Oxford COVID-19 vaccine: India may grant SII emergency authorisation if AstraZeneca gets UK govt's nod
"We expect emergency authorisation for Oxford-Astrazeneca vaccine to be sought in the UK. If so, it will give an opportunity for India regulator also (to consider such an option)," says Dr Vinod Paul, chairman of the National Expert Group on Vaccine Administration for COVID-19

- Nov 21, 2020,
- Updated Nov 22, 2020 12:10 AM IST
Indian drug regulator Drugs Controller General of India (DGCI) may consider giving emergency authorisation to Pune-based Serum Institute to make its COVID-19 vaccine available for immunisation in India if the country of origin of the vaccine - UK - approves such a request made by its global license holder AstraZeneca for marketing approval of the Oxford University vaccine developed in the UK.
"We expect emergency authorisation for Oxford-Astrazeneca vaccine to be sought in the UK. If so, it will give an opportunity for India regulator also (to consider such an option)", Dr Vinod Paul, member Niti Aayog and chairman of the National Expert Group on Vaccine Administration for COVID-19, has said.
Speaking at a virtual panel discussion on "From vaccine to vaccination: Prevention of COVID-19", on November 21, Dr Paul 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 five other vaccines that are undergoing various stages of clinical trials in India.
On vaccine distribution plans, Dr Paul said the government has the strategy in place and specifics are being worked out in association with the state governments. The government will also make extensive use of its digital platform which will incorporate the list of beneficiaries; send out messages informing them the time and location of vaccination to the beneficiaries, and issue digital certifications based on QR codes. Retired medical practitioners, medical and paramedical students etc may all be roped in to augment the human resource needed to carry out mass vaccination.
Indian drug regulator Drugs Controller General of India (DGCI) may consider giving emergency authorisation to Pune-based Serum Institute to make its COVID-19 vaccine available for immunisation in India if the country of origin of the vaccine - UK - approves such a request made by its global license holder AstraZeneca for marketing approval of the Oxford University vaccine developed in the UK.
"We expect emergency authorisation for Oxford-Astrazeneca vaccine to be sought in the UK. If so, it will give an opportunity for India regulator also (to consider such an option)", Dr Vinod Paul, member Niti Aayog and chairman of the National Expert Group on Vaccine Administration for COVID-19, has said.
Speaking at a virtual panel discussion on "From vaccine to vaccination: Prevention of COVID-19", on November 21, Dr Paul 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 five other vaccines that are undergoing various stages of clinical trials in India.
On vaccine distribution plans, Dr Paul said the government has the strategy in place and specifics are being worked out in association with the state governments. The government will also make extensive use of its digital platform which will incorporate the list of beneficiaries; send out messages informing them the time and location of vaccination to the beneficiaries, and issue digital certifications based on QR codes. Retired medical practitioners, medical and paramedical students etc may all be roped in to augment the human resource needed to carry out mass vaccination.