NEW DELHI: An approval for Serum Institute of India’s vaccine by the Drug Controller General of India is at least six months away as the company is focussed on following due processes to be sure about its safety and efficacy, chief executive officer Adar Poonawalla said on Tuesday.
“Once we are confident of a safe and good vaccine for India and the world. We will certainly announce it when we are licensed by the Drug Controller (DCGI), but that is still at least six months away from now,” Poonawalla said at a press conference.
He also said that the trials for the vaccine will be over only by the end of the year.
Serum Institute is in a partnership with British-Swedish drug maker AstraZenaca to manufacture and supply the vaccine being developed by University of Oxford. Under the pact, Serum Institute will supply 1 billion doses of the vaccine in India and other low and middle-income countries, with a commitment to provide 400 million before the end of 2020.
The vaccine being developed by University of Oxford is currently in the most advanced stage of clinical trial with ongoing studies of phase 2 and phase 3 with about 10,000 participants. That vaccine is widely expected to be the first for launch.
Without specifically naming them, Poonawalla also briefly touched upon the letter written by Indian Council of Medical Research director general Balram Bhargava to Bharat Biotech International Ltd over speeding up the trials for ‘Covaxin’ to launch it by 15 August. ‘Covaxin’ is jointly developed by Bharat Biotech and ICMR’s National Institute of Virology in Pune.
“Recently, there was a news about a vaccine candidate which is being rushed. We don’t want to rush anything. We want to ensure safety and efficacy,” Poonawalla said at the unveiling of MyLab Discovery Solution’s ‘Compact XL’ testing system. He had invested in Mylab along with Abhijit Pawar, chairman of impact investor group AP Globale, in April.
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