FDA’s May approvals: an mRNA RSV vax, a bispecific and biosimilars

FDA approved two new modality products in May, an mRNA vaccine and a bispecific antibody.

The mResvia RSV vaccine from Moderna Inc. (NASDAQ:MRNA) is the first mRNA vaccine from any company that is approved for a disease other than COVID-19. The approval was based on efficacy against RSV-associated lower respiratory tract disease (LRTD) of 83.7% with 3.7 months of follow up. Durability of vaccine efficacy has been a question for mRNA vaccines, and the goal of RSV vaccines is for protection to last through at least one season. Moderna has reported additional data since submitting the BLA showing sustained vaccine efficacy of 63.3% through 8.6 months. ...