New Delhi: Bharat Biotech International Limited (BBIL) informed the central government that it has submitted 90 per cent of the documentation to the World Health Organisation (WHO) for obtaining an emergency use listing for the Covaxin vaccine, while the remaining information will be passed on next month, sources revealed on Monday.
In a different development, the BBIL said it is currently in the final stages of negotiations with the Food and Drug Administration (FDA) of the US for conducting phase-III clinical trials on small-scale of Covaxin in the United States.
The problem of the WHO’s authorisation for emergency use listing (EUL) for Covaxin was spoken about at a meeting between the top brass of the BBIL and senior officials of the Ministry of Health, Department of Biotechnology and the Ministry of External Affairs.
An EUL authorisation by the WHO certifies a product’s safety and efficacy. Covishield, which is being manufactured by Pune-based Serum Institute of India, is in the list of coronavirus vaccines which were given emergency use clearances by the global body previously.
The authorisation by the World Health Organisation is also needed for the inclusion of any Covid vaccine in the Covax facility, a global initiative aimed at equitable access to COVID-19 vaccines.
“BBIL noted that they had submitted 90% of the documentation required for EUL to WHO. The remaining is expected to be submitted in June,” said a source.
Back in April, BBIL had applied for the WHO’s EUL.
Covaxin already has received regulatory approval from 11 different nations and there was also interest from 11 companies in seven countries for technology transfer and production of Covaxin, sources revealed. As per reports, he BBIL is also in the final stages of submission of required documents for regulatory approvals to their COVID-19 vaccine in Hungary and Brazil.
The company has held extensive bilateral consultations with both countries, sources, who did not wish to be named, said.
“BBIL is in regular touch with regulatory authorities in these countries. They are confident about the robustness of their dossier, as they have data for much longer duration — for anti-body persistence after six months as well as eight months” the source said.
In the meeting, the BBIL also clarified that all regulatory approvals have both retrospective and prospective effect, they said.