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

RIO DE JANEIRO (Reuters) – Brazilian health regulatory agency Anvisa said on Friday that a COVID-19 vaccine developed by the University of Oxford and AstraZeneca Plc had its full regulatory approval, in a positive development for the vaccine launch. in the country.

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

Brazilian President Jair Bolsonaro, who says he will not receive any COVID-19 injections, is under pressure to oversee the launch of a slow and irregular vaccine, as well as a second brutal wave of infections gaining momentum. The AstraZeneca vaccine is the central pillar of the federal government’s vaccine plan. He has already ordered material to make up to 100 million doses, which will be manufactured by Fiocruz.

Anvisa said it has a period of 60 days to decide whether to authorize the drug, but said it will do its best to streamline the process to the maximum.

However, even if the drug is approved, it does not immediately resolve the headache of the vaccine in Brazil.

A shipment of active ingredients needed to make the British vaccine locally has been repeatedly delayed and has not yet left China. It is not yet clear when it will arrive. Meanwhile, AstraZeneca is facing widespread problems in meeting the demand for its vaccine in markets around the world.

For now, Brazil depends on a Chinese vaccine, developed by Sinovac Biotech Ltd, and 2 million AstraZeneca ready-to-use vaccines imported from India earlier this month to inoculate its 210 million people.

(Reporting by Gabriel Stargardter; Editing by Leslie Adler and Diane Craft)

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