Covaxin has not got emergency use approval from WHO since 6 months. Know the process here

The approval is stuck in the final fifth stage of the process when clinical data on safety, efficacy, quality and risk management plan are evaluated

By DTE Staff
Published: Wednesday 27 October 2021

Bharat Biotech Intl Ltd (BBIL)’s wait for wider approval for its Covaxin is set to continue. The World Health Organization (WHO) October 26, 2021, asked the company to provide “additional information” about its vaccine against the novel coronavirus disease (COVID-19).

BBIL has sought an Emergency Use Assessment and Listing (EUAL) status from WHO for Covaxin, developed jointly with the Indian Council of Medical research.

So far, six vaccines (seven if two vaccines by AstraZeneca plc are considered different) have been approved for emergency use during the pandemic. Bharat Biotech has till the end of the week to send in the additional information.

WHO developed the Emergency Use Assessment and Listing mechanism in response to the 2014-2016 Ebola Virus Disease outbreak. The organisation decided to use this process to approve vaccines, diagnostics and drugs during the COVID-19 pandemic too.

This process has five major steps. The process of applying for an EUAL begins with the company filing an Expression of Interest. Bharat Biotech did this April 16, 2021.

The company then has a pre-submission meeting with WHO. The date for this in case of Covaxin was the end of June. WHO accepted the company’s dossier for review July 6, 2021.

The WHO has a provision to hasten the process under which companies can provide data in a rolling manner as it is generated.

Rolling data accelerate the overall review process. Bharat Biotech expected to receive the approval in July-August. WHO provides periodic updates on the ‘status of assessment’ on its website. As of October 20, the site says that this is ongoing.

The fifth stage is the final.

Experts, both independent and within WHO, evaluate late Phase II, Phase III clinical trial data and data on safety, efficacy, quality and a risk management plan during this process.

As part of the EUAL process, the company has to continue to generate data to enable full licensure and WHO prequalification of the vaccine.

WHO listed the Pfizer / BioNTech vaccine for emergency use December 31, 2020, two AstraZeneca / Oxford COVID-19 vaccines February 15, 2021, COVID-19 vaccine Ad26.COV2.S developed by Janssen March 12, 2021 followed by Moderna’s vaccine on April 30. 

A vaccine by Beijing Institute of Biological Products Co, Ltd and another by Sinovac Life Sciences Co, Ltd received EUAL May 7 and June 1 respectively. 

According to the data provided by WHO October 20, a total of 8 vaccines are providing data to the organisation in a rolling manner. Among these, two are from India, three are from China, one is from Russia and one is from France.

The assessment process of three began in July and the October 20 document lists all these as ongoing. The tentative date has been provided just for Covaxin.

While this document puts the month as October, the decision is likely to now be taken only in November. WHO issued the first EUAL December 31, 2020 to Pfizer’s mRNA vaccine Comirnaty. In the case of AstraZeneca’s vaccine, the total process of assessment took just four weeks. 

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