FDA delays full approval of Novavax Covid-19 vaccine even though it was on track for clearance
The US Food and Drug Administration has delayed granting full approval of Novavax's Covid-19 vaccine despite it being on track to be cleared until Tuesday afternoon, a person familiar with the situation told CNN.
The agency is seeking more data on the vaccine, said the source, who declined to be named because they weren't authorized to speak publicly about the situation. The Wall Street Journal first reported that the FDA had missed its decision deadline.
The move came as the FDA named Dr. Scott Steele acting director of the Center for Biologics Evaluation and Research, which oversees vaccine regulation, days after former director Dr. Peter Marks was forced out. In his resignation letter, Marks cited 'efforts being advanced by some on the adverse health effects of vaccination' that he called 'concerning.'
US Health and Human Services Secretary Robert F. Kennedy Jr., a longtime anti-vaccine advocate, has falsely called vaccines for Covid-19 'the deadliest vaccine ever made' and more recently made misleading statements about the safety of the measles vaccine amid a deadly outbreak centered in West Texas.
The Novavax vaccine, which uses more traditional protein-based technology than the newer mRNA vaccines from Pfizer/BioNTech and Moderna, has been subject to emergency use authorization since 2022. But with FDA action, it would be the third vaccine against Covid-19 to receive full FDA approval. Full approval would make the vaccine available beyond an emergency declaration and could provide additional reassurance to people seeking the vaccine.
The company said Wednesday that it hadn't received an official decision from the FDA but that April 1 was the date by which the agency had been set to issue the decision.
'As of Tuesday, April 1, we had responded to all of the FDA's information requests and we believe that our [Biologics License Application] is ready for approval,' Novavax said in a statement, noting that the application 'included robust Phase 3 clinical trial data that showed our vaccine is safe and effective for the prevention of Covid-19.'
'We are confident our well-tolerated vaccine represents an important alternative to mRNA Covid-19 vaccines for the US,' Novavax said.
The FDA's press office was put on administrative leave Tuesday as part of the HHS Reduction in Force effort. A spokesman for HHS told CNN, 'The FDA's independent review process for the Novavax vaccine, like all vaccines is based solely on ensuring safety and efficacy, not political considerations. Any delays are a result of scientific review.'
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But medical researchers at Michigan State University and the University of Michigan say his administration's abrupt cuts to funding for scientific studies, clinical trials and training programs have all but gutted their life's work and could halt the development of new treatments for diseases like cancer as well as eviscerate the future scientific workforce. University of Michigan psychology professor Toni Antonucci lost the $13 million federal grant that supported her research on health disparities among aging Americans. It focused on minority populations, including African Americans, and comes at a moment in history when the U.S. population is older than it ever has been and is growing increasingly diverse. "I have never thought that politics should be involved in research, and, unfortunately, this is clearly the case here," said Antonucci, who has worked at U-M since the 1970s. 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Harper and SOAR's co-director are scrambling together the money themselves to pay for the final year of the program. Slowly, he said, that is coming together, but his other work through the Adolescent Medicine Trials Network (ATN) for HIV/AIDS Intervention has also been targeted by the federal cuts. A study on transgender youths was canceled, he said, and funding for the leadership group that oversees equity and inclusion in all ATN studies also was eliminated. He also lost grant funding to study gay and bisexual men in Kenya living with HIV. Still, he said, "I'm not going to let this get me down. "I try and show power and strength and resilience to the students, to give them hope that this, too, shall pass. This is a moment in time, but this is not your entire life. ... Your lives do matter. You are special and you are perfect, just the way you are." 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"Not all breast cancers are curable, so that's what I really set off to focus on," she said, explaining that her work involves understanding how to kill cancer cells that are resistant to treatment and discovering new drug therapies. Earlier this year, she applied to renew a $2.07 million federal grant funded by the National Institutes of Health along with a new, $2.79 million grant, but both have been held up for months in a cloud of uncertainty. The initial reviews of her grants were postponed but eventually got through the first stage of the process; they now await the second step of review. There remain no guarantees. "How are they going to choose what they fund?" she said. "I don't know what's going to happen, really. So, we are in a time of uncertainty. Grant funding has always been uncertain. It's always been competitive, but there's always been a process and an infrastructure that researchers have relied on." Bernard runs a research lab at MSU, where a team of scientists are working to 'stop breast cancer from ever starting in the first place or prevent it so much that you've delayed it and you die of some other natural cause before you have to deal with cancer," she said. "I am in a place where I don't know if I should be accepting students in the fall. What's my next move? Am I still allowed to study what I've been studying? So it's a confusing time, a frustrating time, a time of high anxiety in our department of pharmacology and toxicology.' Bernard said the NIH canceled a grant for a graduate student from Puerto Rico who is Hispanic, and had applied through a mechanism that provided funding for predoctoral students who are disabled, identify as Black, Hispanic, American Indian or Alaska Native, or who are from socioeconomically disadvantaged backgrounds. "Just simply because she was a minority, the grant mechanism that she applied with, they withdrew it," Bernard said. "The white woman in my lab, her grant is going to be reviewed. ... It's so awful." The work they're doing, she said, "really should be bipartisan, nonpartisan — not even partisan. It's freaking cancer research." Ph.D. student reexamines future in scientific research The political climate is chasing Alex Chapman, a Ph.D. student at MSU who is studying migraines and pain, away from a career in academia. Chapman, 24, who is originally from Richmond, Virginia, secured a federal grant studying a neuropeptide that's upregulated in people with migraines, before Trump took office in January. Many of her friends and colleagues haven't been so lucky. "Science is being so vilified that I'm considering careers in other places or different avenues because it's just hard to see a future in a place that doesn't value science at all," she said. "It's heartbreaking. ... My career options are kind of dwindling, and the more time that passes, the more fellowships and different opportunities just keep becoming defunded," Chapman said, noting that a fellowship she was eyeing through the U.S. Agency for International Development (USAID) has been axed. She considered shifting toward public policy work, helping government leaders understand "why we should fund pain research," but then she attended a symposium and heard a woman who works in public policy speak about the cuts there, too. "She was like, 'This is a great fellowship. It's been defunded. This was an awesome fellowship. It's been defunded,' " Chapman said. When entrepreneur Elon Musk, who headed the new Department of Government Efficiency early in the Trump administration, criticized the use of federal dollars on scientific studies of legumes and aggression in hamsters, Chapman said, it showed that he couldn't see the full impact of the work. "If you just simplify it like that, maybe it does seem silly, but you're looking at the small picture," she said. "The point of research is to zoom out and look at the bigger picture. When you understand the best process of planting beans or why certain strains of corn are more susceptible to different fungi, you help people more effectively and efficiently plant food. This will help us in the face of climate change. "If you understand why a hamster is aggressive after ingesting a certain substance, you understand the role of that substance and how it could potentially affect humans." That small-picture view — and the cuts made because of it — could have generational impacts on the United States and the world, Chapman said. "This isn't just shutting down one study that focuses on hamsters fighting," she said. "It's preventing a new generation of scientists from coming into the (field), which is going to stunt our growth as a nation, which is going to prevent new ideas from happening, which is going to lead to ... horrible damage that would take years, if not decades, to recover. "People are afraid to come out and criticize this because of the way the government has treated them, especially foreign students. When it gets to the point where the government can strike fear in your heart if you speak out against them, especially about something regarding science, it's a very scary place to be." Local public health departments rattled, services cut Nick Derusha, the director and health officer of the LMAS District Health Department, which also includes Luce and Mackinac counties, said his part of the eastern Upper Peninsula has been rattled by a Trump administration stop-work order that means there's no money to run clinics that provide medicine like methadone to help people wean off opioid drugs and reduce the risk of overdose deaths in Alger and Schoolcraft counties. "We take a really holistic approach to that program," Derusha said. "We're not just providing medication-assisted treatment. We have peer recovery coaches. We have community health workers. We have a lot of staff that are there to support them in many other ways, not just the medication. "When funding is abruptly eliminated like that, we can't just drop people off the caseload. We needed to find a way for them to be able to continue to receive services or some type of off-ramp. We worked with the local hospital, and we agreed for three more months, which is kind of nearing the end here, to continue to provide those services, absent the funding. But the long-term ability of us to do that is not likely." In addition, Derusha said the LMAS department lost $512,000 a year to pay for a courier system for its laboratory services. Because the district is so sprawling — it covers four U.P. counties — when test samples need to be shipped to the regional lab in Luce County, ordinary mail often doesn't get them delivered quickly enough. Without the courier system, it means slower results for important public health testing, he said, which could delay treatments and lead to poorer outcomes. The LMAS District Health Department isn't alone. The Mid-Michigan Health Department, which includes Clinton, Gratiot and Montcalm counties, announced in April it will no longer investigate or treat latent tuberculosis infections because of "funding cuts and workforce limitations." Mental health services for school-age children are being cut, too, said Andrea Cole, president of the Ethel and James Flinn Foundation, a Detroit-based nonprofit dedicated to improving the quality, scope, and delivery of mental health services in Michigan. A $1 billion grant was terminated through the Department of Education in late April to pay for in-school social workers, counselors and other mental health professionals — even though 70% of children who receive mental health services get them through their schools, she said. "A lot of the federal cuts were to the most vulnerable and underserved populations," Cole said. "Schools are faced with the possibility of laying off those people that they hired under that grant if they don't have funding to continue it." And the students will be left without that critical mental health support when "they need it more than ever," Cole said. Hess said all of these cuts, along with proposed legislation — the Big, Beautiful Bill Act, which has passed the U.S. House of Representatives and now is under consideration in the U.S. Senate — that would slash Medicaid and Supplemental Nutrition Assistance Program (SNAP) benefits, and a state Senate budget proposal that also seeks to trim funding even more, public health in Michigan could dramatically change. More: Whitmer: Trump's 'big, beautiful bill' could cost Michigan $900 million a year for food stamps More: 700,000 Michigan residents could lose health insurance under Medicaid cuts, report shows "We don't want to give the impression that the sky is falling, and that public health is going to pack up and go home," Hess said. "We've been here for 100 years, and we've seen ups and downs over the years. Health officers are used to kind of making things work, but this is sort of a unique situation. "Community residents are really going to feel this if all of these things that we are watching come to fruition. Public health will not look the same in their communities, in most places." Contact Kristen Shamus: kshamus@ Subscribe to the Detroit Free Press.
