BRASILIA (Reuters) – Testing of Russia’s “Sputnik-V” COVID-19 vaccine has not begun in Brazil, while its British and Chinese rivals have already begun to file partial results from clinical Phase III trials, the Brazilian health regulator Anvisa said on Tuesday.
Brazil’s Paran and Bahia states, which have testing and production or distribution agreements for the Russian vaccine, have not yet filed requests for clinical trials in Brazil, a spokeswoman for Anvisa said.
“There have been numerous meetings, physical and online, with no documents on the Russian vaccine materializing yet,” she told Reuters.
The Russian Direct Investment Fund (RDIF), which is marketing the Sputnik, touted by Russia as the world’s first registered vaccine, did not immediately reply to a request for comment.
Meanwhile, trials for the vaccine developed by Oxford University and AstraZeneca Plc , and another potential vaccine by China’s Sinovac Biotech Ltd are being conducted at a dozen sites and initial data sent in to Anvisa.
“This is still not a formal request for registration of these vaccines. We will only consider that when all the documents have been filed,” the spokeswoman told Reuters.
To speed up the process, Anvisa last week started a process of continuous filing of paperwork and initial results so that they can be studied simultaneously.
With the second most deadly coronavirus outbreak after the United States, Brazil has become a key testing ground for the vaccines under development.
Anvisa has authorized trials in Brazil for four vaccines, including those under development by Pfizer Inc in partnership with BioNTech and Johnson & Johnson’s pharmaceutical subsidiary Janssen.
Brazil has had almost 5 million confirmed cases of coronavirus and the death toll reached 146,675 on Monday, the Health Ministry said.
(Reporting by Anthony Boadle; Editing by Lisa Shumaker)
