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COVID-19 vaccine: AstraZeneca applies for full regulatory approval in Brazil

Brazilian health regulator Anvisa said it had a period of 60 days to decide on whether to authorize the drug, but said it would strive to expedite the process as much as possible

January 30, 2021 / 10:42 AM IST
AstraZeneca vaccine (Image: Reuters)

AstraZeneca vaccine (Image: Reuters)

Brazilian health regulator Anvisa said on January 29 that a COVID-19 vaccine developed by Oxford University and AstraZeneca had applied for full regulatory approval, in a positive development for the country’s beleaguered vaccine rollout.

The submission, the first of its kind in Brazil, was made by the federally funded Fiocruz Institute, which will manufacture the British vaccine locally. A spokeswoman for AstraZeneca, whose vaccine is already approved for emergency use in Brazil, confirmed the submission.

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Brazilian President Jair Bolsonaro, who says he won’t take any COVID-19 shot, is under pressure for overseeing a slow and patchy vaccine rollout, just as a brutal second wave of infections gathers momentum.

The AstraZeneca vaccine is the central pillar of the federal government’s vaccine plan. It has ordered material to make up to 100 million shots, which will be manufactured by Fiocruz.

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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Anvisa said it had a period of 60 days to decide on whether to authorize the drug, but said it would strive to expedite the process as much as possible.
However, even if the drug is approved, it does not immediately solve Brazil’s vaccine headache.

A shipment of active ingredients needed to make the British vaccine locally has been repeatedly delayed and has still not left China. It remains unclear when it will arrive.

Meanwhile, AstraZeneca is facing widespread problems in meeting the demand for its vaccine in markets around the world.

For the time being, Brazil is reliant on a Chinese vaccine, developed by Sinovac Biotech Ltd, and 2 million ready-to-use AstraZeneca shots imported from India earlier this month to inoculate its 210 million people.

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first published: Jan 30, 2021 10:42 am