The manufacturer of India’s homegrown covid-19 Covaxin vaccine, Bharat Biotech International Limited (BBIL), has submitted 90 percent of the paperwork needed for the World Health Organization’s (WHO) Emergency Use Listing.
The Emergency Usage Listing (EUL) would enable other countries to recognize and use Covaxin, which was created in India.
According to two people familiar with the situation, BBIL has already sent papers for Covaxin’s regulatory approvals in Brazil and Hungary, and the firm is in the final stages of discussions with the US Food and Drug Administration or FDA for performing small-scale Phase-III clinical trials in the US.
According to the individual quoted above, these concerns were discussed at a meeting between BBIL members and officials from the Ministry of Health, Department of Biotechnology, and Ministry of External Affairs. Dr. V. Krishna Mohan, the Hyderabad-based company’s managing director, led the BBIL team. It comes as Indian diplomats and industry officials press for foreign bodies to approve Covaxin.
The meeting was called in response to rumors that certain countries are considering implementing a “vaccine passport,” which would require travelers to provide proof that they have been inoculated with a globally approved anti-covid-19 vaccine. Pfizer and Moderna are two companies that make vaccines that are widely used around the world. Any Chinese vaccines, as well as Russia’s Sputnik vaccine, are in use in some countries.
“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,” the person cited above said.
“On the issue of WHO’s authorization for Emergency Use Listing (EUL), BBIL noted that they had submitted 90% of the documentation required for EUL to WHO,” the person said.
The remaining papers are due to be submitted in June 2021, according to BBIL. According to the individual quoted above, “BBIL is optimistic about receiving WHO EUL in the future, given its experience in having its other vaccines prequalified by WHO.”
Covaxin has now obtained regulatory clearance in 11 countries, with another 11 firms in seven countries expressing interest in transferring technologies and producing Covaxin, according to a second source familiar with the situation. Iran, the Philippines, Mauritius, Mexico, Nepal, Guyana, Paraguay, Zimbabwe, and India are among the countries that have accepted Covaxin.
