The Covaxin vaccine | www.bharatbiotech.com
The Covaxin vaccine | www.bharatbiotech.com
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New Delhi: India is confident that it has supplied all the information the World Health Organization (WHO) needs to approve Bharat Biotech’s Covaxin and is expecting a positive outcome at next week’s meeting of WHO’s Technical Advisory Group (TAG). 

The long wait for the approval has perplexed many and the issue was discussed at great length during Union Health Minister Mansukh Mandaviya’s meeting with WHO Director-General (DG) Dr Tedros Adhanom Ghebreyesus Tuesday, highly placed government sources told ThePrint.

The virtual meeting came a day after the WHO said it could not “cut corners” to approve Covaxin. In a statement, issued Monday, the WHO also said they were awaiting “one last piece of information” on the vaccine from its manufacturer, the Hyderabad-based Bharat Biotech. The next meeting of the TAG is due on 26 October.

Mandaviya, along with Union Health Secretary Rajesh Bhushan and Joint Secretary Lav Agarwal, told Tedros and WHO SEARO (South-east Asia) regional director Dr Poonam Khetrapal Singh that all clinical information, non-clinical information, chemistry, manufacturing information and information about controls have been shared with WHO over eight communications between 16 August and 14 October, the sources said.

“There is no other information that WHO needs for EUL (emergency-use listing). In fact, EUL has a set format and that is how all the data was submitted and all subsequent communications — all eight of them — promptly answered and the data sought thereof provided,” one source said.

“So, we have no idea what is the one information that WHO awaits on Covaxin. We will go by what the DG told our minister and that is that they have what they need. We are not joining issue here or trying to influence WHO procedure but since it is an Indian vaccine we are keenly following it,” the source added.

Top Government of India functionaries maintain that the virtual meeting happened in all cordiality and both sides were satisfied. “We are not joining issue with WHO, if we were, we would have said Sinopharm (Chinese vaccine company) was given EUL in X days and we are waiting for Y days. We have simply represented our side,” the source said.

Minister Mandaviya had tweeted about the meeting Tuesday without mentioning the discussions about Covaxin. 

ThePrint reached Bharat Biotech by email to ask about the nature of information sought by the WHO but there was no response by the time of publishing this report. The WHO, also reached by email, referred ThePrint to its statement from Monday.

Amid the pandemic, with many countries only allowing the entry of people who received WHO-backed vaccines, any delay in the EUL for Covaxin threatens to be a hindrance in recipients’ travel plans. As of Wednesday, over 11.36 crore doses of Covaxin had been administered in India. 

The WHO’s EUL is also a prerequisite for supply under COVAX, the initiative for equitable vaccine distribution.


Also Read: Everything you need to know about Covaxin, India’s controversial Covid vaccine candidate


‘Hold-up diplomatic not scientific’

In its statement Monday, the WHO said the timeframe for its EUL “procedure is dependent on how quickly the 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”. 

“We are aware that many people are waiting for WHO’s recommendation for Covaxin, 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,” it said. 

Bharat Biotech, it added, “has been submitting data to WHO on a rolling basis and submitted additional information at WHO’s request on 27 September”. 

“WHO experts have now reviewed these data and are expecting one last piece of information today. If the information provided addresses all questions raised, WHO and the Technical Advisory Group (TAG) will complete the assessment and come to a final recommendation whether to grant EUL to the vaccine.”

The Indian Council of Medical Research (ICMR), however, believes that the hold-up in the WHO’s approval for the indigenous Covid vaccine Covaxin is “not scientific but diplomatic”.

“Most of the safety and efficacy data for Covaxin are already in the public domain. They also want to know about production capacities. However, for the WHO to give its nod, a crucial criterion also is quality of the vaccine and whether it adheres to global good manufacturing practices (GMP),” said a senior ICMR official who didn’t wish to be named. 

“In my understanding, the hold-up is not scientific, it is diplomatic, that is why there is no reason to doubt our own regulatory process,” the official added, without elaborating on what they meant by “diplomatic” holdup”. 

“It is good that they do not want to cut corners. We are not unduly perturbed,” the ICMR official added. 

The efficacy data for Covaxin are yet to be published in a peer-reviewed journal. In a press statement in July, Bharat Biotech claimed the whole-virion-inactivated Covid-19 vaccine candidate demonstrated an overall efficacy of 77.8 per cent in India’s largest Covid phase 3 clinical trial thus far.

ICMR officials also rejected concerns about Covaxin being based on an older vaccine platform. 

“That is not a problem at all. This is the Macaulay mindset when we tend to doubt anything developed in the country and think everything else foreign is very good. Now a French vaccine is also being developed from a whole virion.”

The reference is to the vaccine being developed by French company Valneva that is yet to complete clinical trials.

The vaccines that have received an EUL from the WHO include those by Pfizer/BioNTech, Astrazeneca-SK Bio, Serum Institute of India, Janssen, Sinopharm, and Moderna.

What is EUL?

During public health emergencies — like the ongoing Covid pandemic — the WHO assesses the efficacy of drugs and therapeutics that are still to be licensed. It then takes a decision on whether to use them after evaluating the positives and the potential side-effects. 

The goal is to ensure that the poorest and the most vulnerable people in the world get access to these products quicker.

According to EUL information available on the WHO website: “When a product submitted for EUL has been assessed through other emergency mechanisms by a WHO-listed authority, WHO does not intend to duplicate work. However, WHO will assess the suitability of products from a global public health perspective and, on a case-by-case basis, may assess aspects of the quality, safety, efficacy and performance of the products.”

(Edited by Sunanda Ranjan)


Also Read: Good news for kids: Expert panel gives Covaxin emergency approval for 2-18-year-olds


 

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