RIO DE JANEIRO (Reuters) – Brazilian health regulator Anvisa on Friday said a COVID-19 vaccine developed by the University of Oxford and AstraZeneca Plc had applied for full regulatory approval, in a positive development for the country’s beleaguered explosion of vaccines.
The submission, the first of its kind in Brazil, was made by the federally funded Fiocruz Institute, which manufactures the British vaccine locally. A spokesman for AstraZeneca, whose vaccine has already been approved for emergency use in Brazil, confirmed the submission.
Brazilian President Jair Bolsonaro, who says he will not take a COVID-19 shot, is under pressure for overseeing a slow and clumsy vaccination, just as a brutal second wave of infections is gaining momentum. The AstraZeneca vaccine is the central pillar of the federal government’s vaccination plan. It ordered materials to make up to 100 million shots, which will be manufactured by Fiocruz.
Anvisa said it had a 60-day period to decide whether the drug would be approved, but said it was striving to speed up the process as much as possible.
Although the drug is approved, however, it does not solve Brazil’s vaccination headaches.
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 major problems in the demand for its vaccine in markets around the world.
For now, Brazil is dependent on a Chinese vaccine, developed by Sinovac Biotech Ltd, and 2 million ready-to-use AstraZeneca shots imported from India earlier this month to vaccinate its 210 million people.
(Reporting by Gabriel Stargardter; Edited by Leslie Adler and Diane Craft)