Russia’s Sputnik V vaccine has hit a stumbling block in Brazil, where the regulator has demanded additional paperwork for its emergency use. Moscow has assured that the vaccine is still on course in the Latin American nation.
The Brazilian Health Regulatory Agency (Anvisa) announced on Saturday that it had returned a request for the emergency use of Sputnik V to the applicant, pharmaceutical company Uniao Quimica. The paperwork submitted by the firm did not meet the “minimum requirements for submission and analysis by Anvisa,” the regulator said.
The Russian Direct Investment Fund (RDIF), which funded the development of the vaccine and is Uniao Quimica’s partner in launching the production of Sputnik V, said the necessary paperwork “will be provided shortly” and stressed that the news did not mean the Russian drug had been rejected by Brazil, contrary to some media reports.
The statement added that “the Brazilian Senate is also currently considering a law which has already been approved by the country’s Congress. If approved, the new legislation will allow the use of vaccines approved by several other countries, including Russia.
“The Sputnik V vaccine has already been registered in Serbia, Belarus, Argentina, Bolivia, Algeria, the State of Palestine, Venezuela and Paraguay. Registrations in two more countries are expected next week.”
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The Sao Paulo-based company intends to produce at least 10 million doses of the Russian-developed vaccine in the first quarter of 2021. Anvisa has said it will not authorize emergency deployment of Sputnik V before Uniao Quimica has launched a Phase 3 trial of the vaccine on Brazilian soil. A request to allow the trial to start was filed by the firm on December 21 and is pending additional information, the agency said.
Uniao Quimica was scheduled to begin production of Sputnik V at its Bthek factory in Brasilia last Friday. According to the Sputnik V Twitter account, at least 20 Brazilians working at the Russian embassy have been given the jab – presumably authorized under the Russian law, since the embassy is considered part of that nation.
RDIF, União Quimica are starting vaccination of Brazil’s population with Sputnik V. First 20 Brazilians working at the embassy in Russia are already being vaccinated.
— Sputnik V (@sputnikvaccine) January 13, 2021
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