Moving another step closer to World Health Organisation (WHO) approval, the rolling data of ‘made in India’ Covid-19 vaccine Covaxin will be starting in July. This has come after the pre-submission meeting held on June 23 with Bharat Biotech.
The status of Covid-19 vaccines within the EUL/PQ (emergency use listing/prequalification) evaluation process was updated on Tuesday by WHO in its latest guidance document.
Emergency Use Listing (EUL) is a procedure to streamline the process by which new or unlicensed products can be used during public health emergencies, WHO guidelines said.
Stating that its Covid-19 vaccine Covaxin adheres to international standards, Bharat Biotech’s joint managing director Suchitra Ella on Tuesday said external timelines are in the company’s hands.
What We Know About Covaxin and WHO Process So Far
• In May, Bharat Biotech submitted application for emergency use listing (EUL) to World Health Organisation (WHO)-Geneva. It said that the listing is expected by July-September.
• On June 23, WHO held a pre-submission meeting with Bharat Biotech. A senior official at the Hyderabad-based pharma company was quoted as saying by Times of India that once Bharat Biotech submits the entire Covaxin Phase-3 clinical trials data, the dossier will be complete and taken up for review by the health body. The official had said the company expects the review process for the EUL application of Covaxin to be taken up in July post submission of the efficacy study data.
• Once data from the final analysis of phase 3 studies are available, Bharat Biotech will reportedly apply for full licensure for Covaxin.
• Bharat Biotech’s American partner, Ocugen, has received a recommendation from the US Food and Drug Administration (FDA) to pursue Biologics License Applications (BLA) path, or full license, for Covaxin, instead of pursuing an Emergency Use Authorisation. The U.S. regulator had sought additional information and data, which the firms said may trigger the need for an additional clinical trial and extend the timelines for getting the approval.
• The US’ National Institute of Health said on Wednesday that results of two studies of blood serum from people who had received Covaxin suggest that the vaccine generates antibodies that effectively neutralise the B.1.1.7 (Alpha) and B.1.617 (Delta) variants of SARS-CoV-2, first identified in the UK and India.