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Int'l Business Times
02-07-2025
- Health
- Int'l Business Times
RFK Jr Declares 'Stop Trusting Experts' as He Pledges AI Revamp for HHS: 'You Can Do Drug Approvals Quickly With AI'
Health Secretary Robert F. Kennedy Jr. is facing renewed scrutiny after declaring the public should "stop trusting experts" while unveiling his plans to integrate artificial intelligence across federal health agencies, including accelerating drug approvals at the FDA. Speaking on "The Tucker Carlson Show" on Monday, Kennedy said he is leading an "AI revolution" within the Department of Health and Human Services, enlisting tech talent from Silicon Valley to overhaul outdated systems like the Vaccine Adverse Event Reporting System (VAERS). His goal, he explained, is to automate and streamline processes like drug approvals without relying on animal testing, arguing that AI tools can achieve results "very, very quickly." "We are at the cutting edge of AI," Kennedy said. "We're implementing it in all of our departments. At FDA, we're accelerating drug approvals so that you don't need to use primates or even animal models. You can do the drug approvals very, very quickly with AI." Kennedy's remarks included sweeping criticisms of the scientific establishment, including the assertion that trusting public health experts is "not a feature of science," but instead akin to "totalitarianism." He claimed that Americans were wrongly discouraged from conducting their own COVID-19 research, adding, "We need to stop trusting the experts, right?" While Kennedy did not specify which AI systems would be used for drug approvals, he suggested the agency would move away from traditional clinical models in favor of simulated testing. During the interview, he repeated misleading claims about COVID-19 vaccine trials, suggested former Director of the National Institute of Allergy and Infectious Diseases Anthony Fauci should face legal consequences and called for a national "truth commission" to investigate the government's pandemic response. While Kennedy says the agency is actively recruiting engineers and data scientists for his AI initiative, he has yet to announce any formal rule changes or provide technical guidance for how AI would meet existing regulatory standards. Originally published on Latin Times
Indianapolis Star
13-05-2025
- Health
- Indianapolis Star
Feds recommend pausing vaccine for mosquito-borne disease chikungunya in people over 60
Federal drug safety officials have recommended pausing the use of a vaccine for a mosquito-borne disease known as chikungunya for people over 60 following reports of serious adverse events. The U.S. Food and Drug Administration said that 17 serious adverse events, including two that resulted in death, have been reported in worldwide recipients of the vaccine Ixchiq over the age of 60. Six of the events occurred in the United States, the FDA said in a safety communication on Monday, May 12. Domestic and global cases have been reported to the Vaccine Adverse Event Reporting System, run by the FDA and the U.S. Centers for Disease Control to flag potential safety problems with vaccines. The reported cases were in individuals with underlying chronic medical conditions and the adverse events "may not be causally related to vaccination," the FDA said. The vaccine's maker, Valneva, said in a statement that it is "upholding the highest safety standards" and pointed to the potential for underlying conditions and other medications as contributing factors in the adverse events. "Thorough evaluation of these cases is critical to ensure the safe use of Ixchiq," the company said. French drug regulators updated their recommendations for Ixchiq in April and the European Medicines Agency announced that its safety committee had launched a review of the vaccine earlier this month and prohibited its use in people 65 and older, according to the Center for Infectious Disease Research and Policy at the University of Minnesota. Chikungunya is a mosquito-borne illness named for the joint pain it causes, according to the Cleveland Clinic. Most people infected by a mosquito bite recover from the illness in about one week, but some have lasting joint pain – the clinic says. There is no cure for the disease and treatment focuses on managing symptoms inlcuding: The FDA approved Ixchiq for the prevention of the disease in adults over 18 in November 2023. It uses a live, though weakened, version of the virus that may cause symptoms similar to the disease, according to the FDA. The FDA said that some of the reported adverse events were consistent with severe complications of chikungunya disease.
USA Today
13-05-2025
- Health
- USA Today
Feds recommend pausing vaccine for mosquito-borne disease chikungunya in people over 60
Feds recommend pausing vaccine for mosquito-borne disease chikungunya in people over 60 Show Caption Hide Caption Trump to sign order to cut prices of medicines Donald Trump said he would sign an order to cut prescription prices to the levels paid by other nations. Federal drug safety officials have recommended pausing the use of a vaccine for a mosquito-borne disease known as chikungunya for people over 60 following reports of serious adverse events. The U.S. Food and Drug Administration said that 17 serious adverse events, including two that resulted in death, have been reported in worldwide recipients of the vaccine Ixchiq over the age of 60. Six of the events occurred in the United States, the FDA said in a safety communication on Monday, May 12. Domestic and global cases have been reported to the Vaccine Adverse Event Reporting System, run by the FDA and the U.S. Centers for Disease Control to flag potential safety problems with vaccines. The reported cases were in individuals with underlying chronic medical conditions and the adverse events "may not be causally related to vaccination," the FDA said. The vaccine's maker, Valneva, said in a statement that it is "upholding the highest safety standards" and pointed to the potential for underlying conditions and other medications as contributing factors in the adverse events. "Thorough evaluation of these cases is critical to ensure the safe use of Ixchiq," the company said. French drug regulators updated their recommendations for Ixchiq in April and the European Medicines Agency announced that its safety committee had launched a review of the vaccine earlier this month and prohibited its use in people 65 and older, according to the Center for Infectious Disease Research and Policy at the University of Minnesota. What is chikungunya? Chikungunya is a mosquito-borne illness named for the joint pain it causes, according to the Cleveland Clinic. Most people infected by a mosquito bite recover from the illness in about one week, but some have lasting joint pain – the clinic says. There is no cure for the disease and treatment focuses on managing symptoms inlcuding: Headache Muscle pain Swelling in joints Rash Fatigue Nausea The FDA approved Ixchiq for the prevention of the disease in adults over 18 in November 2023. It uses a live, though weakened, version of the virus that may cause symptoms similar to the disease, according to the FDA. The FDA said that some of the reported adverse events were consistent with severe complications of chikungunya disease. The FDA said it will conduct an updated benefit-risk assessment for the use of Ixchiq in the 60-and-up age bracket and that both the agency and the CDC will continue monitoring safety reports for the vaccine.
Yahoo
13-05-2025
- Health
- Yahoo
Feds recommend pausing vaccine for mosquito-borne disease chikungunya in people over 60
Federal drug safety officials have recommended pausing the use of a vaccine for a mosquito-borne disease known as chikungunya for people over 60 following reports of serious adverse events. The U.S. Food and Drug Administration said that 17 serious adverse events, including two that resulted in death, have been reported in worldwide recipients of the vaccine Ixchiq over the age of 60. Six of the events occurred in the United States, the FDA said in a safety communication on Monday, May 12. Domestic and global cases have been reported to the Vaccine Adverse Event Reporting System, run by the FDA and the U.S. Centers for Disease Control to flag potential safety problems with vaccines. The reported cases were in individuals with underlying chronic medical conditions and the adverse events "may not be causally related to vaccination," the FDA said. The vaccine's maker, Valneva, said in a statement that it is "upholding the highest safety standards" and pointed to the potential for underlying conditions and other medications as contributing factors in the adverse events. "Thorough evaluation of these cases is critical to ensure the safe use of Ixchiq," the company said. French drug regulators updated their recommendations for Ixchiq in April and the European Medicines Agency announced that its safety committee had launched a review of the vaccine earlier this month and prohibited its use in people 65 and older, according to the Center for Infectious Disease Research and Policy at the University of Minnesota. Chikungunya is a mosquito-borne illness named for the joint pain it causes, according to the Cleveland Clinic. Most people infected by a mosquito bite recover from the illness in about one week, but some have lasting joint pain – the clinic says. There is no cure for the disease and treatment focuses on managing symptoms inlcuding: Headache Muscle pain Swelling in joints Rash Fatigue Nausea The FDA approved Ixchiq for the prevention of the disease in adults over 18 in November 2023. It uses a live, though weakened, version of the virus that may cause symptoms similar to the disease, according to the FDA. The FDA said that some of the reported adverse events were consistent with severe complications of chikungunya disease. The FDA said it will conduct an updated benefit-risk assessment for the use of Ixchiq in the 60-and-up age bracket and that both the agency and the CDC will continue monitoring safety reports for the vaccine. This article originally appeared on USA TODAY: Feds recommend pause for chikungunya vaccine in people over 60
Boston Globe
07-05-2025
- Health
- Boston Globe
RFK Jr.'s effort to undermine COVID boosters is unethical
Advertisement The Washington Post Get The Gavel A weekly SCOTUS explainer newsletter by columnist Kimberly Atkins Stohr. Enter Email Sign Up 'At this point in time, our standard of care has been placebo-controlled trials,' said Jodie Guest, professor and senior vice chair of the department of epidemiology at the Rollins School of Public Health at Emory University. The concern is over how Kennedy will define 'new.' It's not clear if the requirement would apply to updates of existing vaccines. For example, the pneumococcal, Hib, and measles vaccines have all been improved over the years. Most urgently, there are two vaccines — against flu and COVID — that are updated annually. The basic platform of the vaccine remains the same, but the vaccine is changed slightly to better match the strains of illness expected to be circulating in the upcoming season. Advertisement The The original COVID vaccines were tested in clinical trials against placebos. But the annual COVID booster shots, similar to flu shots, are tested by giving the shots to a test population then drawing blood and measuring antibody levels, which are correlated to how much protection the person has against disease. That type of testing involves fewer people and far less time than placebo testing. Kennedy's proposal to potentially require placebo studies for COVID boosters is neither ethical nor effective. As laid out by Advertisement Guest said requiring new placebo-based clinical trials of COVID-19 boosters would also probably take so long that it would be impossible to release annual updates — which, of course, may be exactly what Kennedy intended. To be sure, scientists and public health officials should continue studying COVID boosters over the long term to ensure they are safe and effective. Scientists should be measuring the shots' impact on illness transmission and severity among different populations, from children to the elderly, and making recommendations accordingly. They should be monitoring reports of side effects to the national Vaccine Adverse Event Reporting System and claims made to the National Vaccine Injury Compensation Fund, along with relevant research by other government-based projects that monitor and research vaccine safety. There may certainly be ways to improve safety monitoring for all vaccines — for example, making it easy for vaccine recipients to report side effects via mobile app or structuring databases so researchers can easily search for trends. With any vaccine, doctors should be honest about the risks and benefits so patients and families can make educated decisions. As the Trump administration slashes government budgets, the best way to ensure vaccines remain safe and effective is by keeping in place the staff and infrastructure needed to develop, monitor, and approve vaccines. This means maintaining the databases and Advertisement But adding testing requirements that aren't science-based will only harm Americans' ability to choose the health care that's right for them. Editorials represent the views of the Boston Globe Editorial Board. Follow us
