval standards for new COVID vaccines and the HHS narrowed guidance for who should receive them. So far, there have been 70 human cases of bird flu in the U.S. and one death, according to data from the Centers for Disease Control and Prevention.
Atlantic
06-05-2025
- Health
- Atlantic
The NIH's New Cronyism
Matthew J. Memoli has had an exceptionally good year. At the beginning of January, Memoli was a relatively little-known flu researcher running a small lab at the National Institute for Allergy and Infectious Diseases (NIAID) at the National Institutes of Health. Then the Trump administration handpicked him to be the acting director of the $48 billion federal agency, a role in which he oversaw pauses in award payments, the mass cancellation of grants, the defunding of clinical trials, and the firing of thousands of employees. Now the NIH's principal deputy director, Memoli will soon see his own research thrive as it never has before: He and a close collaborator, Jeffery Taubenberger, also at the NIH, recently approached Health Secretary Robert F. Kennedy Jr. to pitch their research, three current and former NIH officials familiar with the matter told me. And as The Wall Street Journal reported on Thursday, the pair are now set to be awarded up to $500 million for their in-house vaccine research. (All of the current and former NIH officials I spoke with for this story requested anonymity out of fear of professional retribution from the federal government.) In a press release last week, the Department of Health and Human Services described the award's goal as developing universal vaccines against flu viruses, coronaviruses, and other 'pandemic-prone viruses'—at face value, a worthwhile investment. Universal vaccines are designed to guard against multiple strains of a virus at once, including, ideally, versions of a pathogen that haven't yet caused outbreaks. But this particular course toward pandemic prevention is shortsighted and suspect, several vaccine researchers and immunologists told me, especially when the administration has been gutting HHS staff and stripping funds away from hundreds of other infectious-disease-focused projects. As described in the press release, this new project, dubbed Generation Gold Standard, appears to rely on only one vaccination strategy, and not a particularly novel one, several researchers told me. And the way the award was granted represents a stark departure from the government's traditional model of assembling panels of independent scientific experts to consider an array of research strategies, and simultaneously funding several projects at separate institutions, in the hopes that at least one might succeed. Memoli's involvement in this latest award 'is clearly someone taking advantage of the system,' one official told me. When I reached out to HHS and Memoli for comment, they gave conflicting accounts of Generation Gold Standard. An HHS spokesperson confirmed to me that the sum of the award was $500 million and referred only to Memoli and Taubenberger's vaccine technology when discussing the initiative, describing it as 'developed entirely by government scientists.' Memoli, in contrast, wrote to me in an email that the $500 million sum would 'support more than one project,' including partners within NIH and outside the agency, and described Generation Gold Standard as 'a large-scale investment in a host of research.' When I asked HHS for clarification, the spokesperson told me that the funding 'will support multiple projects,' adding that 'the first initiative focuses on influenza.' The spokesperson and Memoli did not respond to questions about the criteria for other projects to be included in this initiative or the timeline on which they will be solicited or funded. Neither Memoli nor Taubenberger's work has ever received this level of financial attention. Both have spent much of their careers running small labs at NIAID. Taubenberger, who did not respond to a request for comment, has long been respected in the field of virology; a few years ago, he received widespread recognition for uncovering and sequencing the flu virus that caused the 1918 flu pandemic. Last month, he was also named the acting director of NIAID, after its previous director, Jeanne Marrazzo, was ousted by the Trump administration. He has frequently collaborated with Memoli, whose work has flown more under the radar. Memoli's appointment to acting director was also unorthodox: Prior to January, he had no experience overseeing grants or running a large federal agency. He had, though, criticized COVID-vaccine mandates as 'extraordinarily problematic' in an email to Anthony Fauci in 2021; Jay Bhattacharya, now the head of NIH, praised Memoli on social media for the scuffle, calling him 'a brave man who stood up when it was hard.' And last year, during an internal NIH review, Memoli described the term DEI —another Trump-administration bugaboo—as 'offensive and demeaning.' (Memoli did not respond to questions about how politics may have influenced his appointment.) Memoli and Taubenberger's vaccine technology could end up yielding an effective product. It relies on a type of vaccine composed of whole viruses that have been chemically inactivated; at least one of the vaccines under development has undergone safety testing, and has some encouraging preliminary data behind it. But flu viruses mutate often, hop frequently across species, and are tricky to durably vaccinate against; although scientists have been trying to concoct a universal-flu-vaccine recipe for decades, none have succeeded. When the goal is this lofty, and the path there this difficult, the smartest and most efficient way to succeed is to 'fund as broadly as you can,' Deepta Bhattacharya, an immunologist at the University of Arizona (who is unrelated to Jay Bhattacharya), told me. That strategy has long been core to the mission of the NIH, which spends the majority of its budget powering research outside the agency itself. Memoli and Taubenberger's whole, inactivated virus strategy is also 'not exactly cutting-edge,' Bhattacharya said. The technology is decades old and has been tried before by many other scientists—and has since mostly fallen out of favor. Newer technologies tend to be more effective, faster to produce, and less likely to cause side effects. And the pair's vaccine candidates have yet to clear the point at which many immunizations fail in clinical trials; usually, funding of this magnitude is reserved for projects that already have strong data to suggest that they're effective at reducing disease or infection, Bhattacharya said. Already, though, HHS seems confident in how the project will play out, according to its press release: The department is targeting FDA approval for at least one of the vaccines in 2029, and claims that the vaccines will be adaptable for other respiratory viruses (such as RSV and parainfluenza). But no published evidence supports the technology's compatibility with those other viruses. Multiple vaccine experts told me that Memoli and Taubenberger's work is not, on its own, a $500 million initiative; half a billion dollars would be 'a truly absurd amount of money' for any single research initiative, one NIH official told me. NIH labs are usually funded by the agency institutes they're based in, and given much smaller budgets: For fiscal year 2025, NIAID sought just $879 million of its total $6.6 billion budget for its roughly 130 internal research groups. At a recent meeting of NIAID leadership, even Taubenberger admitted that he was shocked by the sheer dollar amount that the initial HHS announcement had tied to his platform, an official who attended that meeting told me. In their responses to me, both Memoli and HHS claimed that the $500 million would eventually fund multiple projects. But neither would respond to questions about how that other research would be identified or how much money would be directed to Memoli and Taubenberger's work, which was the only research mentioned in HHS's announcement of the initiative. Memoli and Taubenberger's vaccine does appear to be Generation Gold Standard's linchpin: Memoli and the HHS spokesperson both said that their project would be the initiative's main starting point. That still puts 'a lot of eggs in one basket,' Marion Pepper, an immunologist at the University of Washington, told me. If Memoli and Taubenberger's vaccine technology fails, without clear alternatives, the country may be especially vulnerable when the next big outbreak hits. At the start of the coronavirus pandemic, one NIH official pointed out to me, the first Trump administration did pour billions into developing mRNA-based vaccines —a new technology that was, at the time, unproven. The government invested especially heavily into the pharmaceutical company Moderna, which has continued to receive substantial federal grants for its mRNA vaccine work. (HHS, however, is now reportedly considering pulling funds from one of Moderna's contracts, worth nearly $600 million, awarded to develop vaccines against flu viruses that could cause pandemics, such as the H5N1 bird flu.) But the early data on mRNA vaccines, and the speedy manufacturing timeline they promised, made them 'a smart bet,' the official said. 'I'm not sure Memoli's is.' While funding Moderna, the government also distributed its resources elsewhere—including to several other types of immunizations, made by several other companies, all of them with massive research teams and a long history of scaling up vaccine technology and running enormous clinical trials. The new initiative, meanwhile, appears to come at the expense of other vaccine-related work that was already in motion. The money for Generation Gold Standard, one NIH official told me, comes from HHS's Biomedical Advanced Research and Development Authority (BARDA), and was reallocated from funds originally set aside for Project NextGen, a $5 billion Biden-administration initiative to develop new COVID-19 vaccines and therapeutics. The HHS spokesperson told me that the shuffling of funds 'realigns BARDA with its core mission: preparing for all flu viral pathogens, not just COVID-19,' and called Project NextGen 'wasteful.' (SARS-CoV-2, the coronavirus that causes COVID-19, is not a flu virus.) NIH leaders are well within their rights to funnel money toward favored scientific pursuits. Francis Collins, who served as director until 2021, wasn't shy about pushing through the NIH's neuroscience-focused BRAIN Initiative or the All of Us precision-medicine program. Monica Bertagnolli, who until January directed the NIH, kick-started the health-equity-focused CARE for Health program and advanced a Biden White House initiative on women's health. But those programs funded a wide array of projects—and none concentrated resources of this scale on any single NIH leader's own work. Taubenberger is also listed as an inventor on a patent on the vaccine technology, which isn't unusual in vaccine research, but it means that he could be set up to directly benefit from HHS's huge investment. (When I asked Memoli if he and Taubenberger might both receive royalties from a commercialization of their vaccine technology, he noted that he was not listed as an inventor and had 'no right to royalties on that particular patent.') Heavily funding in-house vaccine research does align, in one way, with the apparent priorities of Kennedy, who has railed against the influence of private companies on medicine. The press release about this 'gold standard' vaccine project brags that the technology is 'fully government-owned and NIH-developed,' which 'ensures radical transparency, public accountability, and freedom from commercial conflicts of interest.' The statement also notes that one of the vaccine technology's assets is its 'traditional' approach—a potential appeal to Kennedy's skepticism of newer vaccine technologies, one NIH official told me. (Kennedy has been critical of COVID-19 vaccines and recently falsely claimed that vaccines that target only one part of a respiratory pathogen—so called single-antigen vaccines—don't work.) Kennedy, a longtime anti-vaccine activist, does not appear to have sought out vaccine research to fund, though. Memoli 'is really the one who has pushed this ahead,' one NIH official told me: A few weeks ago, he dispatched Taubenberger to brief Kennedy on the pair's work. (Memoli did not respond to questions about this briefing or about how he had solicited so much of Kennedy's support.) No matter the instigator, though, the outcome sends an unsettling message to the rest of the American research community—'the only way to overcome HHS priorities is to be part of the inner circle,' the University of Arizona's Bhattacharya told me. One NIH official put it more bluntly: 'It's very clear it's all cronyism going forward.'
Yahoo
01-05-2025
- Health
- Yahoo
HHS touts universal flu, coronavirus vaccine initiative while casting doubt on future of seasonal Covid-19 shots
The US Department of Health and Human Services said Thursday that it aims to accomplish within four years a scientific feat that hasn't been achieved for the past 45: the development of a universal flu vaccine that could protect against multiple virus strains with pandemic potential, including H5N1 avian influenza. 'Generation Gold Standard is a paradigm shift,' National Institutes of Health Director Dr. Jay Bhattacharya said in a statement on the new initiative. 'It extends vaccine protection beyond strain-specific limits and prepares for flu viral threats – not just today's, but tomorrow's as well – using traditional vaccine technology brought into the 21st century.' HHS said the project, being developed in-house at the National Institute of Allergy and Infectious Diseases, is targeting US Food and Drug Administration approval of universal influenza vaccines in 2029, with human clinical trials scheduled to start next year. The Wall Street Journal first reported that it will be funded with $500 million from the Biomedical Advanced Research and Development Authority, a figure confirmed by a spokesperson for HHS. 'I hope it works,' said Dr. Paul Offit, a vaccine scientist at the Children's Hospital of Philadelphia. He noted that he trained in a flu lab in the early 1980s that was working on a universal flu vaccine, and one still hasn't been developed. 'It's not for lack of effort, and it's not for lack of expertise, and it's not for lack of money that we don't have a universal influenza vaccine. It's just really hard to do.' Flu viruses are wily because they mutate from season to season, sometimes significantly, and because efforts to protect against all – or many – strains at once haven't succeeded, we get updated flu shots each year to protect us against the latest circulating strains. A similar paradigm has unfolded for Covid-19 vaccines since they were first authorized in the height of the pandemic at the end of 2020. HHS's new initiative also aims to develop universal coronavirus vaccines that could provide protection against not just the virus that causes Covid-19 – SARS-CoV-2 – but its cousins SARS-CoV-1 and MERS-CoV. The vaccine technology in HHS's new initiative uses inactivated whole-virus vaccines, an older approach that delivers an entire virus that's been chemically tweaked so it can't infect human cells. The project comes from work being driven by Dr. Matthew Memoli, the NIH's principal deputy director, and Dr. Jeffery Taubenberger, acting director of NIAID. Memoli, who gained attention in 2021 for opposing Covid-19 vaccine mandates and reportedly declined Covid-19 vaccination himself, said in 2022 that one of the vaccines being advanced in this project, which can potentially be administered through a squirt up the nose, is an attempt 'to induce a comprehensive immune response that closely mimics immunity gained following a natural influenza infection.' Vaccine experts who are not involved in the project said universal flu and coronavirus vaccines are a worthy goal, but they questioned whether this project could produce one. Dr. Greg Poland, who directs the vaccine research group at the Mayo Clinic, said the accepted scientific definition of a universal flu vaccine is one that would provide at least 75% protection against symptomatic infection with both A and B strain flu viruses for at least a year, and preferably over multiple seasons, for all age groups. Poland says research that's been published on the most advanced candidate in the new initiative, BPL-1357, describes a vaccine that contains inert versions of four A-strain avian influenza viruses but doesn't include any B-strain viruses, 'which tells me they're not aiming at seasonal viruses,' he said. 'They're aiming at those viruses that have the potential for pandemicity,' or the potential to start pandemics. Poland said he was also surprised by the amount of money being devoted to a vaccine technology that science has largely moved away from. 'Why would we devise a major program and devote a tremendous amount of resources to an old platform?' he asked. The advantage of using whole viruses is that they give the body a chance to develop antibodies to many parts of a virus, which tends to create long-lasting protection, even if some parts of the virus mutate. But they can also cause unwanted side effects and adverse reactions. Whole virus vaccines are typically grown in chicken eggs or cells. In this case, the vaccines under study are grown in canine kidney cells. Those viruses are treated with a chemical called beta-propiolactone, which prevents them from being able to copy themselves in the body and infect cells. The inactivated viruses are then purified and mixed into a shot or nasal spray. The US used to use flu vaccines made from whole inactivated viruses but has since moved to safer options, such as subunit or split virus vaccines, which use only a part of the flu virus to create an immune response. Flumist, a nasal spray, uses a whole but weakened version of the virus, so it's not completely inactivated. Inactivated whole-virus flu vaccines are still used in some other countries. Poland and another vaccine expert, Dr. Peter Hotez, director of the Center for Vaccine Development at Texas Children's Hospital, said whole-virus vaccines were once more common, but developers moved away from them because they produce inoculations that are sometimes too strong and can provoke dangerous immune reactions. 'I'm guessing it's going to be quite reactogenic,' Hotez said. He pointed to the 1976 swine flu vaccine, which produced a strong immune response to the whole virus it contained but also caused high rates of Guillain-Barré syndrome, an immune disorder in which the body attacks its own nerves and muscles, causing muscle weakness and paralysis. Other whole-virus vaccines, including the first ones developed to fight respiratory syncytial virus or RSV, have caused problems such as immune enhancement, where exposure to the virus after vaccination makes the infection more dangerous, not less. 'It's a bit of a head-scratcher why they have so much confidence in a whole inactivated virus approach. I don't quite understand that,' Hotez said. Just before it announced its new universal vaccine development plan, late Wednesday HHS threw into question the future of seasonally updated Covid-19 vaccines. The agency said in a statement that 'all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure – a radical departure from past practices.' The FDA typically selects strains for updated Covid-19 vaccines in June so manufacturers can ready them for the fall respiratory virus season. The agency has adopted a system similar to the one used for flu vaccines, holding previously that updating only the strain targeted by the vaccine – and nothing else – didn't represent a change big enough to require new human trials. If HHS now requires placebo-controlled trials before clearing updated Covid-19 vaccines, experts said, that could delay availability of the shots by months, putting vulnerable people at risk. 'The advantage of updating the vaccine every year to make it more close to the circulating strain is, you get better antibody responses, so for four to six months, you will clearly have better protection against mild to moderate disease, and that matters especially for people who are more frail,' particularly people 75 and older, Offit said. A spokesperson for HHS didn't respond to an inquiry about whether the new guidance pertains to updated Covid-19 vaccines, but an official told CNN on Saturday that 'the covid vaccines, including new ones by Pfizer and Moderna, are new and must have more gold standard science to ensure safety and efficacy for the public.' The official drew a distinction from the flu shot, 'which has been tried and tested' for decades. Questions about the fate of Covid vaccines began to swirl after the FDA missed an April 1 deadline to decide whether to grant full approval to the Novavax vaccine, the only non-mRNA vaccine available to protect against the coronavirus. A source familiar with the situation, who wasn't authorized to speak on behalf of the agency, told CNN that the vaccine had been on track to be approved. Novavax later said the FDA had requested a 'postmarketing commitment' for a clinical trial, suggesting that a study would be required of the vaccine after it received full approval (it had been available through emergency use authorization since 2022). HHS's newest statement adds to questions about whether a trial would be required before approval, not just for Novavax's vaccine but also for updated versions of those from Moderna and Pfizer. In a conference call with Wall Street analysts Thursday, Moderna President Dr. Stephen Hoge insisted that the company's interactions with the FDA so far have been 'business as usual' and emphasized the 'real need for Covid vaccination, particularly this coming fall.' Covid-19 has become less deadly since the height of the pandemic as the population developed widespread immunity through both infection and vaccination, but the virus still kills and can be especially dangerous for the elderly. Between September 2023 and August 2024, there were more than 36,000 deaths from Covid-19 among people 65 and older, CDC data showed. This month may reveal whether the FDA shares Moderna's 'business as usual' approach. The company is expecting FDA decisions on a next-generation Covid-19 vaccine by May 31 and on an expansion of approval for its RSV vaccine into younger ages by June 12. It said an FDA decision on its combination flu and Covid-19 vaccine would be pushed back from the end of this year to 2026, as the agency said it requires efficacy data on the flu component to support the application. The company also said it's going to 'de-prioritize' development of the combination flu and Covid-19 vaccine for people under the age of 50, instead focusing on advancing it for older adults, as it shifts some resources to cancer therapies. If the FDA does require placebo-controlled trials before approving updated seasonal Covid-19 vaccines, experts said, it will signal a new standard. 'FDA clearly, after a deliberative process, adopted an approach that treated Covid-19 vaccine boosters like influenza boosters, not like a new product, and held to that over a few years,' said Dorit Reiss, a professor of law at UC Law San Francisco. 'They adopted a standard, and now they're changing it.' The agency does appear to be moving forward at least with the process of selecting strains; it's asked its group of outside advisers to hold May 22 as a date to meet to discuss them, according to a person who viewed the communication who wasn't authorized to speak on behalf of the FDA. In its statement Wednesday, HHS also claimed that current systems for monitoring vaccine safety, including the Vaccine Adverse Event Reporting System and the Vaccine Safety Datalink, don't capture vaccine injuries sufficiently and 'have become templates of regulatory malpractice.' HHS said it's building surveillance systems now 'that will accurately measure vaccine risks as well as benefits.' Vaccine experts pushed back on the assertion that those systems are insufficient. And the plan to build a different surveillance system appeared to come into direct conflict with a pledge that Sen. Bill Cassidy said HHS Secretary Robert F. Kennedy Jr. made to secure his confirmation vote in February. Kennedy, Cassidy said at the time, has 'committed that he would work within the current vaccine approval and safety monitoring systems, and not establish parallel systems.' Cassidy, a Republican doctor from Louisiana, did not respond to CNN's request for comment Thursday.
CNN
01-05-2025
- Health
- CNN
HHS touts universal flu, coronavirus vaccine initiative while casting doubt on future of seasonal Covid-19 shots
The US Department of Health and Human Services said Thursday that it aims to accomplish within four years a scientific feat that hasn't been achieved for the past 45: the development of a universal flu vaccine that could protect against multiple virus strains with pandemic potential, including H5N1 avian influenza. 'Generation Gold Standard is a paradigm shift,' National Institutes of Health Director Dr. Jay Bhattacharya said in a statement on the new initiative. 'It extends vaccine protection beyond strain-specific limits and prepares for flu viral threats – not just today's, but tomorrow's as well – using traditional vaccine technology brought into the 21st century.' HHS said the project, being developed in-house at the National Institute of Allergy and Infectious Diseases, is targeting US Food and Drug Administration approval of universal influenza vaccines in 2029, with human clinical trials scheduled to start next year. The Wall Street Journal first reported that it will be funded with $500 million from the Biomedical Advanced Research and Development Authority, a figure confirmed by a spokesperson for HHS. 'I hope it works,' said Dr. Paul Offit, a vaccine scientist at the Children's Hospital of Philadelphia. He noted that he trained in a flu lab in the early 1980s that was working on a universal flu vaccine, and one still hasn't been developed. 'It's not for lack of effort, and it's not for lack of expertise, and it's not for lack of money that we don't have a universal influenza vaccine. It's just really hard to do.' Flu viruses are wily because they mutate from season to season, sometimes significantly, and because efforts to protect against all – or many – strains at once haven't succeeded, we get updated flu shots each year to protect us against the latest circulating strains. A similar paradigm has unfolded for Covid-19 vaccines since they were first authorized in the height of the pandemic at the end of 2020. HHS's new initiative also aims to develop universal coronavirus vaccines that could provide protection against not just the virus that causes Covid-19 – SARS-CoV-2 – but its cousins SARS-CoV-1 and MERS-CoV. The vaccine technology in HHS's new initiative uses inactivated whole-virus vaccines, an older approach that delivers an entire virus that's been chemically tweaked so it can't infect human cells. The project comes from work being driven by Dr. Matthew Memoli, the NIH's principal deputy director, and Dr. Jeffery Taubenberger, acting director of NIAID. Memoli, who gained attention in 2021 for opposing Covid-19 vaccine mandates and reportedly declined Covid-19 vaccination himself, said in 2022 that one of the vaccines being advanced in this project, which can potentially be administered through a squirt up the nose, is an attempt 'to induce a comprehensive immune response that closely mimics immunity gained following a natural influenza infection.' Vaccine experts who are not involved in the project said universal flu and coronavirus vaccines are a worthy goal, but they questioned whether this project could produce one. Dr. Greg Poland, who directs the vaccine research group at the Mayo Clinic, said the accepted scientific definition of a universal flu vaccine is one that would provide at least 75% protection against symptomatic infection with both A and B strain flu viruses for at least a year, and preferably over multiple seasons, for all age groups. Poland says research that's been published on the most advanced candidate in the new initiative, BPL-1357, describes a vaccine that contains inert versions of four A-strain avian influenza viruses but doesn't include any B-strain viruses, 'which tells me they're not aiming at seasonal viruses,' he said. 'They're aiming at those viruses that have the potential for pandemicity,' or the potential to start pandemics. Poland said he was also surprised by the amount of money being devoted to a vaccine technology that science has largely moved away from. 'Why would we devise a major program and devote a tremendous amount of resources to an old platform?' he asked. The advantage of using whole viruses is that they give the body a chance to develop antibodies to many parts of a virus, which tends to create long-lasting protection, even if some parts of the virus mutate. But they can also cause unwanted side effects and adverse reactions. Whole virus vaccines are typically grown in chicken eggs or cells. In this case, the vaccines under study are grown in canine kidney cells. Those viruses are treated with a chemical called beta-propiolactone, which prevents them from being able to copy themselves in the body and infect cells. The inactivated viruses are then purified and mixed into a shot or nasal spray. The US used to use flu vaccines made from whole inactivated viruses but has since moved to safer options, such as subunit or split virus vaccines, which use only a part of the flu virus to create an immune response. Flumist, a nasal spray, uses a whole but weakened version of the virus, so it's not completely inactivated. Inactivated whole-virus flu vaccines are still used in some other countries. Poland and another vaccine expert, Dr. Peter Hotez, director of the Center for Vaccine Development at Texas Children's Hospital, said whole-virus vaccines were once more common, but developers moved away from them because they produce inoculations that are sometimes too strong and can provoke dangerous immune reactions. 'I'm guessing it's going to be quite reactogenic,' Hotez said. He pointed to the 1976 swine flu vaccine, which produced a strong immune response to the whole virus it contained but also caused high rates of Guillain-Barré syndrome, an immune disorder in which the body attacks its own nerves and muscles, causing muscle weakness and paralysis. Other whole-virus vaccines, including the first ones developed to fight respiratory syncytial virus or RSV, have caused problems such as immune enhancement, where exposure to the virus after vaccination makes the infection more dangerous, not less. 'It's a bit of a head-scratcher why they have so much confidence in a whole inactivated virus approach. I don't quite understand that,' Hotez said. Just before it announced its new universal vaccine development plan, late Wednesday HHS threw into question the future of seasonally updated Covid-19 vaccines. The agency said in a statement that 'all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure – a radical departure from past practices.' The FDA typically selects strains for updated Covid-19 vaccines in June so manufacturers can ready them for the fall respiratory virus season. The agency has adopted a system similar to the one used for flu vaccines, holding previously that updating only the strain targeted by the vaccine – and nothing else – didn't represent a change big enough to require new human trials. If HHS now requires placebo-controlled trials before clearing updated Covid-19 vaccines, experts said, that could delay availability of the shots by months, putting vulnerable people at risk. 'The advantage of updating the vaccine every year to make it more close to the circulating strain is, you get better antibody responses, so for four to six months, you will clearly have better protection against mild to moderate disease, and that matters especially for people who are more frail,' particularly people 75 and older, Offit said. A spokesperson for HHS didn't respond to an inquiry about whether the new guidance pertains to updated Covid-19 vaccines, but an official told CNN on Saturday that 'the covid vaccines, including new ones by Pfizer and Moderna, are new and must have more gold standard science to ensure safety and efficacy for the public.' The official drew a distinction from the flu shot, 'which has been tried and tested' for decades. Questions about the fate of Covid vaccines began to swirl after the FDA missed an April 1 deadline to decide whether to grant full approval to the Novavax vaccine, the only non-mRNA vaccine available to protect against the coronavirus. A source familiar with the situation, who wasn't authorized to speak on behalf of the agency, told CNN that the vaccine had been on track to be approved. Novavax later said the FDA had requested a 'postmarketing commitment' for a clinical trial, suggesting that a study would be required of the vaccine after it received full approval (it had been available through emergency use authorization since 2022). HHS's newest statement adds to questions about whether a trial would be required before approval, not just for Novavax's vaccine but also for updated versions of those from Moderna and Pfizer. In a conference call with Wall Street analysts Thursday, Moderna President Dr. Stephen Hoge insisted that the company's interactions with the FDA so far have been 'business as usual' and emphasized the 'real need for Covid vaccination, particularly this coming fall.' Covid-19 has become less deadly since the height of the pandemic as the population developed widespread immunity through both infection and vaccination, but the virus still kills and can be especially dangerous for the elderly. Between September 2023 and August 2024, there were more than 36,000 deaths from Covid-19 among people 65 and older, CDC data showed. This month may reveal whether the FDA shares Moderna's 'business as usual' approach. The company is expecting FDA decisions on a next-generation Covid-19 vaccine by May 31 and on an expansion of approval for its RSV vaccine into younger ages by June 12. It said an FDA decision on its combination flu and Covid-19 vaccine would be pushed back from the end of this year to 2026, as the agency said it requires efficacy data on the flu component to support the application. The company also said it's going to 'de-prioritize' development of the combination flu and Covid-19 vaccine for people under the age of 50, instead focusing on advancing it for older adults, as it shifts some resources to cancer therapies. If the FDA does require placebo-controlled trials before approving updated seasonal Covid-19 vaccines, experts said, it will signal a new standard. 'FDA clearly, after a deliberative process, adopted an approach that treated Covid-19 vaccine boosters like influenza boosters, not like a new product, and held to that over a few years,' said Dorit Reiss, a professor of law at UC Law San Francisco. 'They adopted a standard, and now they're changing it.' The agency does appear to be moving forward at least with the process of selecting strains; it's asked its group of outside advisers to hold May 22 as a date to meet to discuss them, according to a person who viewed the communication who wasn't authorized to speak on behalf of the FDA. In its statement Wednesday, HHS also claimed that current systems for monitoring vaccine safety, including the Vaccine Adverse Event Reporting System and the Vaccine Safety Datalink, don't capture vaccine injuries sufficiently and 'have become templates of regulatory malpractice.' HHS said it's building surveillance systems now 'that will accurately measure vaccine risks as well as benefits.' Vaccine experts pushed back on the assertion that those systems are insufficient. And the plan to build a different surveillance system appeared to come into direct conflict with a pledge that Sen. Bill Cassidy said HHS Secretary Robert F. Kennedy Jr. made to secure his confirmation vote in February. Kennedy, Cassidy said at the time, has 'committed that he would work within the current vaccine approval and safety monitoring systems, and not establish parallel systems.' Cassidy, a Republican doctor from Louisiana, did not respond to CNN's request for comment Thursday.
The Star
01-05-2025
- Health
- The Star
U.S. launches next-generation universal vaccine platform for pandemic-prone viruses
LOS ANGELES, May 1 (Xinhua) -- The U.S. Department of Health and Human Services (HHS) and the National Institutes for Health (NIH) on Thursday announced the launch of Generation Gold Standard, a next-generation universal vaccine platform designed to combat pandemic-prone viruses. The platform is based on a beta-propiolactone (BPL)-inactivated, whole-virus approach - a modernized take on traditional vaccine technology, according to the NIH. This initiative represents a decisive shift toward transparency, effectiveness, and comprehensive preparedness, funding the NIH's in-house development of universal influenza and coronavirus vaccines, including candidates BPL-1357 and BPL-24910, said the NIH in a release. These vaccines aim to provide broad-spectrum protection against multiple strains of pandemic-prone viruses such as H5N1 avian influenza and coronaviruses including SARS-CoV-2, SARS-CoV-1, and MERS-CoV, according to the NIH. "Generation Gold Standard is a paradigm shift," said NIH Director Dr. Jay Bhattacharya. "It extends vaccine protection beyond strain-specific limits and prepares for flu viral threats - not just today's, but tomorrow's as well - using traditional vaccine technology brought into the 21st century." Clinical trials for universal influenza vaccines are scheduled to begin in 2026, with the U.S. Food and Drug Administration approval targeted for 2029, according to the NIH.
