A ground crew walks past a container held at Indira Gandhi International Airport’s Cargo Terminal 2, which officials say will be used as a COVID-19 vaccine handling and distribution center in New Delhi, India, on December 22, 2020.
Anushree Fadnavis | Reuters
The Indian 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 expected to initiate a large-scale immunization program within weeks, with the AstraZeneca / Oxford injection taking the lead and Bharat Biotech’s COVAXIN administered under more stringent conditions as there are no efficacy data for it released.
The overall efficacy of the AstraZeneca / Oxford vaccine was 70.42%, while COVAXIN from Bharat Biotech was “safe and provides a robust immune response,” said Drugs Controller General of India VG Somani.
The UK-developed AstraZeneca / Oxford image is produced locally by the Serum Institute of India (SII) and will be branded COVISHIELD, while Bharat Biotech has partnered with the government-led Indian Council of Medical Research.
“Vaccines of M / s Serum and M / s Bharat Biotech are approved for limited use in emergency situations,” Somani read from 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 ° Celsius (36 to 48 ° F), he said. Sources told Reuters Saturday that the doses had to be given four weeks apart.
Somani explained that the Bharat Biotech vaccine was approved “in the public interest as an abundant precaution, in clinical trial mode, to have more vaccination options, especially in the case of infection by mutant strains”.
Prime Minister Narendra Modi welcomed the approvals.
“It would make any Indian proud that the two emergency vaccines are made in India!” he said on Twitter, calling it a sign of a “self-reliant” country.
SII, the world’s largest vaccine manufacturer, has already stockpiled more than 50 million doses of the AstraZeneca / Oxford vaccine, even without a formal supply agreement with the government.
“All the risks @SerumInstIndia took with stocking the vaccine have finally paid off,” CEO Adar Poonawalla said on Twitter. “COVISHIELD, India’s first Covid-19 vaccine, is approved, safe, effective and ready to be launched in the coming weeks.”