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Updated on: Saturday, September 18, 2021, 02:12 PM IST

WHO to delay Covaxin's emergency use authorisation till October - What is the holdup?

AFP Photo

AFP Photo

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As India inches closer to the 100 crore vaccination mark, many of the inoculated individuals remain restricted by their choice of jabs. The World Health Organisation is yet to approve Bharat Biotech's Covaxin for emergency use authorisation. And reports suggest that is is likely to be delayed till October 5. As per WHO, the Strategic Advisory Group of Experts on Immunization (SAGE) will be meeting on October 5 to granting EUA to Covaxin.

Thus far, India has approved six vaccines for emergency usage and is presently inoculating citizens with three of them. However only one of these three vaccines have been approved by the World Health Organisation. The Oxford-AstraZeneca COVID-19 jab, manufactured in India as Covishield is one of the seven vaccines approved for use by the WHO.

Emergency use authorisation for Covaxin is expected to be recommended based on the clinical data from the three phases of trial as well as post-marketing studies on safety, immunogenicity, efficacy and effectiveness. The assessment of the SAGE working group on the available pieces of evidence will determine EUA.

Earlier this week, Niti Aayog member Dr VK Paul had opined that a positive decision was likely to come before the end of the month. "We know of positive developments-data sharing, data evaluation going on through multiple reviews and we know that we're close to decision point," he had been quoted as saying.

According to the latest edition of the 'Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process' published by the international health body, the assessment status of Covaxin is ongoing. The EOI has been accepted and pre-submission meeting held and the data has been accepted for review. "Rolling data started 06 July 2021," the guidance document dated 19th August adds.

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Meanwhile, Bharat Biotech on Friday said it has submitted all the data to WHO for Emergency Use Listing of Covaxin and was now waiting for feedback from the UN Public Health Agency. In a series of tweets, Bharat Biotech said that Covaxin clinical trial was fully compiled and available in June 2021. The company declined to speculate or comment further on the approval process and its timelines.

Covaxin was developed by Hyderabad-based Bharat Biotech in association with the Indian Council of Medical Research and the National Institute of Virology. Covaxin, which has been developed in collaboration with the Indian Council of Medical Research (ICMR), contains a whole virion inactivated SARS-CoV-2 vaccine, which is produced in Vero cells.

(With inputs from agencies)

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Published on: Saturday, September 18, 2021, 02:12 PM IST
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