Latest news with #healthagencies
The Independent
2 days ago
- Health
- The Independent
Hundreds of laid-off CDC employees are being reinstated
More than 460 laid-off employees at the nation's top public health agency received notices Wednesday that they are being reinstated, according to a union representing the workers. The U.S. Department of Health and Human Services confirmed reinstatement notices went out to the former Centers for Disease Control and Prevention employees, but provided few details. About 2,400 CDC employees lost their jobs in a wave of cuts across federal health agencies in early April, according to a tally at the time. Whole CDC programs were essentially shut down, including some focused on smoking, lead poisoning, gun violence, asthma and air quality, and workplace safety and health. The entire office that handles Freedom of Information Act requests was shuttered. Infectious disease programs took a hit, too, including programs that fight outbreaks in other countries, labs focused on HIV and hepatitis in the U.S., and staff trying to eliminate tuberculosis. An estimated 200 of the reinstated workers are based in the CDC's National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention, HHS officials confirmed. Staffers at a CDC lab that does testing for sexually transmitted diseases are being brought back, said one CDC employee who wasn't authorized to discuss what happened and spoke to The Associated Press on condition of anonymity. Also reinstated are an estimated 150 employees at the CDC's National Center for Environmental Health, including people staffing a lab that works on lead poisoning, according to the union and employees. Layoffs at federal agencies were challenged in lawsuits, with judges in some cases ordering federal agencies to halt terminations of employees. Officials at HHS have never detailed how they made the layoff decisions in the first place. And they did not answer questions about why the notices went out, or how decisions were made about who to bring back. HHS spokesperson Andrew Nixon said the agency was streamlining operations and that 'the nation's critical public health functions remain intact and effective.' "The Trump Administration is committed to protecting essential services — whether it's supporting coal miners and firefighters through NIOSH, safeguarding public health through lead prevention, or researching and tracking the most prevalent communicable diseases,' he said. This is not the first time that employees at the Atlanta-based agency were told they were being terminated only to then be told to come back. After an earlier round of termination notices went out in February, about 180 CDC employees in March were told to come back. __ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Wall Street Journal
4 days ago
- Health
- Wall Street Journal
RFK Jr.: HHS Moves to Restore Public Trust in Vaccines
Vaccines have become a divisive issue in American politics, but there is one thing all parties can agree on: The U.S. faces a crisis of public trust. Whether toward health agencies, pharmaceutical companies or vaccines themselves, public confidence is waning. Some would try to explain this away by blaming misinformation or antiscience attitudes. To do so, however, ignores a history of conflicts of interest, persecution of dissidents, a lack of curiosity, and skewed science that has plagued the vaccine regulatory apparatus for decades.
The Independent
19-05-2025
- Health
- The Independent
RFK Jr. pledged not to upend US vaccine system, but big changes are underway
Robert F. Kennedy Jr. clinched the political support needed to become the nation's top health official by pledging to work within the decades-old federal system for approval and use of vaccines. Yet his regulators are promising big changes that cloud the outlook for what shots might even be available. The Food and Drug Administration will soon 'unleash a massive framework' for how vaccines are tested and approved, according to Commissioner Marty Makary. Details aren't yet public but the plan is being overseen by the agency's new vaccine chief, Dr. Vinay Prasad, an outspoken critic of FDA's handling of COVID-19 boosters. Makary and other Trump administration officials already have taken unprecedented steps that raise uncertainty about next fall's COVID-19 vaccinations, including delaying FDA scientists'full approval of Novavax's shot — and then restricting its use to people at higher risk from the virus. They've also suggested seasonal tweaks to match the latest circulating virus strains are new products requiring extra testing. The changes cross multiple health agencies. The Centers for Disease Control and Prevention hasn't yet acted on an influential advisory panel's recent recommendations on use of a new meningitis shot or broader RSV vaccination. A meeting of Kennedy's 'Make America Healthy Again' allies was recently told to expect an end to COVID-19 booster recommendations for children — something that vaccine advisory panel was supposed to debate in June. And researchers around the country lost National Institutes of Health funding to study vaccine hesitancy. 'I think you have to assume that RFK Jr.'s intention is to make it harder for vaccines to come to market,' said Dr. Amesh Adalja, a vaccine expert at Johns Hopkins University. The changes are 'looked at suspiciously because this is someone with a proven track record of evading the value of vaccines.' Raising doubts about vaccines In a Senate health committee hearing last week, Kennedy wrongly claimed that the only vaccines tested against a placebo, or dummy shot, were for COVID-19. Sen. Bill Cassidy, a Louisiana Republican who chairs the committee, briefly interrupted the hearing to say, 'For the record, that's not true" — pointing to placebo-controlled studies of the rotavirus, measles and HPV vaccines. Concerned by rhetoric about how vaccines are tested, a group of doctors recently compiled a list of more than 120 vaccine clinical trials spanning decades, most of them placebo-controlled, including for shots against polio, hepatitis B, mumps and tetanus. 'It directly debunks the claim that vaccines were never tested against placebo,' said Dr. Jake Scott, a Stanford University infectious disease physician who's helping lead the project. Antivaccine groups argue that some substances scientists call a placebo may not really qualify, although the list shows simple saline shots are common. Sometimes a vaccine causes enough shot-site pain or swelling that it's evident who's getting the vaccine and who's in the control group — and studies might use another option that slightly irritates the skin to keep the test 'blinded,' Scott explained. And when there's already a proven vaccine for the same disease, it's unethical to test a new version against a placebo, he said. 'We can't always expect placebo-controlled trials,' Scott said. 'It's imperative that be communicated clearly to the public, but it's challenging especially when there's so much noise in social media and so much misinformation.' Trump officials held up vaccine decision The administration's promise of a new vaccine framework comes ahead of a Thursday meeting where FDA advisers will discuss updating COVID-19 shots for this fall and winter. The FDA's credibility has long rested on the independence of its scientific decisions. While the agency is led by a handful of political appointees, approval decisions are almost always handled by career scientists. But that standard appears to be shifting. FDA staffers were poised to approve Novavax's vaccine early last month but the decision was delayed by administration officials, including Makary, according to two people with direct knowledge of the situation who spoke on condition of anonymity to discuss agency matters. The shot was approved late Friday with unusual restrictions. Dr. Tracy Beth Hoeg — a political appointee serving as Makary's special assistant — was involved in the unprecedented demand that Novavax conduct a new clinical trial of its shot after approval, according to the people. The requirement came shortly after the agency's longtime vaccine chief, Dr. Peter Marks, was forced to resign. Hoeg — along with Makary and Prasad — spent much of the COVID-19 pandemic criticizing the FDA's handling of booster shots, particularly in children and young adults. All three were co-authors of a 2022 paper stating that requiring booster shots in young people would cause more harm than benefit. Novavax isn't the only vaccine manufacturer already affected by changing attitudes at FDA. Earlier this month, Moderna pushed back the target date for its new COVID-and-flu combination vaccine to next year after the FDA requested additional effectiveness data. COVID-19 booster critics are in control As the FDA's top official overseeing vaccines, Prasad is now in position to reverse what he recently called 'a number of missteps' in how the FDA assessed the benefits and risks of COVID-19 boosters. He questioned how much benefit yearly vaccinations continue to offer. In a podcast shortly before assuming his FDA job, Prasad suggested companies could study about 20,000 older adults in August or September to show if an updated vaccine prevented COVID-related hospitalizations. There is 'legitimate debate about who should be boosted, how frequently they should be boosted and the value of boosting low-risk individuals,' said Hopkins' Adalja. But he stressed that CDC's Advisory Committee on Immunization Practices has the proper expertise to be making those decisions. And other experts say simply updating the strain that a COVID-19 vaccine targets doesn't make it a new product — and real-world data shows each fall's update has offered benefit. "The data are clear and compelling' that vaccination reduces seniors' risk of hospitalization and serious illness for four to six months, said Michael Osterholm, a University of Minnesota infectious disease researcher. Nor could that kind of study be accomplished quickly enough to get millions of people vaccinated before the yearly winter surge, said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. "You'd always be doing clinical trials and you'd never have a vaccine that was up to date,' he said. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
New York Times
17-05-2025
- Health
- New York Times
F.D.A. Approves Novavax Covid Vaccine With Stricter New Conditions
The Food and Drug Administration on Friday approved the Novavax Covid-19 vaccine, but only for older adults and for others over age 12 who have at least one medical condition that puts them at high risk from Covid. Scientific advisers to the Centers for Disease Control and Prevention, who typically make decisions on who should get approved shots and when, have been debating whether to recommend Covid shots only to the most vulnerable Americans. The F.D.A.'s decision appeared to render at least part of their discussion moot. The new restriction will limit access to the Novavax vaccine for people under 65 who are in good health. It may leave Americans who do not have underlying conditions at risk if a more virulent version of the coronavirus were to emerge. It could also limit options for people who want the vaccine for a wide array of reasons, including to protect a vulnerable loved one. The vaccine had previously been authorized under emergency use. Covid vaccines developed by Pfizer-BioNTech and Moderna, which are more widely used by Americans, were granted full approval in 2022. However, the companies are working on updated shots for the fall, and the new restrictions on the Novavax shot portend a more restrictive approach from the F.D.A. The F.D.A.'s new restrictions also appeared to reflect the high degree of skepticism about vaccines from Robert F. Kennedy Jr., the health secretary, and the other leaders he has appointed at health agencies. 'This is incredibly disappointing,' said Dr. Camille Kotton, an infectious disease physician at Massachusetts General Hospital who cares for immunocompromised patients, and a former adviser to the C.D.C. 'I don't know why they would make this restriction; I don't know of any indication to make this change,' Dr. Kotton said, adding that many people are still hospitalized and dying as a result of Covid. 'This is a dark day in American medicine.' The approval of the shot, called Nuvaxovid, requires the company to complete studies on whether the vaccine is associated with several heart conditions. Some of the required research is possible to complete with available data. But one new study would most likely require the company to follow thousands of healthy people who are 50 to 65 years old who take either the vaccine or a placebo. That study could cost tens of millions of dollars, at least, according to people familiar with such work. 'We've got to make sure the vaccine safety is crystal clear to engender public confidence,' said Dr. Ofer Levy, director of the precision vaccine program at Boston Children's Hospital and an adviser to the F.D.A. on vaccines. 'On the other hand, where's that line where you put in too much regulation, it starts to become so challenging that the economics of even making a vaccine are called into question?' Dr. Levy said. 'I don't pretend to know the answer.' The F.D.A. said that a study of the Novavax shot in people younger than 12 is C. Jacobs, the Novavax chief executive, said the approval was a 'significant milestone' solidifying a pathway for the people who are most likely to seek out Covid vaccination to get the company's shot. The new restrictions on the shot could create a raft of problems for those who want the vaccine. For one, the approval document is unclear about what qualifies as an underlying condition. Prescribing the shots in healthy people under 65 would be considered off-label use, making it less likely that insurers would broadly cover the shots. 'I think we're left confused about what this means for the consumer,' said Dr. Paul Offit, a vaccine expert from Children's Hospital of Philadelphia and an adviser to the F.D.A. 'I think the goal of Robert F. Kennedy Jr. is to make vaccines less available, more expensive and more feared,' Dr. Offit said. 'His goal is to tear away at the vaccine infrastructure, because he believes that vaccines are not beneficial and are only harmful.' Approval of the Novavax Covid shot also bucks norms that have been in place since the vaccines were first approved. This is the first time that the F.D.A. has included health criteria for Covid shots. Those decisions are typically made by the C.D.C.'s advisers. Insurance carriers are required to cover vaccines recommended by the advisers, but the panel usually cannot expand the vaccine's use beyond the bounds of the F.D.A. approval. Novavax's Covid shot was the last to become available during the pandemic because of unexpected manufacturing problems. It has been offered under emergency authorization since July 2022. On Thursday, Dr. Marty Makary, who leads the F.D.A., said the agency would soon release a new framework for evaluating Covid shots. A meeting is scheduled for this coming Thursday to select the version of the virus that the fall Covid shots will cover. Nuvaxovid is based on a more traditional vaccine platform, and is generally thought to have fewer side effects. It has served as an attractive alternative for those who are wary of the newer technology used in the mRNA vaccines made by Pfizer-BioNTech and Moderna. 'I have been recommending this vaccine for everyone who is mRNA-vaccine reluctant,' Dr. Kotton said. She said she and her two sons all opted for Novavax last fall, but none of them would qualify under the new criteria.
CNN
17-05-2025
- Health
- CNN
What are your questions about fluoride?
Federal agencies Water availabilityFacebookTweetLink Follow Fluoride can help prevent tooth decay by strengthening the protective outer layer of enamel that's worn away by acids formed by bacteria, plaque and sugars in the mouth. Since 1945, it has been added to many US water systems and is also available in toothpaste and other supplements. Recently, some states have banned it from water due to questions about safety, cost and personal choice. The US Food and Drug Administration also said it's taking steps to remove prescription fluoride tablets and drops from the market. What do you want to know about fluoride and its safety and effectiveness? Share your questions with CNN below.
