India drug regulator gives approval for 2 vaccines
India’s drugs regulator on Sunday gave final approval for the emergency-use of two coronavirus vaccines, one developed by AstraZeneca and Oxford University and the other by local company Bharat Biotech and a state-run institute.
The decisions mark the first vaccine approvals for the world’s second-most populous country, which after the United States, has recorded the most infections of the COVID-19.
It is now expected to start a massive immunization program within about a week, a government official said, and hopes to inoculate 300 million of its 1.35 billion people free of charge in the first six to eight months of this year.
The AstraZeneca/Oxford shot, already approved in Britain, Argentina and El Salvador, will take the lead and Bharat Biotech’s COVAXIN will be administered under stricter conditions given no efficacy data has been released for it.
“It’s now time to reap the benefits of the robust supply chain infrastructure we’ve put in place for quick and equitable distribution of the vaccine,” said Harsh Vardhan, the health minister of India, which is the world’s biggest vaccine producer and exporter.
“Urge all citizens to entrust the stringent protocols followed for ensuring safety, efficacy and immunogenicity of the approved vaccines.”
Drugs Controller General of India VG Somani said the overall efficacy of the AstraZeneca/Oxford vaccine was 70.42 percent, while COVAXIN was “safe and provides a robust immune response.”
The British-developed AstraZeneca/Oxford shot is being made locally by the Serum Institute of India and will be branded COVISHIELD, while Bharat Biotech has teamed up with the government-run Indian Council of Medical Research.
Both vaccines will be administered in two doses and stored at 2-8 degrees Celsius, Somani said, without clarifying what intervals between shots were being recommended.