Bharat Biotech says 90% documents given to WHO for Covaxin's EUL

Last updated on May 26th, 2021 at 05:04 am

WHO has demanded more information from Bharat Biotech for granting emergency use approval to Covaxin

Bharat Biotech International Limited (BBIL) on Monday said it has submitted 90 percent of the required documents to the World Health Organisation (WHO) for the Emergency Use Listing (EUL) of its Covaxin COVID-19 vaccine. Expressing confidence in obtaining the WHO approval for its vaccine, the drugmaker further noted that it would be filing the remaining documents for the same by June.

However, as per the latest guidance document issued by the WHO on the vaccine’s EUL status, the international health body has asked Bharat Biotech for “more information” related to the vaccine.

Dated May 18, WHO’s ‘Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process’ guidance document said that Bharat Biotech submitted EOI (Expression of Interest) on April 19 and “more information required”.

“A pre-submission meeting is expected to be planned May-June 2021,” the document added.

According to the WHO, the duration of the process of approving emergency use of a vaccine depends on the quality of the data submitted by the vaccine manufacturer as well as the documents meeting WHO criteria.

The WHO approval for the indigenous COVID-19 vaccine ‘Covaxin’ is poignant to India’s ongoing battle against the second wave of the COVID-19 pandemic. So far, more than 2 crore Indian nationals, including Prime Minister Narendra Modi, a number of union ministers, and other senior government officials, have been administered the Covaxin vaccine.

Earlier, senior officials from the Ministry of External Affairs, Health Ministry and Department of Biotech including Foreign Secretary Harsh Vardhan Shringla held a meeting with Bharat Biotech MD Dr V Krishna Mohan and other company executives to discuss the status of Covaxin’s application for the WHO’s emergency use listing. During the meeting, BBIL underlined that Covaxin has received regulatory approval from at least 11 countries across the world.

This development has come as countries globally are preparing to reopen their borders for international travel and tourism. Notably, there are a number of countries including the US, Australia, Canada and the EU that do not have Covaxin on their approved list of vaccines as of now. Currently, the WHO has given approval to Pfizer-BioNTech, Moderna, Sinopharm, and SII’s Covishield vaccine.

Taking this into cognisance, BBIL is scrambling efforts to get the Covaxin vaccine EUL approval from the WHO.

Reportedly, Bharat Biotech is in talks with the FDA (Food and Drug Administration) for carrying out small-scale phase-III clinical trials of the Covaxin vaccine in the United States. At the same time, BBIL is finalising the process of Covaxin’s regulatory approvals in Hungary and Brazil.

“It is important to note that no country has instituted a vaccine passport. Countries have their own requirements for approval, which in most cases involves travel by carrying a negative RT-PCR report,” Bharat Biotech said, as quoted by media reports.