Latest news with #BiomedicalAdvancedResearchandDevelopmentAuthority
5 hours ago
- Health
Breaking down how a massive U.S. funding cut could impact future mRNA vaccines
The Trump administration says it is pulling half a billion dollars from U.S. government-funded research projects to create new mRNA vaccines. In a statement this week, U.S. Health Secretary Robert F. Kennedy Jr., a longtime vaccine critic, announced a co-ordinated wind-down amounting to the cancellation of $500 million worth (new window) of mRNA vaccine development under the Biomedical Advanced Research and Development Authority (BARDA). The technology itself was hailed as recently as the COVID-19 pandemic. In 2023, the Nobel Prize in (new window) Physiology or Medicine (new window) was awarded to two scientists whose mRNA discoveries made it possible to create COVID-19 vaccinations. The committee credited mRNA technology with helping to save millions of lives, prevent severe COVID-19, reduce disease burden and enable societies worldwide to reopen. The loss of research funding has dismayed infectious disease experts who note that mRNA technology allows faster production of shots than older vaccine-production methods, buying precious time if another pandemic virus were to emerge. Here's how medical experts in Canada and the U.S. are reacting to the funding cut and what they say it could mean. WATCH | The U.S. is ending mRNA vaccine funding: What is mRNA vaccine technology and why is it exciting? Vaccines train our immune system to respond to pathogens. Traditionally, vaccines have used inactive or weakened versions of a pathogen that isn't enough to make a person ill, but does kickstart the body's immune response. Messenger RNA (mRNA), discovered in 1961, is a natural molecule that serves as a recipe for the production of proteins in the body. In mRNA vaccines, the approach starts with a snippet of genetic code that carries instructions for making proteins. Scientists pick the protein to target, inject that blueprint into the body's cells, which then make just enough of the proteins to trigger an immune response — essentially producing its own vaccine dose. Scientists are mainly excited about the speed with which mRNA vaccines can get protection into arms. Enlarge image (new window) Dr. Drew Weissman and Katalin Karikó, PhD, struck up a working relationship when they met at the University of Pennsylvania in the 1990s. Together, he, an immunologist, and she, a biochemist, together won the 2023 Nobel Prize for Physiology or Medicine for the development of mRNA technology in Pfizer's and Moderna's COVID-19 vaccines. Photo: Peggy Peterson Photography/Penn Medicine/University of Pennsylvania Michael Osterholm, an expert on pandemic preparation with the University of Minnesota, says using older vaccine technology to target a pandemic flu strain would take 18 months to make enough doses to vaccinate only about one-fourth of the world. He says using mRNA technology to make a flu vaccine could change that timeline dramatically. By the end of the first year, we could vaccinate the world. Besides the advantage of how quickly mRNA vaccines can be made, Dr. Allison McGeer, an infectious diseases specialist in Toronto, says they're also easier to standardize. "It has a whole lot of other flexibilities that if you know it works, makes it a really exciting addition" to older technologies used to make vaccines. LISTEN | How mRNA vaccines went from medical miracle to political football (new window) What mRNA vaccine research is going on now? Beyond COVID vaccines, mRNA vaccine technology is in a Health Canada approved vaccine for respiratory syncytial virus (RSV). An mRNA vaccine for influenza has also reached Phase 3 clinical trial, the last step before manufacturers submit to regulators to release a vaccine to market. There have also been more than 100 clinical trials (new window) to assess the potential of mRNA vaccine technology to treat various cancers including lung, breast, prostate, melanoma and, more recently, pancreatic cancer (new window) . Dr. Peter Hotez, a professor of pediatrics and molecular virology at Baylor College of Medicine in Houston, says there's concern that cancelling funding for mRNA vaccine research will have negative consequences for research on other diseases. The mRNA technology is looking really exciting for next-generation cancer immunotherapeutics, said Hotez, who also works at Texas Children's Hospital Center for Vaccine Development. So will this throw cold water on a whole big effort that we're pursuing as well to develop next-generation cancer vaccine? That's an unknown question. Other research teams are testing potential mRNA-based vaccines to fight HIV (new window) and to treat autoimmune diseases (new window) . These are in early stage clinical trials or animal-stage studies. Enlarge image (new window) The technology used in mRNA vaccines, like the Pfizer-BioNTech COVID-19 vaccine seen being produced at the Allergopharma plant in Germany in April 2021, means they can be adapted to different diseases or variants. Infectious disease experts say this technology allows faster production of shots. Photo: AFP/Getty Images / Christian Charisius Could other countries pick up the slack? Though there are other countries working on mRNA vaccine technology, Hotez called the U.S. the single largest vaccine market. He says the announcement that funding was being cut could dissuade pharmaceutical companies from pursuing the vaccine technology if they believe it won't sell there. He says it's unclear whether other industrialized countries could pool their support to make up the $500 million US cut. Are there safety issues with mRNA vaccines as RFK Jr. suggested? In a video (new window) on the social media platform X, Kennedy claimed that mRNA vaccines were unsafe and ineffective. He said that after reviewing the science and consulting top U.S. experts, the department of Health and Human Services (HHS) has determined that mRNA technology poses more risk than benefits against these respiratory viruses. In the video, Kennedy also claimed that mRNA vaccines paradoxically encourage new mutations and can actually prolong pandemics as the virus constantly mutates to escape the protective effects of the vaccine. Angela Rasmussen, a virologist at the University of Saskatchewan, says Kennedy is wrong about what prolongs pandemics. WATCH | What RFK Jr. gets wrong on mRNA vaccines: Viruses mutate when they replicate, and they replicate when they spread through a population of people, Rasmussen said. The best way to prevent a virus from spreading through a population of people is to make sure those people are protected against the virus by vaccination. In a news release (new window) on Tuesday, Kennedy also referred to COVID and flu as upper respiratory infections, which Hotez notes is incorrect. Unlike the common cold, he says, COVID-19 and influenza are lower respiratory tract infections with significant cardiovascular and other health effects. That's part of the disinformation machine … to downplay the severity of these illnesses, said Hotez. Will lack of funding hurt access to existing flu vaccines? Rasmussen says influenza vaccines won't be affected in the U.S. as they're manufactured using the inactivated virus method, not mRNA. In the video posted to social media, Kennedy said the U.S. supports safe, effective vaccines for every American who wants them. But many infectious disease experts have noted that mRNA vaccines themselves are also safe and effective. The mRNA technology has been proven to be highly effective, Hotez said. By some estimates, 3.2 million American lives were saved by COVID mRNA vaccines during the pandemic. Amina Zafar (new window) · CBC News · Journalist Amina Zafar covers medical sciences and health care for CBC. She contributes to CBC Health's Second Opinion, which won silver for best editorial newsletter at the 2024 Digital Publishing Awards. She holds an undergraduate degree in environmental science and a master's in journalism. With files from CBC's Anand Ram and The Associated Press
CNN
8 hours ago
- Health
- CNN
Cutting federal funds for mRNA vaccine leaves the US vulnerable, experts say
Vaccines Respiratory viruses Donald Trump Corporate newsFacebookTweetLink Follow This week, President Donald Trump called Operation Warp Speed, a public-private federal program that helped speed up the development and distribution of mRNA Covid-19 vaccines in record time 'one of the most incredible things ever done in this country.' It was just a day after US Health and Human Services Secretary Robert F. Kennedy Jr. announced the federal government was canceling a half-billion dollars in investments into the same technology, saying no new mRNA projects will be initiated under the Biomedical Advanced Research and Development Authority. Vaccine and preparedness experts said the decision could be disastrous for the United States, rendering another Operation Warp Speed impossible in case of threat from disease or bioweapons. Kennedy, who has a long history of spreading vaccine misinformation, incorrectly suggested in his announcement that mRNA vaccine technology is ineffective, unsafe and unethical — comments that experts worry will put a chill on development even beyond the projects the government cut. Dr. Paul Offit joins The Lead In a statement about the cancellation, Kennedy said the decision was based on a review of science and expert opinions. 'Let me be absolutely clear: HHS supports safe, effective vaccines for every American who wants them,' Kennedy said in this week's announcement. 'That's why we're moving beyond the limitations of mRNA and investing in better solutions.' Kennedy said funding will be shifted 'toward safer, broader vaccine platforms that remain effective even as viruses mutate,' such as whole virus vaccines, which use a weakened or deactivated version of a virus to trigger immunity. China developed a whole virus Covid-19 vaccine, but studies showed it wasn't nearly as effective as the mRNA vaccines. 'I wonder why we want to try and go back to the way it was in the 1940s when we had vaccines, but it took a really long time to make them,' Dr. Cynthia Leifer, a professor of immunology at Cornell University said. She equates the abandonment of mRNA research at this point to partially paying for a kitchen remodel and stopping to save money after the walls have been demolished. 'You'd be out your money and you don't have a kitchen,' Leifer said. The mRNA vaccine platform is uniquely suited to protect a country during a pandemic, said Dr. Jennifer Nuzzo, an epidemiologist and director of the Pandemic Center at the Brown University School of Public Health. Not knowing what will cause the next pandemic, she said, 'mRNA vaccines offer real flexibility that other vaccine approaches don't.' For a flu vaccine, for example, makers use eggs to grow the virus. It's a complicated process that may require several months to make enough, Nuzzo said. But mRNA vaccines can be developed much faster, sometimes even in days, and don't require time to grow virus cultures. When making an mRNA vaccine, scientists take messenger RNA, a single strand of the genetic code, that can teach cells how 'read' and make a protein that triggers an immune response. Dr. Michael Osterholm, a University of Minnesota epidemiologist, said the decision to 'wind down' the government's investment in mRNA vaccines is one of the worst public health decisions in decades, particularly for pandemic preparedness. Osterholm, who is the founding director of the Center for Infectious Disease Research and Policy and author of the forthcoming book 'The Big One: How We Must Prepare for Future Deadly Pandemics,' said vaccines are a 'very, very small part of the pharmaceutical industry's portfolio' since there's not a lot of profit in vaccines. It's government money that drives companies to make them. Some mRNA projects are funded through other parts of the government, but Kennedy's announcement may undermine mRNA vaccines in general. 'The constant undercutting of support for vaccines is really a challenge. So the damage was twofold,' Osterholm said. 'If we had another pandemic today, we would have to watch large parts of the world not get vaccinated for several years and based on what's just happened, the United States would probably be at the end of the line, not the head of the line like it was in Covid.' Nuzzo said it's possible another pandemic may not happen during Trump's term, but the decision leaves the US vulnerable in another way: Retreat from investment in mRNA vaccines may even be seen as an opening for an attack. 'Defense posturing and defense preparation are the best form of deterrence for a biological attack,' she said.'It sends a bad signal to our adversaries about our commitments to protecting ourselves and our vulnerabilities to attack, let alone it stifles medical innovation.' Leaders in the Trump administration have pushed to bring drug manufacturing to the United States but experts say the choice to stop investing in mRNA vaccines will do the opposite. Dr. Katalin Karikó, who shared the Nobel prize in 2023 for her pioneering work on the mRNA vaccines, told CNN this week that she moved to the US from Hungary because America offered opportunities to develop innovative science. US scientists in the same position today will not see the same opportunities, she said, and they'll go where there's investment in their work. 'It is really the next generation that will suffer the most,' Karikó told CNN, Wednesday. 'When we have the next pandemic other countries will have to help us out.' CNNI's Christina MacFarlane and CNN's Betsy Klein contributed to this report
The Hill
a day ago
- Health
- The Hill
Experts alarmed over mRNA research cuts
The contracts were funded through the Biomedical Advanced Research and Development Authority. Kennedy falsely argued that the vaccines fail to effectively protect people against upper respiratory infections like COVID-19 and the flu, and don't work if a virus mutates. Kennedy now wants HHS to focus on vaccine platforms with 'stronger safety records.' The FDA approved two mRNA vaccines against the COVID-19 virus, and research shows that the shots prevented 14.4 million deaths during the first year they were used. Vaccines typically take years to develop, but the mRNA shots were developed in record time thanks to a massive influx of funding from the first Trump administration, dubbed Operation Warp Speed. Kennedy's moves threaten to undercut those achievements. 'It's pretty clear that the administration, or at least the secretary, has a political vendetta not just against vaccines but against mRNA in general,' said Jeff Coller, a professor of RNA biology and therapeutics at Johns Hopkins University. Kennedy, a well-known vaccine skeptic, has faced pressure from fellow anti-vaccine supporters to push mRNA vaccines off the market. He has a particular dislike for mRNA vaccines and once falsely claimed that the mRNA COVID-19 vaccine was the 'deadliest vaccine ever made.' Health experts warn that the move also places the U.S. behind other countries in biomedical research and sends a message to scientists to avoid work related to mRNA technology. Preliminary data show that mRNA vaccines have potential use for treating diseases like cancer. If scientists don't further explore how the technology can be used, sick Americans could miss out on breakthrough treatments. Other experts worry the decision weakens national security and could open the country up to public health emergencies caused by biological warfare. 'One of the ways to deter that from happening is to say the United States is committed to preparedness,' said Jennifer Nuzzo, a professor of epidemiology and director of the Pandemic Center at Brown University School of Public Health. She added that when the U.S. removes multiple protections from biological hazards, it sends a signal to its adversaries that it is 'no longer interested' in defending itself.
USA Today
a day ago
- Health
- USA Today
Jerome Adams, ex-Trump surgeon general, says mRNA vaccine cuts are 'going to cost lives'
Jerome Adams, the U.S. Surgeon General under President Trump 's first term, criticized the Department of Health and Human Services ' move this week to cut funding for mRNA vaccine development. "I've tried to be objective & non-alarmist in response to current HHS actions – but quite frankly this move is going to cost lives," Adams said in a post on X on Aug. 5. He added, "mRNA technology has uses that go far beyond vaccines… and the vaccine they helped develop in record time is credited with saving millions." The HHS, now being led by Secretary Robert F. Kennedy Jr., said in a release on Aug. 5 it is cutting nearly $500 million at the Biomedical Advanced Research and Development Authority, which helps develop mRNA vaccine technology. Kennedy called the vaccine technology "ineffective" in a video posted on X Aug. 5. Messenger RNA, or mRNA, is used in the two most common COVID-19 vaccines licensed in the United States, which were developed by Pfizer-BioNTech and Moderna during Trump's first administration and Adams' tenure as surgeon general. How do mRNA vaccines work? The COVID-19 vaccine works by instructing the body's immune system to recognize the virus and creating fighting antibodies to attack it. Messenger RNA, or mRNA, is a code that tells the body's cells to produce just a piece of the virus, the protein on the surface. The code is protected by a lipid coating, like a fat bubble. Once injected into the body, the vaccine releases the mRNA to program the cell to produce the spike proteins like those on the surface of SARS-CoV-2, the COVID-19 virus. Our immune system recognizes those vaccine-created spike proteins as invaders and creates antibodies to block future attacks from the virus. Messenger RNA vaccines contain only a fraction of the virus, so unlike some vaccines, they can't give people the disease they're trying to prevent or trigger allergies to eggs or other traditional vaccine ingredients. What does defunding mRNA technology mean? The most obvious consequence of defunding mRNA vaccine development is losing resources to continue improving the technology for vaccines that target infectious diseases, such as COVID-19 and the bird flu, and cancers, said Jeff Coller, Bloomberg Distinguished Professor of RNA biology and therapeutics at Johns Hopkins University. However, he also said it sends a 'chilling' message to vaccine companies about continuing this type of research in the United States. While they may be able to afford research without federal help, companies could be hesitant to pursue mRNA technology if there's a chance the Food and Drug Administration may not approve their vaccines. This could lead companies to move operations and marketing to other countries, which would not only make these therapies more expensive in the United States, but also displace it as 'the world leader in biotechnology,' Coller said. 'The rest of the world is doubling down on mRNA medicines. It's a fact, and the U.S. is going to lose the race,' Coller told USA TODAY on August 6. 'The decision coming from Kennedy is essentially destroying our dominance in the biotech space.'
Yahoo
a day ago
- Health
- Yahoo
RFK Jr. pulls funding for mRNA vaccines as scientists pursue breakthrough treatments for HIV, cancer, the flu and more
Health Secretary Robert F. Kennedy Jr. announced Tuesday that the federal government is canceling nearly $500 million in funding for the development of mRNA vaccines, a revolutionary new technology that was first put into widespread use during the COVID-19 pandemic. In a video explaining the decision posted to social media, Kennedy said that the Department of Health and Human Services has determined that 'mRNA technology poses more risk than benefits' for respiratory viruses like COVID-19. He also claimed that the pandemic showed 'mRNA vaccines don't perform well against viruses that affect the upper respiratory tract.' That statement runs counter to a wide body of research finding that COVID vaccines saved millions — if not tens of millions — of lives over the course of the pandemic. A total of 22 projects funded by a government agency called the Biomedical Advanced Research and Development Authority (BARDA) will be affected by the funding freeze, according to the department. A few projects that are in their final stages will be allowed to continue, but 'no new mRNA-based projects will be initiated.' 'This isn't just about vaccines. It's about whether we'll be ready when the next crisis hits. Cutting mRNA development now puts every American at greater risk,' Rick Bright, who directed BARDA in the early stages of the pandemic before being reassigned by the Trump administration, told NBC News. The decision doesn't mean that research into mRNA vaccines will stop entirely, but it does cut off a major source of funding that helped the vaccines become a reality in the first place. By the time the pandemic had started, the government had already given an estimated $337 million in grants for research into mRNA vaccines. That support over the course of decades put scientists in a position to make COVID vaccines available to the public at a record-shattering pace of less than a year. How do mRNA vaccines work? The 'm' in mRNA stands for messenger. In the most basic terms, it's a piece of genetic code that tells our cells what to do. Scientists have discovered how to harness this process to make vaccine development much faster and less expensive. Traditional vaccines typically use a dead or weakened version of a virus to stimulate an immune response that effectively teaches the body how to combat the real version if it ever encounters it. These types of vaccines can take a long time to develop because they rely on the slow, often complicated process of cultivating and modifying the actual virus into a safe and effective form. Using mRNA is much faster because the crucial ingredients can be created and customized in a lab. It took Moderna just two days to produce its mRNA vaccine for COVID in January 2020, before most people had ever even heard of the virus. The vaccines carry a snippet of mRNA that instructs the body to produce a small portion of a virus, usually a protein on its outer membrane, which is enough to trigger the same type of immune response that is prompted by traditional vaccines. The quicker process also means that existing mRNA vaccines can be modified more rapidly when viruses evolve. Despite Kennedy's claims, mRNA-based COVID vaccines have been found to be just as effective at preventing severe infections and death as vaccines made using other methods. After the vaccines became widely available, unvaccinated people were 11 times more likely to die of COVID than those who were fully vaccinated, according to data from the Centers for Disease Control and Prevention. Two researchers who helped achieve early breakthroughs in mRNA vaccines were awarded the Nobel Prize in 2023. Applications beyond COVID The introduction of COVID vaccines didn't just mark a turning point in the deadliest pandemic in modern history. It also provided evidence of mRNA's potential to protect people from a whole range of diseases. Just last week, researchers released promising results from early trials of new mRNA-based vaccines for HIV, a huge breakthrough in a pursuit that has confounded scientists for more than 40 years. There have been tremendous strides made in drugs that protect people from catching the virus or keep them healthy if they do contract it, but the limitations of those treatments still mean that more than 600,000 people are dying every year of AIDS — mostly in the developing world. Experts see a potential vaccine as a key to finally conquering the virus. There is also optimism that mRNA could be an effective tool in combating the seasonal flu. Current flu vaccines vary widely in effectiveness from year to year, and are only about 60% effective at their best, because it can be hard for experts to predict which strain of the virus will be more dominant in any given flu season. Several pharmaceutical companies are developing mRNA flu vaccines that could become a powerful tool for fighting influenza because of how quickly they can be adapted to match the nature of the virus at any given time. That speed could be especially important if a novel flu strain, like bird flu, causes a severe outbreak. There is even some promise that mRNA might one day be used to make a universal flu vaccine that covers all strains. The holy grail for mRNA is cancer. Though vaccines are typically used to prevent disease, there are several vaccines in development that show 'real hope' of being an effective treatment for people with cancer. Those include 'individualized' vaccines that are custom-made for each patient's specific needs. An mRNA vaccine for RSV is already available to certain high-risk adults. Other possible applications include the Zika virus and cytomegalovirus, an infection that is particularly dangerous for babies and people with compromised immune systems. Though experts say the rollback of U.S. government funding is a setback for these projects, some also expressed optimism that mRNA breakthroughs will continue to come even without America's support. 'Will this dent what's going on in the U.S.? Unquestionably,' Kate Bingham, who led the United Kingdom's COVID vaccine task force, told the Guardian. 'Does that mean it's negative for the world? Not necessarily.' Solve the daily Crossword
