No Emergency Use Listing approval for Covaxin yet, more clarifications needed

SWITZERLAND – The World Health Organization’s technical advisory group requested “additional clarifications” from Bharat Biotech on Tuesday for its COVID-19 vaccine Covaxin in order to conduct a final “risk-benefit assessment” for the vaccine’s Emergency Use Listing.

The technical advisory group will now meet on November 3 to conduct a final evaluation.

The Technical Advisory Group for Emergency Use Listing (TAG-EUL) is an independent advisory group that advises WHO on whether or not a Covid 19 vaccine should be listed for emergency use under the EUL procedure.

Bharat Biotech has been submitting data to WHO on a rolling basis, and on September 27th, the UN health body requested additional information.

The technical advisory group has concluded its meeting to review data on Covaxin for the emergency use listing of India”s indigenously manufactured vaccine.

The TAG met today (26 October 2021) and decided that additional clarifications from the manufacturer are required to conduct a final EUL risk-benefit assessment for global use of the vaccine,” the WHO said.

Covaxin, India’s first indigenous COVID-19 vaccine, is developed in collaboration with the Indian Council of Medical Research and Hyderabad-based Bharat Biotech.

The Covaxin has showed 77.8% efficacy against symptomatic COVID-19 and 65.2% protection against the new Delta variant.

The company announced in June that it had completed the final analysis of Covaxin efficacy from Phase 3 trials.

According to Bharat Biotech, the Covaxin vaccine has been approved in 14 countries and 70 million doses have been distributed internationally.

Bharat Biotech’s Covaxin and AstraZeneca and Oxford University’s Covishield are the two widely used vaccines in India.

WHO had previously stated that it expects one more piece of information from Bharat Biotech regarding Covaxin and stressed that it must thoroughly evaluate vaccines to ensure their safety and “cannot cut corners” before recommending a vaccine for emergency use.

WHO has stated that the timeframe for its Emergency Use Listing procedure is determined by how quickly a company producing the vaccine can provide the data required for WHO to evaluate the vaccine’s quality, safety, efficacy, and suitability for low- and middle-income countries.

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