Bharat Biotech has enrolled 25,800 volunteers for phase 3 clinical trials of its COVID-19 vaccine, the company said today. The maker of Covaxin is one of the two firms cleared by the government to deploy their product for mass inoculation in the country. The other is Oxford-AstraZeneca's Covishield manufactured by the Serum Institute of India.
Bharat Biotech chairman Dr Krishna Ella in a press briefing on January 5 had hit out at critics for questioning the vaccine's efficacy. "We don't deserve this backlash," Dr Ella had said.
Covaxin has completed two of the three required trial phases; the third - which tests for efficacy - began in November.
Dr Ella cited a 2019 government notification that said "good quality immunogenicity data" from phase 1 and 2 trials could be presented, among other data, to get an emergency use licence.
A second dry run for COVID-19 vaccination will be held in all the states tomorrow. The first massive dry run was held on January 2. The exercise checked the best way to vaccinate people against COVID-19 and plug loopholes in logistics and training.
The government has said vaccination for COVID-19 would start within 10 days from the day when vaccine-makers were given emergency use authorisation.
Bharat Biotech is setting up four vaccine manufacturing facilities with a combined capacity of 700 million doses per year, Dr Ella said on Monday.
"We have four facilities coming up. We are planning around 200 million doses (per year) in Hyderabad, 500 million doses in other cities. By 2021, we will have 700 million doses capacity... As we speak we have 20 million doses," he told reporters.
The Serum Institute of India, which started manufacturing Covishield, now has 50 million doses available.
The government has prioritised groups who will get the vaccine first, including doctors, healthcare workers, police and others engaged directly in fighting the pandemic.
All the anti-coronavirus vaccines developed in India can be stored at 2-8 degree Celsius as the logistics have been worked out considering temperature as a factor, Department of Biotechnology Secretary Renu Swarup said on Tuesday.