SEC Recommends Oxford-AstraZeneca COVID Vaccine For Emergency Use, DCGI To Take Final Call

Serum Institute of India’s emergency-use authorisation approval comes after UK’s Medicines and Healthcare products Regulatory Agency gave approval to the Oxford-AstraZeneca vaccine earlier.

(FILES) An undated handout picture released by the University of Oxford on November 23, 2020 shows a vial of the University's COVID-19 candidate vaccine, known as AZD1222, co-invented by the University of Oxford and Vaccitech in partnership with pharmaceutical giant AstraZeneca. - Britain on December 30, 2020 became the first country in the world to approve the coronavirus vaccine developed by drug firm AstraZeneca and Oxford University, with a mass rollout planned from January 4, 2021. (Photo by John Cairns / University of Oxford / AFP) / RESTRICTED TO EDITORIAL USE - MANDATORY CREDIT "AFP PHOTO / UNIVERSITY OF OXFORD / John Cairns " - NO MARKETING - NO ADVERTISING CAMPAIGNS - RESTRICTED TO ILLUSTRATING STORIES RELATED TO THE PARTICULAR VACCINE, EVENTS AND FACTS MENTIONED IN THE CAPTION - DISTRIBUTED AS A SERVICE TO CLIENTS /

Serum Institute of India’s (SII) emergency-use authorisation (EUA) application for the coronavirus vaccine developed by Oxford-AstraZeneca got the nod from the subject expert committee (SEC) of the national drugs regulator today. However, the Drugs Controller General Of India (DCGI) will take a final call on the matter. The Central Drugs Standard Control Organisation (CDSCO) had met thrice before, over the approval of vaccines.

This move comes after UK’s Medicines and Healthcare products Regulatory Agency (MHRA) gave emergency-use approval to the Oxford-AstraZeneca vaccine earlier. Serum Institute of India, Bharat Biotech, and US-based Pfizer , all three, had earlier submitted applications for emergency use authorisation.

Central Drugs Standard Control Organisation (CDSCO) had asked SII on December 9 to submit additional clinical trials data in order to review the application for approval.

Oxford and AstraZeneca’s combined effort for coronavirus vaccine is reported to give around 70% efficacy, which is lesser than the Pfizer's COVID-19 vaccine efficacy at 90%. However, what gives Oxford/AstraZeneca's shot edge is the way it has to be preserved. Unlike Pfizer's Covid-19 vaccine, which has to be kept in ultracold freezers, AstraZeneca-Oxford's coronavirus vaccine can be preserved in normal refrigeration. Meanwhile, SII has already stockpiled around 50 million doses of the shot and plans to manufacture a total of 400 million doses by July.

Taking a step forward in defeating dreaded Coronavirus, government has decided to conduct a a countrywide mega dry run of the Covid-19 vaccination process in India from January 2. The important decision was taken in the high-level meeting of the Health Ministry on Thursday. For the dry run of Corona vaccine in all states of the country, training has been given to 96 thousand doctors. For information related to the vaccination process, helpline number 104 has been issued. The central government has instructed all states to remain on high alert for the dry run.

Till now, Covid-19 vaccination dry run was done in 4 states of the country which are Punjab, Assam, Gujarat and Andhra Pradesh. The mega drill was conducted on December 28, 29, which has reportedly yielded good results.