Brazil’s government approved the Russian-made Chinese coronavirus vaccine candidate Sputnik V “for import and emergency use in several states,” the Moscow Times reported Monday.
The announcement reverses a decision by Brazil’s health regulator, the National Health Surveillance Agency (ANVISA), in April banning imports of Sputnik V to Brazil. ANVISA claimed at the time Russia had sent batches of Sputnik V to Brazil “containing a live version of a common cold-causing virus,” according to the Moscow Times. Sputnik V’s developer, the Russian state-run Gamaleya Institute, denied ANVISA’s allegations. Sputnik V’s financial backer, the Russian Direct Investment Fund (RDIF), threatened to sue ANVISA in a Brazilian court for defamation.
“Sputnik V is undertaking a legal defamation proceeding in Brazil against Anvisa for knowingly spreading false and inaccurate information,” the official Twitter account for Sputnik V wrote in a statement posted April 29.
Despite its hiccups with Brazil’s health regulator, the RDIF used the same Sputnik V Twitter account to announce on June 4,”#SputnikV will be used in Brazil following ANVISA’s approval.”
“Brazil has become the 67th country in the world to authorize Sputnik V,” the statement read.
“The Sputnik V team fully answered all questions from ANVISA on the vaccine’s efficacy & safety [sic],” the Tweet further read.
“Sputnik V will arrive in Brazil in July,” Sputnik V CEO Kirill Dmitriev said in an additional statement shared by the vaccine candidate’s Twitter account on June 4. Dmitriev directs the RDIF, which is a Russian sovereign wealth fund that funds and markets Sputnik V.
The Gamaleya Institute developed Sputnik V last year as the world’s first available Chinese coronavirus vaccine candidate. Russia’s government approved Sputnik V for emergency use in the country in August 2020 before the vaccine candidate had completed late-stage clinical trials. The Lancet medical journal published data from late-stage clinical trials of Sputnik V in February indicating the vaccine candidate was about 92 percent effective against the Chinese coronavirus. An international group of scientists published an open letter to the Lancet in May expressing doubts about the clinical research used to produce the Sputnik V study published by the medical journal in February.
“In an open letter to The Lancet … scientists blasted the vaccine’s developers for ‘data discrepancies,’ ‘numerical inconsistencies’ and ‘substandard reporting’ of the clinical trial results [sic],” according to the Moscow Times.
The Brazilian pharmaceutical company Uniao Quimica announced plans in May to “start producing the Sputnik V coronavirus vaccine in Brazil before the national regulator (Anvisa) gives its approval,” Russia’s state-run TASS news agency reported.
“We will get a batch of the active component from Moscow next week and will start bottling the vaccine at the plant in Guarulhos,” Uniao Quimica CEO Fernando Marques said on May 7. “We will start production immediately after receiving components and will await registration enabling us to start its use in the country.”
“We will receive equipment in late May, making it possible to scale up production volumes,” Marques added.
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