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Brazil's drug regulator Anvisa inspects Bharat Biotech's facility, may give nod to Covaxin soon

Brazil is the first country to sign a definitive supply agreement with Bharat Biotech to procure 20 million doses of Covaxin on February 26. The deliveries are expected to begin during Q2 and Q3 of 2021.

March 08, 2021 / 06:59 PM IST
Bharat Biotech on March 3 said its vaccine was 81 percent effective in preventing COVID-19 after a third round of clinicals trials.

Bharat Biotech on March 3 said its vaccine was 81 percent effective in preventing COVID-19 after a third round of clinicals trials.

A team from Brazil's drug regulator Anvisa has started conducting inspections at Bharat Biotech's manufacturing facilities. The Brazilian government and private companies have recently signed contracts to procure the Indian company's COVID-19 vaccine Covaxin for public immunisation and the private market.

The inspections will focus on Bharat Biotech's good manufacturing practices.

Brazil is the first country to sign a definitive supply agreement with Bharat Biotech to procure 20 million doses of Covaxin on February 26. The deliveries are expected to begin during Q2 and Q3 of 2021.

It is still not known whether Bharat Biotech has approached Anvisa seeking authorisation to carry out clinical studies of Covaxin in Brazil, or to register the emergency use of the vaccine in that country. The story will be updated as and when the company responds to Moneycontrol's queries.

Brazilian company Precis Medicamentos had also signed an agreement to import Covaxin. The use of Covaxin however will depend on Anvisa's authorisation.

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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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Affordability is crucial

Brazil is the second worst-hit country from the novel coronavirus after the US, in terms of deaths. Brazil saw 265,500 deaths and 11 million cases.  The South American country has approved Chinese Sinovac vaccine, AstraZeneca-Oxford vaccine and Pfizer-BioNTech vaccine. While Sinovac and AstraZeneca-Oxford are produced locally, the Pfizer vaccine is imported. Brazil with a population of 21.2 crore is a large market but affordability holds the key.

Brazil news agency Busca EBC reported that Anvisa wants either to carry out clinical trials of Covaxin in Brazil for a definitive registration or the presentation of results of phase 3 studies carried out in other countries, which may lead to the endorsement for the emergency use of the vaccine.

"Vaccines for the private market will arrive after Anvisa's authorisation for the sale of the immuniser in the country,” said Precis Medicamentos, the Brazilian company that will be distributing the vaccine there, on its blog.

Bharat Biotech has a production capacity of approximately 300 million doses of COVAXIN and is currently in the process of expanding to 500 million doses. The company currently is producing more than 40 million doses of Covaxin from its three factories.

Bharat Biotech last week said that more than 40 countries have expressed their interest in Covaxin.

Moneycontrol reported that France is also looking to import Covaxin. Earlier, a committee of experts in Mexico has recommended the approval of Covaxin.

Covaxin has shown 81 percent efficacy in the first interim analysis of phase-3 trials, the company said, giving a shot in the arm for the Indian firm that is eyeing exports and hopes to join the World Health Organization’s COVAX programme for vaccination in poor and middle-income countries.

With this announcement on March 3, Bharat Biotech has pulled off its second coup in three days. Earlier, Prime Minister Narendra Modi received a made-in-India Covaxin shot in the full media glare, which is expected to encourage people to participate in India’s massive vaccination programme.

The first interim analysis is based on 43 cases, of which 36 cases of COVID-19 were observed in the placebo group versus 7 cases observed in the Covaxin group, resulting in a point estimate of vaccine efficacy of 80.6 percent.

Interim analysis

The Hyderabad-based company said it would share the second interim analysis based on 87 cases, and the final analysis from 130 cases in the coming weeks. This will give a more robust picture on the efficacy of the vaccine.

Covaxin, which is based on a whole-virion inactivated platform, is considered to be effective against mutating strains. The vaccine is stable at 2 to 8°C (refrigerated) and doesn't require ultracold storage logistics that makes handling of vaccines expensive.

"These countries are highly satisfied with the safe, inactivated vaccine technology and robust data package for safety and immunogenicity," the company said.
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: Mar 8, 2021 06:54 pm

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