A ground staff passes a container kept at Indira Gandhi International Airport Freight Terminal 2, which officials say will be used as a COVID-19 vaccine handling and distribution center in New Delhi, India, December 22 2020.
Anushree Fadnavis | Reuters
India’s drug regulator gave final approval on Sunday for the emergency use of two coronavirus vaccines, one developed by AstraZeneca and Oxford University and the other by local company Bharat Biotech.
The second most populous country in the world is now expected to begin a massive immunization program in a few weeks, with the AstraZeneca / Oxford shot taking over and the Bharat Biotech COVAXIN administered under stricter conditions with no published efficacy data.
The overall effectiveness of the AstraZeneca / Oxford vaccine was 70.42%, while Bharat Biotech’s COVAXIN was “safe and provides a robust immune response,” said VG Somani, India’s comptroller general.
The British-developed image, AstraZeneca / Oxford, is made locally by the Serum Institute of India (SII) and will be called COVISHIELD, while Bharat Biotech has teamed up with the government-led Indian Medical Research Council.
“M / s and M / s Bharat Biotech serum vaccines are approved for restricted use in emergencies,” Somani said in a written statement at a news conference. Somani did not take any questions.
Both vaccines will be given in two doses and stored at 2-8 degrees Celsius (36-48 ° F), he said. Sources told Reuters on Saturday that the doses should be administered every four weeks.
Somani explained that the Bharat Biotech vaccine was approved “in the public interest as a precautionary measure, in clinical trial mode, to have more options for vaccinations, especially in case of infection with mutant strains.”
Prime Minister Narendra Modi welcomed the approvals.
“It would make every Indian proud that the two vaccines that have been given emergency approval for use are made in India!” he said on Twitter, calling it the sign of an “autonomous” country.
SII, the world’s largest vaccine manufacturer, has already stockpiled more than 50 million doses of AstraZeneca / Oxford vaccine even without a formal supply agreement with the government.
“All the risks that @SerumInstIndia has taken with the vaccine storage have finally paid off,” CEO Adar Poonawalla said on Twitter. “COVISHIELD, India’s first Covid-19 vaccine, is approved, safe, effective and ready for release in the coming weeks.”