CM – WHO is considering granting EUL for Covaxin from Bharat Biotech on October 26th

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NEW DELHI :

The World Health Organization (WHO) will consider granting EUL (Emergency List) for Covid-19-Covaxin from Bharat Biotech at a meeting of its technical advisory group on October 26, said Soumya Swaminathan, WHO chief scientist.

“The technical advisory group will meet on October 26th to consider the EUL for #Covaxin. @WHO worked closely with @BharatBiotech to complete the dossier. Our goal is to have a broad portfolio of emergency vaccines that are & approved to expand access to populations everywhere, ”Swaminathan said in a tweet.

The development assumes that people in India will be vaccinated with Covaxin, as WHO approval will make international travel easier for Indians who have received the homemade vaccine as part of India’s national Covid vaccination program. The delay is affecting students and business people planning to travel to countries that require a vaccination card for WHO-approved vaccines. As on Monday, over 11.30 crores doses of Covaxin were given to various age groups over the age of 18.

In addition, the WHO EUL is a prerequisite for the provision of vaccines under the Covax Facility, a multilateral initiative to promote global access to Covid vaccines. Once approved, Covaxin will also be placed in an important place on the world map as it can be given to more and more countries.

The UN health authority announced on October 5 that the manufacturer of Covaxin, Bharat Biotech, had continuously transmitted data to the WHO and provided additional information on September 27 at the WHO’s request. WHO experts are currently reviewing this information, and if they answer all of the questions raised, the WHO’s assessment will be completed next week, the global health agency Apex said.

On Thursday, Foreign Minister Harsh Vardhan Shringla said that Bharat Biotech said it had submitted all clinical trial data to the global health agency Apex for EUL and is awaiting feedback. “It is not an administrative or political process, but a technical process of the WHO. The Technical Committee will evaluate the Bharat Biotech submissions that Covaxin created. I am sure that Covaxin will be approved by the WHO as soon as possible. ”He had said.

Covaxin, India’s first domestically developed Covid vaccine, has received EUAs from 14 countries and another 50 are in preparation. In June, the drug manufacturer announced that its US partner Ocugen had received a recommendation from the US Food and Drug Administration to submit applications for approval of biologicals (BLA) for Covaxin. Applications must follow the BLA process, which is the 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 have responded to all the clarifications requested by WHO and are waiting for further feedback. We are working diligently with WHO to get the EUL at the earliest, « the Hyderabad-based pharmaceutical company tweeted on September 28. On August 21, the Union Minister of Health, Mansukh Mandaviya, met Swaminathan to discuss the approval process for Covaxin.

“Covaxin, which we developed in-house, is a highly effective vaccine, as several studies have shown. It is even approved for children aged two and over. Over 100 million doses have been injected in India alone and production is ramping up to much higher levels so it can be exported to the less fortunate parts of the world. We are eagerly awaiting WHO approval of this vaccine, « said Dr. Harsh Mahajan, President of the Indian Health Association NATHEALTH.

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Keywords:

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