India has formally approved the use of two Covid-19 vaccines for emergency use, one made by AstraZeneca and Oxford University and the other developed locally, the country's Drugs Controller General said in a Sunday briefing.
"After adequate examination ... vaccines of Serum Institute and Bharat Biotech are being approved for restricted use in emergency situations," said VG Somani, Drugs Controller General of India (DCGI).
Both vaccines will have to be administered in two doses and are to be stored at 2 to 8 degrees Celsius (35.6 degrees to 46.4 degrees Fahrenheit), he added.
The Serum Institute of India has been producing the Oxford/AstraZeneca vaccine in India, while Indian biotech company Bharat Biotech developed Covaxin.
India's Prime Minister Narendra Modi called the announcement a "decisive turning point" on Twitter.
“DCGI granting approval to vaccines of @SerumInstIndia and @BharatBiotech accelerates the road to a healthier and Covid-free nation," he wrote. "Congratulations India. Congratulations to our hardworking scientists and innovators."
Adar Poonawalla, the CEO of the Serum Institute of India, said all the risks the Institute took with stockpiling the vaccine have finally paid off.
"India's first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks."
Last month, Bharat Biotech, the private company developing Covaxin with the government-run Indian Council of Medical Research (ICMR), said that the vaccine "demonstrated acceptable safety profile and high immune response. . . No serious (grade 3-4) adverse events were reported."
The background: India has reported the second most coronavirus cases in the world, trailing only the United States.
The first phase of its vaccination plan covers 300 million people -- almost as many as the entire US population. India conducted a nationwide Covid-19 vaccine drill on Saturday ahead of plans for mass vaccinations, India's state-run broadcaster Doordarshan reported.