
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. |