Covaxin’s Phase 3 trials results likely next month

The results of third phase trials of India’s first indigenously developed Covid-19 vaccine Covaxin are expected to be released next month.

Covaxin manufacturer Bharat Biotech said its service provider, IQVIA, has started final statistical analysis.

Raches Ella, who leads the Covid-19 projects at Bharat Biotech, tweeted that after submitting efficacy and 2-months of safety to Central Drugs Standard Control Organisation (CDSCO) in July, it is expected to instantly reach pre-print server. Peer review will take another 2-4 months.

Ella made a series of tweets on the status of the long awaited results from third phase and this comes amid a raging debate on a recent pre-print study which said that while both Covaxin and Covishield showed a good immune response after two doses, Covishield produced more antibodies than Covaxin.

He termed phase 3 trials as the largest efficacy trial conducted in the developing world with sample size of 25,800.

“The last participant (participant #25,800) received the second dose in Mid March, add two months (based on CDSCO/FDA requirements for 2-months post-dose-2 safety follow-up), and we are in Mid May with sufficient data for quality checks and analysis,” he wrote.

Ella also revealed about the massive data generated from the trials. “Data captured thus far: each participant has 30 separate forms and with 25,800 participants individual data pointsp.4 Lakh. Quality (query) checks completed 2.1 Lakh. Thanks to the courageous investigators and field staff (350), ensuring compliance in the midst of the second wave.”

He also claimed that nine publications on Covaxin are a testament to Bharat and ICMR’s scientific prowess. “The efficacy paper will be our 10th. If you are looking for Covid vaccine data generated in India, rest assured you will only find Covaxin. Thank you for the support, and stay safe,” Ella added.

Meanwhile, Suchitra Ella, Joint Managing Director of Bharat Biotech, has tweeted that Covaxin has reached private hospitals in as many as 28 cities in India. The supplies were made between June 1 and June 7.