COVID-19 Vaccine | WHO says 'more information' required from Bharat Biotech for emergency use listing of Covaxin

Bharat Biotech has reportedly conveyed to the government that it has already submitted 90 percent of documents to WHO for obtaining emergency use listing (EUL) for the Covaxin vaccine

PTI
May 25, 2021 / 09:37 AM IST

The WHO has said that "more information" is "required" from Bharat Biotech, which is seeking emergency use listing (EUL) for its Covaxin vaccine for COVID-19.

The World Health Organisation (WHO) has said that "more information" is "required" from Bharat Biotech, which is seeking emergency use listing (EUL) for its Covaxin vaccine for COVID-19.

The latest "Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process" guidance document dated May 18 on the WHO website said Bharat Biotech submitted EOI (Expression of Interest) on April 19 and that "More information required". A pre-submission meeting is expected "to be planned May-June 2021," the guidance document said.

According to the WHO, submissions to it for prequalification or listing under the emergency use procedure are confidential.

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If a product submitted for assessment is found to meet the criteria for listing, WHO will publish the results widely. Duration of the emergency use listing process depends on the quality of the data submitted by the vaccine manufacturer and on those data meeting WHO criteria, according to the agency.

COVID-19 Vaccine

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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Meanwhile, Hyderabad-based Bharat Biotech International Limited (BBIL) has conveyed to the government that it has already submitted 90 percent of documents to WHO for obtaining emergency use listing (EUL) for the Covaxin vaccine, sources said in New Delhi on Monday.

The remaining documents are expected to be submitted by June, the Hyderabad-based Bharat Biotech Ltd told the Central government during a discussion on obtaining the World Health Organisation''s authorisation for emergency use listing for Covaxin, sources said.

"BBIL is confident about obtaining WHO's emergency use listing," said a source. Noting that Covaxin has already received regulatory approval from 11 countries, sources said there was also interest from other 11 companies in seven nations for technology transfer and production of Covaxin.

The company is in the final stages of negotiations with the Food and Drug Administration of the US for conducting small-scale phase-III clinical trials of Covaxin in the United States, sources said.

Sources said the meeting with BBIL on the EUL was attended by the company's managing director V Krishna Mohan and his colleagues besides senior officers of the Ministry of Health, Department of Biotechnology and Ministry of External Affairs.

Foreign Secretary Harsh Vardhan Shringla was among those who attended the meeting.
PTI
TAGS: #Bharat Biotech #coronavirus #Current Affairs #India #World News
first published: May 25, 2021 09:36 am