Bharat Biotech confident of Covaxin making it to WHO emergency use listing: Sources
Bharat Biotech International Limited (BBIL), the manufacturer of indigenous coronavirus vaccine Covaxin, is confident of being included in the World Health Organization’s (WHO) Emergency Use Listing (EUL) given that other vaccines produced by the company have been previously prequalified by WHO, reported news agency ANI.
“BBIL is confident about obtaining WHO EUL subsequently, given its experience of getting its other vaccines prequalified by WHO,” said ANI citing sources.
WHO developed the process of listing vaccines for emergency use to help deal with public health emergencies similar to the Covid-19 pandemic. EUL helps the United Nations in procurement agencies and WHO member-states in determining if any necessary unlicensed medical product should be approved for use. The rotavirus, polio, and typhoid vaccines produced by the Hyderabad-based Bharat Biotech have been pre-qualified by WHO.
Bharat Biotech is also in the final stages of submission of documents for regulatory approval of Covaxin in Brazil and Hungary, who are reportedly confident about the efficacy of the vaccine as they are in possession of data to show that antibodies following immunization persist even after 6-8 months after vaccination.
“BBIL is in the final stages of submission of required documents for Covaxin’s regulatory approvals in Brazil and Hungary,” sources told news agencies.
“BBIL is in regular touch with regulatory authorities in Hungary & Brazil. They're confident about the robustness of their dossier, as they've data for antibody persistence after 6 as well as 8 months,” the source added.
Bharat Biotech held a meeting with government officials to discuss the EUL listing of Covaxin, sources told agencies. The meeting was attended by the managing director V Krishna Mohan, senior officers of the Ministry of Health, department of Biotechnology and Ministry of External Affairs.
Foreign secretary Harsh Vardhan Shringla was also in attendance, reported PTI. The manufacturer conveyed to the government that 90% of the required documents asked for by WHO for emergency listing has already been handed over and the rest will be submitted in June.
Individuals inoculated with both Covaxin and Russia’s Sputnik V may not be allowed to travel as WHO is yet to include either in its emergency use listing. Covaxin needs to be included in WHO’s EUL to be eligible for procurement through global vaccine alliance Covax.