New Delhi: Bharat Biotech hopes to apply for regulatory approval on covacin by June 2021. The company estimates that it will take at least six months to extract data from ongoing trials in the country. "The company has not even spoken to the government about immediate approval of the vaccine," Sai Prasad, executive director of Bharat Biotech, told our correspondent Economic Times. Phase 1-2 clinical trials of covacin are currently complete. The trial of the third phase of the vaccine will begin soon on more than 26,000 people. The company has invested Rs 400 crore on the corona virus vaccine, most of which is being spent on trials.
'Emergency approval in government hands'
"Emergency clearance is not in our hands," Sai Prasad, executive director of Bharat Biotech, told our associate Economic Times. Drug controllers in India have all the data that we have and can give emergency approval to the vaccine at any time if they want. The government has also indicated that some industries may purchase vaccines directly if needed. So it is up to the government to decide on such issues.
Large trials to determine if covaxin is safe
Sai Prasad further said that a big country like India needs a big trial of any vaccine. He said, "We felt that it was important to trial large-scale (vaccine) effects in a country of our size, just as most international companies do. Safety of the vaccine is of utmost importance to us. ' He said if the company waits for the Phase 3 trial to be completed, the final license could come by the second quarter of next year.
No comments:
Post a Comment