WHO to take final decision on Covaxin nod next week

The World Health Organisation’s (WHO) experts will meet next week to take the final decision on whether to grant emergency use listing to Bharat Biotech’s coronavirus vaccine, Covaxin, the UN health body announced on Tuesday in a series of tweets.

The approval could greatly influence how other countries treat people vaccinated with Covaxin. Experts from WHO, and a group of independent experts, are going through data, and are expected to carry out the risk-benefit assessment before arriving at a conclusion.

“WHO & an independent group of experts are scheduled to meet next week to carry out the risk/benefit assessment and come to a final decision whether to grant Emergency Use Listing to Covaxin,” said the UN health body in a tweet.

It was not immediately clear whether the Strategic Advisory Group of Experts on Immunization (SAGE) meeting on Covaxin on the agenda for Tuesday took place or not.

On July 12, Bharat Biotech announced that it had submitted all relevant documents to set in motion the EUL proceedings to WHO. At least 105, 984,630 doses of Covaxin have been delivered to people in India.

WHO began a rolling review of Covaxin on July 6, 2021.

In another tweet, WHO also confirmed that the company submitted all necessary documents, including the additional information that was sought towards the end of last month.

“Covaxin manufacturer, Bharat Biotech, has been submitting data to WHO on a rolling basis & submitted additional info at WHO’s request on 27 September. WHO experts are currently reviewing this info & if it addresses all questions raised, WHO assessment will be finalized next week,” read the tweet.

It also said that the emergency use listing was a thorough exercise undertaken by WHO and the technical advisory group of independent experts to determine if a manufactured product, in this case Covaxin, is quality-assured, safe and effective or not.

As part of the analysis, experts will be looking at the presentation of clinical data on Covaxin from phase 1, 2, 3 and post marketing studies on safety, immunogenicity, efficacy and effectiveness.

Bharat Biotech also attended a pre-submission meeting scheduled with representatives of WHO on June 23. A day earlier, on June 22, the subject expert committee (SEC) of the central drugs standards control organisation (CDSCO) assessed Bharat Biotech’s phase 3 clinical trials data of Covaxin and found it to be 77.8% efficacious.

While the Indian regulator has approved six coronavirus vaccines for emergency use, Covaxin and Serum Institute of India-manufactured Covishield are the mainstay of the country’s inoculation campaign.

Covishield was granted EUL in February this year; and with grant of EUL, Covaxin will be eligible for use in low and middle income countries under the COVAX facility.