NEW DELHI: Bharat Biotech International Ltd 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 then, based on data from earlier phases of clinical trials. CEO Sai Prasad told Mint.
“If the government has the intention, they could proceed by granting us an emergency use authorization, for example reviewing the data from phase 2. They (the government) can say that we need it now because it is quite important and we (Bharat Biotech) we have good testing and phase 1 and 2 data, “Prasad said, adding that in China and Russia, emergency use authorizations have been led by the government.
The company plans to begin enrolling up to 26,000 participants ages 18 and older in its phase 3 trials starting the middle of next month. The trial will take place at 25-30 sites across the country, and the process to gain approval from the individual site ethics committee is underway, he said.
The primary endpoint of the late-stage trial, which is used to determine the efficacy of a vaccine, will be to see whether the two-dose injection can prevent a patient from developing COVID-19 symptoms.
The subject matter expert committee (SEC) of the Central Organization for the Control of Drug Standards earlier this week gave its approval for the phase 3 trials.
While the data from Phase 2 of the trials is not publicly available, the company received an approval from the SEC on Tuesday based on the Phase I and II data along with the animal challenge data.
However, Prasad declined to elaborate on the prices of the vaccine, saying that discussions are ongoing and depend on a variety of factors, such as the cost of production, investments, and also the number of doses required.
“We don’t have an upper limit yet, but we don’t expect it to be out of the reach of our government and what COVAX can buy. But for other companies like Serum (Institute of India) and some others, they were given funding from COVAX and Gates Foundation. We haven’t received that kind of funding, “Prasad said.
Instead, the company is spending 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, he 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 said.
The Bharat Biotech vaccine is one of three candidates currently in human trials in India, with the other two being ‘Covishield’ from the Serum Institute of India, which was developed by the University of Oxford and Astrazeneca plc, and ZyCoV-D from Zydus Cadila. While Serum’s Covishield is in phase 3 and is considered the pioneer among vaccines in India, Zydus Cadila, like Bharat Biotech, is in phase 2 and is expected to move into late-stage trials soon.
Earlier this month, Union Minister Harsh Vardhan said the government’s rough estimate is to receive and use 400 to 500 million doses by July 2021 to immunize 200-250 million people.
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