Expert committee to consider SII's emergency use approval for COVID-19 vaccine
Dec 30, 2020
New Delhi [India], December 30 : Subject Expert Committee (SEC) of Drugs Controller of India will take a meeting to consider Serum Institute of India's application for emergency use approval of its COVID-19 vaccine, says a government official.
According to the sources, only Serum Institute's application will be considered.
The recommendation of SEC will be sent for drug regulator's approval, later today after the meeting.
Covishield is being manufactured on the Chimpanzee Adenovirus platform and by the SII in Pune. The collaborative company is Astrazeneca. "The regulator had allowed the phase 2 and 3 clubbed clinical trials of the vaccine to them and they have applied for emergency use authorisation," he said.
The SII is the first indigenous company that has sought emergency approval for the vaccine developed along with global pharma giant AstraZeneca and Oxford University.
The Pune-based company earlier stated that ChAdOx1 nCov-2019 coronavirus vaccine, developed by teams at the University of Oxford, has been shown to trigger a robust immune response in healthy adults aged 56-69 and those over 70 years of age.
After Prime Minister Narendra Modi visited the company's pandemic level facility in Pune last month, SII Chief Executive Officer (CEO) Adar Poonawalla had said that indications suggest that the Central government may purchase 300-400 million doses by July 2021.
He further said the SII has already produced 40-50 million doses of the vaccine per month, and the pharma giant is planning to stretch it up to 100 million doses of the vaccine per month by February.
