AstraZeneca-Oxford Vaccine Still Under Review: UK Drug Regulator

Mumbai/ New Delhi, 19 Dec 2020:

The UK’s drug regulator, Medicines and Healthcare Products Regulatory Agency (MHRA) is still reviewing the AstraZeneca/ Oxford vaccine, which has implications for Serum Institute of India’s (SII) Covid vaccine approval in India.

The subject expert committee in India is awaiting a nod from the UK's regulator to sign o on the marketing authorisation for SII to deliver the vaccines in India, write ET. “Our rolling review of Oxford/AstraZeneca Covid-19 vaccine is ongoing,” an MHRA spokesperson said in an emailed statement to ET. “We will rigorously assess the data in the shortest time possible, without compromising the thoroughness of our review,” the spokesperson added.

The MHRA is reviewing two data sets from AZ/Oxford, one that is two doses with 67% efficacy and the other with half and full dose with over 90 % efficacy. AZ/Oxford are also running an additional trial with the half and full dose vaccine in the UK. The MHRA did not respond to ET’s query on whether it would approve a two-dose vaccine or the half and full dose shot.Economic Times