SII’s application for emergency use approval of Covid-19 vaccine to be reviewed by expert committee

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Pune-based Serum Institute of India (SII) had applied for the emergency use authorization of the Covid-19 vaccine developed by the Oxford University and AstraZeneca , which will be considered and reviewed in a meeting by Subject Expert Committee (SEC) of Drugs Controller of India, revealed a government official.

After the meeting is over, based on the discussion, the recommendation for SII will be sent for the approval for drug’s regulator.

The vaccine candidate, Covid shield is being manufactured by the SII in Pune and on the Chimpanzee Adenovirus platform. The company in collaboration with the manufacturing is AstraZeneca. He said, “The regulator had allowed the phase 2 and phase 3 clubbed clinical trials of the vaccine to them and they have applied for emergency use authorization.”

SII is the first Indian pharmaceutical company which has applied for emergency approval for the vaccine which has been developed by the AstraZeneca and Oxford University’s collaboration. SII had given a statement earlier that ChAdOx1 nCov-2019 vaccine candidate developed by University of Oxford, has proven to be effective and led to a positive immune response among the healthy adults aged 56-69 and for those above 70 years of age. 

Post the visit of Prime Minister Narendra Modi in SII last month, the company’s Chief Executive Officer (CEO) Adar Poonawalla revealed about the probability that Central Government may purchase 300-400 million doses by July 2021. He added that SII had produced 40 – 50 million doses per month and the Pune-based company is making complete attempts to stretch it to 100 million doses of the vaccine per month by February 2021.

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