Bharat Biotech announces commencement of phase 1 clinical trials of India's first Covid-19 vaccine

Hyderabad based Bharat Biotech has announced the initiation of phase-1 clinical trials of India’s first indigenous Covid-19 vaccine Covaxin.

It may be recalled that Bharat Biotech International Limited has, on 29 June, announced that it had “successfully developed Covaxin, India’s first vaccine candidate for Covid-19”, in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).

“Phase-1 trials began across the country on 15 July. This is a randomized, double-blind, placebo-controlled clinical trial in 375 volunteers in India,” the company stated.

Double-blind testing is a trial process especially of a drug where the dose content (test vaccine or placebo) is revealed neither to the subject/volunteer nor the administrator.

The SARS-CoV-2 strain was isolated in NIV, Pune, and transferred to Bharat Biotech. The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Biosafety Level 3) high containment facility located in the Genome Valley, Hyderabad.

The Drug Controller General of India, Ministry of Health and Family Welfare granted permission for initiation of Phase I and II human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response, the company said.

Bharat Biotech had, at that time, announced human clinical trials as scheduled to begin across India in July 2020.

However, controversy broke out a few days later, with a letter from the ICMR Director General Balram Bhargava stating that the vaccine is envisaged to be launched for public health use by 15 August, “after completion of all clinical trials.”

“BBIL is working expeditiously to meet the target, however, the final outcome will depend on the cooperation of all the clinical trial sites involved in this project,” the letter dated July 2 from Bhargava to all the partners in the project.

It has, further, “strictly advised” trial sites to “fast track all approvals related to initiation of the clinical trial and ensure that the subject enrollment is initiated no later than July 7.”

A section of experts and opposition parties criticized the government for “rushing through an elaborate and time taking vaccine testing process.”

ICMR later clarified that the DG's letter “was meant to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants.”

The Nizam's Institute of Medical Sciences in Hyderabad and the King George Hospital in Visakhapatnam are among the 12 trial sites. NIMS reportedly commenced the process on July 7.