Phase three trials of India’s first vaccine against COVID-19 has started in what is the largest human trials to be conducted with about 26,000 participants, Bharat Biotech announced on Monday.
The Hyderabad-based company has been developing the vaccine, Covaxin, in collaboration with the Indian Council of Medical Research (ICMR) – India’s premier medical research body.
The first doses of the vaccine were administered to volunteers at the Nizam’s Institute of Medical Sciences (NIMS) in Hyderabad on Monday as part of the trial which will be monitored over the next year.
Covaxin has shown promising safety and immunogenicity data in trials done during phase one and phase two, the company said.
The India trial comes a day after the US biotech firm Moderna Inc said preliminary data from a continuing phase three study of its experimental COVID-19 vaccine showed it to be 94.5 percent effective.
India is the second-worst hit by COVID-19 with nearly 9 million cases [File: Adnan Abidi/Reuters]Last week, drugmakers Pfizer and BioNTech said their experimental vaccine may be 90 percent effective at preventing COVID-19 raising hopes for a major victory in the fight against the coronavirus pandemic, which has killed more than one million people globally.
On November 5, a senior Indian government scientist told the Reuters news agency the Covaxin vaccine could be launched as early as February – months earlier than expected.
“The vaccine has shown good efficacy,” senior ICMR scientist Rajni Kant, who is also a member of its COVID-19 task force, said at the research body’s New Delhi headquarters on November 5.
“It is expected that by the beginning of next year, February or March, something would be available.”
India is the second-worst hit by COVID-19 – the disease caused by the novel coronavirus – with nearly nine million cases. On Monday, India saw less than 30,000 with number gradually declining since October.
Addressing the UN in September, Indian Prime Minister Narendra Modi pledged that his country’s vaccine production capacity would be made available globally to fight the coronavirus crisis. India is the largest producer of vaccines in the world.