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During a presser, when asked about the delay in granting Emergency Use Listing (EUL) for Bharat Biotech’s Covaxin by the World Health Organisation (WHO), Indian Foreign Secretary Harsh Vardhan Shringla said India is hopeful of getting approval soon.

According to Shringla, the regulatory body was concerned and had put some questions to Bharat Biotech and approval for the vaccine should come if the queries are responded to effectively.

“It is a technical and regulatory group. The emergency authorisation by the WHO is based on technical considerations and we are carefully following up the discussions at the WHO. We are hopeful that Covaxin will get approval soon,” Shringla said.

He also added, “India has proposed to its partner countries, primarily countries that Indian citizens normally travel to, that we should have a mutual (mechanism) that you recognise our vaccine certification and we will mutually recognise your vaccine certification,”.

“Now the advantage of this is that as we keep adding new vaccines to our stock of national vaccines, you do not need to go to every country to try and get recognition. You recognise the certification that we issue, you recognise its integrity and we will give you mutual treatment,” he said.

The foreign secretary said a number of countries have already agreed to the mutually acceptable COVID-19 vaccine certification framework proposal. He, however, did not name the countries. “So we have achieved some reciprocal arrangements with a number of countries. We are working with all of our partner countries to have similar arrangements. It will simplify international travel, it will normalise international travel,” Shringla said.

However, as Prime Minister Narendra Modi heads for the G20 summit, this mechanism could be helpful in the recovering from the economic impact of the Coronavirus pandemic. “Business travellers, tourists which contribute to the recovery of economies will be greatly benefitted from this simplified international travel regime that we are proposing and we have taken it up with the G20, we have taken it up bilaterally, we have taken it up in plurilateral forums,” he said.

“We will continue to advocate this as a means of better and easier access to citizens travelling all over the world,” Shringla added.

On India proposing waivers by the World Trade Organisation on Covid-related medical products including vaccines, he said, “We have advocated for technology transfer and diversification of supply chain and production hubs to ensure affordable and equitable access to COVID-19 disease control tools,” he said.

“I am happy to share that G20 has recognised extensive vaccination as a global public good and I think that is where discussions in the G20 will be relevant,” he added.

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The post Foreign Secretary Shringla hopes Covaxin will soon get approval as PM Modi heads for G20 summit appeared first on The Commune.

The World Health Organisation’s (WHO) technical advisory group on Tuesday (October 26) again sought “additional clarifications” from Bharat Biotech for its COVID-19 vaccine Covaxin to conduct a final ‘risk-benefit assessment’ for Emergency Use Listing of the vaccine.

As per the WHO the technical advisory group will now meet on November 3 for a final assessment, however, many in India see this as a deliberate ploy to ensure that Covaxin is delayed for as long as possible so it cannot compete with other pharma companies and also Chinese influence over WHO is also now being questioned. 

“The @WHO independent Technical Advisory Group (TAG) met today & asked for additional clarifications from the manufacturer @BharatBiotech to conduct a final EUL risk-benefit assessment for global use of #Covaxin. It will reconvene for the final assessment on Wednesday, 3 November if data is received soon,” WHO chief scientist Dr Soumya Swaminathan said in a tweet.

Update: The @WHO independent TAG met today & asked for addnl clarifications from the manufacturer @BharatBiotech to conduct a final EUL risk-benefit assessment for global use of #Covaxin. It will reconvene for the final assessment on Wednesday, 3 November if data received soon

— Soumya Swaminathan (@doctorsoumya) October 26, 2021

Hyderabad-based Bharat Biotech, which has developed Covaxin, had submitted EOI (Expression of Interest) to the WHO on April 19 for the vaccine’s Emergency Use Listing (EUL). In the meanwhile other vaccines developed by the likes of Pfizer, Johnson and Johnson, Moderna, and sinopharm was approved undet EUL.  

The technical advisory group met on Tuesday to review data on Covaxin for the emergency use listing and said”The TAG met today (26 October 2021) and decided that additional clarifications from the manufacturer are needed to conduct a final EUL risk-benefit assessment for global use of the vaccine.

“The TAG expects to receive these clarifications from the manufacturer by the end of this week, and aims to reconvene for the final risk-benefit assessment on Wednesday, 3 November,” it added.

But already there is enough data wherein it has been proved that Covaxin has demonstrated 77.8 per cent effectiveness against symptomatic COVID-19 and 65.2 per cent protection against the new Delta variant.

However, WHO has 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,”.

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The post WHO again delays giving EUL for Bharat Biotech’s Covaxin for want of additional info appeared first on The Commune.

The wait for people in India who took the indigenous COVID-19 vaccine Covaxin, manufactured by Bharat Biotech just got longer as the World Health Organisation (WHO) has said it wants additional inputs from the vaccine maker.

India has now been waiting for a long time to get Emergency Use Listing (EUL) because many Indians who took Covaxin are planning international travel and without recognition, International travel will not be possible as countries won’t recognise these individuals as fully vaccinated.

In a statement, the WHO said, “while it is aware that many people are waiting for its recommendation for Covaxin to be included in the EUL, it clarified that it “cannot cut corners’ before recommending a product for emergency use, we must evaluate it thoroughly to make sure it is safe and effective,” said the agency.

WHO also said that Bharat Biotech – the manufacturer of Covaxin – has been submitting data to the 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 timeframe for the WHO EUL 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,” said the body.

The agency said that when it is fully satisfied with the information provided that addresses all questions raised, the WHO and the technical advisory group will then complete the assessment and come to a final recommendation on whether to grant EUL to the vaccine.

Though Covaxin has received the support of the Indian government and the latter has strongly advocated its efficacy, but it is clear that the reason why WHO deferred its decision till October on the pretext of requiring additional data must be questioned.

There are reports that a group of pharmaceutical companies and the Chinese government are lobbying to ensure Covaxin is not given EUL because for some of the pharma giants, it would mean loss of revenue, and for China, the export of Covaxin would give India more recognition on the international diplomatic stage. 

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