New Delhi: Hyderabad-based Bharat Biotech’s pre-submission meeting has been scheduled on June 23 for evaluation of the World Health Organisation (WHO)’s Emergency Use Listing (EUL) of its indigenous COVID-19 vaccine Covaxin.
Earlier, last month, Bharat Biotech had informed that it had submitted 90 per cent of the documentation needed for WHO’s EUL.
The company added that it would submit the rest of the documents by this month.
The External Affairs Ministry is coordinating with Bharat Biotech to secure WHO recognition for the COVID-19 vaccine. Covaxin is among three vaccines currently being administered in India against the COVID-19 pandemic.
On June 10, the US Food and Drug Administration (FDA) refused an emergency use authorization (EUA) to Covaxin on the basis of inadequate data from clinical trials. The news was shared by Bharat Biotech’s US partner Ocugen, which stated they have decided to pursue a biologics license application (BLA) for its COVID-19 vaccine candidate, Covaxin.
On February 2, 2021, Ocugen entered into an agreement with Bharat Biotech International Limited (Bharat Biotech) for development and commercialisation of Covaxin, for the US and Canadian market. More than 13 countries have given emergency authorisation to Covaxin so far.
India started the world’s largest vaccination drive on January 16 this year in a phased manner with healthcare workers (HCWs) getting inoculated first. The vaccination of frontline workers (FLWs) started on February 2.
The next phase of COVID-19 vaccination commenced from March 1 for those over 60 years of age and for people aged 45 and above with specific co-morbid conditions. India launched vaccination for all people aged more than 45 from April 1. Phase 3 of the vaccination drive was started on May 1 for the beneficiaries belonging to the age group 18-44.
(With inputs from ANI and PTI)