Wed May 21 14:55:53 UTC 2025: **Summary:**

Bharat Biotech’s oral cholera vaccine, Hillchol, has successfully completed Phase III clinical trials in India. The trials, involving 1,800 participants across age groups, demonstrated the vaccine’s safety, immunogenicity, and non-inferiority compared to existing vaccines. Hillchol showed a significant increase in vibriocidal antibodies and was well-tolerated. With a production capacity of up to 200 million doses annually, Bharat Biotech aims to address the global shortage of oral cholera vaccines, particularly in lower- and middle-income countries.

**News Article:**

**Bharat Biotech’s Oral Cholera Vaccine Hillchol Proves Successful in Phase III Trials**

**HYDERABAD, INDIA – May 21, 2025** – Indian vaccine manufacturer Bharat Biotech announced today the successful completion of Phase III clinical trials for its oral cholera vaccine, Hillchol (BBV131). The trials, conducted across 10 clinical sites in India, demonstrated the vaccine’s safety, immunogenicity, and efficacy in a diverse participant group ranging from infants to adults.

The double-blind, randomised study compared Hillchol to an existing cholera vaccine, Shanchol, and found it to be non-inferior. Participants who received Hillchol showed a greater than four-fold increase in vibriocidal antibodies against both Ogawa and Inaba serotypes, key indicators of protection against cholera. Adverse events were mild and comparable between the two vaccines, indicating a favorable safety profile.

“The publication reaffirms our commitment to advancing vaccines built on rigorous research, thorough clinical trials and reliable clinical data,” said Bharat Biotech Executive Chairman Krishna Ella. “It highlights our continued commitment to providing affordable, effective and accessible vaccines for the populations who need them the most.”

Cholera, a vaccine-preventable disease, has seen a resurgence in outbreaks globally, exacerbating existing vaccine shortages. Hillchol, featuring a simplified single stable O1 Hikojima strain, aims to improve production efficiency and affordability, particularly for vulnerable populations in lower- and middle-income countries where waterborne diseases remain a major health threat.

With a production capacity of up to 200 million doses annually at its facilities in Hyderabad and Bhubaneswar, Bharat Biotech is poised to significantly contribute to addressing the global demand for oral cholera vaccines, currently estimated at nearly 100 million doses per year. Hillchol has already received market authorization in India and is expected to be distributed within the next few months.

The study findings have been published in the journal *Vaccine* on ScienceDirect.

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