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After suspending EUA request, Brazil now shelves import authorisation of Covaxin

According to a statement issued by the National Health Surveillance Agency of Brazil, Anvisa its Collegiate Board on Tuesday took a decision to suspend the exceptional and temporary authorisation for import and distribution of Covaxin after Bharat Biotech informed the South America government about the termination of its pact with its Brazilian partners.

July 29, 2021 / 11:06 AM IST
Bharat Biotech's Covaxin was granted restricted emergency use approval in 'clinical trial mode' on January 2.

Bharat Biotech's Covaxin was granted restricted emergency use approval in 'clinical trial mode' on January 2.


After suspending the proposed clinical trials of Bharat Bioetch's COVID-19 vaccine Covaxin and a request for Emergency Use Authorisation, Brazil now has suspended its decision to import four million doses of the jab into that country.


According to a statement issued by the National Health Surveillance Agency of Brazil, Anvisa its Collegiate Board on Tuesday took a decision to suspend the exceptional and temporary authorisation for import and distribution of Covaxin after Bharat Biotech informed the South America government about the termination of its pact with its Brazilian partners.


"The Collegiate Board of Anvisaunanimously decided, on Tuesday (27/7), to provisionally suspend the exceptional and temporary authorisation for import and distribution of the vaccine against Covid-19-Covaxin, requested by the Ministry of Health," Anvisa said in statement posted on its website.


Bharat Biotech on July 23 said it terminated the MoU it entered with Precisa Medicamentos and Envixia Pharmaceuticals LLC for its COVID-19 vaccine Covaxin for Brazilian market.


The termination of the MoU came after the deal with the Brazilian government for supply of 20 million doses of Covaxin landed in controversy and attracted investigation by authorities in that country.

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COVID-19 Vaccine

Frequently Asked Questions

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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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"The measure prevails until there is new information that allows us to conclude that the legal and technical security of maintaining the decision that authorised the importation is maintained," Anvisa further said in a roughly translated version of Portuguese of the statement.


Though the exceptional and temporary importation of the vaccine had been authorized on June 4, at the ninth Extraordinary Meeting of the Collegiate Board of Anvisa, Brazil never imported the jab.

Bharat Biotech will continue to work diligently with Anvisa, to complete the regulatory approval process for Covaxin, Bharat Biotech had said while announcing the termination of its pact with its Brazilian partners.

PTI
first published: Jul 29, 2021 11:06 am
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