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COVID-19 update | Brazilian regulator says Bharat Biotech's Covaxin manufacturing facility fails to meet CGMP standards

The city-based vaccine maker said it is working towards resolving the issues cited during the inspection and the order of 20 million doses from the Brazilian government is still active.

March 31, 2021 / 05:31 PM IST
Indian Health Minister Harsh Vardhan holds a dose of Bharat Biotech's COVID-19 vaccine called COVAXIN, during a vaccination campaign at All India Institute of Medical Sciences (AIIMS) hospital in New Delhi, India, January 16, 2021. (PC-REUTERS/Adnan Abidi)

Indian Health Minister Harsh Vardhan holds a dose of Bharat Biotech's COVID-19 vaccine called COVAXIN, during a vaccination campaign at All India Institute of Medical Sciences (AIIMS) hospital in New Delhi, India, January 16, 2021. (PC-REUTERS/Adnan Abidi)

The Brazilian health regulator Anvisa has denied permission to import Bharat Biotech's COVID-19 vaccine Covaxin into the country after its authorities found that the plant in which the vaccine is being made did not meet the Current Good Manufacturing Practice(CGMP) requirements.

Reacting to it, the city-based vaccine maker said it is working towards resolving the issues cited during the inspection and the order of 20 million doses from the Brazilian government is still active.

Bharat Biotech ties up with CSIR-IICT to locally make vaccine raw materials

National Health Surveillance Agency Anvisa in its website said it received a request from the Brazilian Health Ministry to import 20 million doses of Covaxin. However a decision on that was suspended by the regulator due to the absence of some key documents. "…considering the non-compliance with the requirements of Good Manufacturing Practices for Medicines, or the non-compliance with the petition procedures submitted for analysis, advocated by current legislation,resolves: Refuse the Request (s) for Certification of Good Manufacturing Practices for Medicines of the company (ies) contained in the ANNEX," a Brazilian government gazette said on March29.

Bharat Biotech in an email reply did not comment on the CGMP issues.

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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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Bharat Biotech International Limited on February 26 said it has signed an agreement with the Brazilian government for supply of 20 million doses of Covaxin during the second and third quarters of the current year.

The company had earlier said it also signed an agreement with Brazil-based Precisa Medicamentos for the supplies of Covaxin for the private markets in the South American country.

"The requirements pointed out during inspection will be fulfilled, the timelines for fulfillment is under discussion with the Brazil NRA and will be resolved soon," the company told.
PTI

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