Bharat Biotech to launch Covaxin in Q2 2021
Bharat Biotech is planning to launch its vaccine for Covid-19 in the second quarter next year if it gets the requisite approvals from the Indian regulatory authorities, a top company official said. It said its immediate focus is to conduct the Phase 3 trials successfully across sites in the country.
The company’s vaccine candidate -Covaxin- has been developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV) using inactivated Sars-Cov-2, the virus that causes Covid-19. The virus was isolated in an ICMR lab.
“If we get all the approvals after establishing strong experimental evidence and data, and efficacy and safety data in our last stage of trials, we aim to launch the vaccine in Q2 of 2021,” Bharat Biotech International Executive Director Sai Prasad told PTI.
After the company received approval from the Drugs Controller General of India (DCGI) to conduct Phase 3 clinical trial to establish the efficacy of the vaccine candidate, it has begun site preparatory exercises for Phase 3, recruitment and dosage will begin in November, he added. “The trial to be conducted in 25 to 30 sites across 13-14 states will provide two doses each for the vaccine and placebo recipients. About 2,000 subjects could be enrolled per hospital,” Prasad said.
Asked about the investment on the vaccine, he said: “Our investment is about Rs 350-400 crore for the development of vaccine and the new manufacturing facilities, which include our investments for conducting the Phase 3 clinical trial, in the next six months”.
On the company’s plan to sell the vaccine to the government or to private players, Prasad said: “We are looking to supply for both government and private markets. We are also in preliminary discussions with other countries for probable supply.” Prasad said the price of the vaccine is yet to be determined, as the company is still looking at the cost of product development.
“Our immediate focus is to conduct Phase 3 trial successfully across sites,” he added.
Enter your email to get our daily newsletter in your inbox
- The list of Padma awards also comprised 10 Padma Bhushan and 102 Padma Shri recipients.
- On January 8, state election commissioner N Ramesh Kumar released the schedule for elections to be held in four phases
- The police say about 30,000 tractors are likely to participate in the rally, but farm leaders said the number of vehicles will be closer to 200,000.
- The break-up of 946 police personnel who have been awarded medals on the occasion of the Republic Day, 2021.
- "We have promised ourselves that we will not just meet our Paris Agreement targets but exceed them...” PM Modi said.
- The Nagaland government had come to the Supreme Court in exceptional circumstances for orders to restrain the sitting Lokayukta from hearing any case or exercising his powers or functions under the Nagaland Lokayukta Act, 2017.
- His mother said she was not at all happy to receive the news that her son was conferred Maha Vir Chakra. “I expected the top medal, not this,” she said.
- In a letter sent to all government ministries and departments Cabinet Secretary Rajiv Gauba warned "that serious view would be taken" against those who fail to attend the ceremony despite invitations
- Of the 1.92 lakh beneficiaries that were to be vaccinated till January 25, the state has covered 1.77 lakh.