The U.S. Food and Drug Administration (FDA) has expanded the approval of GSK’s (GSK.L) respiratory syncytial virus (RSV) vaccine, Arexvy, to include adults aged 50 to 59. This decision makes Arexvy the first RSV vaccine approved for this age group.
Market Leadership and Competitors
Arexvy, along with vaccines from Pfizer (PFE.N) and Moderna (MRNA.O), was previously approved for individuals aged 60 and older. RSV, which typically causes cold-like symptoms, is a significant cause of pneumonia in toddlers and older adults, leading to 177,000 hospitalizations and 14,000 deaths annually in the United States.
Since its launch last year, Arexvy has dominated the U.S. RSV vaccine market, securing a two-thirds market share in the first quarter and outperforming Pfizer’s Abrysvo. Moderna’s RSV vaccine was approved last month, further intensifying market competition.
CDC Approval Pending
The U.S. Centers for Disease Control and Prevention (CDC) has yet to approve the use of GSK’s vaccine for the newly expanded age group. A panel of independent experts from the CDC is scheduled to meet between June 26 and 28 to discuss this matter.
Market Potential and Insurance Coverage
With the FDA’s approval, GSK expects to add 13 million individuals to the eligible pool for Arexvy. The company projects peak annual sales of £3 billion ($3.82 billion) from the vaccine. Leonard Friedland, Director of Scientific Affairs and Public Health, Vaccines at GSK, mentioned that the company does not anticipate any significant insurance barriers for people aged 50-59, as the Affordable Care Act ensures reimbursement for the shot.
Sales Performance and Future Outlook
In 2023, Arexvy generated £1.2 billion in sales, while Pfizer’s Abrysvo earned $890 million. Morningstar analyst Damien Conover predicts that GSK’s vaccine will maintain a dominant share of the over $5-billion-a-year market compared to Pfizer. In April, Pfizer reported that its RSV vaccine succeeded in a trial involving adults under 60 and plans to seek expanded approval for use in adults aged 18 to 59.
Conclusion
The FDA’s expanded approval of GSK’s Arexvy marks a significant milestone in protecting a broader age group from RSV. As the CDC’s decision looms, the market dynamics for RSV vaccines continue to evolve, with GSK positioned to retain its leadership.