The Serum institute of India has applied to the Drugs Controller General of India for emergency use authorisation for its Oxford Covid-19 vaccine in the country.
Covishield, being developed by the SII with Oxford and AstraZeneca,is the first candidate that is being tested in the country to seek emergency approval.
The application cited data from four clinical studies — two in the UK and one each in India and Brazil — to show Covishield is highly effective against symptomatic and against severe Covid-19 infections.
“Covishield is safe and well-tolerated and can be used effectively for prevention of Covid-19 in the targeted population. Thus, the benefit to risk ratio strongly supports its widespread use,” PTI quoted a source as saying, citing the SII’s application.
The development comes a day after US pharma giant Pfizer’s India arm sought a similar emergency approval from the DCGI for its vaccine candidate.
The Indian Express has reportedly learnt the DGCI has placed Pfizer’s application before an expert committee to examine the data of its clinical trial conducted abroad.
The Subject Expert Committee, consisting of a panel of experts, will give its recommendations to the regulator and a decision will be taken based on that.
“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,” sources said.
Government sources said the regulatory process of emergency authorisation approvals for vaccine candidates being tested in India, specifically Covishield and ICMR-Bharat Biotech’s Covaxin vaccine candidate, will take place in the next few days.
On December 2, the UK became the first country to grant temporary authorisation for the emergency use of Pfizer’s mRNA vaccine (BNT162b2) against Covid-19.
Pfizer in its application sought permission to import its vaccine and also to waive the need for clinical trials on the Indian population under relevant provisions of the New Drugs and Clinical Trial Rules, 209. Sources said the waiver will be “scrutnised by the SEC”.