Cannot cut corners, thorough evaluation needed for COVAXIN EUL: WHO
The World Health Organization (WHO) Monday clarified the reason behind the delay in COVAXIN's emergency use listing (EUL), stating that it is expecting more information from Bharat Biotech on its COVID-19 vaccine. The WHO's comments came as COVAXIN manufacturer Bharat Biotech has been pursuing clearance by the agency for several months. However, the WHO clarified that such approval is only possible after thorough evaluation.
WHO awaiting 'one additional piece of information' from Bharat Biotech
In a series of tweets, the WHO said that Bharat Biotech has been submitting the required data on its vaccine on a rolling basis, and experts have been reviewing them. It said it is expecting "one additional piece of information" from the company for a thorough evaluation of its vaccine. The WHO added it "cannot cut corners before recommending a product for emergency use."
'Timeframe for EUL depends on how quickly data is provided'
The WHO said the timeframe for the EUL grant to vaccines depends on how quickly the manufacturing company is being able to provide the required data "for WHO to evaluate the vaccine's quality, safety, efficacy, and suitability for low-and middle-income countries."
You can read the WHO's tweet here
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. pic.twitter.com/GDx8GAc1KU— World Health Organization (WHO) (@WHO) October 18, 2021
When will COVAXIN likely get EUL?
The WHO has made it clear that without a complete assessment of all the data sought by it, a vaccine cannot get EUL. "When the information provided addresses all questions raised, WHO and the Technical Advisory Group will complete the assessment and come to a final recommendation whether to grant Emergency Use Listing to the vaccine," the global health body added.
Routine process, will not lead to much delay: Source
A WHO source quoted by CNN-News18 said the agency is simply following a routine process, adding that it is unlikely to cause much delay in approval. "It's the usual process. Experts raise queries, which need to be answered by the company," the source told the publication. About any possible delay in approval, the source added, "No, it should not be delayed...Maybe a few weeks."
How will EUL grant help Bharat Biotech?
Without WHO's approval, COVAXIN is unlikely to be accepted as a valid COVID-19 vaccine around the world. Notably, it is one of the three COVID-19 vaccines administered in India. Reportedly, 112 million doses of COVAXIN have been administered in India so far.