Moneycontrol PRO
HomeNewsBusinessCompaniesBharat Biotech submits fresh request before Brazilian regulator for Covaxin GMP certificate

Bharat Biotech submits fresh request before Brazilian regulator for Covaxin GMP certificate

Brazilian regulator Anvisa had in March denied a certificate for good manufacturing practices to Bharat Biotech citing certain violations of GMP at Bharat Biotech facility. Anvisa’s clearance is a necessary step for the country’s process of authorising this vaccine for emergency use.

May 27, 2021 / 11:06 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.

Bharat Biotech on May 25 submitted a new request to the Brazilian regulator Anvisa for certification of Good Manufacturing Practices (GMP) for Covaxin.

Anvisa had in March denied a certificate for good manufacturing practices to Bharat Biotech citing certain violations of GMP at the Bharat Biotech facility.

The Brazilian government signed a contract with Precis Medicamentos, Bharat Biotech’s representative in Brazil, to buy 20 million doses of the vaccine. Anvisa’s clearance is a necessary step for the country’s process of authorising this vaccine for emergency use.

The application for GMP certification of production of the vaccine comes one day after Brazil's Ministry of Health filed a new application for authorisation to import 20 million doses of the Covaxin manufactured in India, where the vaccine is authorised for emergency use.

"The two requests for certification, input and production of the vaccine, cover the entire manufacturing chain of the vaccine," Anvisa said in a release.

COVID-19 Vaccine

Frequently Asked Questions

View more
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.

View more
Show

GMP certification of all stages of vaccine production is a prerequisite for the registration of the vaccine in Brazil. For the exceptional import order, only the minimum data of Good Production Practices are analyzed, but without the need for the certificate in question.

Viswanath Pilla
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
first published: May 27, 2021 11:05 am

Discover the latest Business News, Sensex, and Nifty updates. Obtain Personal Finance insights, tax queries, and expert opinions on Moneycontrol or download the Moneycontrol App to stay updated!

Subscribe to Tech Newsletters

  • On Saturdays

    Find the best of Al News in one place, specially curated for you every weekend.

  • Daily-Weekdays

    Stay on top of the latest tech trends and biggest startup news.

Advisory Alert: It has come to our attention that certain individuals are representing themselves as affiliates of Moneycontrol and soliciting funds on the false promise of assured returns on their investments. We wish to reiterate that Moneycontrol does not solicit funds from investors and neither does it promise any assured returns. In case you are approached by anyone making such claims, please write to us at grievanceofficer@nw18.com or call on 02268882347