Kushal Kumar Jha
After Pfizer, now Serum Institute seeks emergency use authorisation for Oxford-AstraZeneca vaccine
According to official sources, the Serum Institute of India (SII) on Sunday applied to the Drugs Controller General of India (DCGI) for emergency use authorisation for the Oxford-AstraZeneca vaccine against COVID-19. The development comes days after Pfizer India had sought approval from the DCGI for its COVID-19 vaccine after getting the same approval in the UK and Bahrain. According to a report published in The Indian Express, DCGI has placed Pfizer's application before a committee of experts to examine the data of its trial conducted abroad: “The request by Pfizer has been placed before the subject expert committee late Saturday evening. The company submits the safety, efficacy, and immunogenicity data, and also informs whether the data is complete or incomplete. The SEC examines this data, can hold virtual meetings, or can seek further clarifications.” While Pfizer has claimed that the efficacy of their mRNA based COVID-19 vaccine is about 95%, Oxford-AstraZeneca's 'COVISHIELD' has an average efficacy of 70%. However, the data for the efficacy of COVISHIELD is based upon their UK and Brazil trials, and Indian data is yet to be shared by the SII.