Sunday, January 3, 2021 1:06 AM EST
The approvals were announced at a news conference in New Delhi on Sunday.
Dr. V.G. Somani, the drugs controller general of India, said the decision
to approve the Oxford-AstraZeneca vaccine
and a local vaccine developed by Bharat Biotech
came after “careful examination” of both by the Central Drugs Standard Control Organization
India’s pharmaceutical regulator.
Krishna Ella, chairman of Bharat Biotech, said the approval of Covaxin had not been rushed.
"Under Indian laws we can get emergency approval for the vaccine
based on fulfilling five parameters after Phase 2 trails.
That is what has happened with our vaccine. So it is not a premature approval," he said.
"We will complete the Phase 3 trials soon and provide the efficacy data for the vaccine by February."
India will launch its vaccination drive against the coronavirus on 16 January
PM Narendra Modi called it a "landmark step"
and said the aim was to vaccinate 300 million people by July.
India has a population of 1.3 billion.
Healthcare staff and front-line workers will be among the first to receive doses, he added.
India has recorded the second-highest number of Covid-19 infections in the world, after the US.
[img ]https://ichef.bbci.co.uk/news/976/cpsprodpb/32B4/production/_116408921_gettyimages-1230493194.jpg[/img]
India's Drugs Controller General, VG Somani
insisted Covaxin was "safe and provides a robust immune response".
"The vaccines are 100% safe," he said, adding that side effects such as
"mild fever, pain and allergy are common for every vaccine".
The regulator said the vaccine had been approved for :
"restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode
especially in the context of infection by mutant strains".