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According to the European Centre for Disease Prevention and Control, globally in 2024, about 6,20,000 cases and 213 deaths were reported across multiple continents
India’s apex drug regulatory panel, the Subject Expert Committee (SEC), recently reviewed Zydus’s proposal for an inactivated chikungunya vaccine.
India may soon have its own protection against chikungunya, with leading vaccine makers pushing their candidates into advanced trials and Zydus Life Sciences now joining the race.
India’s apex drug regulatory panel, the Subject Expert Committee (SEC), recently reviewed Zydus’s proposal for an inactivated chikungunya vaccine. The company presented a Phase I/II trial plan. However, regulators have asked to revise the protocol and provide additional data before the first human trials can begin.
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According to the minutes of the meeting of the SEC on vaccines, seen by News18, Zydus has developed its candidate using the chikungunya parent virus strain and completed animal toxicity studies.
The development places Zydus alongside Bharat Biotech, which is already in late-stage testing of its own inactivated vaccine, BBV87, being developed with the International Vaccine Institute and CEPI (Coalition for Epidemic Preparedness Innovations). Bharat Biotech has secured approval to move into Phase III trials after encouraging Phase II results, making it the frontrunner in India’s effort. CEPI is a global partnership launched in 2017 at the World Economic Forum in Davos, set up to finance and coordinate the development of vaccines against emerging infectious diseases and to improve preparedness for future epidemics and pandemics.
Globally, vaccines against chikungunya have begun to reach the market. French company Valneva won US approval in 2023 for its live-attenuated vaccine IXCHIQ, while Bavarian Nordic has introduced VIMKUNYA, a virus-like particle vaccine cleared for use in adolescents and adults. Valneva has also partnered with the Pune-based Serum Institute of India (SII) for regional manufacturing, potentially bringing imported supplies into the country.
According to the World Health Organisation, Chikungunya is a viral illness caused by the chikungunya virus (CHIKV), which belongs to the Alphavirus genus in the Togaviridae family. Transmission occurs primarily via Aedes mosquitoes, especially Aedes aegypti and Aedes albopictus, which bite a person infected with the virus and then spread it to others.
According to the European Centre for Disease Prevention and Control, globally in 2024, about 6,20,000 cases and 213 deaths were reported across multiple continents.
Status of Zydus Vaccine
With the regulator making clear that safety and robust data will be the deciding factors, the document noted that the firm has completed acute and repeat dose toxicity studies to determine the starting dose for the human trial. However, the document said, the firm has not provided a report of any lethal dose challenge study in the animal model or non-human primate model to confirm the protective human dose of the vaccine.
The committee also noted that the firm has not provided a Developmental and Reproductive Toxicology (DART) study report. It pointed out that the firm has not provided immunogenicity data to support the protective dose selection of the vaccine. The expert panel noted that, based on the animal toxicity studies, the firm has proposed to conduct a Phase I followed by a Phase II study as a single-dose/two-dose study depending on the data generated from the Phase I study.
The committee opined that since the vaccine is derived from the parent strain of the chikungunya virus, the Phase I and Phase II studies should be conducted separately to first establish the safety and tolerability of the vaccine in human subjects.
After detailed deliberation, the committee recommended that the firm should submit a revised Phase I protocol addressing the observations, including protective dose selection criteria, for further consideration by the committee.
About the Author
Himani Chandna, Senior Associate Editor at CNN News18, specialises in healthcare and pharmaceuticals. With firsthand insights into India’s COVID-19 battle, she brings a seasoned perspective. She is particular…Read More
Himani Chandna, Senior Associate Editor at CNN News18, specialises in healthcare and pharmaceuticals. With firsthand insights into India’s COVID-19 battle, she brings a seasoned perspective. She is particular… Read More
October 01, 2025, 09:31 IST
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