Pfizer's Abrysvo Gains FDA Approval for Younger Adults, Challenging GSK's Market Hold
The FDA has expanded approval of Pfizer's Abrysvo vaccine to include adults aged 18 to 59 who are at increased risk of respiratory syncytial virus (RSV). This expansion positions Abrysvo as the first RSV vaccine in the U.S. available for this younger demographic, who are susceptible to RSV-related lower respiratory tract disease due to chronic conditions such as obesity or diabetes[1][2]. The decision is supported by successful results from the Phase 3 MONeT trial, which demonstrated strong immune responses in at-risk individuals, including the immunocompromised[3][4]. This approval may strengthen Pfizer's position in the RSV vaccine market against competitors such as GSK's Arexvy.
References
- With expanded FDA nod for RSV shot Abrysvo, Pfizer gains edge on GSK's Arexvy. But will it amount to much?
- Pfizer Wins FDA Approval of RSV Vaccine for Broader Adult Population
- Pfizer’s RSV vaccine cleared by FDA for use in some younger adults
- U.S. FDA Approves Pfizer’s RSV Vaccine ABRYSVO® for Adults Aged 18 to 59 at Increased Risk for Disease
Explore Further
How does Pfizer's Abrysvo approval impact the market competition with GSK's Arexvy?
What are the potential implications of the FDA's decision on CDC guidelines for RSV vaccines?
How did the Phase 3 MONeT trial contribute to Abrysvo's expanded approval for younger adults?
What chronic conditions are considered risk factors for younger adults eligible for the Abrysvo vaccine?
How might Pfizer's future research presentations influence CDC recommendations and market dynamics?