Ground personnel pass a container stored at cargo terminal 2 at Indira Gandhi International Airport, which officials say will be used as a COVID-19 vaccine distribution and handling center in New Delhi, India. , on December 22, 2020.
Anushree Fadnavis | Reuters
India’s drug regulator on Sunday gave final approval for 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 start a massive vaccination program in a few weeks, with the shooting of AstraZeneca / Oxford and Bharat Biotech’s COVAXIN administered under stricter conditions without efficacy data being released.
The overall efficacy 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 of Medicines.
The UK-developed AstraZeneca / Oxford shot is made locally by the Serum Institute of India (SII) and will be branded COVISHIELD, while Bharat Biotech has teamed up with the government-led Indian Medical Research Council. .
“M / s Serum and M / s Bharat Biotech vaccines are being approved for restricted use in emergency situations,” Somani read in a press release. Somani did not accept questions.
Both vaccines will be given in two doses and stored at 2-8 ° C (36 to 48 ° F), he said. Sources told Reuters on Saturday that the doses should be distributed within four weeks.
Somani explained that the Bharat Biotech vaccine had been approved “in the public interest as an abundant precaution, in clinical trial mode, to have more vaccination options, especially in case of infection by mutant strains.”
Prime Minister Narendra Modi welcomed the approvals.
“It would make all Indians proud that the two vaccines that have received emergency approval be made in India!” he said on Twitter, calling it a sign of a “self-sufficient” country.
SII, the world’s largest vaccine producer, 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 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 to roll out in the coming weeks.”