Pfizer and GSK Compete For RSV Vaccine Market

US drugmaker Pfizer and British pharma major GSK are set to face significant competition in the respiratory syncytial virus (RSV) vaccine market. Arexvy, a new vaccine developed by GSK and authorized by the US Food and Drug Administration in May, is the first RSV vaccine approved for use in the United States (1^✔ ✔Trusted Source
FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine

Go to source). It was also recently approved by the European Commission (EC) for the prevention of RSV-related lower respiratory tract infections (LRTI) in adults 60 and older, making it the first RSV vaccine available throughout the EU. Despite these historic approvals, GSK's supremacy in the unexplored RSV vaccine area is threatened by Pfizer, which is aggressively pursuing market share for its own RSV vaccine Abrysvo (2^✔ ✔Trusted Source
FDA Approves Pfizer RSV Vaccine: URMC Researchers at Center of Development

Go to source), according to research by GlobalData, a major data and analytics firm.

Arexvy's First-Mover Advantage in RSV Vaccines

"While Arexvy was first to gain US approval, which marked the first time a vaccine was authorised for use against RSV in any population, anywhere in the world, Pfizer's Abrysvo was approved by the FDA quickly after, allowing sufficient time for both vaccines to be available for US launch around the same time this fall, before the winter RSV season," said Nancy Jaser, Pharma Analyst at GlobalData, in a statement.

"Therefore, GSK is not likely to experience a significant first-mover advantage for market share in the US. However, Arexvy may still benefit from a first-mover advantage in the EU as Pfizer's Abrysvo has yet to gain approval for use by the EC. A decision is expected later this year," Jaser added.

Pfizer's Abrysvo Could be a Leading RSV Vaccine

While both vaccines showed excellent efficacy in pivotal studies, Pfizer's vaccine has a significant edge over Arexvy. Abrysvo is now being evaluated in the United States as a maternal vaccine to protect newborns against RSV at birth. According to the report, the FDA's Vaccines Advisory Committee voted in favor of recommending Abrysvo as a maternal RSV vaccination.

Moderna's RSV vaccine, mRNA-1345, is expected to pose more competition. Positive Phase III data in older adults were released in January, and Moderna plans to apply for US clearance in the first half of 2023.

"Abrysvo will likely be the first approved RSV vaccine to protect infants worldwide, potentially leading to a higher market share than its competitors. It is currently the only vaccine candidate in late-stage development that targets multiple patient segments," Jaser said.

References:

1. FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine - (https://www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine)
2. FDA Approves Pfizer RSV Vaccine: URMC Researchers at Center of Development - (https://www.urmc.rochester.edu/news/story/race-to-rsv-vaccine-approval-urmc-researchers-leading-the-way)

Source-Medindia