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

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

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

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

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

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

Five Vaccines under different phases of clinical trials 

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

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

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