Latest news with #TheFoodandDrugAdministration
Bloomberg
29-03-2025
- Health
- Bloomberg
Top US Vaccine Official Resigns Citing RFK ‘Misinformation' Push
The Food and Drug Administration 's top vaccine regulator abruptly resigned Friday, citing what he called Health and Human Services Secretary Robert F. Kennedy Jr.'s efforts to spread misinformation about the safety of immunizations, according to a letter obtained by Bloomberg. Peter Marks, who was a key figure in Operation Warp Speed, stepped down from his position as the director of the FDA's Center for Biologics Evaluation and Research, which is responsible for the safety and effectiveness of vaccines, along with gene therapies and blood products.
New York Times
29-03-2025
- Health
- New York Times
Top FDA Vaccine Official Resigns, Citing Kennedy's ‘Misinformation and Lies'
The Food and Drug Administration's top vaccine official, Dr. Peter Marks, abruptly resigned Friday, saying in a searing letter that Health Secretary Robert F. Kennedy Jr.'s aggressive stance on vaccines was irresponsible and posed a danger to the public. '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,' Dr. Marks wrote to Sara Brenner, the agency's acting commissioner. Dr. Marks resigned under pressure, according to a person familiar with the matter who said an official with the Department of Health and Human Services told Dr. Marks on Friday that he could either resign or be fired. Hours earlier in West Virginia, Mr. Kennedy asserted that Covid did not kill healthy people, contrary to research showing that 30 percent of those who died early in the pandemic did not have underlying conditions. Mr. Kennedy has also extolled the value of vitamin A as a treatment during a major measles outbreak in Texas, while downplaying the value of vaccines. On Thursday, he announced that he was creating a new office to study vaccine injuries. Dr. Marks noted in his letter that measles, 'which killed more than 100,000 unvaccinated children last year in Africa and Asia,' because of complications, 'had been eliminated from our shores.' He added that he had been willing to address Mr. Kennedy's concerns about vaccine safety and transparency with a series of public meetings and by working with the National Academies of Sciences, Engineering and Medicine, but was rebuffed. Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times. Thank you for your patience while we verify access. Already a subscriber? Log in. Want all of The Times? Subscribe.
NBC News
25-03-2025
- Health
- NBC News
FDA approves first new antibiotic for UTIs in nearly 30 years
The Food and Drug Administration on Tuesday approved the first drug in a new class of antibiotics for treating urinary tract infections — the first time that's happened in nearly 30 years. The drug, a pill called Blujepa from drugmaker GSK, was approved for women and girls 12 and up with uncomplicated UTIs — the most common type of the infection in women, often caused by bacteria including E. coli. Most UTIs are easy to treat, usually clearing up within a few days or weeks after a short course of antibiotics. But the bacteria that commonly cause them are increasingly becoming resistant to the standard antibiotics, making treatment more difficult, said Dr. Sovrin Shah, an associate professor of urology at Mount Sinai Hospital in New York. More than 2.8 million antimicrobial-resistant infections occur in the U.S. each year, according to the Centers for Disease Control and Prevention. A 2019 study found resistance to at least one drug in more than 92% of bacteria that can cause UTIs. Around 80% showed resistance to at least two. Developing new antibiotics that attack bacteria in different ways reduces the risk of drug resistance, helping to keep treatment options open, said Dr. Candace Granberg, a pediatric urologist and surgeon-in-chief at Mayo Clinic Children's in Rochester, Minnesota. UTI symptoms include a burning feeling when urinating, blood in the urine, a strong urge to urinate and urinating more often. Untreated, they can lead to complications including bladder infections and kidney damage. 'We absolutely need new antibiotics for uncomplicated UTIs,' Granberg said. Blujepa is part of a new class of antibiotics called triazaacenaphthylenes, which work by targeting two key enzymes that E. coli bacteria need to copy itself and survive. 'In simple terms, this new antibiotic works its magic by using a novel binding method to block a bacteria's ability to replicate,' Granberg said. According to GSK, the last time the FDA cleared a new class of antibiotics for uncomplicated UTIs was in 1996, with the approval of fosfomycin. (Last year, the agency approved the drug Pivya for UTIs, which belongs to the penicillin drug class.) In two phase 3 clinical trials of 3,000 adults and teens, Blujepa was shown to successfully treat 50% to 58% of patients' infections when taken twice a day for five days, compared to 43% to 47% in a group that received the antibiotic nitrofurantoin. More than half of women will experience at least one UTI in their lifetime, according to a 2019 report, and around 30% will experience a recurring infection. GSK is also studying whether the drug can treat gonorrhea, according to Tony Wood, the company's chief scientific officer. Blujepa is expected to be available in the second half of the year. Wood didn't disclose how much it would cost — although, as a brand-name drug, its cost is expected to be higher than other antibiotics that have been on the market for years and have generic options. Shah, of Mount Sinai Hospital, said that cost is an important consideration, noting that physicians would likely gravitate toward generics. Still, the overuse of the same antibiotics can promote drug resistance, so a new option is helpful, he added.
Yahoo
28-02-2025
- Health
- Yahoo
So Much For RFK, Jr.'s Promise of 'Radical Transparency' at HHS
The Food and Drug Administration's (FDA) upcoming Vaccine and Related Biological Products Advisory Committee meeting on March 13 was abruptly canceled via email on Wednesday. The committee was to consider the selection of strains to be included in the influenza virus vaccines for the 2025–2026 flu season. This is the second vaccine-related advisory meeting canceled since Robert F. Kennedy, Jr. took over at the Department of Health and Human Services (HHS). No reason for the cancellation was given, and the committee members were warned against forwarding the email. It suggested that members decline to answer questions from media. So much for Kennedy's pledge earlier this month of "radical transparency." He added, "We will make our data and our policy process so transparent that people won't even have to file a FOIA [Freedom of Information Act] request." In addition to suggesting members of the FDA's vaccine committee stifle themselves, the HHS will publish a notice next week in the Federal Register to eliminate public comment on that agency's plans and decisions. While past meetings have been open to public scrutiny and participation, it is not clear if the new limits will apply to future meetings of the committee. Radical transparency, indeed. With respect to the normal processes for evaluating and developing annual flu vaccines, the FDA has previously explained: The job of producing a new vaccine for the next flu season starts well before the current season ends. For the FDA, it's a year-round initiative. Flu viruses are constantly evolving. The flu viruses that circulate and cause disease in people often change from one year to another, necessitating a new vaccine every year. To accomplish this, the FDA, World Health Organization, the Centers for Disease Control and Prevention and other partners collaborate by collecting and reviewing data on the circulating flu strains from around the world to identify those likely to cause the most illness in the upcoming season. In late February/early March — well before the new influenza season begins, the FDA convenes its vaccines advisory committee to review data about which flu viruses have caused disease in the past year, how the viruses are changing, and disease trends so they can recommend the flu virus strains to include in the vaccines for the upcoming U.S. flu season. Once the strains are selected, vaccine manufacturers begin the manufacturing process to include the newly selected flu strains in their FDA-approved vaccines. The different virus strains are combined to formulate the vaccine into standard dosages. The vaccine is then filled into vials, syringes and, for the nasal vaccine, sprayers. Flu vaccine effectiveness varies from year to year depending, among other things, on whether the FDA guessed right about which strains will be circulating each season. The current vaccine is around 40 percent to 60 percent effective against influenza-associated hospitalization. Noting that the U.S. is currently experiencing one of the worst flu seasons in a decade, Infectious Diseases Society of America president Tina Tan warns that "cancelling a critically important Food and Drug Administration meeting that is vital to the development of effective flu vaccines for next flu season is irresponsible." She adds, "Cancelling this meeting means vaccine makers may not have the vital information and time they need to produce and distribute targeted vaccines before the next flu season. If the FDA meeting is not immediately rescheduled, many lives that could be saved by vaccination will be lost." RFK, Jr.'s HHS promises that the FDA "will make public its recommendations to manufacturers in time for updated vaccines to be available for the 2025-2026 influenza season." We'll see. The post So Much For RFK, Jr.'s Promise of 'Radical Transparency' at HHS appeared first on
CBS News
27-02-2025
- Health
- CBS News
FDA cancels meeting to update next season's flu vaccines
The Food and Drug Administration unexpectedly canceled an annual meeting of its advisers to update next season's influenza vaccines, an adviser on the panel and multiple officials confirm to CBS News, potentially upending the process to start manufacturing next winter's flu shots. "We're all left trying to understand what is going on. Why was this meeting canceled? It's an important meeting. What's the plan for flu vaccines this year," Dr. Paul Offit, a member of the FDA advisory committee and director of the Vaccine Education Center at Children's Hospital of Philadelphia, told CBS News. Offit said he received the notification that the meeting was canceled shortly after 4 p.m. The FDA's Vaccines and Related Biological Products Advisory Committee was supposed to meet on March 13 to discuss how to update the shots for the next flu season, Offit said. One former and one current federal health official also confirmed that the committee's upcoming meeting had been canceled without explanation. An FDA spokesperson did not immediately respond to a request for comment. The companies that manufacture influenza vaccines rely on the FDA each year to pick out the strains to use in shots made for the American market. The specific strains are chosen each year based on predictions of what flu variants will be circulating in the coming winter. That selection is usually done by the committee in early March, drawing in large part on findings from a meeting of the World Health Organization's advisers reviewing data on influenza from across the Northern Hemisphere. "Because the vaccine is grown in eggs, for the most part, it requires six months to produce. So March is six months before September, which is when these vaccines roll out," said Offit. Last year, the FDA asked the committee to meet on March 5 to decide on how to update the influenza shots for the 2024 to 2025 season. The agency usually announces these meeting dates around a month in advance. Next month's meeting had not yet been publicly disclosed. Even if the meeting is eventually scheduled for later this year, a delay could affect availability of shots at the beginning of flu season. "This delay will really put manufacturers behind. It takes time to optimize updated vaccine virus strain production. They need as much time as possible before the upcoming fall vaccine season," a former federal health official told CBS News. Which strains are picked to be targeted by the vaccines can have a significant impact on how effective the shots are. Early data from the Centers for Disease Control and Prevention's testing suggests that this past season's vaccine may have been a poor match for one of the common strains of the virus. More data on the effectiveness of the vaccine is expected to be released Thursday. The cancellation is just the latest federal vaccine meeting to be disrupted. A quarterly meeting of the CDC's Advisory Committee on Immunization Practices was unexpectedly postponed earlier this month, citing the need "to accommodate public comment in advance of the meeting."
