Bharat Biotech has said it’s confident that the World Health Organisation (WHO) would approve its Covid-19 jab, Covaxin, given its “experience of getting its other vaccines prequalified” by the global health body.
The company has already submitted an application to the WHO for Emergency Use Listing (EUL), and regulatory approvals are expected between July-September.
In the wake of Covaxin not yet making it to the list of vaccines approved by WHO and several other countries, there are fears among people that this may hamper their travel-abroad plans.
The US, Canada, Australia, Ireland and the EU are among those that do not have Covaxin on their approved list of vaccines.
The WHO has approved Pfizer, Moderna and Covishield, but for Covaxin, it said “more information required”.
Bharat Biotech, at a meeting on Tuesday with the government on the status of its application before the WHO, said the company was on track and had submitted “90 per cent of the documentation required” for WHO’s authorisation.
“The remaining is expected to be submitted in June,” the company said.
According to government sources, regulatory approvals for Covaxin are in process in more than 60 countries, including the US, Brazil and Hungary.
Emergency use authorisations have been obtained in 13 countries, with more to follow.
Negotiation With US For Phase 3 Trials
The company is also in the “final stages of negotiations with the FDA (Food and Drug Administration) of the US for conducting small-scale phase-III clinical trials” in the country, the company has told the central government.
Bharat Biotech further said it is in touch with the regulatory authorities in the countries mentioned above, and was confident about its data.
“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 company added.