Bharat Biotech, WHO hold 'pre-submission' meeting for Emergency Use Listing of Covaxin

Domestic pharmaceutical firm Bharat Biotech and the World Health Organization (WHO) held a 'pre-submission' meeting on Wednesday for the international Emergency Use Listing (EUL) of the Covaxin COVID-19 vaccine. The meeting is a chance for the Hyderabad-based pharmaceutical firm to obtain proper guidance from the international health community before it finally submits Covaxin for approval. Earlier, the international health agency had accepted the Expression of Interest (EoI) for Covaxin from Bharat Biotech.

Explaining the process of the 'pre-submission' meeting, WHO said, "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)".

The EUL procedure has been established to help streamline the process by which new or unlicensed products like Covaxin can be utilised during a public health emergency, according to WHO guidelines. Only seven vaccines have been granted EUL to date. These include Covishield, Pfizer, Moderna and others.

As per Bharat Biotech's report, the firm had submitted 90 per cent of the required documents to WHO in April. The firm is planning to submit the rest of the documents by the end of this month in order to obtain EUL for its COVID-19 vaccine.

Covaxin is one of the three COVID-19 vaccines which are being used for India's nationwide vaccination drive. The other two are Sputnik V and Covishield.

Bharat Biotech had developed Covaxin in association with the Indian Council of Medical Research (ICMR). Bharat Biotech has submitted Phase III clinical trials data to the Drugs Controller General of India (DCGI). 

(Edited by Purnima Priyadarsini)

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