NEW DELHI: Bharat Biotech International Ltd has started massive phase 3 clinical trials of its covid-19 ‘Covaxin’ vaccine. The company plans to enroll 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 enroll at 25 trial sites across the country over the next several months. The trial volunteers will receive two intramuscular injections approximately 28 days apart.
Volunteers wishing to participate in this trial must be 18 years or older. Participants will be equally randomized to receive two 6-microgram (mcg) injections of Covaxin or two injections of a placebo. The trial is double-blind, so researchers, participants and the company will not know 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, and the company said the results showed promising safety and immunogenicity data.
Of the 25 sites, eight have received approval from their respective ethics committees for the clinical trial, based on data from the government’s clinical trial registry. Per clinical trial guidelines, each trial site has its own ethics committee that oversees whether the trial conducted at the site complies with study ethics and protocol.
On Wednesday, Aligarh Muslim University (AMU) Vice Chancellor Tariq Mansoor said he has signed up to be the first volunteer for the trials at the university.
According to the trial protocol, the primary endpoint of the late-stage trial, which is used to determine the efficacy of a vaccine, will be to see if the two-dose injection can prevent a patient from developing COVID-19 symptoms. The secondary endpoint will be to measure the efficacy of the vaccine in preventing severe disease symptoms in a patient and death.
Bharat Biotech CEO Sai Prasad had said last month that the company plans to launch its covid-19 vaccine, Covaxin, by June next year, unless the government decides to grant the vaccine an emergency use authorization. before that, based on previous data. phases of clinical trials.
If the efficacy data is strong, it could be launched in February, making it the second vaccine likely to be launched in India after Covishield from the Serum Institute of India.
The company spends around ₹150 crore in phase 3 trial and another ₹120-150 crore in the creation of a new facility that will be operational in December, Prasad said.
Bharat Biotech has started manufacturing some at-risk doses at its Hyderabad plant, using its current capacity of around 150 million doses a year.
In addition to establishing a new plant, the company is also exploring the use of a third facility for Covaxin production.
“We are also exploring in another city in India where we have access to a large-scale facility like the one we have in Hyderabad to make Covaxin and use that (and the new plant), scale it even north of 500 million to 1 billion doses. a year, “Prasad had said.
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