The FDA has postponed its decision on Valneva’s chikungunya vaccine candidate, VLA1553, moving the PDUFA action date to the end of November, as confirmed by Valneva on Monday. The initial decision was scheduled for the end of August.
This extension was granted to provide ample time to harmonize and finalize a phase 4 trial, essential for the agency’s accelerated approval process, as per Valneva’s statement. No additional clinical data was requested by the FDA for the application process.
Valneva’s VLA1553, a live-attenuated vaccine under investigation, holds potential to be the “first vaccine approved via the accelerated route for an outbreak disease,” stated Juan Carlos Jaramillo, Valneva’s Chief Medical Officer. This underscores the significance of its Phase IV design, which could set a benchmark for future industry standards.
Despite this setback, Valneva anticipates the vaccine’s release in 2023, contingent on its approval. This postponement doesn’t impinge on its regulatory applications in other regions.
In June 2023, Valneva, the French biotech firm, revealed Phase III results, indicating that VLA1553 stimulates a robust immune response. As documented in The Lancet, the vaccine provided seroprotection for 98.6% of adults between 18 to 64 and 100% for those aged 65 and over.
Notably, VLA1553 can be administered as a one-time dose, offering immunity within weeks, vital for halting chikungunya outbreaks.
This delay might offer Bavarian Nordic, a major competitor, an opportunity to narrow the gap. The Danish biotech recently disclosed Phase III results for its vaccine, CHIKV VLP. This vaccine induced chikungunya antibodies in 98% of participants aged 12 to 64.
Furthermore, 97% of vaccinated individuals exhibited these antibodies within a fortnight post-vaccination, signifying a “swift initiation of protective immunity levels,” as per the company’s release.
In June 2023, it was also confirmed that Bavarian Nordic’s vaccine was effective for seniors aged 65 and over.
Bavarian Nordic aims to leverage these findings for future regulatory submissions, eyeing a potential product release by 2025.
Valneva and Bavarian Nordic lead the quest to introduce a chikungunya vaccine. This follows Merck’s exit from its chikungunya initiative in February 2023. As Fierce Biotech reported, a Merck representative attributed this decision to standard pipeline reshuffling.