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Clarification from Bharat Biotech on Covaxin likely by weekend: WHO

A clarification is expected from Bharat Biotech by the end of this week: WHO (Representational)

United Nations/Geneva:

The World Health Organization on Wednesday said it expects to receive clarification from Bharat Biotech on its COVID-19 vaccine – Covaxin – by the end of this week and will meet on November 3 for a final risk-benefit assessment for emergency use list . .

“The WHO Technical Advisory Group for Emergency Use Listing (EUL) is an independent advisory group that provides recommendations to the WHO on whether the #COVID19 vaccine can be listed for emergency use under the EUL process,” WHO tweeted. WHO tweeted.

The Technical Advisory Group met on 26 October and “decided that the global use of Covaxin vaccine requires additional clarification from the manufacturer (Bharat Biotech) to conduct a final EUL risk-benefit assessment”.

The WHO tweeted, “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 a final risk-benefit assessment on Wednesday, November 3, 2021.” Is.”

The global health body also tweeted a video of Dr Mike Ryan, executive director of the WHO Health Emergencies Programme, who said the World Health Organization was “very clear that we want all countries to recognize EUL vaccines that are listed on the Emergency Use List (EUL). The WHO advisory process. But it’s also very important that the WHO, when it makes a recommendation like this, is making that globally.”

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

Further explaining how the WHO Technical Advisory Group works, he said that vaccine manufacturers would first have to request and respond and say they want their vaccines to be kept for the EUL and then have documentation on the whole process. Provide – efficacy studies and manufacturing process.

“Sometimes visits are needed to look at and examine manufacturing practices and all of them have to come together in a dossier that is presented within this advisory group mechanism, and then it is from there that the WHO comes up with a can recommend,” he said.

Ryan stresses that the whole process, even if people can’t see it “day-to-day”, is “very measured” because “we have to say to the world ‘We’ve looked at it carefully, we’ve looked at each piece of data. , we have looked at the entire production cycle and we can say with our hands on our hearts, looking at all that data, here is a safe, effective and well produced product that you as our member state or you as a member of the world You can take it with confidence as a citizen.

“It’s very, very important and it sometimes takes longer and it’s frustrating. And it’s especially frustrating if you have a certain vaccine that isn’t recognized by another country and you can’t travel.” It 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.

“It’s a hugely important task. It’s extremely involved and measured, and the outputs of this process are of a very high quality … through this pandemic. And if it takes a week or two, that’s what we have to do To make sure the dossier is complete to make sure that the committee has a chance to look into it and then WHO can make the right determination and give the right advice to the world.”

Ryan has said that the Emergency Committee on International Health Regulations has been “very, very clear” and advised countries that vaccination certification should not be used as the sole measure and means of restricting travel.

“We have other ways to make travel safer, including testing, serological testing, and we believe very strongly that using vaccination status as the sole parameter of travel creates a double disparity because countries where They don’t have access to vaccines, they really have no access to either. To travel. And that’s a double disparity,” he has said.

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

“It is very important to highlight that no vaccine candidate should be used or issued emergency approval at the country level if it has not finished phase three trials as it is during phase three trials.” You assess efficacy and safety,” she said. Video.

“When it comes to authorization assessment, it already has data on both efficacy and safety. The work is not finished because to authorize at the country level after that, you need to assess that Whether the vaccine was “well made”” and complied with “good manufacturing practices and quality controls,” Simao said.

“So that is to say, as long as it has been authorized at the country level, it has gone through a lot of scrutiny. So it is great to highlight that the safety and efficacy will be guaranteed by the process that we have put in place. ” he said.

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

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