Latest news with #CenterforBiologicsEvaluationandResearch
Epoch Times
10-06-2025
- Health
- Epoch Times
FDA Officials Say They're Focused on Cutting Red Tape for New Drugs
The Food and Drug Administration is looking to cut down on the time to bring new products to market, two of the agency's top officials said on June 10. FDA reviews that usually took a year were completed in weeks during the COVID-19 pandemic, which is 'clear demonstration that rapid or instant reviews are possible,' Dr. Marty Makary, the FDA's commissioner, and Dr. Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research,
Epoch Times
05-06-2025
- Health
- Epoch Times
FDA Not Recommending Newly Approved COVID-19 Vaccine: Official
The Food and Drug Administration (FDA) approved a new COVID-19 vaccine but is not recommending people receive it, the agency's top vaccine officials said on June 4. 'There's another misconception I want to clarify, which is, people have said, 'You at FDA are recommending the shots to high risk people and older people.' I want to be very clear, the FDA is not your doctor. We are not, we don't recommend shots to people,' Dr. Vinay Prasad, head of the FDA's Center for Biologics Evaluation and Research, said in a
Yahoo
23-05-2025
- Health
- Yahoo
FDA says it will limit access to Covid-19 boosters for Americans under 65
The Food and Drug Administration (FDA) announced on Tuesday that it will limit access to seasonal Covid-19 boosters for healthy Americans under 65 without clear evidence of clinical benefit – a shift, critics say, that will make access difficult for people who are not high risk but want to be vaccinated against the disease. Top officials at the FDA outlined a new framework for approving Covid-19 vaccines, saying that the US would make the boosters available for Americans over the age of 65 and for adults and children above the age of 6 months with at least one condition that increases their risk of severe Covid-19. The newly installed FDA commissioner Marty Makary and Vinay Prasad, the controversial director of the Center for Biologics Evaluation and Research, laid out the new guidelines in a commentary piece published in the New England Journal of Medicine. Related: Critic of Covid boosters set to enact tough agenda as top US vaccines official They wrote that manufacturers would have to conduct randomized, controlled clinical trials before updated vaccines would receive approval for healthier people. Elsewhere in the piece, the officials argued that the US is an outlier among countries in Europe and other high-income countries where Covid-19 boosters are recommended only for older adults and people at high risk. They estimate that more than 100 million Americans will still qualify for the annual shots under the new terms. The US Centers for Disease Control and Prevention lists many conditions that make a person higher risk for getting very sick from Covid, including obesity, diabetes, asthma or chronic lung disease as well as a compromised immune system, pregnancy and disability. Makary, appointed by Donald Trump, and Prasad are both vocal critics of pandemic-era policies and of the government's response to Covid-19. The agency is overseen by the Department of Health and Human Services, which is now run by Robert F Kennedy Jr, a long-time vaccine skeptic who has been slashing the department as part of the White House's effort to downsize the federal government. 'Although the rapid development of multiple Covid-19 vaccines in 2020 represents a major scientific, medical, and regulatory accomplishment, the benefit of repeat dosing – particularly among low-risk persons who may have previously received multiple doses of Covid-19 vaccines, had multiple Covid-19 infections, or both – is uncertain,' Makary and Prasad wrote. 'The American people, along with many health care providers, remain unconvinced.' The American universal access policy, they contend, was based on the assumption that 'the American people are not sophisticated enough to understand age- and risk-based recommendations' – a view they say the agency now explicitly rejects. Since becoming the country's top health official in February, Kennedy has filled the FDA and other health agencies with outspoken critics of the government's handling of Covid shots, including Makary and Prasad. 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. Health experts say there are legitimate questions about how much everyone still benefits from yearly Covid vaccination or whether they should be recommended only for people at increased risk. Prior to this announcement, the FDA had hinted that changes were coming. Last week, the agency granted approval of Novavax's Covid-19 vaccine but with restrictions that reflect its new guidelines. Makary and Prasad said they expect the FDA will approve the boosters for adults over the age of 65 years 'on the basis of immunogenicity' – whether the vaccine produces a robust antibody response. But for lower-risk groups, the FDA will now require what the authors describe as 'robust, gold-standard data' from drugmakers before approval is granted. Critics say the new guidelines will limit access for people who want the booster, including parents and their children. And some experts have raised questions about how the new framework will be applied. '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 told the Associated Press. 'The only thing that can come of this will make vaccines less insurable and less available.' In June, an influential panel of advisers to the CDC is scheduled 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. Provisional data from the Centers for Disease Control and Prevention shows that more than 47,000 Americans died from Covid-related causes last year. The virus was the underlying cause of two-thirds of those deaths and was a contributing factor for the rest. Among the dead were 231 children whose deaths were deemed Covid-related, 134 of them where the virus was the direct cause – numbers similar to yearly pediatric deaths from the flu.
Time Magazine
21-05-2025
- Health
- Time Magazine
What the New COVID-19 Vaccine Guidance Means For You
On May 20, the federal government announced a major shift in how it plans to review and recommend COVID-19 vaccines for Americans. Among the changes: when manufacturers want to update the vaccine each year to target the latest variants, they will be required to conduct additional studies to show the effectiveness of the vaccine in people who are not at high risk of severe COVID-19. Since 2023, federal health officials have recommended an annual COVID-19 shot for most people, and vaccine makers have not needed to conduct additional tests on each year's updated vaccine. It's similar to the way the annual flu shot is updated to target the newest influenza strains, without new studies to re-confirm the effectiveness and safety of the vaccine. Here's how COVID-19 vaccine guidance is changing in the U.S. For people at high risk of severe COVID-19 The process of reviewing and recommending yearly updates to the COVID-19 vaccine would remain essentially the same for anyone at high risk of developing severe COVID-19, which includes older people and anyone with compromised immune systems or a broad range of risk factors. 'If you're older than 65 or you are at high risk of COVID-19, we're going to use the immunologic endpoints we've been using to grant approval," said Dr. Vinay Prasad, head of the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research (the group that oversees approvals for vaccines and biologic treatments), during a May 20 briefing. "This is a tremendously broad category; this effectively means 100 million to 200 million Americans, those with the most favorable benefit-to-harm balance, will be covered by these approvals.' That means that additional studies of updated vaccines involving these groups will not be required. Vaccine makers will continue, however, to conduct studies to ensure the shots are safe after they are available. In a medical journal commentary describing the changes, Prasad and FDA commissioner Dr. Martin Makary said that such a study "does not preclude the conduct of additional randomized studies, particularly studies in pediatric populations." Prasad said during the briefing that another scenario that might require additional studies on updated vaccines would be if the virus mutates and changes in a significant way. These would be conducted on an as-needed basis, but not necessarily yearly. The "high-risk" category is broad. It includes conditions like asthma, diabetes, and depression—but also physical inactivity, which can be a more subjective health characteristic and applies to most U.S. adults. It's not clear how much documentation, if any, people will have to provide in order to be eligible to receive a COVID-19 vaccine if they want to get immunized. As they did when a different policy restricted the original COVID-19 vaccines to high-risk groups, doctors and pharmacists will likely make individual and varied decisions about whether people who have these risk factors qualify—and may err on the side of vaccinating people if they want the shot. For people who are not at high risk of severe COVID-19 Prasad said the process for approving annual COVID-19 vaccines for people not at high risk will change. The FDA is now telling vaccine makers to conduct additional studies to show that their vaccines provide benefit—in outcomes including lower rates of symptoms, hospitalizations, and deaths from COVID-19—compared to people receiving placebo. The six-month trials would follow people ages 50 to 64 years. (Those results would then be generalized to healthy people as young as six months.) But because some people don't develop symptoms, and others may only experience mild ones—especially after repeat infections—it could take a very large study to get enough cases to give the results enough statistical power to make them meaningful. That would add to the cost of the vaccines for manufacturers, which could then get passed down to consumers. 'We are evaluating the details shared today and discussions with the FDA are ongoing," said Pfizer in a statement. "We stand by the science behind the Pfizer-BioNTech COVID-19 vaccine and continue to believe that broad vaccination programs are an essential tool for helping to prevent COVID-19 associated hospitalizations and severe disease, including death. The Pfizer-BioNTech COVID-19 vaccines have been administered to over a billion individuals, including adults, adolescents and children, generating robust data demonstrating a favorable safety profile.' Moderna responded to the new policies by saying 'we appreciate the FDA's clear guidance and remain committed to working with the Agency to provide the data they need to ensure access for Americans.' As of April 2025, only about 23% of U.S. adults got the latest COVID-19 shot—which Prasad cites as evidence that the public is unconvinced that the shot adequately protects against disease. He also said that many Americans have now had multiple COVID-19 infections, which provides immunity for some period of time, and that the effectiveness of the vaccines in providing protection in such a population isn't clear. Public-health experts acknowledge that specific studies on these populations have not been conducted, but point to generally declining rates of hospitalizations and deaths from COVID-19 as an indicator that immunity to the virus, provided in part by vaccinations, is likely playing a role.
Time of India
21-05-2025
- Health
- Time of India
New Trump vaccine policy might limit access to your future COVID shots: 10 points
Stricter FDA policy for Covid vaccines: 10 points Live Events (You can now subscribe to our (You can now subscribe to our Economic Times WhatsApp channel The US Food and Drug Administration is changing the way it approves Covid-19 vaccines for Americans. The FDA has announced that it will only recommend COVID-19 vaccines for adults 65 and older and people at risk for severe agency is changing the type of evidence it will accept from vaccine manufacturers to approve updated Covid-19 shots, Dr. Vinay Prasad, the new director of the FDA's Center for Biologics Evaluation and Research, and FDA Commissioner Dr. Marty Makary said in an editorial published Tuesday in the New England Journal of Medicine.-The Food and Drug Administration (FDA) announced on Tuesday that it will limit access to seasonal Covid-19 boosters for healthy Americans under 65. Critics said the move will make access difficult for people who are not high risk but want to be vaccinated against the disease.-The new strategy would continue the current vaccine approval process for people ages 65 and older and younger people with health problems that put them at high risk, according to an article published Tuesday in The New England Journal of Medicine.-Top FDA officials have introduced a new framework for approving COVID-19 vaccines. Under this plan, booster shots will be made available to Americans aged 65 and older, as well as to adults and children over 6 months old who have at least one condition that heightens their risk of developing severe COVID-19.-The FDA framework, published Tuesday in the New England Journal of Medicine, urges companies to conduct large, lengthy studies before tweaked vaccines can be approved for healthier people, reports news agency AP. It is in contrary from the previous federal policy recommending an annual COVID shot for all Americans six months and older.-Vinay Prasad, the controversial director of the Center for Biologics Evaluation and Research, described the new approach as a 'reasonable compromise' that will allow vaccinations in high-risk groups to continue while generating new data about whether they still benefit healthier people.-The nation's leading pediatrics group said FDA's approach will limit options for parents and their children. 'If the vaccine were no longer available or covered by insurance, it will take the choice away from families who wish to protect their children from COVID-19, especially among families already facing barriers to care,' said Dr. Sean O'Leary of the American Academy of Pediatrics -According to provisional data from the Centers for Disease Control and Prevention, over 47,000 Americans died from causes related to COVID-19 last year. In two-thirds of those cases, the virus was identified as the primary cause of death, while in the remaining cases, it was a contributing factor.-The new FDA approach is the culmination of a series of recent steps under Health Secretary Robert F. Kennedy Jr. scrutinizing the use of COVID shots and raising questions about the broader availability of vaccines. It was released two days ahead of the first meeting of FDA's outside vaccine experts under Trump.-Last week, the FDA granted full approval to Novavax's COVID-19 vaccine, but with significant restrictions on eligibility — restrictions that were echoed in Tuesday's guidance. The decision followed an intervention by Trump-appointed officials, who overruled FDA scientists' initial plans to approve the vaccine without limitations.-For years, federal health officials have advised most Americans to anticipate yearly COVID-19 vaccine updates, much like the annual flu shot. As with flu vaccines, the FDA has so far approved updated COVID vaccines as long as they provide immune protection comparable to the prior year's formulation.(With inputs from AP)
