Bharat Biotech has submitted additional data requested by the World Health Organisation (WHO) for a final decision on granting the Emergency Use Listing (EUL) to its COVID-19 vaccine Covaxin.
The Technical Advisory Group (TAG) of the WHO had sought gender-wise immunogenicity data on adults aged above 60 from the Hyderabad-based vaccine maker, as per an Economic Times report.
Separate data for both male and female was needed from the company. The data was submitted on Friday, sources told the publication.
Bharat Biotech had submitted EOI (Expression of Interest) to the World Health Organisation on April 19 for the vaccine’s Emergency Use Listing (EUL).
During the last meeting on October 26, the WHO had sought “additional clarifications” from Bharat Biotech to conduct a final “risk-benefit assessment” for Emergency Use Listing of its COVID-19 vaccine.
The technical advisory group will now meet on November 3 for a final assessment.
The WHO has so far approved Covid-19 vaccines of Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson & Johnson-Janssen, Moderna, and Sinopharm for emergency use.
WHO has so far approved Covid-19 vaccines of Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson & Johnson-Janssen, Moderna, and Sinopharm for emergency use.
Meanwhile, Australia’s medicines and medical devices regulator on November 1 formally recognised Covaxin as the country’s border was reopened for the first time in nearly 20 months.
“Today, the Therapeutic Goods Administration (TGA) determined that Covaxin (manufactured by Bharat Biotech, India) and BBIBP-CorV (manufactured by Sinopharm, China) vaccines would be ‘recognised’ for the purpose of establishing a traveller’s vaccination status, Australia’s medicines and medical devices regulator TGA said.
This recognition is for travellers aged 12 and over who have been vaccinated with Covaxin, and those 18 to 60 who have been vaccinated with BBIBP-CorV.
Welcoming Canberra’s decision, Prime Minister Narendra Modi thanked his Australian counterpart Scott Morrison for the recognition of Covaxin.