Bharat Biotech has applied to the World Health Organization (WHO) for the Emergency Use Listing (EUL) of its COVID vaccine Covaxin and regulatory approvals are expected by June-September.
So far, Bharat Biotech has submitted 90 percent of documents to WHO for obtaining the EUL for Covaxin, news agency PTI reported.
The WHO, however, has sought more documents, which are expected to be submitted by the company in June. As per sources, Bharat Biotech is confident about obtaining WHO’s emergency use listing.
Bharat Biotech announced on 25 May that regulatory approvals for Covaxin are in the process for over 60 countries, including the US, Brazil, Hungary, etc. The Hyderabad-based company also announced that emergency-use approval (EUA) has been obtained in 13 countries with more to follow.
Covaxin is among the three vaccines currently being administered in India. It was granted restricted emergency use approval in 'clinical trial mode' on 2 January.
How is Emergency Use Listing Granted?
The quality, safety, and efficacy of COVID-19 vaccines, as well as risk management plans and programmatic suitability, such as cold chain requirements, are assessed for Emergency Use Listing.
Bharat Biotech is also in its final stages of negotiations with United States’ agency Food and Drug Administration (FDA) for conducting small-scale phase-III clinical trials of Covaxin in the US.
Covaxin has received regulatory approval in 11 countries and there is interest in technology transfer and production from 11 companies in seven countries, PTI reported.
Bharat Biotech is also in the final stages of submission of required documents for regulatory approvals for Covaxin in Brazil and Hungary.
In April, the firm had issued a statement, saying that the second interim data from its phase 3 trial of almost 26,000 participants showed that the vaccine has an efficacy of 78 percent in preventing the virus, which was partially lower than the 80.6 percent found in the first interim data in March.
WHO’s cutoff for the efficacy of COVID-19 vaccines is 50 percent, the same as the lower limit set by regulators in India, the US, and other countries.
The manufacturing capacity of Bharat Biotech’s Covaxin will be ramped up to 700 million doses by the end of this year.
(With inputs from PTI)
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