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Earlier this month, three vaccine makers had applied to the DCGI for grant of emergency use authorisation to their vaccines.
India may approve Oxford/AstraZeneca's COVID-19 vaccine for emergency use even before the UK, hopefully by next week, as Serum Institute of India (SII) has submitted additional data sought by the authorities. SII is conducting phase 2 and phase 3 clinical trials of the Covid-19 vaccine candidate of Oxford-AstraZeneca, called Covishield in India, at 15 different centres across the country. The Pune-based firm had submitted an application to the Drugs Controller General of India (DGCI) seeking EUA for the vaccine on December 6.
Including Serum Institute, three vaccine makers have applied to the DCGI for grant of emergency use authorisation to their vaccines. The other two are Pfizer and Bharat Biotech. After reviewing the applications on December 9, an expert committee of the Central Drugs Standard Control Organisation (CDSCO) had demanded additional late-stage safety and efficacy data from Bharat Biotech and SII.
Quoting sources with knowledge of the matter, Reuters on Tuesday reported that SII has submitted the fresh data to the regulator. A leading newspaper also confirmed the news on Wednesday quoting government sources.
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Meanwhile, another report said that Bharat Biotech will be submitting the additional data sought by the drug regulator in a "week or two".
The Hyderabad-based company is developing the country's indigenous coronavirus vaccine, called Covaxin, in collaboration with the Indian Council of Medical Research (ICMR). Phase III human clinical trials of the inactivated vaccine candidate is currently undergoing, with plans to include 26,000 volunteers at 25 centres across India. On Tuesday, the company had announced that the Phase-3 trial has crossed 13,000 subjects the half-way mark.
While applying for the emergency use authorisation (EUA) of its vaccine on December 7, Bharat Biotech had submitted the interim safety and immunogenicity data of Phase I and II clinical trials.
The vaccine was evaluated in approximately 1,000 subjects in the first two phases, which showed promising results. However, the CDSCO expert panel had sought the safety and efficacy data from the ongoing Phase III clinical trial in the country for further consideration of their application for grant of EUA.
"The company has yet not submitted the data. It will take another week or two," a company source told IANS on the condition of anonymity.
The CDSCO, however, has not given any official confirmation in this regard.
American drugmaker Pfizer Inc, which was the first to apply for the EUA of their vaccine candidate BNT162b2 on December 4, has not yet submitted data for its vaccine candidate to the DCGI. However, Pfizer's COVID-19 vaccine has been approved in some countries including the US, UK, Canada, Bahrain, Singapore and Kuwait. A few of these countries have already started vaccinating their people with the Pfizer jab.