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

RIO DE JANEIRO: Brazilian health regulator Anvisa said on Friday that a COVID-19 vaccine developed by Oxford University and AstraZeneca Plc 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.

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.

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 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.