COVID mRNA Vaccines Safe, Effective for Babies and Toddlers, Says FDA Staff
Moderna and Pfizer/BioNTech’s COVID-19 vaccines proved safe and effective for kids under 5 years of age, paving the way for immunization of the only age group still awaiting access, according to FDA briefing documents released ahead of 2 days of advisory meetings. On Tuesday, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet […]
Study Leaves Transvaginal Mesh Controversy at Impasse
Transvaginal mesh proved noninferior to native tissue repair for vaginal prolapse but missed the superiority target in an FDA-mandated, postmarket, prospective parallel-cohort study. The 36-month composite treatment success rates were 89.3% with mesh repair and 80.2% with native tissue repair, falling within the prespecified 12% margin for noninferiority but not achieving superiority. However, mesh demonstrated […]
New COVID Vaccines From Canada, China Score in International Trials
A plant-based vaccine developed in Canada and a protein subunit vaccine from China proved safe and effective against symptomatic COVID-19, a pair of phase III trials found. The two-dose plant-based vaccine, a combination of coronavirus-like particles in plants plus an adjuvant, showed 69.5% efficacy (95% CI 56.7-78.8) against any symptomatic disease caused by five pre-Omicron […]
Bifunctional Protein Shows Promise in HPV-Related Cancers
A bifunctional fusion protein with immunotherapeutic activity proved active in advanced, difficult-to-treat cancers associated with human papillomavirus (HPV), according to pooled data from two prospective studies. Overall, 21 of 75 patients had confirmed responses with bintrafusp alfa, which inhibits tumor growth factor-beta (TGF-β) and PD-L1 interaction with its receptor. Responses were durable in many cases […]