'Can't Cut Corners': WHO Seeks More Data On Covaxin Before Decision On Emergency Use Listing
The agency said that when the information provided addresses all questions raised, the WHO and the technical advisory group will complete the assessment and come to a final recommendation
NEW DELHI: The wait for emergency use listing (EUL) of COVID-19 vaccine Covaxin by the World Health Organisation is set to get longer as the UN health body on Monday said that it had sought additional inputs from the vaccine maker.
Covaxin EUL by the WHO is particularly significant for those planning international travel as it will also pave the way for recognition by many countries.
In a statement, the WHO said while it is aware that many people are waiting for its recommendation for Covaxin to be included in the EUL, it clarified that it “cannot cut corners' before recommending a product for emergency use.
“We must evaluate it thoroughly to make sure it is safe and effective,” said the agency.
It also said that Bharat Biotech - the manufacturer of Covaxin - has been submitting data to the WHO on a rolling basis and WHO experts have reviewed the data.
“WHO is expecting one additional piece of information from the company today. The timeframe for the WHO EUL 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,” said the body.
The agency said that when the information provided addresses all questions raised, the WHO and the technical advisory group will complete the assessment and come to a final recommendation on whether to grant EUL to the vaccine.
On its part, the vaccine maker, supported by the Indian government, has been pushing for the recommendation by the WHO which was expected to come in September but was deferred to October due to the requirement for additional data.
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