New Delhi: Covaxin, India’s first indigenous COVID-19 vaccine candidate, developed by Bharat Biotech is expected to have at least 60 per cent effectiveness, Hindustan Times (HT) reported.
The Drugs Controller General of India (DCGI) on Thursday permitted the company to conduct a phase 3 clinical trial to establish Covaxin’s efficacy, the interim results of which are likely to be released by April or May 2021.
“The benchmark for the efficacy of our anti-Covid-19 vaccine is 60%. We will be conducting the largest Phase 3 trial for Covaxin, and the efficacy results should be available by early April-May, 2021,” HT quoted Sai Prasad, Executive Director, Bharat Biotech International Ltd, as saying.
“The WHO, US FDA (Food and Drug Administration) and even India’s Central Drugs Standard Control Organisation (CDSCO) approve a respiratory vaccine if it achieves 50% efficacy; for Covaxin, we aim to achieve at least 60%, but it could also be more. Chances of the vaccine being less than 50% effective are remote, as suggested by our trial results so far, which include results from animal studies,” he added.
Prasad told HT that “site preparatory exercises” have begun for phase 3 trails, while recruitment and dosage will commence in November. The trial will involve 26,000 study subjects at 25 to 30 locations across 13-14 states.
