Bharat Biotech likely to attend pre-submission meeting with WHO

Bharat Biotech is likely to attend a pre-submission meeting with World Health Organisation today. Sources said that it is a step that will push the vaccine producer closer to WHO emergency use listing (EUL). However, as per WHO reports, the vaccine manufacturers will have an opportunity to submit a summary on the overall quality of the shot.

Previously. on June 18 WHO accepted Bharat Biotech’s Expression of Interest (EoI) for Covaxin and scheduled a pre-submission meeting for Wednesday. Last month, Bharat Biotech in an interview with a leading daily said that it expects approval for its Covid vaccine from the health organisation for emergency use listing during July to September.

ELU is basically a procedure with new unlicensed products that can be used during public health emergencies like the covid-19 pandemic. PTI reported that “The pre-submission meeting does not include a detailed review of data or full study reports. However, an essential aspect of the meeting is the submission (at least two weeks in advance of the pre-submission meeting) of a completed QOS-PD (Quality overall summary product dossiers),”

An official report stated that Bharat Biotech has already submitted 90 per cent of the documents to WHO for getting EUL for Covaxin.  The company said that it expects to submit the remaining documents by June. The firm had submitted the results of its phase-3 trial efficacy data of Covaxin to the Drugs Controller General of India (DCGI) over the weekend.