National Institute of Allergy & Infectious Diseases

A new program—dubbed “Generation Gold Standard”—comes from in-house efforts at the National Institutes for Health.\n The U.S. government is putting down $500 million toward the development of a “universal” vaccine—a shot designed to protect against multiple strains of a pandemic-prone virus at once. The concept is one scientists have chased for decades to no avail and represents a shift away from the government prioritizing next-gen COVID-19 vaccines.The program—dubbed “Generation Gold Standard”—comes from in-house efforts at the National Institutes for Health (NIH), according to a May 1 release from the Department of Health and Human Services (HHS).The HHS did not publicly state how much money was being channeled into the program, though a spokesperson confirmed the the $500 million figure that was initially reported by The Wall Street Journal.The move comes amid mass cuts at the agency, such as terminated NIH research grants and a workforce reduction designed to impact nearly 20,000 HHS staffers. A document leaked last month revealed unofficial plans from President Donald Trump’s administration to slash the NIH’s budget by about 40%, from $47 billion to $27 billion. Given that backdrop, the announcement is somewhat baffling. Past and current HHS officials who spoke to the WSJ under the condition of anonymity said they were surprised by the $500 million figure.The new project’s funds will come from the Biomedical Advanced Research and Development Authority (BARDA), an HHS center designed to finance medical countermeasures against public health threats.The initiative seeks to replace the Biden’s administration’s Project NextGen, a $5 billion effort to accelerate next-gen COVID-19 countermeasures to address waning immunity and resistance. In a statement, the HHS spokesperson said the Biden-era program was \"wasteful\" and \"neglecting broader pandemic preparedness.\" The new initiative centers around a beta-propiolactone (BPL)-inactivated, whole-virus platform and is championed by Matthew Memoli, M.D., the newly tapped principal deputy director for the NIH, and Jeffery Taubenberger, M.D., Ph.D., who became acting director of the National Institute of Allergy and Infectious Diseases last month.\"Developed entirely by government scientists—free from industry influence—the BPL vaccine platform could provide broad, long-lasting protection against all influenza viral pathogens, including influenza and coronaviruses, with the added potential to block transmission and stop outbreaks at the source,\" the HHS spokesperson told Fierce Biotech.The Generation Gold Standard project includes research on a universal flu vaccine co-developed by Memoli, who argued against COVID-19 vaccination mandates and declined to be vaccinated in 2021, according to the WSJ.Both Memoli and Taubenberger have contributed to science behind the candidate, dubbed BPL-1357. The asset is made up of four strains of noninfectious, chemically inactivated, avian flu virus and can be delivered by injection or nose inhalation.The vaccine was found to be safe and well tolerated in a phase 1 study of 45 adults, with investigators recording mild side effects such as fever, headaches and pain at the injection site.The HHS said the intranasal BPL-1357 version is currently being tested out in phase 1b and 2/3 trials, though there is no record of these studies on ClinicalTrials.gov. The candidate is on track for an FDA review by 2029, according to the release.More clinical trials for other investigational universal influenza vaccines are scheduled to launch in 2026, according to the HHS.Another candidate touted by the HHS, called BPL-24910, is also absent from the national trial registry. However, the HHS did shell out $716,374 in 2022 to a contractor called the Lovelace Biomedical Research Institute in New Mexico to run toxicology studies for the program. The HHS claims that the BPL platform also holds potential for respiratory syncytial virus, metapneumovirus and parainfluenza.The approach—creating vaccines from chemically inactivated whole viruses—stems all the way back to the 1940s.This kind of vaccine can be produced quickly, which would lend itself to a pandemic context, Arnold Monto, M.D., co-director of the Center for Respiratory Virus Research and Response at the University of Michigan School of Public Health, told the WSJ.The vaccines can also prompt a strong immune response from the body but are tied to more frequent mild side effects, especially in children, prompting the industry to largely drop the approach years ago.“It isn’t a eureka moment in terms of approaches,” Monto told the WSJ. “It’s going back to the way certain vaccines were produced in the past.” Other scientists have attempted to develop universal flu vaccines for years without finding success. Still, the HHS argues the new program “marks the future of vaccine development.”“Generation Gold Standard is a paradigm shift,” NIH Director Jayanta Bhattacharya, M.D., Ph.D., said in the release. “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.”At the same time, the FDA is implementing \"radical\" changes to how it signs off on new vaccines, with new vaccines now expected to undergo safety testing in placebo-controlled trials prior to licensure. 

TB Alliance's third licensed manufacturer makes pretomanid available through the Global Drug Facility, further improving affordability and access NEW YORK, April 24, 2025 /PRNewswire/ -- TB Alliance applauds a new milestone in the fight against drug-resistant tuberculosis (DR-TB): a 25% price reduction for pretomanid, a key component of the BPaL/M regimens. Pretomanid is now available through the Global Drug Facility (GDF) at just $169 per treatment course—less than $1 per day, a key pricing benchmark identified by the global TB advocacy community. This latest price drop—down from $364 upon pretomanid's initial approval in 2019, and down further from $224 in October 2024—reflects ongoing efforts by TB Alliance and its partners to broaden access and improve affordability through a multi-manufacturer approach to access. TB Alliance, a nonprofit organization that developed pretomanid, has pioneered an innovative access model by partnering with multiple quality-assured manufacturers. This strategy helped launch pretomanid at an initial low price and ensured rapid, sustainable, and affordable access across high-TB burden countries. Simultaneously, by enabling healthy competition and fostering multiple high-quality supply sources, TB Alliance's strategy expanded availability while driving down costs. "This progress demonstrates how thoughtful collaboration and planning can translate into real-world impact," said Dr. Mel Spigelman, President and CEO of TB Alliance. "By enabling multiple high-quality producers to supply this medicine, we're fostering a healthy and sustainable market to deliver on our mandate that the life-saving medicines we develop will be adopted, available, and affordable to all those in need. We're grateful to partners such as Lupin and GDF for their shared commitment to supplying the market with life-saving TB medicines and stand committed to working with all our manufacturing partners to ensure equitable and affordable access." The current GDF price reduction, led by Lupin Limited, represents a crucial step in delivering on this vision. Procurement through GDF will save an estimated $37 million annually according to The Stop TB Partnership, the organization responsible for managing GDF, allowing for the treatment of an additional 120,000 people with DR-TB. Together with recent price reductions for the other regimen components, the cost of a full BPaL/M treatment course has dropped to a new low of $310—less than $2 per day, and a 47% reduction from its December 2022 price. BPaL/M is a six-month treatment recommended by the World Health Organization to treat most forms of DR-TB. It consists of bedaquiline (B), pretomanid (Pa), and linezolid (L), with or without moxifloxacin (M). In 2024 alone, approximately 110,000 courses of pretomanid were ordered across the world—enough to treat more than 60% of the global market for DR-TB treatment, perhaps the fastest ever scale up for a new TB medicine in modern times. "Lupin is proud to collaborate with TB Alliance and the Global Drug Facility to make pretomanid, an essential medicine in the fight against multidrug-resistant TB, more accessible and affordable for TB patients across the globe," said Ramesh Swaminathan, Global CFO, Executive Director, Head of API Plus SBU at Lupin. "The recent price reduction reflects our strong and deep-rooted commitment to delivering high-quality and affordable medicines to TB patients worldwide. Through this partnership, we reaffirm our dedication to patient-centric innovation and equitable access, ensuring that countries burdened by TB have the necessary treatment options they need to save lives and strengthen public health systems." "For years, advocates from the TB community have called for TB treatments that are not just effective, but also affordable for every person who needs them," said Olya Klymenko, Development Director of TBPeopleUkraine. "The full BPaL/M regimen now costing less than $2 per day is deeply meaningful. We express our gratitude to everyone who made this result possible. There really is no reason for governments and health systems around the world to not provide these treatments to every person who can benefit from them." TB Alliance remains committed to expanding its innovative access model to ensure new innovations in TB treatment reach all who need them as rapidly as possible. With additional planned future tenders, TB Alliance expects additional price reductions for pretomanid in the future. Beyond pricing strategies, TB Alliance continues to develop and execute innovative market access initiatives like LIFT-TB, SLASH-TB, and the PeerLINC Knowledge Hub to speed the global uptake, procurement, and implementation of shortened DR-TB treatments for all who need them around the world. About TB TB is a difficult infection to cure, requiring patients to take a combination of medicines for at least four to six months. Even after symptoms disappear, medicines still need to be taken so that all traces of the disease can be fully eradicated. The scope and intensity of TB globally is in large part fueled by antiquated and inadequate TB drugs. Novel drug regimens are urgently needed to bring the TB pandemic under control. About BPaL The BPaL regimen—which combines the antibiotics bedaquiline (B), pretomanid (Pa), and linezolid (L)—was first clinically studied by TB Alliance. Pretomanid, as part of the BPaL regimen, received its first regulatory approval in August 2019 for use against highly drug-resistant strains of TB. Previously, less than two-thirds of drug-resistant TB patients around the world had been successfully treated. Treatment options were limited, expensive, toxic, and lengthy – requiring patients to take more than 20 pills per day for 9-20 months. About TB Alliance TB Alliance is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight TB. Through innovative science and with partners around the globe, we aim to ensure equitable access to faster, better TB cures that will advance global health and prosperity. TB Alliance operates with support from Australia's Department of Foreign Affairs and Trade, Bill & Melinda Gates Foundation, Foreign, Commonwealth and Development Office (United Kingdom), Cystic Fibrosis Foundation, Germany's Federal Ministry of Education and Research through KfW, Global Disease Eradication Fund (South Korea), Global Health Innovative Technology Fund, Irish Aid, Korea International Cooperation Agency, National Institute of Allergy and Infectious Diseases, South Korea's Ministry of Foreign Affairs, Unitaid, and the United States Agency for International Development. For more information, please visit: . Media Contact: Jess Wiggs at [email protected] SOURCE TB Alliance WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The White House has replaced a federal website that provided information about COVID-19 with a web page titled "Lab Leak: The True Origins of COVID-19" that cites the controversial theory that the virus was leaked from a Wuhan lab in China. The previous websites, covidtests.gov and covid.gov, provided information on treatment options for COVID-19, vaccinations and testing. Those sites now redirect to the new webpage that features an image of President Donald Trump walking between the words "Lab" and "Leak." According to the lab leak theory, COVID-19 originated from an accidental release of the SARS-CoV-2 virus at a government-run research facility in Wuhan, China, before spreading around the world. In December, the Select Subcommittee on the Coronavirus Pandemic led by U.S. Rep. Brad Wenstrup, R-Ohio, released a report stating that the virus "most likely emerged from a laboratory in Wuhan" and includes arguments to support the "lab leak" theory. The White House's new webpage mimics the report's findings, stating, "A lab-related incident involving gain-of-function research is the most likely the [sic] origin of COVID-19. Current government mechanisms for overseeing this dangerous gain-of-function research are incomplete, severely convoluted, and lack global applicability." The new page also states The Proximal Origin of SARS-CoV-2 publication "was prompted by Dr. [Anthony] Fauci to push the preferred narrative that COVID-19 originated in nature." The Proximal Origin publication was disseminated in Nature in 2020 and revealed a scientific consensus that "analyses clearly show that SARS-CoV-2 is not a laboratory construct or a purposefully manipulated virus." The White House's new webpage further claims the Biden administration's Department of Health and Human Services (HHS) "engaged in a multi-year campaign of delay, confusion, and non-responsiveness in an attempt to obstruct the Select Subcommittee's investigation and hide evidence that could incriminate or embarrass senior public health officials. It appears that HHS even intentionally under-resourced its component that responds to legislative oversight requests." It criticizes the World Health Organization's (WHO's) response to the pandemic, the six-feet social distancing recommendation, mask efficacy, prolonged lockdowns and former New York Governor Andrew Cuomo's order, "which forced nursing homes to accept COVID-19 positive patients." It says public health officials like Fauci, who led the National Institute of Allergy and Infectious Diseases during the pandemic, misled the American people, and the site displays President Joe Biden's document pardoning Fauci. Information on COVID-19 can still be found on the Centers for Disease Control and Prevention (CDC) website, and an archived version of covid.gov is available here. THE LARGER TREND Last year, Fauci was called before a House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic to testify about the origins of the COVID-19 pandemic. Lawmakers questioned whether his agency was involved in an email coverup to hide the theory that the virus originated from the Wuhan Institute of Virology. Fauci strongly denied the allegations and said he believed the most likely origin of COVID was animal-to-human transmission, but he had an open mind regarding the lab theory. "I've also been very, very clear, and said multiple times, that I don't think the concept of there being a lab [leak] is inherently a conspiracy theory," Fauci said, according to Reuters. "What is conspiracy is the kind of distortions of that particular subject, like it was a lab leak, and I was parachuted into the CIA like Jason Bourne and told the CIA that they should really not be talking about a lab leak." The origins of the COVID-19 pandemic have long been a topic of debate. In a 2021 report penned by the WHO and Chinese scientists, the joint teams said the likelihood of zoonotic spillover (or the transmissions of disease-causing pathogens from animals to humans) was considered a possible-to-likely pathway when considering the origins of COVID-19. The report said the introduction of the virus through a laboratory incident was "considered to be an extremely unlikely pathway." In 2023, the Wall Street Journal reported that the U.S. Energy Department concluded that the virus most likely arose from a laboratory leak, "according to a classified intelligence report recently provided to the White House and key members of Congress." "The new report highlights how different parts of the intelligence community have arrived at disparate judgments about the pandemic's origin. The Energy Department now joins the Federal Bureau of Investigation in saying the virus likely spread via a mishap at a Chinese laboratory. Four other agencies, along with a national intelligence panel, still judge that it was likely the result of a natural transmission, and two are undecided," the WSJ wrote.