Happy New Year: India may begin 2021 with COVID-19 vaccines
New Delhi, Dec 31: The New Year in India may just begin with a COVID-19 vaccine. "We will have a Happy New Year with something in hand, that's all I can hint at," VG Somani, Drug Controller General of India (DCGI).
The subject expert committee under the Central Drugs Standard Control Organisation will meet on January 1 to consider the emergency use authorisation application of the three companies, Pfizer, Serum Institute of India that is to manufacture the Oxford AstraZeneca vaccine, and Bharat Biotech's Covaxin.
"There has been no compromise on the safety of efficacy of the data. The only thing is that the regulator has accepted partial data," Somani said.
"With the manufacturing and stockpiling license, SII has already been able to stockpile 75 million doses of the Oxford AstraZeneca vaccine and by the first week of January we will have 1 million doses. Nobody across the world has so much stock and we can start supplying as soon as we get the approval. After the phase 2 data of Novovax is released, we will start stockpiling the other vaccine too," Umesh Shalingam from SII said at the webinar.
Somani said that the approval process was fast-tracked in view of the pandemic and applications were quickly processed, allowing parallel phase 1 and 2 trials without waiting for the complete data.