Brazilian state Bahia’s Governor Rui Costa has said that an agreement has been signed to conduct Phase III clinical trials of the Russian COVID-19 vaccine ‘Sputnik V.’ The state also plans on buying 50 million doses later when Brazil’s health regulator Anvisa approves the protocol for testing.
First supplies will arrive in November, pending approval by Brazil regulators “with the consideration of results of post-registration trials”, CEO of the Russian Direct Investment Fund (RDIF) added, as per Reuters reports. If the trials that are expected to start in October are successful, Bahia will look to market the Russian vaccine in Brazil through its pharmaceutical research centre Bahiafarma, said Fabio Vilas-Boas Pinto, Bahia state Health Secretary.
A separate Phase III trial will also be conducted on 10,000 volunteers in Brazil in 2021, the technology institute for the state of Paraná said last week. Imported dosses will be used for trials but by the end of the year, domestic production will start. Deals to export the vaccine have also been signed by the RDIF.
RDIF said this week it expects to supply up to 100 million doses of the vaccine to Latin America, around a fifth of what it expects to be able to produce annually through global manufacturing partnerships. CEO of RDIF said that clinical trials in Saudi Arabia, United Arab Emirates (UAE), the Philippines, India and Brazil will begin this month.”The preliminary results of the Phase 3 trial will be published in October-November 2020,” an RDIF official said.
The vaccine produced an antibody response in all participants in early-stage trials, according to results published on Friday by The Lancet medical journal that was hailed by Moscow as an answer to its critics
