Adar Poonawalla, the head of vaccine-making company Serum Institute of India (SII), on Monday informed the company has applied for an emergency use authorisation for Covishield coronavirus vaccine to the Drugs Controller General of India (DCGI).
Poonawalla wrote on Twitter, "As promised, before the end of 2020, @SerumInstIndia has applied for emergency use authorisation for the first made-in-India vaccine, COVISHIELD."
He further said: "This will save countless lives, and I thank the Government of India and Sri @narendramodi ji for their invaluable support".
As promised, before the end of 2020, @SerumInstIndia has applied for emergency use authorisation for the first made-in-India vaccine, COVISHIELD. This will save countless lives, and I thank the Government of India and Sri @narendramodi ji for their invaluable support.— Adar Poonawalla (@adarpoonawalla) December 7, 2020
Serum Institute, which is the world's largest vaccine producer by volume, has become the second company to apply for the emergency authorisation after Pfizer India.
According to the Indian Council for Medical Research (ICMR), the SII has already manufactured 40 million doses of the vaccine under the at-risk manufacturing and stockpiling license it obtained from the DCGI.
The Pune-based institute has partnered with Oxford University and a British-Swedish pharmaceutical company AstraZeneca to manufacture the COVID-19 vaccine in India.
On November 23, the world heard how AstraZeneca and Oxford University's COVID-19 vaccine was highly effective in advanced trials. However, questions were raised about the clinical trials, when AstraZeneca revealed three different data on the vaccine's efficacy--an overall efficacy of 70 per cent, a lower one of 62 per cent and a high of 90 per cent.
However, in India, the Serum Institute administered its Covidshield vaccine to around 1,600 participants as two full doses 28 days apart. According to experts, the Oxford covid vaccine is logistically feasible for distribution in India since it could be stored at two to eight degrees Celsius.