Source – Bavarian Nordic
Bavarian Nordic has achieved a significant milestone with its chikungunya virus vaccine candidate, marking its second successful Phase III trial victory. Following encouraging results in older adults, the biotech company has now unveiled pivotal outcomes in younger adults. This accomplishment positions Bavarian Nordic to seek regulatory approval next year, intensifying the competition with Valneva in the emerging market.
Valneva has been at the forefront of the race to develop a chikungunya virus vaccine. With an upcoming FDA decision later this month, the French biotech could potentially secure the distinction of sponsoring the first approved chikungunya vaccine in the US. This achievement could come with the added benefit of obtaining a priority review voucher. However, Bavarian Nordic’s recent data signifies that Valneva might face a formidable challenge in terms of market share.
Bavarian Nordic entered this competitive arena through a substantial $380 million deal, a strategic move that has positioned it as a strong contender against Valneva. In its second Phase III trial, the Danish pharmaceutical company observed an impressive “strong induction” of neutralizing antibodies in 98% of vaccine recipients just 22 days after administration. Furthermore, a substantial 97% of subjects exhibited significant antibody levels just 14 days after vaccination.
What sets Bavarian Nordic’s approach apart is the speed of the immune response. Valneva had established a high standard for response rates by reporting seroprotective chikungunya virus neutralizing antibody levels in 99% of subjects. However, Valneva’s Phase III trial measured antibody levels 28 days after vaccination for the primary evaluation, whereas Bavarian Nordic examined antibody levels 14 days after vaccination, revealing a potentially quicker response time. Immune responses for Bavarian Nordic surged between day eight and day 29, resulting in a remarkable increase in antibody titers for subjects aged 18 to 64.
Another pivotal aspect of consideration is the durability of the vaccine’s effect. Both Bavarian Nordic and Valneva observed a decline in antibody levels after the initial analysis, but both managed to demonstrate sustained protection for at least six months. Impressively, Bavarian Nordic’s clinical trial revealed that 86% of subjects retained seroprotective levels of neutralizing antibodies during the six-month analysis.
Looking ahead, Bavarian Nordic has ambitious plans to file for regulatory approval in both the US and European Union in the coming year, aiming to introduce the vaccine to the market by 2025. This timeline suggests that Valneva might have an initial head start of over a year in the US, Bavarian Nordic’s competitive offering and faster response times could potentially reshape the landscape of chikungunya virus vaccination.
