'Covaxin Safe Like Water, Phase-3 Efficacy Data By March', Says Bharat Biotech Chairman

Bharat Biotech MD Krishna Ella said that the vaccine is absolutely safe and the phase 3 trial data will be available by March 2021.

Amid controversies and questions regarding the emergency approval of Bharat Biotech's Coronavirus vaccine, the company's MD held a press conference to address several queries on the row. Bharat Biotech's chairman Dr Krishna Ella said that 'Covaxin' is absolutely safe to use and it shouldn't be called a backup. The chairman hit out at critics on Monday flagging the lack of Phase III trial data and others questioning the drug's efficacy, branding it "... safe, like water". "We don't deserve this backlash," an indignant Dr Krishna Ella declared. Bharat Biotech MD Krishna Ella said, “Covaxin has generated excellent safety data with robust immune responses to multiple viral proteins that persist”. Ella’s remarks came a day after the firm was given approval for the restricted emergency use of its vaccine developed to prevent COVID-19. The approval, however, led to a political row as Bharat Biotech has yet to complete clinical trials of Covaxin and submit efficacy data. Coming out today to defend the vaccine, the pharma company’s MD told the press: “While this vaccine addresses an unmet medical need during this pandemic, our goal is to provide global access to populations that need it the most.” He described the approval granted to Covaxin for emergency use as “a giant leap for innovation and novel product development in India”. “It is a proud moment for the nation and a great milestone in India’s scientific capability, a kickstart to the innovation ecosystem in India,” Ella asserted.

'Trials being conducted in more than 12 countries': Bharat Biotech Chairman

He said that its vaccine is safe and the company is conducting trials in more than 12 countries apart from India. “We are not a company without experience in vaccines. We have tremendous experience in vaccine." Ella said that the company expects to release the efficacy data of Covaxin's Phase 3 trials, which are currently ongoing, by March. He also mentioned that there has been no interim analysis of the efficacy in the Phase 3 trials has been done so far and added that there was 100% protection in Covaxin animal trials.

Only vaccine for 12 years and above: Bharat Biotech MD

Ella also mentioned that the Covaxin vaccine was the "only vaccine for 12 years and above, age group. He also said that the company plans to do clinical trials in children as well. "Covaxin is a purely inactivated virus vaccine. I am confident that Covaxin will be effective against the UK mutant virus strain," he added. Meanwhile, the drug regulator has also allowed Bharat Biotech to conduct its trials on children who are above the age of 12 years. The Covid-19 vaccine has already been used for children above 12 in the last round and has been found safe. The Hyderabad-based firm is conducting Phase 3 trials in India. About the availability of vaccine doses, Ella said, "Currently, we have 20 million doses. We are aiming to achieve 700 million doses capacity in four facilities -- three in Hyderabad and one in Bengaluru" He also informed that the company was "encountering so many problems including related to logistics." On Sunday the Drug Controller General of India granted emergency approval to Covaxin and AstraZeneca-Oxford University's Covishield, which will be produced by Pune-based Serum Institute. The decision to green-light Covaxin triggered a row, with critics pointing to a lack of efficacy data at this time. Covaxin has completed only two of three required trial phases; the third - which tests for efficacy - began in November. The two earlier phases only ensured that the drug is safe. Covishield, meanwhile, has completed all three phases, with trials taking place in India and around the world, and submitted data to the DCGI, which said the drug was 70.42 per cent effective.