CDC Panel: Thumbs Down on Pfizer Booster for Healthcare Workers
The CDC’s Advisory Committee on Immunization Practices (ACIP) voted Thursday to unanimously recommend a booster dose of Pfizer’s COVID-19 vaccine (Comirnaty) for adults ages 65 and up and those in long-term care facilities, as well as for adults ages 50 to 64 with high-risk medical conditions (by a vote of 13-2), but that was where […]
Liver Toxicity in Gene Therapy Trials Could Merit Stricter Entry Criteria
An FDA advisory committee offered up lower vector doses, stricter exclusion criteria, and long-term animal studies to grapple with liver toxicities associated with adeno-associated virus (AAV) vector-based gene therapies. During the second of four sessions on AAV safety, the Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) weighed evidence of hepatotoxicity — ranging from liver […]
After Pandemic Missteps: Senators Seek Lessons for Future Emergencies
Members of the Senate Health, Education, Labor and Pensions (HELP) Committee played the blame game for false steps during the pandemic. At a hearing on Tuesday, HELP committee chair Patty Murray (D-Wash.) said the nation was ill-equipped to respond to the COVID-19 pandemic because of a weak and underfunded public health infrastructure. She called for […]
Safety Concerns Turn FDA Panel Thumbs Down for Novel CKD-Anemia Drug
An FDA advisory committee almost unanimously agreed that the risks were just too high for the chronic kidney disease (CKD)-related anemia drug roxadustat in any patient population. In a 13-1 vote Thursday, members of the Cardiovascular and Renal Drugs Advisory Committee felt that although there’s an unmet need for new anemia therapeutics, this particular drug […]