A ground crew passes through a container held at Cargo Terminal 2 at Indira Gandhi International Airport, which according to officials will be used as a COVID-19 vaccine handling and distribution center in New Delhi, India, on 22 December 2020.
Anushree Fadnavis | Reuters
India’s drug 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.
The second most populous country in the world is now expected to start a massive immunization program within weeks, with the AstraZeneca / Oxford injection taking the lead and Bharat Biotech’s COVAXIN administered under stricter conditions, since no efficacy data has been released.
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 India’s General Drug Controller VG Somani.
The British AstraZeneca / Oxford injection is being made locally by the Serum Institute of India (SII) and will carry the COVISHIELD brand, while Bharat Biotech has partnered with the government government Indian Council of Medical Research.
“M / s Serum and M / s Bharat Biotech vaccines are being approved for restricted use in emergency situations,” read Somani in a written statement at a news conference. Somani did not answer questions.
Both vaccines will be administered in two doses and stored at 2-8 degrees Celsius (36 to 48 ° F), he said. Sources told Reuters on Saturday that doses would have to be administered 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.
“All Indians would be proud that the two vaccines that received approval for emergency use were 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 stocked 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 storing the vaccine were finally worth it,” said CEO Adar Poonawalla on Twitter. “COVISHIELD, India’s first Covid-19 vaccine, is approved, safe, effective and ready to be launched in the coming weeks.”