Doctors worry about FDA scrutiny of RSV shots to protect babies

Key Points:

• A federal judge in Boston has temporarily blocked Health and Human Services Secretary Robert F. Kennedy Jr.'s proposed cuts to federally backed childhood vaccines and other controversial vaccine policies, creating uncertainty around the Trump administration's vaccine stance.
• RSV (respiratory syncytial virus) is a leading cause of hospitalization in infants, but new monoclonal antibody shots have been about 80% effective in preventing severe RSV cases, with over half of U.S. infants having received them.
• The FDA announced a safety review of these monoclonal antibody shots in December, sparking concern among infectious disease experts who view it as an attempt to undermine vaccines, while some groups highlight reported adverse reactions including fevers, seizures, and deaths.
• Manufacturers Sanofi and Merck assert the shots are safe and that no deaths were linked to the immunizations during clinical trials, but public health experts worry the FDA review could lead to restrictions reducing infant access to RSV protection.
• There is also concern that expanding the federal Vaccine Injury Compensation Program to cover more conditions could discourage vaccination by increasing fears about vaccine safety and liability.