Bharat Biotech International Limited (BBIL), the company manufacturing the Covid-19 vaccine has expressed confidence to get included in the World Health Organization’s (WHO) Emergency Use Listing (EUL), considering the other vaccines developed by the company have been approved by WHO, according to news agency ANI.
ANI stated quoting the sources, “BBIL is confident about obtaining WHO EUL subsequently, given its experience of getting its other vaccines prequalified by WHO.”
WHO manufactured the process of listing the vaccines to tackle public health emergencies like Covid-19.
Bharat Biotech is in the final stage to submit documents to receive the approval of Covaxin in Brazil and Hungary, which is positive about the efficacy of the vaccine as they are in possession of the data to show that antibodies following immunization remain even post 6-8 months after vaccination.
Sources revealed, “BBIL is in the final stages of submission of required documents for Covaxin’s regulatory approvals in Brazil and Hungary.”
The sources added, “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.”
Bharat Biotech had organized a meeting with the government officials to discuss the EUL listing of Covaxin, revealed the sources. At the meeting, the managing director V Krishna Mohan senior officers of the Ministry of Health, Department of Biotechnology and Ministry of External Affairs were present. Foreign secretary Harsh Vardhan Shringla also attended the meeting, reported PTI.
The manufacturer confirmed that 90 per cent of the documents asked by WHO’s emergency listing has been submitted, and the remaining ones will be sent in June.
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