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Clarifications From Bharat Biotech On Covaxin Likely By Weekend: WHO


Expect to obtain clarifications from Bharat Biotech by finish of this week: WHO (Representational)

United Nations/Geneva:

The World Health Organisation on Wednesday mentioned it expects to obtain clarifications from Bharat Biotech by the tip of this week on its COVID-19 vaccine — Covaxin — and can meet on November 3 for a last risk-benefit evaluation 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”.

“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 international well being physique additionally tweeted a video of WHO Health Emergencies Programme Executive Director Dr Mike Ryan, who mentioned the World Health Organisation “is very clear that we want all countries to recognize 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 mentioned “we have to be absolutely sure” and it is actually vital 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 mentioned the vaccine producers to begin with should request and reply and say that they need their vaccines to be put for EUL after which present documentation on the entire course of – the efficacy research and the manufacturing course of.

“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 mentioned.

Ryan emphasised that your entire course of, even when individuals can’t see it “day to day”, is “very measured” as a result of “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, crucial and that typically takes longer and it’s irritating. And it’s significantly irritating in case you’ve had a sure vaccine that’s not recognised by one other nation and you’ll’t journey. That turns into a problem,” 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 try this.

“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 nations have been suggested that vaccination certification shouldn’t be used as the one measure and technique of proscribing journey.

“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 mentioned.

In one other video tweeted by WHO, Dr Mariangela Simao, Assistant Director General, Access to Medicines and Health Products at WHO, defined the method of emergency approvals of those vaccines and the way security is ensured on this course of.

“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 evaluation of efficacy and security”, she said in the video.

“When it involves the evaluation of the authority, it already has knowledge on each efficacy and security. The job shouldn’t be completed but as a result of after this so as to authorise at nation degree, you might want to assess whether or not the vaccine was ”properly made”,” and complied with “good manufacturing practices and high quality management,” Simao said.

“So that is to say that by the point it is authorised on the nation degree, it has gone by means of numerous scrutiny. So it is superb to focus on that security and efficacy will likely be assured by the method that we’ve got put in place,” she said.

(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)





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