India may grant SII emergency use nod for Oxford Covid vaccine; DGCI awaiting UK decision

Niti Aayog member and chairman of the National Expert Group on Vaccine Administration Dr Vinod Paul has said that India may grant Pune’s Serum Institute of India (SII) with the emergency use authorisation of Oxford and AstraZeneca’s COVID-19 vaccine if the British-Swedish pharmaceutical firm gets such an approval from the UK government.

'It will give an opportunity for India's regulator'

"We expect emergency authorisation for Oxford-Astrazeneca vaccine to be sought in the UK. If so, it will give an opportunity for India regulator (Drugs Controller General of India) also (to consider such an option)," Dr Vinod Paul was quoted by a business magazine. He also said the Serum Institute vaccine, undergoing final-stage Phase III clinical trials in 16-17 cities in India, is "the closest in terms of market authorisation" among 5 vaccines that are undergoing various stages of clinical trials in India.

News agency PTI on Sunday reported that the government is exploring the modalities of emergency authorisation and usage of anti-Coronavirus vaccines pending completion of phase-three clinical trial and regular licensure. The issue of advance purchase commitment for vaccines, including pricing, was also discussed in a recent meeting attended by NITI Aayog Member (Health) Vinod Paul, Principal Scientific Advisor to the government K VijayRaghavan and Union Health Secretary Rajesh Bhushan.

"It was decided that the PMO-constituted Vaccine Task Force (VTF) will lay down the principles for emergency use authorisation while the National Expert Group On Vaccine Administration for COVID-19 (NEGVAC) should take the lead in setting the principles for advance market commitment, including vaccine pricing," the report quoted a source as saying.

Five Vaccines under different phases of clinical trials 

These developments assume significance against the backdrop of Pfizer seeking emergency use authorisation of its COVID-19 vaccine from the US regulators. Another US-based biotechnology giant, Moderna, said it also intends to apply for an emergency use authorisation (EUA) with the US Food and Drug Administration (USFDA) in the coming weeks. 

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Meanwhile, five vaccines are under different phases of clinical trials in India. The Serum Institute of India is conducting the phase-three trial of the Oxford-AstraZeneca COVID-19 vaccine as well as for COVISHIELD, while Bharat Biotech and ICMR have already started the phase-three trail of the indigenously developed COVAXIN. An indigenously developed vaccine by Zydus Cadila has completed phase-two clinical trial in the country. Dr Reddy's Laboratories will soon start combined phase two and three trials of the Russian COVID-19 vaccine Sputnik V in India.

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