Latest news with #CBER
Yahoo
20-05-2025
- Health
- Yahoo
Covid boosters no longer necessary for most Americans
Covid-19 booster jabs will be limited to people over 65 or those at higher risk of serious illness, under new US government rules. New placebo-controlled trials will be required to justify the booster vaccines for healthy individuals moving forward, a Food and Drug Administration (FDA) spokesman said. In a letter to the New England Journal of Medicine, director of the FDA's Centre for Biologics Evaluation and Research (CBER) Vinayak Prasad and Commissioner Martin Makary said the shift brought US policy more in line with Europe. They described the initial rollout of Covid-19 vaccines as 'a major scientific, medical, and regulatory accomplishment' – but said the benefits of repeated boosters in low-risk individuals remained uncertain. They contrasted the US approach with that of countries such as the UK, France and Germany, which limit booster recommendations to the elderly and those with underlying conditions. Going forward, the FDA said it believes it will continue to find the benefit-risk balance of continued boosters for people over 65, and people over the age of six months with one or more underlying conditions. However, 'for all healthy persons – those with no risk factors for severe Covid-19 – between the ages of six months and 64 years, the FDA anticipates the need for randomised, controlled trial data,' they said. They identified adults aged 50 to 64 as an ideal study population, and said trials should assess whether boosters reduce symptomatic illness, severe disease, hospitalisation, and death. The Centres for Disease Control and Prevention's definition of risk factors is 'vast, including obesity and even mental health conditions such as depression,' they wrote, adding that between 100 million and 200 million Americans would likely still qualify under this guidance. Dr Prasad, a haematologist-oncologist who now leads the FDA's Centre for Biologics Evaluation and Research (CBER), rose to prominence during the pandemic for publicly questioning the widespread use of boosters. Broaden your horizons with award-winning British journalism. Try The Telegraph free for 1 month with unlimited access to our award-winning website, exclusive app, money-saving offers and more.
Yahoo
19-05-2025
- Health
- Yahoo
An Anti-Science MAHA Extremist Is Playing a Major Role at the FDA
If there's anything that Dr. Vinay Prasad, the controversial new appointee to lead the Center for Biologics Evaluation and Research, or CBER, a top office at the Food and Drug Administration, loves to do, it's hurl an insult. Upon first glance, Prasad seems far more qualified than many other Trump appointees. He is a hematologist-oncologist and University of California at San Francisco professor who has amassed an unbelievable number of publications. But a quick visit to his now inactive Twitter/X page or his YouTube channel, which has almost 200,000 followers—quickly disproves that notion. Though he's always been somewhat iconoclastic, since the beginning of the pandemic, Prasad has become a radical Covid contrarian, amassing a following for his rampant tell-it-like-it-isn't views. Like a schoolyard bully, Prasad scuttles around the right-wing libertarian techbro corners of the internet, gleefully spreading misinformation in the basest terms possible, blocking many who disagree. A few examples: On public health leadership: 'These pieces of shit are still lying…. They're still fucking lying.' On the CDC and American Academy of Pediatrics: 'The CDC lied repeatedly, and all the employees at CDC and AAP who told us to cloth mask 2 year olds should be fired for stupidity.' (AAP did not respond to my request for comment on Prasad's appointment to CBER.) On people who wear masks to protect themselves from smoke inhalation during fires: 'Masking without evidence is an untreated mental illness plaguing public health.' On long Covid: He has repeatedly downplayed it and called it 'overblown.' He claimed that Pulitzer Prize-winning journalist Ed Yong 'did invent long Covid.' On people with long Covid trying to avoid reinfection: 'Haha double long covid. Just like double IPA!' On Covid testing, in June 2022: 'Break every home test…. The testing profiteers are killing us.' On his online critics: 'When you're dead, no one will ever think about you ever again.' On Covid restrictions: He says they are akin to a path to Naziism. And on the FDA, where he will hold a top role, just last year: '[we'd] probably be better off as a result of not having the FDA.' 'I am very disappointed with this appointment,' a prominent physician and researcher, who did not give his name for fear of retribution, told me. 'Prasad demonstrably got it repeatedly wrong during the pandemic. He is known for his contrarian views–which is not a bad thing if he got it right every once in a while; but he has a perfect record of striking out. What also worries me a great deal is his attitude toward patients and vulnerable populations; he has made multiple disparaging remarks toward patients with chronic illness.' Prasad has advocated for more trials and testing of new medical treatments before approval, reversing approval for the pediatric Covid vaccination, and a let-it-rip mentality when it comes to kids getting repeatedly infected. As early as 2021, he advocated that kids knowingly get each other sick and that Covid testing be banned. In 2023, he wrote a post entitled, 'Do not report COVID cases to schools & do not test yourself if you feel ill: Only non-violent resistance can halt irrational public health actors.' He has repeatedly said masks were ineffective, contrary to mountains of evidence. Though our public health institutions and the pharmaceutical industry certainly do deserve criticism, Prasad's way of doing business actually undercuts the efforts of legitimate reformers to bring the industry's bad actors to heel and unwind their worst policies. In this way, people like Prasad actually serve as the brilliant ally of these corporate interests, in that he helps to undermine the credibility of good-faith critics of the industry. More to the point, however, Prasad's behavior reveals a psychopathic lack of empathy, and his conclusions are almost always shockingly wrong. As he wrote in January 2023: It's important to remember that it was likely a lab leak, masks don't work, mandates didn't work, vaccines were not needed in people who had COVID, nor children, closing school was a human rights violation, masking kids didn't work, vaccine mandates were unethical, vaccine passports were useless, boosters don't have good data, paxlovid doesn't have good data, long COVID is overblown, et cetera. These are obvious things to those of us who can read. Many of Prasad's views that were seen as fringe in the earlier years of the pandemic, particularly around reopening schools, were slowly normalized during the Biden administration and have already informed policy, rather than science. Under the MAHA agenda, that will now go to extremes. 'A lot of the anti-vax folks use specious arguments to push disinformation,' said Dr. Michael Hoerger, a PhD researcher and top expert in tracking Covid data. 'That works well on social media, but they are going to be under much more scrutiny in government positions.' The fact that biotech stocks fell five percent within hours of the announcement of his appointment to CBER is telling. As virologist Angela Rasmussen put it in a tweet, he is 'seen as a menace to an entire industry.' Nicole Paulk, a biotech company CEO, elaborated in Citeline, a trade publication: 'Based on [Prasad's] books that he's written and the tweets that he has shared, and podcast that he has been on and all of these various public forums, it would seem to be that his position, kind of broadly regardless of modality is pretty anti-FDA, fairly anti-innovation, fairly anti-accelerated anything.' Case in point: Prasad has come out against the use of experimental treatments like Elevidys, a gene therapy that could help patients with Duchenne Muscular Dystrophy, a fatal muscle-wasting disease, despite the fact that patient advocates favor its approval. Prasad's appointment arrives in the context of an unprecedented dismantling of public health and research in this country, under the guise of 'Make America Healthy Again.' With Robert F. Kennedy Jr. at the head of the Department of Health & Human Services, responsible public health policies as we know them are effectively dead. Elon Musk's so-called 'Department of Government Efficiency' has gutted the National Institutes of Health, leaving it unable to carry out even its most basic duties and cutting off critical, life-saving research. Anti-vaccine rhetoric is, of course, central to Kennedy's MAHA agenda, and future vaccine research and availability is already under threat as kids are already dying of measles, completely unnecessarily. Experts have been pushed out of their posts, and a culture of fear is already pervading health institutions. 'It is obvious that many doctors and scientists are self-censoring,' said Dr. Jonathan Howard, a neurologist at NYU Langone and author of the book, We Want Them Infected, which chronicles how certain doctors came to embrace the anti-vaccine movement. 'Given the purges at these agencies and vast canceling of grants, this is no surprise.' Indeed, a number of doctors to whom I reached out about Prasad's appointment to head CBER either declined to comment or wished to remain anonymous. I did not receive responses from major medical associations I contacted, either. Health initiatives related to the distinct outcomes for certain groups caught up in Trump's war against 'woke'—such as women—have been axed. Without research and data on future public health risks, such as bird flu, or current and ongoing ones like Covid-19, more people will get sick and die—and there's only so long that the Trump administration can pretend it isn't happening. That doesn't mean they won't try to hide such outcomes from the public view. Here, Prasad has signaled a willingness to participate in the cover-up: He seems to support the dangerous idea of blacking out critical data on Covid and other diseases. At their core, these policies constitute a basic disregard for human life. The Food and Drug Administration is being dealt a similar fate. Critical programs ensuring food safety, as well as vaccine research, have been unceremoniously cut. Prasad replaces the former head of CBER at the FDA, Peter Marks, who resigned in March due to RFK Jr.'s spreading of 'misinformation and lies.' Prasad, in his signature flippant tone, has compared Marks to 'a bobblehead doll that just stamps approval.' Now, Prasad serves under FDA director Martin Makary, a Trump lackey, while Jay Bhattacharya, another vociferous Covid critic, heads up NIH. All are part of the same contrarian clown show of dangerous anti-vax, anti-health MAGA bros loudly proclaiming their messages to audiences on X and YouTube—and now, the broader American public. Though in his initial remarks to the FDA, Prasad took on a more measured tone, FDA employees are panicking. STAT News reported that staff 'were alarmed by the decision to hire Prasad, who lacks regulatory experience and has more explicitly political views than center directors in the past. 'It's very bad,' one employee said. 'Another completely unqualified person who has no idea what regulation is running an important center.'' Under this leadership, Covid booster availability will likely be restricted, and approval for vaccines tackling future variants could be limited or halted entirely. Though uptake for boosters was already low, hovering around 23 percent for the 2024-2025 vaccine, it is clear that making it less available and discouraging it will only cause harm to the population. 'If boosters are not approved for next year, it's hard to imagine that COVID's impact would not disproportionately affect sick, vulnerable populations,' said Howard. 'Given prior comments downplaying the importance of vaccines, I am concerned about delays in vaccine approval,' added Hoerger. 'Delays in vaccine approvals will cost lives.'
Express Tribune
15-05-2025
- Business
- Express Tribune
IBA Karachi hosts pre-budget seminar
IBA Karachi hosted a pre-budget seminar, "Pakistan Economic Outlook for Budget 2025-26", critically examining Pakistan's economic landscape and the upcoming Federal Budget 2025-26 at the main campus, organised by the Centre for Business and Economics Research (CBER) at School of Economics and Social Sciences (SESS). Given the targets set, Former Finance Minister Dr Miftah Ismail highlighted the challenge the government may face in meeting the revenue targets in the upcoming fiscal year. He emphasised that Pakistan already has higher tax rates than its regional counterparts.
The Guardian
14-05-2025
- Health
- The Guardian
Critic of Covid boosters set to enact tough agenda as top US vaccines official
Vinay Prasad, an oncologist and hematologist who has called for more regulatory scrutiny of pharmaceuticals, including Covid vaccines, was named the top US vaccines official earlier this month. Marty Makary, commissioner of the US Food and Drug Administration (FDA), announced in a 6 May email obtained by the Guardian that Prasad would now lead the Center for Biologics Evaluation and Research (CBER), which oversees biological products like blood, vaccines, and cellular and gene therapies. Biotech stocks plunged at the news. Prasad has signaled, in blogposts, podcast episodes and social media posts, that he is likely to enact tougher regulatory scrutiny for new therapies, especially when it comes to the rapid approval of new medications. He has also repeatedly decried Covid boosters and called for extensive studies to see whether grouping childhood vaccines together causes autism, which multiple studies have debunked. Since 2020, Prasad has been a professor of epidemiology and biostatistics and medicine at the University of California, San Francisco, and he sees patients at San Francisco general hospital. He is licensed as a physician, but he is no longer board-certified in internal medicine, hematology, or oncology – which means he's unlikely to continue practicing clinical medicine, said David Gorski, a professor of surgery and oncology at Wayne State University. 'There are a lot of doctors who, when they transition to a non-clinical position, let their board certifications lapse because it's expensive and a lot of work to keep them up – but it's unusual for someone that young,' Gorski said. Prasad will oversee more than 1,000 employees at the CBER, but does not seem to have held previous leadership positions beyond his research lab. He did not respond to the Guardian's interview request. An analysis of Prasad's public statements reveals an outspoken critic of the pharmaceutical industry – and of his peers in public health. Prasad has called out the practice of pharmaceutical companies offering payments to doctors. He has strongly advocated for limitations on the relationships between pharmaceutical companies and regulators, arguing that regulators with recent pharma work, such as running clinical trials, should be removed, and recommending that regulators should not have consulted for pharma for five years before joining the FDA. Prasad has also proposed making randomized trials less bureaucratic and thus less expensive. He has long pushed for stronger regulations around the approval of new medications, especially for cancer and for rare conditions such as Duchenne muscular dystrophy. In the accelerated approval process, regulators 'didn't follow up on these trials to make sure that the post-marketing licensure trials lined up with the results that led to the accelerated provisional approval,' Gorksi said – a practice that Prasad sharply criticized, and a stance with which others including Gorski agreed. But in 2021, he had a 'heel turn' and began strenuously opposing Covid boosters and other precautions, like wearing face masks, as well, Gorski said. Prasad started questioning 'how dangerous Covid actually was', he said. Prasad has frequently advocated for removing the Covid vaccine from the US childhood immunization schedule, and that it was 'malpractice' for doctors to recommend the booster for children. Prasad said it was 'only a matter of time' before a serious safety signal emerges from the vaccines, which have been administered to millions of people around the globe, and called annual update boosters 'a game of Russian roulette' in a blogpost. He believes the risk of myocarditis and other side effects from mRNA Covid shots outweigh the benefits of preventing illness and death. Myocarditis is a markedly more common side effect from Covid infection, which also remains a top cause of death. 'Dr Vinay Prasad spent the past four years spreading misinformation on Covid and the Covid vaccine,' said Jonathan Howard, an associate professor of neurology and psychiatry at NYU Langone Health and author of the book We Want Them Infected. Prasad recently called for a clinical trial, separated by age, to assess the effectiveness of each updated Covid shot. The vaccine would only be authorized 'if it works', Prasad wrote – but he believed it won't: 'I suspect the trials may only be positive in the above 80 and nursing home group. The rest will be negative.' Holding new trials for updated vaccines is unusual. It's a lengthy process that means vaccines would likely not be available before the fall, when updated boosters have been rolled out in the past. This approach would also throw flu vaccines into uncertainty. 'It's time to reform the flu vaccine process for the 21st century,' Prasad wrote in March. Gorski doubts 'that there will be an updated Covid vaccine' and doesn't 'think this will be an issue with the flu vaccines right away, but I think we're moving that way'. Covid (and flu) shots are still greatly needed, Gorski said, as 'the virus keeps mutating and evolving to evade pre-existing immunity. It still kills a lot of people.' Prasas has repeated several anti-vaccine talking points, including the call for more studies on the effects of clustering childhood immunizations together; a greater focus on saline placebo trials; and revamping the current system to allow more lawsuits against vaccine makers. By criticizing how clinical trials are done, skeptics such as Prasad 'cast doubt on the current evidence by implying that whatever you're criticizing has never been adequately studied and probably doesn't work', Gorski said. Prasad has also regularly mocked scientists and doctors for wearing masks, and he called the public health workforce 'the dumbest people in the country' and 'dummies talking out their ass' because they are willing to accept low wages for their work. He has repeatedly criticized Peter Marks, the person who last held this job and who says he was pushed out by health secretary Robert F Kennedy Jr, calling Marks 'dangerous'. Prasad has also called out other officials previously at the helm of health agencies, including Mandy Cohen, Rochelle Walensky and Robert Califf. 'In my opinion, these pieces of shit are still lying,' Prasad said of public health leaders on a podcast interview. 'Using vulgar, unprofessional language, Dr Prasad excoriated the previous medical establishment for not doing randomized-controlled trials for every variant and demographic. That's his job now, and we can hold him to the same standards,' Howard said. Gorski agreed: 'He is now the medical-proof establishment. Prasad owns it now when it comes to vaccines – he owns it all.'
Epoch Times
09-05-2025
- Health
- Epoch Times
New Top FDA Official Says He's Not Anti-Vaccine, but Evidence Required
A new top Food and Drug Administration (FDA) official said on May 8 that vaccines are good but that they need to be backed by evidence. In his first comments since being named the director of the FDA's Center for Biologics Evaluation and Research (CBER), Dr. Vinay Prasad said that the FDA is going to have a standard of 'solid evidence' when dealing with vaccines. 'I think vaccines are like drugs, which is that when given at the right time and the right moment to the right person, they're life-saving,' Prasad said. 'But just like drugs, they need to be evaluated on a case-by-case basis, and always take into the context that you're giving.' Prasad has been a consistent critic of the government's stance on COVID-19 vaccines, which in the past included vaccine mandates and currently recommends at least one dose annually for Americans aged 6 months and older. 'The current childhood vaccination schedule is not correct. Covid-19 vaccine needs to be removed for babies. It would be irresponsible not to do that,' Prasad Health Secretary Robert F. Kennedy Jr. has said that officials are reviewing the placement of COVID-19 vaccines on the Centers for Disease Control and Prevention's childhood vaccination schedule because they may not belong there. Related Stories 5/6/2025 4/28/2025 In a 2022 'Marty and I, throughout the pandemic, we were proponents of vaccines for the people in whom it had a huge benefit, but we were always a bit skeptical from a scientific standpoint about perhaps overdoing it in some low-risk populations,' Prasad said on Wednesday. Questioning that 'is not anti-vax, it's pro-science,' he added later. Prasad was speaking with Makary in a video Before joining the agency, Prasad was a professor at the University of California, San Francisco, and a hematologist-oncologist at the San Francisco General Hospital. He said that he thinks he has administered more vaccines than many doctors, given how many of his patients have compromised immune systems following transplants. 'You need to give these patients vaccines,' Prasad said. 'So we love vaccines when done right, when given appropriately, when based on solid evidence, and we're going to hold up that standard at FDA.' Prasad had 'It needs to either remove itself from the picture, or demand randomized trials measuring appropriate endpoints,' he said. The FDA is currently considering whether to license Novavax's COVID-19 vaccine and whether to clear updated COVID-19 shots from Novavax, Pfizer, and Moderna. Makary recently indicated that clearance will not happen unless the companies present clinical data supporting updated formulations, which was not provided when the FDA approved and authorized the vaccines in 2023 and 2024. Prasad noted that uptake of the COVID-19 vaccines from 2023 to 2025 is low— The new CBER head also said that in some cases, clinical trials would be difficult or impossible to complete, such as for rare diseases. He said that the FDA is going to have a 'flexible regulatory standard' that takes into account 'the context of a disease.'
