UNITED KINGDOM —European regulators have granted approval for the first vaccine targeting respiratory syncytial virus (RSV) in the region.
Developed by British pharmaceutical company GSK, the vaccine named Arexvy aims to safeguard individuals aged 60 and above from this respiratory illness.
RSV typically manifests as cold-like symptoms but poses a greater threat by causing pneumonia, particularly in toddlers and the elderly.
Efforts to develop an effective RSV vaccine have been hindered for decades due to the complex molecular structure of the virus and safety concerns associated with previous vaccine attempts since its discovery in 1956.
However, the recent endorsement from the European Medicines Agency and subsequent approval by the European Commission have paved the way for Arexvy’s introduction. The vaccine received authorization from the U.S. health regulator approximately a month ago.
GSK anticipates launching Arexvy in Europe this autumn, ahead of the 2023/2024 RSV season, pending national recommendations and reimbursement discussions.
However, GSK’s Chief Commercial Officer Luke Miels noted that a substantial rollout across Europe is not expected this year, as stated in his interview with Reuters last month.
As one of the world’s largest vaccine manufacturers, GSK is strategically relying on Arexvy to drive long-term growth, particularly considering the impending loss of patent protection for a key HIV compound and setbacks in its marketed oncology portfolio.
In a parallel development, Pfizer, a rival pharmaceutical company, also received approval from the U.S. Food and Drug Administration for their similar RSV vaccine called Abrysvo just last week.
However, due to variations in the trial endpoints between GSK and Pfizer, it is challenging to make a direct comparison of efficacy.
The race for a share of the estimated US$13 billion global market for respiratory syncytial virus (RSV) vaccines has intensified between GSK and Pfizer.
According to the projections of Jefferies analyst Peter Welford, this lucrative market has the potential to generate substantial revenue.
Welford predicts that GSK’s Arexvy will reach its peak global sales at around US$4 billion, reflecting the confidence in its market potential.
While Pfizer poses formidable competition, TD Cowen analyst Steve Scala suggests that GSK remains optimistic about its ability to capture more than half of the adult RSV market.
The ongoing competition between these pharmaceutical giants will ultimately shape the dynamics of the RSV vaccine landscape.
Within Europe, the impact of RSV cannot be understated. Annually, the virus leads to over 270,000 hospitalizations and approximately 20,000 in-hospital deaths among adults over the age of 60.
The approval of Arexvy marks a significant milestone in addressing this pressing health burden. It offers a new weapon in combating RSV-related illnesses, providing hope for reducing the devastating consequences experienced by individuals in the region.
Excitingly, more RSV vaccines are on the horizon. Moderna, renowned for its mRNA technology, is nearing the completion of its Phase 3 trial for an mRNA-based RSV vaccine targeting older adults.
The company expects to submit the trial results to the U.S. Food and Drug Administration in the coming months, signaling the potential for another innovative vaccine to enter the market.
Additionally, Bavarian Nordic is also making progress in the development of an RSV vaccine specifically designed for older adults.
The company plans to report the results from its Phase 3 trial later this year, further expanding the pool of potential options for combating RSV.
For all the latest healthcare industry news from Africa and the World, subscribe to our NEWSLETTER, and YouTube Channel, follow us on Twitter and LinkedIn, and like us on Facebook.
