Given its experience of having its other vaccines prequalified” by the World Health Organization (WHO), NBharat Biotech is optimistic that the WHO will authorise its Covid-19 jab, Covaxin.
The corporation has already sent an Emergency Use Listing (EUL) proposal to the WHO, and regulatory approvals are due between July and September.
People are concerned that since Covaxin has not yet been added to the list of vaccines accepted by the World Health Organization (WHO) and many other nations, their attempts to travel overseas would be hampered.
Covaxin is not on the authorised registry of vaccines in the United States, Canada, Australia, Ireland, or the European Union.
Pfizer, Moderna, and Covishield have been accepted by the WHO, but further evidence is required for Covaxin.
According to NDTV, Bharat Biotech said at a meeting with the government on Tuesday about the status of its WHO application that the company was on track and had submitted “90% of the documents needed” for WHO approval.
The rest is scheduled to be submitted in June, according to the firm.
Regulatory approvals for Covaxin are in the works in more than 60 countries, according to government sources, including the United States, Brazil, and Hungary.
Authorizations for emergency use have been issued in 13 countries, with more to come.
According to the firm, it is in the final stages of negotiations with the FDA (Food and Drug Administration) of the United States to perform small-scale phase-III clinical trials in the region.
Bharat Biotech also stated that it is in contact with regulatory authorities in the aforementioned countries and that it is secure in its data.
It’s worth noting that no nation has yet implemented a vaccine passport. Countries have their own approval conditions, which in most cases entails traveling with a negative RT-PCR record, according to the company.
