In a monumental stride forward, U.S. regulators have granted approval to the first vaccine designed to safeguard against respiratory syncytial virus (RSV), marking a watershed moment in the relentless six-decade endeavor to shield vulnerable individuals from this ailment.
The vaccine, named Arexvy and developed by pharmaceutical leader GSK, has been given the green light by the Food and Drug Administration (FDA) to protect adults aged 60 and above. This approval heralds the initiation of a new era in RSV prevention. Pfizer's vaccine is also on the cusp of approval, with considerations for safeguarding older adults and pregnant individuals, as well as providing maternal vaccination to shield newborns. Furthermore, an innovative monoclonal antibody treatment crafted by Sanofi and AstraZeneca, aiming to provide vaccine-like protection during the winter RSV season for babies, is under evaluation.
GSK's Arexvy is poised to be introduced in the fall, just ahead of the winter RSV season, with an ample supply ready for distribution. The vaccine demonstrated its potency in a significant clinical trial involving nearly 25,000 participants. Administered prior to the RSV season, it exhibited an impressive 83 percent protection against deep lung RSV infection, accompanied by even more robust defense against severe illness. These remarkable outcomes were documented in this year's New England Journal of Medicine.
The company’s chief commercial officer, Luke Miels, told Reuters that the vaccine would cost above $120 a shot, if an upcoming study shows the vaccine offers protection for two RSV seasons. This progress is particularly timely, as public awareness about wintertime respiratory diseases is elevated due to the challenges faced during last year's severe RSV season, which strained children's hospitals nationwide. While RSV is akin to a seasonal cold for most healthy individuals, it thrusts infants into intensive care units, triggering breathlessness, and sends over 60,000 older adults to hospitals annually. The virus claims 6,000 to 10,000 lives among adults aged 65 and older, as indicated by the FDA.
This milestone in vaccine development holds promise for a healthier future, signaling a victory against a persistent adversary. By offering protection against a virus responsible for severe illness and death, this breakthrough stands as a triumph for humanity's ongoing battle for improved public health and well-being.
Sources: Sunny, Mariam. Reuters. "US FDA approves first RSV vaccine from GSK", https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-first-rsv-vaccine-gsk-2023-05-03/ May 8, 2023. [Date accessed: May 10th 2023]
FDA. "FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine". https://www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine. May 03, 2023. [Accessed: May 7th 2023]
Walmsley, Emma. "Q1 2023 Results". https://www.gsk.com/media/10017/q1-2023-slides.pdf. 26 April 2023. [Accessed: May 1 2023].
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