Not enough information to approve Sputnik V, say regulators

The Brazilian National Health Surveillance Agency (Anvisa) has told the Supreme Court it is unable to give its approval for Russian-made coronavirus vaccine Sputnik V, as manufacturers have not provided enough information to substantiate the request.

Anvisa turned down a plea for the emergency approval of Sputnik V, which caused the state government of Bahia to take regulators to court. In September Bahia signed a deal to purchase 50 million doses of Sputnik V. In its lawsuit, the state claims Anvisa should follow the lead of the Pan-American Health Organization (PAHO), which greenlit the Russian vaccine.

But Anvisa says that the Gamaleya Research Institute — part of Russia’s Health Ministry — supplied less than 10 percent of the documentation provided by Brazil’s Butantan Biological Institute and Oswaldo Cruz Foundation, which carried out clinical trials for the Sinovac and AstraZeneca vaccines, respectively.

As reporter Renato Alves revealed in our January 22 story, the Goiás-based pharmaceutical company União Química has a deal in place with Gamaleya and the Russian Direct Investment Fund (RDIF) for the transfer of technology that would allow the lab to produce Sputnik V vaccines in Brazil, which would “give Brazil vaccine autonomy.”

Regulators, however, fear that an unproven vaccine could reach patients before its safety and efficacy are thoroughly scrutinized.

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