Bharat Biotech’s Covaxin gets WHO approval for emergency use listing, says report

Last month, WHO had said that additional clarifications from Bharat Biotech are needed to conduct a final EUL risk-benefit assessment for the global use of Covaxin.

The World Health Organisation (WHO) on Wednesday granted approval for Emergency Use Listing (EUL) to Bharat Biotech’s Covaxin, news agency PTI reported citing its sources.

Covaxin is one of the six vaccines that have received emergency use authorisation from India’s drug regulator and is being used in the nationwide inoculation programme, along with Covishield and Sputnik V.

The Centre had told Rajya Sabha in July that all documents required for the WHO’s EUL have been submitted by Bharat Biotech as of July 9, and the global health body had commenced the review process.

On October 18, the WHO had said that it was expecting “one additional piece of information” from Bharat Biotech on Covaxin, which is being examined by WHO’s experts for grant of Emergency Use Listing (EUL).

In a series of tweets back then, the WHO said it could not “cut corners”, and that the timeframe for its Emergency Use Listing was dependent on how quickly vaccine manufacturers were able to provide the required data.

The WHO had said that once “the information provided addresses all questions raised”, the organisation and its Technical Advisory Group would “complete the assessment and come to a final recommendation whether to grant Emergency Use Listing to the vaccine”.

Later, WHO said that the Technical Advisory Group EUL has decided that additional clarifications from Bharat Biotech are needed to conduct a final EUL risk-benefit assessment for global use of Covaxin.

In an e-mail response to The Indian Express on the outcome of the meeting that took place on October 26 on the grant of EUL to Covaxin, the WHO said the TAG “expects to receive these clarifications from the manufacturer by the end of this week, and aims to reconvene for the final risk-benefit assessment on Wednesday, 3 November”.

“The Technical Advisory Group for Emergency Use Listing (TAG-EUL) is an independent advisory group that provides recommendations to WHO on whether a Covid-19 vaccine can be listed for emergency use under the EUL procedure. The TAG met today (26 October 2021) and decided that additional clarifications from the manufacturer are needed to conduct a final EUL risk-benefit assessment for global use of the vaccine,” it added.

The WHO has so far approved Covid vaccines developed by Pfizer-BioNTech, US pharma majors Johnson & Johnson, Moderna, China’s Sinopharm and Oxford-AstraZeneca for emergency use.

Meanwhile, Bharat Biotech on Wednesday said the Central Drugs Standard Control Organisation (CDSCO) has approved the extension of shelf life of Covaxin up to 12 months from the date of manufacture.

“The CDSCO has approved the extension of shelf life of Covaxin up to 12 months, from the date of manufacture. This approval of shelf life extension is based on the availability of additional stability data, which was submitted to CDSCO,” Bharat Biotech said in a tweet.

 

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