Bharat Biotech begins Phase-III trials for COVID-19 vaccine, Covaxin, with 26,000 volunteers

HYDERABAD: Bharat Biotech International announced the commencement of phase-III clinical trial of Covaxin, the Covid-19 vaccine candidate it has developed with Indian Council of Medical Research (ICMR).

The trial, being touted as the country's largest-ever phase-III efficacy study, involves 26,000 volunteers across 25 centres in India.

"This is India's first phase-III efficacy study for a Covid-19 vaccine, and the largest phase-III efficacy trial ever conducted in India," said Bharat Biotech in a statement on Monday, adding that the trial was registered at ICMR and approved by the Drugs Controller General of India.


Hyderabad-headquartered Bharat Biotech said the participating volunteers who undergo vaccination in this phase of the trial will be monitored over the next one year to detect occurrence of Covid-19, the disease caused by the SARS-CoV-2 virus.

"Trial volunteers will receive two intramuscular injections approximately 28 days apart. Participants will be randomly assigned 1:1 to receive either two 6 microgram (mcg) injections of Covaxin or two shots of a placebo," said the company. "The trial is double blinded, such that the investigators, the participants and the company will not be aware of who is assigned to which group."

Covaxin is being developed and manufactured at Bharat Biotech's BSL-3 (Bio-Safety Level 3) high containment facility on the outskirts of Hyderabad. The vaccine maker said Covaxin is a highly purified and inactivated vaccine, manufactured in a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses supplied. Bharat Biotech said Covaxin was evaluated in around 1,000 subjects in Phase-I and II clinical trials, with promising safety and immunogenicity data.

Addressing an annual conference of ISB, on Monday, Bharat Biotech founder Krishna Ella said one of the challenges in vaccinating 1.3 billion Indians is the requirement of over 2.6 billion syringes and needles.