Hyderabad: Bharat Biotech on Tuesday said the company has approached World Health Organization (WHO) for Emergency Use Listing (EUL) of `Covaxin' and they expect regulatory approvals anytime from July to September.
Covaxin has become the second India-made vaccine to apply for WHO's an authorization.
Bharat Biotech had submitted Covid-19 vaccine data to World Health Organization (WHO) for pre-qualification. However, the company had insisted that a pre-qualification from WHO is not a requirement for Covaxin beneficiaries to get a vaccine passport.
"Covaxin is in the process to get regulatory approvals in more than 60 countries including the USA, Brazil, and Hungary," Bharat Biotech tweeted
Most countries recommend vaccinations against Covid-19. Unvaccinated travelers can travel with negative RT-PCR reports prior to travel, Bharat Biotech said.
The company said so far Covaxin has acquired emergency use authorization in 13 countries, and more will follow.
"Application for (emergency use listing) EUL has been submitted to the WHO and regulatory approvals are expected by July-September 2021," Bharat Biotech said.
Pre-qualification is a procedure adopted by the World Health Organization to ensure the supply of quality-assured products. It has origin in the expanded program of immunization, which had started globally in 1974. The pre-qualification is done through utilizing accepted international regulatory standards on products as well as after the physical inspection of the corresponding manufacturing sites.
If any country bringing out the vaccine passport, the Covaxin-vaccinated people will be left out as it has not yet qualified by WHO. Many countries such as the US and European Union countries are considering vaccine passports.
While Bharat Biotech had submitted its expression of interest for Covaxin's EUL to the WHO on April 19, it's not yet clear if the company has made its final submission yet.