Latest news with #MatthewMemoli
Yahoo
06-05-2025
- Health
- Yahoo
‘It's All Cronyism Going Forward'
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 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.' Article originally published at The Atlantic
New York Times
06-05-2025
- Health
- New York Times
N.I.H. Bars New Funding From U.S. Scientists to Partners Abroad
The National Institutes of Health will no longer allow American scientists to direct its funding to research partners overseas, casting doubt on the future of studies on subjects including malaria and childhood cancer. Dr. Jay Bhattacharya, the new director of the N.I.H., announced the policy on Thursday, the same day Dr. Matthew J. Memoli, the principal deputy director, blasted these so-called subawards in an email obtained by The New York Times. 'If you can't clearly justify why you are doing something overseas, as in it can't possibly be done anywhere else and it benefits the American people,' Dr. Memoli wrote, 'then the project should be closed down.' The new restrictions, which will apply to domestic subawards as well in the future, come amid deep reductions in N.I.H. funding and the freezing of federal grants at many top universities, along with executive orders seeking to reshape the nation's scientific agenda.
Epoch Times
01-05-2025
- Health
- Epoch Times
Health Officials Announce New Effort to Develop Universal Vaccines Targeting Multiple Virus Strains
Federal health officials on May 1 announced a new effort to develop vaccines targeting a range of viruses, including the virus that causes COVID-19. The Generation Gold Standard project will fund the National Institutes of Health (NIH) development of 'universal influenza and coronavirus vaccines' that 'aim to provide broad-spectrum protection against multiple strains of pandemic-prone viruses,' including the avian influenza—commonly known as the bird flu—and SARS-CoV-2, or the virus that causes COVID-19, the NIH and its parent agency The budget of the new project has not been disclosed. Officials said that it was being promoted over Project NextGen, a $5 billion initiative started in 2023 under the previous administration that focused primarily on COVID-19. 'It delivers a cost-effective, accountable alternative to the Biden administration's wasteful Project NextGen, which spent $1.63 billion on COVID-19 vaccines and $1.19 billion on therapeutics, neglecting broader pandemic preparedness,' a spokesperson for the Department of Health and Human Services (HHS), the NIH's parent agency, told The Epoch Times in an email. One of the NIH's vaccine candidates, BPL-1357, performed well in a phase one safety study, the NIH's principal deputy director, Dr. Matthew Memoli, and other researchers BPL-1357, an intranasal vaccine billed as providing protection against a number of influenza A viruses, is being tested in clinical trials and is on track for regulatory approval by 2029, officials said. Related Stories 4/18/2025 5/1/2025 Another candidate, BPL-24910, has been tested for toxicity, according to The platform from which the vaccines come is fully owned by the government, which 'ensures radical transparency, public accountability, and freedom from commercial conflicts of interest,' health officials said. They also said that vaccines could eventually be developed with the platform against several other viruses, including the respiratory syncytial virus, or RSV. 'Our commitment is clear: every innovation in vaccine development must be grounded in gold standard science and transparency, and subjected to the highest standards of safety and efficacy testing,' Health Secretary Robert F. Kennedy Jr. said in a statement. NIH Director Dr. Jay Bhattacharya added: 'Generation Gold Standard is a paradigm shift. '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.' Officials had Some companies, including Moderna, have been working on vaccines that target both COVID-19 and the flu, but none have been submitted for approval. Project NextGen provided funding for multiple companies to develop new COVID-19 vaccines, in addition to funding for new treatments and other measures that could help with future COVID-19 outbreaks. HHS stopped distributing funding to Vaxart and Geovax, which are developing COVID-19 vaccines under Project NextGen, although it recently lifted the stop-work order for Vaxart's study.
The Guardian
27-03-2025
- Health
- The Guardian
Trump administration at ‘war' with mRNA technology: scientists alarmed vaccine skeptics could kill research
A cutting-edge technology expected to foster new medical breakthroughs in treatments for cancers and infectious disease is being treated 'like a four-letter word' inside the Trump administration, causing panic among scientists who fear Trump-appointed health officials, driven by misinformation and conspiracy theories about the Covid-19 vaccine, will cut critical research in the field. Scientists and public health experts interviewed by the Guardian are sounding the alarm over a recent move by the National Institutes of Health to collect information about funding for research into mRNA technology. Some fear it is the first step in a move to cut or defund grants that involve the technology, which was an essential component in the rapid creation of vaccines against Covid-19, a major accomplishment of the first Trump term in fighting the pandemic. Messenger RNA technology, which in the case of Covid-19 teaches the body to fight infection by introducing immune cells to the coronavirus's characteristic spike proteins, is being tested for use against diseases ranging from bird flu and dengue, to pancreatic cancer and melanoma. While the NIH has not formally stated that it is cutting mRNA vaccine and therapy research, scientists who were interviewed by the Guardian said they have been told informally that the NIH is performing key word searches on grants that mention mRNA vaccine-related technology and related phrases. 'Colleagues have also been advised not to apply for mRNA vaccine grants. This is all through the grapevine. There has not been an official statement about it,' said one New York-based scientist. The NIH confirmed in a statement to the Guardian that it made a 'data call' to learn more information about the funding of mRNA vaccine grants. Nature, the scientific journal, first reported the data call, and said it had been conducted by the acting NIH director Matthew Memoli on 6 March. Scientists were given one day to report the information, and NIH collected information about 130 mRNA grants as a result. Many of the scientists, public health experts and medical researchers interviewed by the Guardian spoke on the condition of anonymity, fearing that they might be targeted if they expressed concerns publicly. One former senior NIH official who resigned recently said what was happening inside the organization was 'not understandable'. 'So far, any attempt at reasoning with people has fallen on deaf ears. Everything is being run by the department [Department of Health and Human Services] or the White House,' the person said. KFF Health News separately reported that all grants involving mRNA research were to be reported to Memoli, for referral to the office of health secretary Robert F Kennedy Jr and the White House. Adding to concerns is the administration's February decision to review a nearly $600m contract between HHS and Moderna, which was set to fund research into potential mRNA vaccines against five flu subtypes, including H5N1 or bird flu. 'mRNA has become the new four letter word. I mean, it's crazy. It goes beyond just anti-vax,' the person said, referring to the anti-vaccine movement in the US. 'It's about anything associated with the Covid response, which has been weaponized by extreme people in the administration,' the person said. Paul Offit, director of the vaccine education center and an attending physician at Children's Hospital of Philadelphia, said he knew of one researcher working on mRNA technology who had their grants 'flagged'. 'That doesn't necessarily mean they won't get it, but it is worrisome that they might not get it,' he said. 'There seems to be a war against mRNA technology. 'Why?' is the question.' Most experts agree that it relates to the politicization of the pandemic and misinformation about the Covid-19 vaccines. 'Prior to the pandemic, even anti-vaccine groups were not focused on mRNA vaccines,' said Dorit Rubinstein Reiss, an expert in vaccine law and professor at the University of California College of Law in San Francisco. Most prominent among Trump's vaccine skeptics is Kennedy, the recently confirmed head of HHS. Kennedy criticized mRNA vaccines while he led the anti-vaccine nonprofit Children's Health Defense. In 2021, the group then led by Kennedy filed a petition to the FDA to revoke emergency approval of Covid-19 vaccines, 'because the current risks of serious adverse events or deaths outweigh the benefits'. Studies later showed that claim was inaccurate. A study by the Commonwealth Fund found that Covid-19 vaccines saved 3.2 million American lives and prevented more than 18 million hospitalizations through November 2022. Kennedy denied being anti-vaccine in Senate confirmation hearings. Others promoted into positions of power in the Trump administration also questioned Covid-19 strategies; Dr Jay Bhattacharya, who is expected to be confirmed as the new director of the NIH, and Martin Makary, who has just been confirmed as the new head of the Food and Drug Administration (FDA). Jonathan Howard, a New York neurologist who closely tracked medical misinformation over the last four years, has been critical of both Bhattacharya and Makary, who Howard has alleged sought to try to convince people that the world overreacted to the Covid-19 pandemic. Bhattacharya was one of three authors of the Great Barrington Declaration, a statement that argued against Covid-19 lockdowns in favor of so-called herd immunity. Signed in October 2020 on the campus of the right-leaning American Institute for Economic Research, the declaration called for isolating the 'old and infirm' and allowing people less vulnerable to death from Covid-19 to socialize. 'Keeping [lockdown] measures in place until a vaccine is available will cause irreparable damage, with the underprivileged disproportionately harmed,' the declaration said. 'Those who are not vulnerable should immediately be allowed to resume life as normal.' The statement was widely criticized for oversimplifying the protection of the vulnerable. Vaccines would become available just two months later, in December 2020. In a post on X in June 2024, Bhattacharya said he would support pulling the regulatory authorization for the marketing of the Covid mRNA vaccines. While he said he initially hesitated to sign on to a petition calling for the move, he had been convinced that doing so would lead to 'good clinical trial evidence testing' to check whether some patient groups still benefit from the vaccine. Makary is not anti-vaccine, but in June 2021 suggested parents should 'think twice' before giving the Covid vaccine to healthy children. In an article he also said he was not aware of a single case of a healthy child who had died of Covid-19. Scientific studies at the time did, however, report that healthy children had died of the virus. Three experts, including two who have closely monitored the growth of the anti-Covid vaccine movement in the US, said they believed that any opposition to mRNA-related research may influence others under the HHS umbrella, including the FDA, which regulates the approval of drugs and therapies. 'I am sure companies will continue to invest in mRNA research. The key will be whether the FDA will continue to approve mRNA vaccines,' said a former senior NIH official. 'That to me is the big question because if there is a concerted effort to erase anything related to mRna vaccines, then obviously support for research is only one aspect. Hopefully, they are not going to do that, but I don't have much hope for this crowd.' Another former senior official, who worked on the deployment of the Covid-19 vaccine during the Biden administration, said he had not seen any evidence to suggest that the FDA would take any unilateral position against approval of drugs and therapies that use mRNA technology. The person pointed to the fact that Dr Peter Marks, who serves as the FDA's center for biologics evaluation and research, which is responsible for assuring the safety and efficacy of products including vaccines, was still in his job. The former official said he believed Marks would, in effect, serve as a 'guardrail' to protect the drug approval process against politicization. The Guardian asked the FDA about its position on reviewing mRNA vaccines, and whether its position was under review. The Guardian also asked the FDA to comment on concerns among scientists about whether such vaccines will continue to be given approval by the FDA. The FDA did not directly respond to the questions. It said in a statement: 'The FDA is a science-based regulatory agency that evaluates the safety and effectiveness of all products based upon data submitted by sponsors and the totality of the available scientific evidence … The decision to vaccinate is a personal one. People should consult with their healthcare provider to understand their options to get a vaccine and should be informed about the potential risks and benefits associated with vaccines.' The Guardian contacted Pfizer, Moderna, Merck and PhRMA, the drug industry's lobbying group, to ask whether the Trump administration's apparent mistrust of mRNA vaccines was an area of concern. None responded to the Guardian's questions. 'I don't know when the shoe is going to drop. As a vaccine researcher we are all extremely nervous about what can happen to research funding,' said the New York scientist who spoke on the condition of anonymity. 'There is no Plan B. It is economic madness as well as the elimination of a powerful technology against future pandemics. It is a freaking nightmare.' Do you have a tip? Please contact or on Signal at 646-886-8761.
Yahoo
27-01-2025
- Health
- Yahoo
After 'confusion' over Trump team's directives, critical NIH research will continue for now
Despite concerns about the future of research at the National Institutes of Health, current clinical trials can continue as scheduled, the agency's acting director told staff scientists in an email Monday. The clarification followed what staffers called 'chaos' Wednesday when the Trump administration 'paused' all communications from federal health agencies and suspended all government travel. The directive left NIH staff members with unanswered questions about their work and even whether they'd be able to continue caring for their patients. The acting director, Dr. Matthew Memoli, a longtime infectious disease expert and flu vaccine researcher at the NIH, wrote in the email, a copy of which was obtained by NBC News, that he sought to clear up 'confusion on the scope of the pause.' 'Clinical trials at NIH or NIH-funded institutions are ongoing,' he wrote. 'Research participants can continue to participate in clinical trials at the NIH Clinical Center and at NIH-funded facilities.' He also clarified that investigators could continue to spend money on supplies and pay for research participants to travel to the NIH Clinical Center in Bethesda, Maryland, for treatment. The NIH conducts more than a thousand clinical trials every year. A staff scientist who wasn't authorized to speak publicly said the email was 'good news' that seemed to 'put things back closer to normal,' as least for clinical work. Funding for any new projects, however, remains on hold. It's unclear whether the NIH will continue approving money for research grants through its review groups, called study sections. Without grants, scientists are unable to start any new research on conditions from asthma and pediatric cancer to Covid and Ebola. The NIH awards more than 60,000 grants every year, supporting at least 300,000 researchers. Dr. Jay Bhattacharya, a Stanford University professor who publicly criticized how the NIH handled the Covid pandemic, has been tapped by President Donald Trump to be the next NIH director. A Senate hearing on whether to confirm Bhattacharya has not been scheduled. Meantime, acting director Memoli said he expects additional guidance to come from the Department of Health and Human Services this week. The overall pause in external communications is expected to last until Saturday. This article was originally published on
