WHO says it can leave no stone unturned to recommend Covaxin for EUL

The development comes amid a major debate over the delay in approving the Indian Covid-19 vaccine by the WHO.

“We know that many people are waiting for a WHO recommendation for Covaxin to be added to the #COVID19 emergency use list, but we can’t cut corners – from recommending a product for emergency use First, we must evaluate it thoroughly to ensure it is safe and effective,” WHO tweeted.

“The deadline for WHO’s emergency use listing process depends on how quickly the vaccine maker is required by WHO to evaluate the quality, safety, efficacy and suitability of the vaccine for low- and middle-income countries. able to provide data. ,” the UN health agency said in a series of tweets.

It further said, “When all questions raised in the given information are addressed, WHO and the Technical Advisory Group will complete the assessment and come to a final recommendation on whether to list the vaccine for emergency use.”

Bharat Biotech, the manufacturer of Covaxin, is continuously submitting data to WHO and the data has been reviewed by WHO experts. The WHO is expecting an additional information from the company today, the United Nations health agency said via Twitter.

WHO Chief Scientist Soumya Swaminathan said that WHO will consider granting EUL for Bharat Biotech’s Covid-19 covaccine in its technical advisory group meeting on October 26.

“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 expanding the reach to the population everywhere,” Swaminathan said in a tweet.

The development emphasizes the importance of vaccination with Covaccine for people in India, as the WHO approval will facilitate international travel for Indians who have received the homemade vaccine under India’s national Covid immunization programme. The delay is affecting students and businessmen who wish to travel to countries where vaccination certificates are mandatory for WHO-approved vaccines. As of Monday, more than 113 million doses of Covaxin have been administered to people over the age of 18 in India.

In addition, WHO’s EUL is a prerequisite for the supply of vaccines under the COVAX facility, a multilateral initiative aimed at promoting global access to COVID vaccines. If done, the approval would also place Covaxin at an important place on the world map as it could be awarded to more countries.

The UN health agency said on 5 October that covaxin maker Bharat Biotech was submitting data to the WHO on an ongoing basis and on 27 September submitted additional information at the WHO’s request. WHO experts are currently reviewing this information and if it addresses all the questions raised, the WHO assessment will be finalized next week, the top 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 obtaining the EUL and was awaiting a response. “This is not an administrative or political process, rather it is a technical process of WHO. The technical committee will evaluate the submissions made by Bharat Biotech which made Covaxin. I am sure the approval of Covaxin from WHO will be received at the earliest.” He said that.

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 said that its US partner, Ocugen, had received a recommendation from the US Food and Drug Administration to pursue a biologics license application (BLA) for Covaxin. Applications have to follow the BLA process, which is standard for vaccines.

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

“Indigenously developed Covaxin is a highly efficacious vaccine as shown by several studies. It is even being approved for children over the age of two. More than 100 million doses have been injected in India alone and its production is being scaled up to a much higher level, so that it can be exported to less fortunate parts of the world. We are eagerly waiting for the approval from WHO for this vaccine,” said Dr Harsh Mahajan, President, NATHEALTH, Healthcare Federation of India.