BHARAT BIOTECH’S 90% DOCUMENTATION DONE WITH WHO

... in final stages of negotiations with FDA for small-scale Ph-III clinical trials of Covaxin in US

NEWDELHI: Bharat Biotech International Limited (BBIL) has conveyed to the government it has submitted 90% of the documentation to the World Health Organisation to obtain an emergency use listing for the Covaxin vaccine and the remaining details will be supplied next month, sources said on Monday.

In a separate development, the BBIL is in the final stages of negotiations with the Food and Drug Administration of the US for conducting small-scale phase-III clinical trials of Covaxin in the US, sources said.

The issue of the WHO’s authorisation for emergency use listing (EUL) for Covaxin was discussed at a meeting between the top brass of the BBIL and senior officials of the Ministry of Health, Dept of Biotechnology and the Ministry of External Affairs.

An EUL authorisation by the WHO reflects a product’s safety and efficacy. Covishield, manufactured by Punebased Serum Institute of India, is in the list of Covid-19 vaccines which were given emergency use authorisation by the global body.

The authorisation by the WHO is also required for the inclusion of any vaccine in the Covax facility, a global initiative aimed at equitable access to Covid-19 vaccines.

Sources said BBIL is confident of obtaining WHO’s emergency use listing and the MEA would extend all possible assistance, if required. “BBIL noted they had submitted 90% of the documentation required for EUL to WHO. The remaining is likely to be submitted in June,” said a source.

The BBIL had applied for the WHO’s EUL in April.

Covaxin has already received regulatory approval from 11 countries and there was interest from 11 firms in 7 nations for technology transfer and production of Covaxin, the sources said.