The Hyderabad-based company stated that application for Emergency Use Listing (EUL) has been submitted to WHO, Geneva and regulatory approvals are expected by July-September 2021.
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Bharat Biotech has said on Tuesday that it is expecting regulatory approvals from the World Health Organisation (WHO) for its Covid-19 vaccine Covaxin by July-September 2021. The Hyderabad-based company stated that application for Emergency Use Listing (EUL) has been submitted to WHO, Geneva and regulatory approvals are expected by July-September 2021.
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It also said regulatory approvals for Covaxin are in process in more than 60 countries including the United States, Brazil and Hungary. "Emergency use authorisations have been obtained in 13 countries with more to follow," it said. Most countries recommend vaccinations against Covid-19. Unvaccinated travellers can travel with negative RT-PCR tests prior to travel, in the absence of any other country specific travel restrictions, it added.
Also read: More information required from Bharat Biotech for emergency use listing of Covaxin: WHO
Bharat Biotech's statement came out amid reports that people who have taken Covaxin and plan to travel abroad were nervous as it is not in the list of WHO approved vaccines. With countries gearing up to resume travel and tourism, intending travellers from India who have taken Covaxin jabs will be anxiously waiting for Covaxin's approval by WHO.
Pfizer, Moderna and Covishield are on WHO's approved list and people who have taken these vaccines may not face any restrictions while travelling. Those who have taken vaccines which are not on the approved list of WHO may have to undergo quarantine on landing in the destination countries.
Bharat Biotech is reported to have submitted 90 per cent of the documentation to the WHO for EUL. WHO's EUL is expected to open the doors for Covaxin to be accepted by countries around the world. Covaxin and Covishield are the two vaccines which are currently included in the Covid vaccination programme in India. Russia's Sputnik is soon likely to join the vaccination drive.
In January, India's drug regulator had approved Covaxin for emergency use but the move came under criticism as the full data from its clinical trials was not available. This was believed to be one of the reasons for vaccine hesitancy among the target groups in the initial stages of the vaccine drive. Bharat Biotech and the Indian Council of Medical Research (ICMR) claimed last month that Covaxin had shown overall interim effectiveness of 78 per cent.
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