WHO says likely to receive clarifications from Bharat Biotech on Covaxin by weekend

The World Health Organization on Wednesday said it expects to receive clarifications from Bharat Biotech by the end of this week on its Covid-19 vaccine -- Covaxin -- and will meet on November 3 for a final risk-benefit assessment for the Emergency Use Listing.

“WHO Technical Advisory Group for Emergency Use Listing (EUL) is an independent advisory group that provides recommendations to WHO on whether a #Covid19 vaccine can be listed for emergency use under the EUL procedure,” the WHO tweeted.

The Technical Advisory Group met October 26 and “decided that additional clarifications from the manufacturer (Bharat Biotech) are needed to conduct a final EUL risk-benefit assessment for global use of the Covaxin vaccine".

Also read: WHO seeks 'additional clarifications' from Bharat Biotech for Covaxin to conduct final 'risk-benefit assessment'

“The Technical Advisory Group expects to receive these clarifications from the manufacturer (Bharat Biotech) by the end of this week, and aims to reconvene for the final risk-benefit assessment on Wednesday, November 3, 2021,” the WHO tweeted.

The global health body also tweeted a video of WHO Health Emergencies Programme Executive Director Dr Mike Ryan, who said the World Health Organization “is very clear that we want all countries to recognise EUL vaccines that have been given an Emergency Use Listing (EUL) by the WHO advisory process. But it's also very important that WHO, when it makes a recommendation like that, is making that globally.”

Ryan had said “we have to be absolutely sure” and it’s really important that “we gather all of the necessary information not only on the vaccine itself but on the manufacturing processes and all of that, because we're recommending to the world that this vaccine is safe, effective and it's been produced using the highest quality standards".

Further explaining how the WHO technical advisory group works, he said the vaccine manufacturers first of all have to request and respond and say that they want their vaccines to be put for EUL and then provide documentation on the whole process - the efficacy studies and the manufacturing process.

“Sometimes that requires visits to look at and examine the manufacturing practices and all of that has to come together into a dossier that's presented within this advisory group mechanism, and then it's from there that WHO can make a recommendation," he said.

Ryan emphasised that the entire process, even if people cannot see it “day to day”, is “very measured" because “we're having to say to the world ‘we've looked at this carefully, we've looked at every piece of data, we've looked at the whole production cycle and we can say with our hands on our hearts, having looked at all that data, here is a safe, effective, and well-produced product that you as our member state or you as a citizen of the world can take with confidence’.

“That's very, very important and that sometimes takes longer and it is frustrating. And it is particularly frustrating if you've had a certain vaccine that is not recognised by another country and you can't travel. That becomes an issue,” he said.

Ryan said the work done by the advisory group and its members has been of the highest quality, and “it takes time to do that".

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“It’s a hugely important task. It's extremely involved and measured, and the outputs of this process have been of very high quality right ...through this pandemic. And if it takes another week or two, that's what we'll have to take to ensure that the dossier is complete to ensure that the committee have a chance to look at that and then WHO can make the right determination and give the right advice to the world.”

Ryan has added that the Emergency Committee of the International Health Regulations has been “very, very clear" and countries have been advised that vaccination certification should not be used as the only measure and means of restricting travel.

“We have other ways of making travel safe, including testing, serologic testing, and we very strongly believe that using vaccination status as the only parameter of travel creates a double inequity because countries who have no access to vaccines then by de facto have no access to travel either. And that's a double inequity,” he has said.

In another video tweeted by WHO, Dr Mariangela Simao, Assistant Director General, Access to Medicines and Health Products at WHO, explained the process of emergency approvals of these vaccines and how safety is ensured in this process.

"It's very important to highlight that no vaccine candidate should be used or issued an emergency approval at country level if it has not finished phase three trials because it’s during phase three trials that “you do the assessment of efficacy and safety", she said in the video.

“When it comes to the assessment of the authority, it already has data on both efficacy and safety. The job is not finished yet because after this in order to authorise at country level, you need to assess whether the vaccine was 'well made',” and complied with “good manufacturing practices and quality control,” Simao said.

“So this is to say that by the time it's authorised at the country level, it has gone through a lot of scrutiny. So it's very good to highlight that safety and efficacy will be guaranteed by the process that we have put in place,” she said.

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