The board of Brazilian health regulator on Monday rejected importing Sputnik V after technical staff warned of flaws in its development along with incomplete data regarding the vaccine's safety and efficacy.
A crucial issue for the Brazilian regulator was the risk of other viruses used to make the vaccine reproducing in patients, which an Anvisa expert had called a "serious" defect.
Anvisa said the company was authorized to conduct Phase II and III trials in Brazil. Sichuan Clover is planning to test the vaccine on 22,000 volunteers in Latin America, South Africa, Belgium, China, Spain, Poland and United Kingdom.
The Brazilian government signed a contract last month to buy 20 million doses of the Indian drugmaker's vaccine. Bharat Biotech applied for emergency use of the vaccine in Brazil on March 8.
The AstraZeneca vaccine is already being administered in Brazil, but is registered only for emergency use, and the doses have been imported from India.
In an online address, Anvisa director Gustavo Mendes said that the doses manufactured by Fiocruz are expected to be delivered to the Health Ministry later this month.
The Pfizer/BioNTech shot is the first vaccine against the novel coronavirus to receive full approval in Brazil, Anvisa said. Other vaccines developed by AstraZeneca and China's Sinovac Biotech Ltd, have only been approved for emergency use so far.
The approval is good news for a country whose immunization campaign has been plagued by delays and political squabbling.
Anvisa officials had said previously that the Sputnik V vaccine would have to be submitted to Phase III clinical trials in Brazil before its use can be authorized.
The rise in deaths in Brazil comes amid growing pressure to speed up the vaccine roll out, which is lagging regional peers. Mexico, Chile and Argentina have already begun immunizations.
A Supreme Court ruling would clear the way for São Paulo state to start vaccinating people in January, as planned, with doses of China's CoronaVac vaccine made by Sinovac Biotech Ltd.