Valneva nears the Chikungunya finish line

If Valneva manages to avoid manufacturing issues – witness Gilead and Mallinckrodt’s failings here – it will have the first approved vaccine for Chikungunya, beating the likes of Merck & Co to the finish line. Six-month follow-up data from the pivotal trial of VLA1553 show that the vaccine’s efficacy appears to have held up, with protective neutralising antibody titres seen in 98.9% of subjects after one month and in 96.3% after six. Importantly, safety questions have been answered; only 2% of participants in the 3,082-patient trial reported severe adverse effects, mostly fever. And, while half of subjects experienced side effects, most were mild or moderate including headache, fatigue and muscle pain. An FDA submission is planned for the second half of 2022, and with breakthrough therapy and fast-track designations, Stifel analysts are forecasting a 2023 launch and $150m of sales in 2028. Approval will be welcome news given the slow progress of Valneva’s Covid vaccine. However, for VLA1553 to hit its forecasts the group will need a pick-up in international travel, whose slowdown has hit its Japanese encephalitis and cholera vaccines. Government contracts will also need to be secured where Chikungunya is endemic.  

Chikungunya vaccines/treatments in clinical development
Project Company Description Trial details
VLA1553 Valneva Live-attenuated virus vaccine Pivotal VLA1553-301 trial met primary endpoint
PXVX0317 Emergent Biosolutions Virus-like particle vaccine Ph3 completes Mar 2022
BBV87 Bharat Biotech/International Vaccine Institute Inactivated whole virion vaccine Ph2/3 completes Dec 2022
V184 Merck & Co (via Themis) Live recombinant measles-vectored vaccine Ph2 completed Jun 2021
EVT894 Evotec Antiviral MAb Ph1 initiated Jan 2021
Source: Evaluate Pharma & company statements.

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