The World Health Organisation (WHO) said on Monday that it was expecting “one additional piece of information” from Bharat Biotech on its Covid-19 vaccine Covaxin, which is being examined by WHO’s experts for grant of Emergency Use Listing (EUL).
This additional information was expected “today”, the WHO said.
In a series of tweets, 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.
“We are aware that many people are waiting for WHO’s recommendation for Covaxin to be included in the #COVID19 Emergency Use Listing, but we cannot cut corners — before recommending a product for emergency use, we must evaluate it thoroughly to make sure it is safe and effective,” the WHO said.
WHO clearance is a crucial step in Covaxin being accepted by foreign governments. EUL is important to remove uncertainty around overseas travel by Indians inoculated with this vaccine. EUL is also a prerequisite for a vaccine to be supplied through COVAX.
“Bharat Biotech — the manufacturer of Covaxin — has been submitting data to WHO on a rolling basis and WHO experts have reviewed these data. WHO is expecting one additional piece of information from the company today.
“The timeframe for the WHO Emergency Use Listing procedure is dependent on how quickly a company producing the vaccine is able to provide the data required for WHO to evaluate the vaccine’s quality, safety, efficacy and its suitability for low- and middle-income countries.”
The WHO 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”.
Reached for a comment, a senior official of the Hyderabad-based Bharat Biotech told The Indian Express late on Monday evening that the WHO was following the normal review process, and the company was providing all information that was being sought.
On Sunday, WHO Chief Scientist Dr Soumya Swaminathan had posted on Twitter that the “technical advisory group will meet on Oct 26th to consider EUL for #Covaxin”. She said that WHO was “working closely” with BharatBiotech “to complete the dossier”.
“Our goal is to have a broad portfolio of vaccines approved for emergency use & to expand access to populations everywhere,” Dr Soumya said.
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