Bharat Biotech International Limited – a multidimensional biotechnology company specialising in product-oriented research and development – has started phase three clinical trials of its Covid-19 vaccine, Covaxin, on a large scale.
The company plans to enroll a total of 26,000 participants in the largest efficacy test conducted in India and the first phase three clinical trials of the Covid-19 vaccine.
As part of the trials, the participants will sign up at 25 trial sites across India in the next few months.
The volunteers will then take two doses of the vaccine at intervals of about 28 days.
Volunteers wishing to take part in this test must be over 18 years of age. Participants will be randomly divided to receive two six-micrograms (MCG) injections of Covaxin or two placebo shots.
A statement from the agency said the trial will be kept confidential, as investigators, volunteers and the company will not know who was placed in which groups.
So far, Covaxin has been tested on 1,000 participants in the first and second stage clinical trials and the agency says the vaccine has shown promising protection and immunity.
According to the government's clinical trial registry, eight of the 25 sites have received approval from their respective ethics committees for clinical trials.
According to the clinical trial criteria, each trial site has its own ethics committee that monitors whether the conducted trial is complying with ethics and research protocols.
Aligarh Muslim University (AMU) Vice-chancellor Tariq Mansoor said on Wednesday that he has registered as the first volunteer for the trial at the university.
According to the trial protocol, the final stage test to determine the effectiveness of a vaccine will first look at whether two-dose shots can prevent a patient from developing symptoms of Covid-19.
Secondly, the effectiveness of the vaccine at preventing severe Covid-19 symptoms and death in a patient will be measured.
Sai Prasad, executive director of Bharat Biotech, said last month that the company plans to launch its Covid-19 vaccine by June next year, unless the government decides to allow the vaccine to be used urgently on the basis of previous clinical trials.
If the data on effectiveness is positive, it could be launched in early February.
Then it will be the second vaccine to be introduced in India after Covishield of the Serum Institute.
Prasad said the company is spending around Rs150 crore on the third phase of testing and another Rs120-150 crore on setting up a new plant which will be commissioned by December.
Bharat Biotech has started production of some doses on its own responsibility at its Hyderabad plant, with a current annual production capacity of about 150 million doses.
In addition to setting up new plants, the company is trying to use a third installation to produce Covaxin.
"We are trying to build another large-scale plant like ours in Hyderabad in another city through which [old and new plants] we will increase Covaxin production from 500 million to 1 billion a year," Prasad said.