A Brazilian pharmaceutical company said on Friday it has signed an agreement with the Russian Direct Investment Fund (RDIF) to produce Russia’s Sputnik V vaccine against COVID-19 starting in the second half of November.
The private company União Quimica said on Friday that it was bound by a confidentiality agreement not to give any technical or scientific details. It still must obtain approval from Brazil’s health regulator Anvisa.
This is the second agreement to produce the Russian vaccine in Brazil, where four other vaccines are already being tested.
The Russian vaccine is being developed by Moscow’s Gamaleya Research Institute and marketed by the RDIF, which last month also entered an agreement with the Brazilian state of Paraná to test and produce the vaccine.
The Brazilian state of Bahia has also signed an agreement to conduct Phase III clinical trials of the Sputnik V vaccine and plans to buy 50 million doses to market in northeastern Brazil.
It is not clear, however, when such testing can begin.
A spokeswoman for Anvisa said neither Paraná nor Bahia state governments had filed requests for approval of their plans to test the Russian vaccine, let alone produce it.
Bahia secretary of health, Fabio Vilas-Boas, told Reuters that the Russian sovereign fund and the Gamaleya Institute are dealing directly with Anvisa regarding data on earlier testing.
“We have to conduct a Phase III clinical trial, which should start in November and take until January or February,” said Vilas-Boas, who has committed Bahia to buying 50 million doses.
“Only after that study will Anvisa decide on registering the Russian vaccine. That is all we know until now,” he said.
With more than 5.3 million cases of coronavirus reported in Brazil, the third-worst outbreak after the United States and India, the South American country has become a testing ground in the race to find a vaccine.
Late-stage trials are underway for vaccines under development by Oxford University/AstraZeneca, China’s Sinovac Biotech, Pfizer Inc in partnership with BioNTech, and Johnson & Johnson’s pharmaceutical subsidiary Janssen.