Latest news with #PaulOffit
Yahoo
16-06-2025
- Health
- Yahoo
US experts fear all vaccines at risk as Trump officials target mRNA jabs
As top US health officials turn against some mRNA vaccines, experts fear for the country's preparedness for the next pandemic and worry that other vaccines will be targeted next. Donald Trump's administration recently canceled a $766m award to Moderna on the research and development of H5N1 bird flu vaccines, and officials have announced new restrictions and regulations for Covid mRNA vaccines – actions that signal a move away from the breakthrough technology. These changes add to other vaccine-related shakeups at health agencies, including layoffs and resignations of top vaccine officials and the abrupt termination of HIV vaccine research. On Monday, Robert F Kennedy Jr, secretary of health and human services, announced he was disbanding the independent advisory committee on vaccines for the US Centers for Disease Control and Prevention (CDC). 'I think mRNA vaccines are particularly at risk, although I think all vaccines are at risk,' said Paul Offit, professor of pediatrics at the University of Pennsylvania Perelman School of Medicine. 'I think that this administration will do everything it can to make vaccines less available, less affordable and more feared.' Messenger RNA, or mRNA, vaccines heralded a major breakthrough in battling the Covid pandemic, building on three decades of scientific work and earning a Nobel prize. The Covid vaccines, some of which were co-developed by US government scientists, were taken by millions of people around the globe, and international scientists and officials closely monitored their side effects and effectiveness. mRNA vaccines and therapeutics show promise for treating or preventing certain cancers, rare conditions and infectious diseases – including, potentially, the next pandemic, experts said. 'We don't know what the next pandemic virus is going to be,' said Jennifer Nuzzo, professor of epidemiology and director of the Pandemic Center at Brown University School of Public Health. With mRNA, she said, 'you can pivot faster when you find a new virus to make a vaccine that's tailored to that virus'. The mRNA vaccines also don't need to be incubated in eggs, which is time-consuming and potentially difficult if there are egg shortages from bird flu outbreaks. In 2009, the US didn't have enough vaccines to battle the swine flu pandemic, Nuzzo said. 'It seems like we're determined to repeat those mistakes.' Despite their promise, mRNA vaccines have been plagued by misinformation. Some skeptics believe the vaccines affect fertility or cause birth defects, though research shows no link – and, in fact, studies show that the vaccines reduce these risks by preventing infections with Covid, which can be especially dangerous to pregnant people and newborns. Because mRNA sounds similar to DNA, some people mistakenly think it interferes with their genes. Conspiracy theorists also claim the vaccine causes people to die suddenly, or that the shots implant microchips or impart 5G connectivity. Meghan McCain recently endorsed, in a now-deleted social media post, an unregulated supplement company's 'spike detox' for those who 'regret' getting vaccinated. Kennedy, a longtime anti-vaccine activist, called the mRNA Covid shots the 'deadliest vaccine ever made,' incorrectly claiming the vaccines cause more illnesses and deaths than they prevent. Kennedy rose to greater prominence through the pandemic as previously fringe conspiracies about vaccines began dominating more mainstream narratives. 'Anti-vaccine sentiment goes back to the first days of vaccines in the 1700 and 1800s,' said John Moore, professor of microbiology and immunology at Weill Cornell Medical College. 'It's been a perpetual theme in society for 200-plus years, but it has been turbocharged by the Covid pandemic.' Some states are now considering laws against mRNA vaccines, and US health officials have taken several steps to limit Covid shots in recent weeks. Officials with the Food and Drug Administration (FDA) announced plans to limit boosters to older people and those with certain health conditions, as well as plans to conduct placebo-controlled clinical trials again. The CDC removed the vaccination recommendation for pregnant people and softened the recommendation for children's shots. About 165,000 Americans were hospitalized and 40,000 died in the previous year because of Covid, the CDC said at an April meeting. About 6,700 of those hospitalizations were among children, especially young children, and 152 children died from Covid in that time, the data showed. About 5% of children under five are vaccinated against Covid – rates much lower than other age groups. 'That's why, if you look at the numbers of hospitalizations and deaths for children now, especially young children less than four years old, it's really not much different than the beginning of this pandemic,' Offit said. There's also 'extensive evidence' for benefits to pregnant people and their babies, he said. While the FDA recently approved Moderna's 'next generation' Covid vaccine, which was even more effective that their current shot in clinical trials, the agency limited the new shot only for older adults and for people aged 12 to 64 with health conditions putting them at higher risk. The FDA also announced new requirements for mRNA Covid vaccine makers to add additional warnings about the risks of myocarditis, or heart inflammation, based on data the FDA has not made public. During the Biden administration, Moderna received two awards totaling $766m to develop potential bird flu vaccines. Despite the changeover in administrations, Moderna's work continued as normal – until February, when health officials said in an article that the funding was being reviewed. Moderna hadn't received any notification of this review, which recently culminated in having the funding cancelled. Halting the H5N1 vaccine research, which was in phase 3 trials, leaves the US vulnerable in a potential flu pandemic, Nuzzo said. It also means other countries could build upon US investments to procure the vaccines for themselves. mRNA has shown promise in treating pancreatic cancer and other cancers, as well as rare conditions and hard-to-treat infectious diseases. Moderna, for instance, is working on vaccines for melanoma, lung cancer, norovirus, flu, and CMV, or cytomegalovirus, a fairly common infection that can cause lasting health problems for infants. The company also has an RSV vaccine, currently approved for older adults, that could be expanded for other age groups. But those efforts could be hampered by the administration's moves against mRNA and terminations of vaccine scientists and independent advisors who offer vaccine recommendations. 'We don't want to see kids kicked out of school because a 12-year-old girl is not getting her fifth Covid booster shot,' Marty Makary, head of the FDA, said in a recent interview. Yet no states require Covid vaccination for school attendance. Pushing back against mandates is a common tactic from anti-vaccine activists working to dismantle all vaccine mandates, Offit said. In addition to claiming the Covid vaccines are deadly, Kennedy has 'also said no vaccine is beneficial', he said. Kennedy recently unveiled a sweeping and controversial $50m research project on autism, including an autism research database. If that effort somehow links autism to vaccines – despite decades of studies showing no connection – it could open lawmakers up to lawsuits, Offit said. 'He could manipulate the Vaccine Injury Compensation Program,' Offit said. If Kennedy adds autism to the compensable list of injuries, 'it would break the program'. That would mean the people who experience very rare severe side effects from vaccines may then face challenges getting compensated. And it could prompt vaccine makers to stop producing routine childhood immunizations because of legal liability. 'It's a fragile market,' Offit said. Kennedy 'is an anti-vaccine activist, science denialist and conspiracy theorist', he continued. 'I think that he will continue this onslaught against vaccines.'
The Guardian
14-06-2025
- Health
- The Guardian
US experts fear all vaccines at risk as Trump officials target mRNA jabs
As top US health officials turn against some mRNA vaccines, experts fear for the country's preparedness for the next pandemic and worry that other vaccines will be targeted next. Donald Trump's administration recently canceled a $766m award to Moderna on the research and development of H5N1 bird flu vaccines, and officials have announced new restrictions and regulations for Covid mRNA vaccines – actions that signal a move away from the breakthrough technology. These changes add to other vaccine-related shakeups at health agencies, including layoffs and resignations of top vaccine officials and the abrupt termination of HIV vaccine research. On Monday, Robert F Kennedy Jr, secretary of health and human services, announced he was disbanding the independent advisory committee on vaccines for the US Centers for Disease Control and Prevention (CDC). 'I think mRNA vaccines are particularly at risk, although I think all vaccines are at risk,' said Paul Offit, professor of pediatrics at the University of Pennsylvania Perelman School of Medicine. 'I think that this administration will do everything it can to make vaccines less available, less affordable and more feared.' Messenger RNA, or mRNA, vaccines heralded a major breakthrough in battling the Covid pandemic, building on three decades of scientific work and earning a Nobel prize. The Covid vaccines, some of which were co-developed by US government scientists, were taken by millions of people around the globe, and international scientists and officials closely monitored their side effects and effectiveness. mRNA vaccines and therapeutics show promise for treating or preventing certain cancers, rare conditions and infectious diseases – including, potentially, the next pandemic, experts said. 'We don't know what the next pandemic virus is going to be,' said Jennifer Nuzzo, professor of epidemiology and director of the Pandemic Center at Brown University School of Public Health. With mRNA, she said, 'you can pivot faster when you find a new virus to make a vaccine that's tailored to that virus'. The mRNA vaccines also don't need to be incubated in eggs, which is time-consuming and potentially difficult if there are egg shortages from bird flu outbreaks. In 2009, the US didn't have enough vaccines to battle the swine flu pandemic, Nuzzo said. 'It seems like we're determined to repeat those mistakes.' Despite their promise, mRNA vaccines have been plagued by misinformation. Some skeptics believe the vaccines affect fertility or cause birth defects, though research shows no link – and, in fact, studies show that the vaccines reduce these risks by preventing infections with Covid, which can be especially dangerous to pregnant people and newborns. Because mRNA sounds similar to DNA, some people mistakenly think it interferes with their genes. Conspiracy theorists also claim the vaccine causes people to die suddenly, or that the shots implant microchips or impart 5G connectivity. Meghan McCain recently endorsed, in a now-deleted social media post, an unregulated supplement company's 'spike detox' for those who 'regret' getting vaccinated. Kennedy, a longtime anti-vaccine activist, called the mRNA Covid shots the 'deadliest vaccine ever made,' incorrectly claiming the vaccines cause more illnesses and deaths than they prevent. Kennedy rose to greater prominence through the pandemic as previously fringe conspiracies about vaccines began dominating more mainstream narratives. 'Anti-vaccine sentiment goes back to the first days of vaccines in the 1700 and 1800s,' said John Moore, professor of microbiology and immunology at Weill Cornell Medical College. 'It's been a perpetual theme in society for 200-plus years, but it has been turbocharged by the Covid pandemic.' Some states are now considering laws against mRNA vaccines, and US health officials have taken several steps to limit Covid shots in recent weeks. Officials with the Food and Drug Administration (FDA) announced plans to limit boosters to older people and those with certain health conditions, as well as plans to conduct placebo-controlled clinical trials again. The CDC removed the vaccination recommendation for pregnant people and softened the recommendation for children's shots. About 165,000 Americans were hospitalized and 40,000 died in the previous year because of Covid, the CDC said at an April meeting. About 6,700 of those hospitalizations were among children, especially young children, and 152 children died from Covid in that time, the data showed. About 5% of children under five are vaccinated against Covid – rates much lower than other age groups. 'That's why, if you look at the numbers of hospitalizations and deaths for children now, especially young children less than four years old, it's really not much different than the beginning of this pandemic,' Offit said. There's also 'extensive evidence' for benefits to pregnant people and their babies, he said. While the FDA recently approved Moderna's 'next generation' Covid vaccine, which was even more effective that their current shot in clinical trials, the agency limited the new shot only for older adults and for people aged 12 to 64 with health conditions putting them at higher risk. The FDA also announced new requirements for mRNA Covid vaccine makers to add additional warnings about the risks of myocarditis, or heart inflammation, based on data the FDA has not made public. During the Biden administration, Moderna received two awards totaling $766m to develop potential bird flu vaccines. Despite the changeover in administrations, Moderna's work continued as normal – until February, when health officials said in an article that the funding was being reviewed. Moderna hadn't received any notification of this review, which recently culminated in having the funding cancelled. Halting the H5N1 vaccine research, which was in phase 3 trials, leaves the US vulnerable in a potential flu pandemic, Nuzzo said. It also means other countries could build upon US investments to procure the vaccines for themselves. mRNA has shown promise in treating pancreatic cancer and other cancers, as well as rare conditions and hard-to-treat infectious diseases. Moderna, for instance, is working on vaccines for melanoma, lung cancer, norovirus, flu, and CMV, or cytomegalovirus, a fairly common infection that can cause lasting health problems for infants. The company also has an RSV vaccine, currently approved for older adults, that could be expanded for other age groups. But those efforts could be hampered by the administration's moves against mRNA and terminations of vaccine scientists and independent advisors who offer vaccine recommendations. 'We don't want to see kids kicked out of school because a 12-year-old girl is not getting her fifth Covid booster shot,' Marty Makary, head of the FDA, said in a recent interview. Yet no states require Covid vaccination for school attendance. Pushing back against mandates is a common tactic from anti-vaccine activists working to dismantle all vaccine mandates, Offit said. In addition to claiming the Covid vaccines are deadly, Kennedy has 'also said no vaccine is beneficial', he said. Kennedy recently unveiled a sweeping and controversial $50m research project on autism, including an autism research database. If that effort somehow links autism to vaccines – despite decades of studies showing no connection – it could open lawmakers up to lawsuits, Offit said. 'He could manipulate the Vaccine Injury Compensation Program,' Offit said. If Kennedy adds autism to the compensable list of injuries, 'it would break the program'. That would mean the people who experience very rare severe side effects from vaccines may then face challenges getting compensated. And it could prompt vaccine makers to stop producing routine childhood immunizations because of legal liability. 'It's a fragile market,' Offit said. Kennedy 'is an anti-vaccine activist, science denialist and conspiracy theorist', he continued. 'I think that he will continue this onslaught against vaccines.'
The Verge
21-05-2025
- Health
- The Verge
The FDA is making it more difficult for Americans to get vaccinated for covid
The Trump administration is working to limit access to covid booster shots by creating more regulatory hoops for companies developing vaccines for 'healthy persons.' The Food and Drug Administration (FDA) says it's only prioritizing covid vaccine approvals for adults older than 65 and others over the age of 6 months who have at least one 'risk factor' for a severe case of covid-19. 'The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk,' FDA officials write in commentary laying out their plans in the New England Journal of Medicine (NEJM). The move comes as notorious antivax crusader Robert F. Kennedy reshapes the US Department of Health and Human Services, recently pushing out the FDA's top vaccine official and thousands of other federal health workers. Some public health experts are already voicing skepticism over whether the FDA's new guidance for covid boosters will reap any benefits. 'This is overly restrictive and will deny many people who want to be vaccinated a vaccine.' 'This is overly restrictive and will deny many people who want to be vaccinated a vaccine,' Anna Durbin, director of the Center for Immunization Research at Johns Hopkins University, said in an email to the New York Times. 'The only thing that can come of this will make vaccines less insurable and less available,' Paul Offit, a vaccine scientist, virologist, and professor of pediatrics at the Children's Hospital of Philadelphia, told The Associated Press. The FDA says it will require more data from additional clinical trials before approvals can be granted for covid-19 vaccines being developed for people not considered to be at heightened risk from severe sickness. It says 100 to 200 million Americans will still have annual access to covid vaccines after its policy change. That would be less than 60 percent of the US population. Last week, the agency approved the Novavax covid-19 vaccine for only older adults and people at higher risk from the disease. 'We simply don't know whether a healthy 52-year-old woman with a normal BMI who has had Covid-19 three times and has received six previous doses of a Covid-19 vaccine will benefit from the seventh dose,' the NEJM commentary says. But previous CDC studies have shown that getting a booster can help prevent mild to moderate cases of covid up to six months after getting the shot regardless of whether a person is at higher risk or not, Offit tells The Associated Press. And even if someone does get sick, being vaccinated can make the illness shorter and less severe and reduce the risk of developing long covid, according to the Centers for Disease Control and Prevention. The rate of covid-19-associated hospitalizations was 71.2 per 100,000 people during the 2024–25 season, according to the CDC — although hospitals haven't been required to report covid-related hospital admissions to HHS since May of last year. Vaccines are an important safeguard for people with a weakened immune system. The FDA's new directive raises questions about whether people considered healthy will be able to get vaccinated if they want to protect someone close to them who's at greater risk. In the NEJM article, the FDA notes that covid booster uptake has been low in the US, with less than a quarter of people getting the shot each year. 'There may even be a ripple effect: public trust in vaccination in general has declined,' it says. 'It has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies,' Peter Marks, former director of the FDA's Center for Biologics Evaluation and Research (CBER) that regulates vaccines, wrote in a resignation letter in March.
The Verge
20-05-2025
- Health
- The Verge
The FDA is making it more difficult for many Americans to get vaccinated for covid
The Trump administration is working to limit access to covid booster shots by creating more regulatory hoops for companies developing vaccines for 'healthy persons.' The Food and Drug Administration (FDA) says it's only prioritizing covid vaccine approvals for adults older than 65 and others over the age of 6 months who have at least one 'risk factor' for a severe case of covid-19. 'The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk,' FDA officials write in commentary laying out their plans in the New England Journal of Medicine (NEJM). The move comes as notorious antivax crusader Robert F. Kennedy reshapes the US Department of Health and Human Services, recently pushing out the FDA's top vaccine official and thousands of other federal health workers. Some public health experts are already voicing skepticism over whether the FDA's new guidance for covid boosters will reap any benefits. ''This is overly restrictive and will deny many people who want to be vaccinated a vaccine.' 'This is overly restrictive and will deny many people who want to be vaccinated a vaccine,' Anna Durbin, director of the Center for Immunization Research at Johns Hopkins University, said in an email to the New York Times. 'The only thing that can come of this will make vaccines less insurable and less available,' Paul Offit, a vaccine scientist, virologist, and professor of pediatrics at the Children's Hospital of Philadelphia, told The Associated Press. The FDA says it will require more data from additional clinical trials before approvals can be granted for covid-19 vaccines being developed for people not considered to be at heightened risk from severe sickness. It says 100 to 200 million Americans will still have annual access to covid vaccines after its policy change. That would be less than 60 percent of the US population. Last week, the agency approved the Novavax covid-19 vaccine for only older adults and people at higher risk from the disease. 'We simply don't know whether a healthy 52-year-old woman with a normal BMI who has had Covid-19 three times and has received six previous doses of a Covid-19 vaccine will benefit from the seventh dose,' the NEJM commentary says. But previous CDC studies have shown that getting a booster can help prevent mild to moderate cases of covid up to six months after getting the shot regardless of whether a person is at higher risk or not, Offit tells The Associated Press. And even if someone does get sick, being vaccinated can make the illness shorter and less severe and reduce the risk of developing long covid, according to the Centers for Disease Control and Prevention. The rate of covid-19-associated hospitalizations was 71.2 per 100,000 people during the 2024–25 season, according to the CDC — although hospitals haven't been required to report covid-related hospital admissions to HHS since May of last year. Vaccines are an important safeguard for people with a weakened immune system. The FDA's new directive raises questions about whether people considered healthy will be able to get vaccinated if they want to protect someone close to them who's at greater risk. In the NEJM article, the FDA notes that covid booster uptake has been low in the US, with less than a quarter of people getting the shot each year. 'There may even be a ripple effect: public trust in vaccination in general has declined,' it says. 'It has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies,' Peter Marks, former director of the FDA's Center for Biologics Evaluation and Research (CBER) that regulates vaccines, wrote in a resignation letter in March.
Yahoo
20-05-2025
- Health
- Yahoo
New Trump policy will make it harder for young people, children to get COVID vaccines
WASHINGTON (AP) — Annual COVID-19 shots for healthy younger adults and children will no longer be routinely approved under a major new policy shift unveiled Tuesday by the Trump administration. Top officials for the Food and Drug Administration laid out new requirements for access to yearly COVID shots, saying they'd continue to use a streamlined approach that would continue offering them to adults 65 and older as well as children and younger adults with at least one health problem that puts them at higher risk. But the FDA framework urges companies to conduct large, lengthy studies before tweaked vaccines can be approved for healthier people. In a framework published Tuesday in the New England Journal of Medicine, agency officials said the approach still could keep annual vaccinations available for between 100 million and 200 million people. The upcoming changes raise questions for people who may still want a fall COVID-19 shot but don't clearly fit into one of the categories. 'Is the pharmacist going to determine if you're in a high-risk group?' asked Dr. Paul Offit, a vaccine expert at Children's Hospital of Philadelphia. 'The only thing that can come of this will make vaccines less insurable and less available.' The framework is the culmination of a series of recent steps scrutinizing the use of COVID shots and raising major questions about the broader availability of vaccines under President Donald Trump. It was released two days ahead of the first meeting of FDA's outside vaccine experts under the Trump administration. Last week the FDA granted full approval of Novavax's COVID-19 vaccine but with major restrictions on who can get it — and Tuesday's guidance mirrors those restrictions. The approval came after Trump appointees overruled FDA scientists' earlier plans to approve the shot without restrictions. Pfizer and Moderna, which make the most widely used COVID-19 vaccines, didn't immediately comment. For years, federal health officials have told most Americans to expect annual updates to COVID-19 vaccines, similar to the annual flu shot. Just like with flu vaccines, until now the FDA has approved updated COVID shots when manufacturers provide evidence that they spark just as much immune protection as the previous year's version. But FDA's new guidance appears to be the end of that approach under Health Secretary Robert F. Kennedy, who has filled the FDA and other health agencies with outspoken critics of the government's handling of COVID shots, particularly their recommendation for young, healthy adults and children. Under federal procedures, the FDA releases new guidance in draft form and allows the public to comment before finalizing its plans. The publication of Tuesday's policy in a medical journal is highly unusual and could run afoul of federal procedures, according to FDA experts. Tuesday's update, written by FDA Commissioner Marty Makary and FDA vaccine chief Vinay Prasad, criticized the U.S.'s 'one-size-fits-all' approach and states that the U.S. has been 'the most aggressive' in recommending COVID boosters, when compared with European countries. 'We simply don't know whether a healthy 52-year-old woman with a normal BMI who has had COVID-19 three times and has received six previous doses of a COVID-19 vaccine will benefit from the seventh dose,' they wrote. Makary and Prasad recommended that companies study people not deemed at high risk for six months, randomly assigning them to get a vaccine or a placebo and tracking outcomes with special attention to severe disease, hospitalization or death. Experts say there are legitimate questions about how much everyone still benefits from yearly COVID-19 vaccination or whether they should be recommended for people at increased risk. An influential panel of advisers to the Centers for Disease Control and Prevention is set to debate which vaccines should be recommended to which groups. The FDA's announcement appears to usurp that advisory panel's job, Offit said. He added that CDC studies have made clear that booster doses do offer protection against mild to moderate illness for four to six months after the shot even in healthy people. Biden relative calls new book 'political fairy smut' after cancer diagnosis MIT, Harvard scientists make important breakthrough in Alzheimer's research Baystate CEO's apology dances around multiple instances of plagiarism Read the original article on MassLive.
