Covaxin is one of the two anti-COVID vaccines used by India in its nationwide vaccination campaign.
The World Health Organization (WHO) on Monday said it was expecting additional information from India’s Bharat Biotech about its COVID-19 jab Covaxin, adding that it is looking for a vaccine for emergency use. “Can’t cut corners” before recommending.
The global health agency also stressed that it must thoroughly evaluate a vaccine to ensure it is “safe and effective”.
Hyderabad-based Bharat Biotech, which has developed Covaxin, submitted the EOI (Expression of Interest) to the WHO on April 19 for the Emergency Use List (EUL) of the vaccine.
In a series of tweets, the WHO said, “We know many people are waiting for the WHO recommendation for Covaxin to be added to the #COVID-19 emergency use list, but we can’t cut corners – Before recommending a product for emergency use, we must thoroughly evaluate it to ensure it is safe and effective.”
It also said that Bharat Biotech is submitting data to WHO on an ongoing basis and these data have been reviewed by WHO experts.
“WHO is expecting an additional information from the company today,” it said.
“When the information provided addresses all questions raised, WHO and the Technical Advisory Group will complete the assessment and come to a final recommendation on whether to give the vaccine an EUL,” it said.
The WHO said the deadline for its EUL process depends on how quickly the vaccine maker is able to provide the data it needs.
WHO will evaluate vaccine quality, safety, efficacy and suitability for low- and middle-income countries.
The WHO’s tweet comes a day after its chief scientist Soumya Swaminathan said that the agency’s technical advisory group will meet on October 26 to consider India’s emergency use list of the vaccine, which can be used as the country’s nationwide anti-COVID. 19 is being done in the vaccination programme.
“Technical Advisory Group will meet on 26 October to consider the EUL for #Covaxin. Working closely with @BharatBiotech to complete the @WHO dossier. We aim to have a broad portfolio of vaccines approved for emergency use And to expand access to the population everywhere,” she said.
Bharat Biotech said last month that it has submitted all data related to Covaxin to WHO for EUL and is awaiting a response from the global health watchdog.
“#COVAXIN clinical trial data was fully compiled and available in June 2021. All data for EUL application was submitted to WHO in early July. We responded to any clarification sought by #WHO and awaiting further response,” it said in a tweet.
“We are working with WHO to obtain the EUL as soon as possible,” the company said.
Covaxin is one of the two anti-COVID vaccines used by India in its nationwide vaccination campaign.
Earlier this month, WHO said in a tweet that Bharat Biotech is “submitting data to WHO on an ongoing basis and submitting additional information on September 27. WHO experts are currently reviewing this information and If this addresses all the questions raised, the WHO’s assessment will be finalized next week.
Rolling data allows WHO to begin its review immediately, as information continues to come in to accelerate the overall review process.
According to WHO, submissions for pre-qualification or listing under the EUL process are confidential and if a product submitted for evaluation is found to meet the listing criteria, WHO will publish the results widely.
Read also: WHO’s Technical Advisory Group to meet on October 26 to approve Covaxin: Soumya Swaminathan
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