WHO says it cannot cut corners in recommending Covaxin for EUL

The development comes amid a major debate over delay in granting approval to Indian covid-19 vaccine by WHO.

“We are aware that many people are awaiting 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 tweeted.

“The time frame 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 UN health agency said in the series of tweets.

It further 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 whether to grant Emergency Use Listing to the vaccine.”

Bharat Biotech, the manufacturer of Covaxin, has been submitting data to 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 UN health agency said via Twitter.

Soumya Swaminathan, chief scientist at WHO, said the WHO will consider granting EUL for Bharat Biotech’s covid-19 Covaxin on 26 October in a meeting of its technical advisory group.

“The technical advisory group will meet on Oct 26th to consider EUL for #Covaxin. @WHO has been 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,” Swaminathan said in a tweet.

The development assumes importance for people in India vaccinated with Covaxin, as WHO’s approval will facilitate international travel for Indians who have received the home-made vaccine under India’s national covid vaccination programme. The delay has been impacting students and businessmen who want to travel to countries where a vaccination certificate for WHO-approved vaccines is mandatory. As on Monday over 113 million doses of Covaxin have been administered in India among different age groups above 18.

Also, WHO’s EUL is a prerequisite for supplying vaccines under the Covax Facility, a multilateral initiative aimed at fostering global access to covid vaccines. If done, the approval will also place Covaxin in an important spot in the world map as it can be given to more and more countries.

The UN health agency on 5 October had said that Covaxin manufacturer Bharat Biotech has been submitting data to WHO on a rolling basis and submitted additional info at WHO’s request on 27 September. WHO experts are currently reviewing this information and if it addresses all questions raised, WHO assessment will be finalized next week, the apex global public health agency had said.

On Thursday, foreign secretary Harsh Vardhan Shringla said Bharat Biotech had submitted all clinical trial data to the apex global public health agency for getting EUL and was awaiting feedback. “It is not the administrative or political process, rather it is a technical process of WHO. Technical Committee will evaluate the submissions made by Bharat Biotech which created Covaxin. I am sure the approval of Covaxin from WHO will come at the soonest possible,” he had said.

Covaxin, India’s first indigenously developed covid vaccine, has received EUAs from 14 countries and another 50 are in the process. In June, the drugmaker had said that its US partner, Ocugen, has received a recommendation from the US Food and Drug Administration to pursue biologics licence applications (BLA) for Covaxin. Applications have to follow the BLA process, which is the standard for vaccines.

“Covaxin’s clinical trial data was fully compiled with and made available in June. All data was submitted to WHO for EUL application in early July. We have responded to all clarifications sought by WHO and are awaiting further feedback. We are diligently working with WHO to obtain EUL at the earliest,” the Hyderabad-based pharmaceutical company tweeted on 28 September. On 21 August, Union health minister Mansukh Mandaviya met Swaminathan, to discuss the approval process for Covaxin.

“The indigenously developed Covaxin is a highly efficacious vaccine as has been shown by multiple studies. It is even being approved for children above the age of two years. Over 100 million doses have been injected in India alone and its production is being ramped up to much higher levels, so that it could be exported to the less fortunate parts of the world. We eagerly await approval from WHO for this vaccine,” said Dr Harsh Mahajan, President, NATHEALTH, healthcare federation of India.