Oxford COVID-19 vaccine: India may grant SII emergency authorisation if AstraZeneca gets UK govt’s nod

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.

Also Read: COVID-19 vaccine update: Pfizer files for emergency use; Covaxin trials to start in metro cities

According to Dr Paul, if everything goes by the script, the Phase III clinical trials of Serum vaccine should be over by January/February 2021. An emergency authorisation before that would strengthen the possibility of the vaccine getting administered to the people in the priority list – frontline workers, senior citizens, people with comorbidity etc – early next year.

Also Read : Coronavirus vaccine update: Pfizer applies for emergency approval, 10 things to know

The second vaccine in Phase III clinical trials is the indigenous inactivated virus vaccine jointly developed by ICMR and Bharat Biotech. The third is a DNA COVID-19 vaccine being developed by Zydus Cadilla. The Sputnik V vaccine, the Russian vaccine to be marketed by Dr. Reddy’s, and indigenously developed vaccine using MIT platform by Biological E are the other promising COVID-19 vaccines that are being tested in India, Dr Paul said.

Also read: Covid-19 vaccine: Sputnik V to arrive in India next week for Phase 2,3 clinical trials

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.