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NEW DELHI : The World Health Organization (WHO) will take a decision on the emergency use listing (EUL) of Bharat Biotech’s covid vaccine by the end of October, according to the latest update by the UN agency issued on Thursday.

WHO said it was assessing the rolling data on the Covaxin trials since 6 July, and is awaiting all responses to the assessors’ questions.

“We know that scientific data, public health considerations and international health requirements are all considered on which the clearance is given by WHO. All these have been provided, and are being assessed by WHO," said Balram Bhargava, director general, Indian Council of Medical Research (ICMR).

Bharat Biotech said it had submitted all clinical trial data to the apex global public health agency for getting EUL and is awaiting feedback.

“Covaxin’s clinical trial data was fully compiled with and made available in June. All data was submitted to WHO for EUL application in early July. We have responded to all clarifications sought by WHO and are awaiting further feedback. We are diligently working with WHO to obtain EUL at the earliest," the Hyderabad-based pharmaceutical company tweeted on 28 September.

On 21 August, Union health minister Mansukh Mandaviya met Soumya Swaminathan, chief scientist, WHO, to discuss the approval process for Covaxin. In July, Swaminathan said WHO may take a decision on granting the EUL to Covaxin within four-six weeks.

WHO’s EUL is a prerequisite for supplying vaccines under the Covax Facility, a multilateral initiative aimed at fostering global access to covid vaccines.

EUL assesses the quality, safety and efficacy of vaccine candidates, as well as the risk management plans and programmatic suitability, such as cold chain requirements. The assessment is performed by the product evaluation group, comprising regulatory experts from across the world and a technical advisory group (TAG) to perform the risk-benefit assessment for an independent recommendation on whether a vaccine can be listed for emergency use and, if so, under what conditions. So far, WHO has given EUL to six covid vaccines. 

Covaxin, India’s first indigenously developed covid vaccine, has received EUAs from 14 countries and another 50 are in the process. In June, the drugmaker had said that its US partner, Ocugen, has received a recommendation from the US Food and Drug Administration to pursue biologics license applications (BLA) for Covaxin. Applications have to follow the BLA process, which is the standard for vaccines.

WHO’s approval will facilitate international travel for Indians who have received Covaxin under India’s national covid vaccination programme.

A delay may impact students and businessmen who want to travel to countries where a vaccination certificate for WHO-approved vaccines is mandatory. Union health ministry officials also said that Covaxin is expected to receive the EUL from WHO soon.

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