Sanofi presented data of its anticipated multi-billion blockbuster, Beyfortus, demonstrating consistent efficacy in pediatrics.
Sanofi presented the full cohort data of the Phase 3 MELODY study, evaluating the efficacy of Beyfortus (nirsevimab), a long-acting antibody designed to prevent RSV infection in infants.
Beyfortus reduced the medically attended RSV lower respiratory tract infections by 80%. It has a similar safety profile as a placebo.
Beyfortus was developed by Sanofi and AstraZeneca and is the protective option that has been approved in Europe and the United Kingdom. The drug should be administered before the RSV season.
Pfizer is aiming to bring the first maternal RSV vaccine to the market.
Pfizer announced that the U.S. Food and Drug Administration (FDA) accepted the biological license application of maternal Respiratory Syncytial Virus for priority review. Pfizer is developing PF-06928316 or RSVpreF vaccine to prevent the medically attended lower respiratory tract illness caused by RSV in infants by immunizing pregnant individuals.
Pfizer is submitting the Phase 3 trial MATISSE results to support the regulatory applications. Pfizer announced that it would present the data at the ReSViNET conference.
Pfizer has submitted a marketing authorization application (MAA) under accelerated assessment for its RSV candidate in Europe.
Moderna to present the data of its mRNA RSV vaccine candidate.
Moderna has announced that it will present its mRNA RSV vaccine's top-line safety and efficacy data at the ReSViNET conference. Moderna is conducting the Phase 3 trial to evaluate the efficacy in older adults.
Moderna is developing vaccines for pediatrics and is in Phase 1.