Bharat Biotech may launch the completely indigenous COVID-19 vaccine by February 2021, as studies have showed it is safe and effective, a senior government scientist has said.
Covaxin is slated to start its stage 3 trials this month.
“The vaccine has shown good efficacy …it is expected that by the beginning of next year, February or March, something would be available,” senior Indian Council of Medical Research (ICMR) scientist Rajni Kant, also a member of the COVID-19 task force, said on Thursday (November 5), reported Reuters.
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While Bharat Biotech didn’t confirm this, a top company official earlier this week had said that the vaccine is likely to be released in the second quarter of 2021 if the required approvals are in place.
Sai Prasad, the company’s executive director, however, said that Covaxin was found to be safe in the first two stages of the trials and did not show any “major adverse events”. The trials involved about 1,000 participants. “Having received the approval from DCGI after assessing data from Phase I and II as well as the results of animal challenge study, we have moved into the last phase of trials,” he said, reported IANS.
The vaccine is being developed by the company in collaboration with the ICMR. There are vaccine candidates developed in other countries undergoing trials in the country, but Covaxin has been developed completely in India without any foreign collaboration.
Rajni Kant said it is the health ministry’s call whether to administer Covaxin shots before the Stage 3 trials are completed.
“It has shown safety and efficacy in the Phase 1 and 2 trials and in the animal studies. So it is safe but you can’t be 100% sure unless the phase 3 trials are over,” he was quoted as saying.
India’s COVID-19 tally has crossed the 80 lakh mark with the total number of deaths reaching 1,24,315.
Earlier in the day, British-Swedish drugmaker AstraZeneca had said that it expects results from the late-stage trials of its vaccine candidate developed in partnership with Oxford University towards the end of the year, depending on the rate of infection among trial participants.
Currently, there are over 200 vaccine candidates under development and the vaccine being developed by Oxford and licensed to British drugmaker AstraZeneca is seen as a front-runner. The company has given Pune-based Serum Institute the licence to develop the vaccine once it is ready. The institute is currently carrying out Phase II/III trials of the vaccine.
On Wednesday, it had said that it expects the vaccine to be in the market by January if all approvals are in place in time.