Bharat Biotech Starts Massive 26,000-Participant Phase III Trials for COVAXIN

NEW DELHI: Bharat Biotech International Ltd has started the massive phase 3 of clinical trials of its covid-19 vaccine ‘Covaxin’. The company plans to enrol 26,000 participants in total, making it the first phase 3 efficacy study for a covid-19 vaccine and the largest efficacy trial ever conducted in India.

 

As part of the trial, 26,000 participants will be enrolled at 25 trial sites across the country over the coming months. Trial volunteers will then receive two intramuscular injections about 28 days apart.

 

Volunteers who wish to participate in this trial should be over 18 years of age. Participants will be randomly assigned equally to receive either two 6 microgram (mcg) injections of Covaxin or two shots of a placebo. 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, the company said in a statement.

Covaxin has so far been evaluated in 1,000 participants in Phase 1 and 2 clinical trials, with the company saying that the results showed promising safety and immunogencity data.

 

Of the 25 sites, eight have received approval from their respective ethics committees for the clinical trial, according to data on the government’s clinical trial registry. As per clinical trial norms, each trial site has its own ethics committee which monitors whether the trial conducted at the centre is meeting ethics and the study protocol.

 

On Wednesday, Aligarh Muslim University (AMU) vice chancellor Tariq Mansoor said he has got himself registered to be the first volunteer for the trials at the university.

 

According to trial protocol, the primary end-point of the late-stage trial, used to determine the efficacy of a vaccine, will be to see if the two-dose shot can prevent a patient from developing symptoms of covid-19. The secondary end-point will be to measure how effective the vaccine is in avoiding severe symptoms of the disease in a patient, and death.

Bharat Biotech executive director Sai Prasad had last month said the company plans to launch its covid-19 vaccine–Covaxin–by June next year, unless the government decides to give the vaccine an emergency use authorisation before that, based on data from earlier phases of clinical trials.

 

If the efficacy data is robust, it could be launched as early as February, making it the second vaccine likely to be launched in India after Serum Institute of India’s Covishield.

 

The company is spending around ₹150 crore on phase 3 trial and another ₹120-150 crore in setting up a new facility that will be operational by December, Prasad had said.

 

Bharat Biotech has started manufacturing some doses at-risk at its Hyderabad plant, using its current capacity of around 150 million doses per annum.

Apart from setting up a new plant, the company is also exploring using a third facility for production of Covaxin.

 

“We’re also exploring in another city in India where we have access to a large scale facility like the one that we have in Hyderabad for manufacturing Covaxin and using that (and the new plant), scale it up even north of 500 million to 1 billion doses per annum,” Prasad had said.