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FDA Staff Scrutinizes Evidence Supporting Moderna’s Flu Vaccine
Food and Drug Administration scientists evaluating a potentially new messenger RNA flu vaccine from Moderna have expressed skepticism about the evidence supporting its benefits, according to documents filed days before a crucial advisory committee meeting. On Thursday, the FDA will convene a panel of experts to discuss use of the shot, dubbed mFlusiva and in development for seasonal influenza.
Panelists are set to vote on whether the benefits of vaccination outweigh the risks in people either between the ages of 50 and 64, or those who are 65 and older. Moderna hopes the discussion will set the stage for approval of a vaccine U.S. regulators controversially refused to review earlier this year before abruptly changing course.
Documents filed on Tuesday summarize the position of staff scientists and provide a window into how the agency views the data Moderna has compiled to date. They show that reviewers found no “major deficiencies” with the vaccine, but unearthed gaps in evidence that leave unclear how well it works, particularly in the elderly.
UC Irvine Researcher Receives $1.8 Million NIH Grant to Study Cancer Risks From Low-Dose Radiation Exposure
With a $1.8 million grant from the National Cancer Institute, David Richardson, associate dean of research and professor of environmental and occupational health in the Joe C. Wen School of Population & Public Health at the University of California, Irvine, will investigate the long-term cancer risks associated with low-dose exposure to ionizing radiation.
An internationally recognized expert in occupational and environmental health, Richardson designs studies to help researchers identify the causes of disease and generate evidence to prevent it. The five-year award will support research examining an international cohort of more than 300,000 radiation-monitored workers across France, the United Kingdom and the U.S.
The project will extend the existing International Nuclear Workers Study by an additional decade, providing one of the most comprehensive assessments of low-dose radiation exposure and cancer risk to date.
FDA Issues Warning Letter to Maker of Popular Baby Bassinet
The U.S. Food and Drug Administration has sent a warning letter to Happiest Baby, Inc., the manufacturer of the $1,700 SNOO Smart Sleeper baby bassinet, over unauthorized products and quality system violations. The company had been selling new sizes of the sleep sacks used in its bassinets that haven’t been reviewed for safety or effectiveness, the FDA said Monday. It also noted unsanitary conditions, including mold, reported on some items in recent years.
The federal agency considers the SNOO bassinet, which uses movements and sound to help newborns sleep, to be a medical device that falls under its regulation.
“The FDA strongly cautions patients, caregivers and health care providers that the X-Small and X-Large sleep sacks, and the SNOO Hospital Bundle, have not been evaluated for safety and effectiveness by the FDA and pose increased risks as described in the Warning Letter,” the agency said in a social media post on Monday.
USDA Steps Up Screwworm Monitoring as Cases Expand in Texas
The US Department of Agriculture is stepping up its surveillance of New World screwworm, seeking to work with the Department of Homeland Security to contain a growing outbreak threatening the nation’s cattle herd. Agriculture Secretary Brooke Rollins said in a Monday press conference that the two agencies were planning to enter into an official memorandum of understanding this week, which will establish a formal framework for greater collaboration on response efforts to a deadly parasite.
The agency is also looking into utilizing dogs, drones and artificial intelligence to detect larvae and assess where animals may need inspection. The increased monitoring comes as the parasitic fly has stretched beyond an initial control zone in Texas as the number of infections grows to a dozen, adding some urgency to efforts to contain the pest.
The latest cases include a sheep in Sutton County and a head of cattle in Tom Green County, about 200 miles away from the first US case in South Texas, according to the US Department of Agriculture.
