India's drug regulator calls top SEC meeting after UK approves Oxford's COVID-19 vaccine

A Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) will meet later on Wednesday likely to examine Serum Institute of India’s (SII) emergency-use authorisation (EUA) application for Oxford-AstraZeneca’s Coronavirus vaccine. The development comes moments after the United Kingdom government authorized for emergency use the vaccine developed by the University of Oxford and AstraZeneca.

Serum Institute of India (SII) last week also had submitted some additional data required by the Drug Controller General of India (DCGI), PTI quoting official sources said last week. It is likely that Oxford-AstraZeneca vaccine candidate may be the first anti-COVID-19 vaccine to be granted emergency-use approval in India. Besides SII, Bharat Biotech and Pfizer have also applied to DCGI seeking emergency use authorisation for their COVID-19 vaccines early this month.

The approval of Oxford-AstraZeneca's vaccine by Medicines and Healthcare products Regulatory Agency (MHRA) means the vaccine is both safe and effective. The vaccine, which also has a tie-up with the Serum Institute of India, was being evaluated by the MHRA after the final cut of data was submitted by the government last Monday. Britain has ordered 100 million doses of the vaccine, with 40 million expected to be available by the end of March. 

'The vaccine is our way out of the pandemic'

Taking to Twitter, UK Health Secretary Matt Hancock confirmed the development and said, "Brilliant to end 2020 with such a moment of hope." "The Coronavirus vaccine is our way out of the pandemic- now we need to hold our nerve while we get through this together," he said.  "Government has today accepted the recommendation from the Medicines and Healthcare products Regulatory Agency to authorise Oxford University/AstraZeneca’s Covid-19 vaccine for use," the UK government said.

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Meanwhile, the Serum Institute of India has already produced around 50 million dosages of the Oxford-AstraZeneca COVID-19 vaccine 'Covishield' and plans to scale it up to 100 million by March next year even as it awaits approval for emergency use authorisation, SII CEO Adar Poonawalla said on Monday. In order to introduce an urgently needed vaccine against COVID-19 in India, Pune based Serum Institute of India (SII), the world's largest vaccine manufacturer, has entered into a collaboration with the University of Oxford and AstraZeneca to manufacture Covishield. By next month, the vaccine can also be approved in India, he noted.

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