Brazil’s Supreme Court gives Health Regulator deadline to decide on Sputnik V import

RIO DE JANEIRO, BRAZIL – Supreme Court (STF) Justice Ricardo Lewandowski ordered the Brazilian Health Regulatory Agency (ANVISA) to analyze the Sputnik V exceptional request for import permission, by the end of April.

Should the agency fail to decide on the issue within this period, the magistrate stated that the state of Maranhão, which filed the lawsuit, will be automatically authorized to import the Russian vaccine and distribute it to the population.

The decision in favor of Maranhão should open the way for other states to seek authorization to import Sputnik V. At least 12 state governments have asked ANVISA for approval to import the Russian immunizer.

The deadline granted by Lewandowski began on March 29th and runs until April 29th.

“The state of Maranhão filed a request for authorization to import, on an exceptional basis, doses of the Sputnik V vaccine on March 29th, 2021, meeting all the requirements of RDC 476/2021,” he said, in reference to an ANVISA resolution.

The Justice said that the import of vaccines by states “will represent an important reinforcement to the actions developed under the auspices of the National Immunization Plan, notoriously insufficient, given the surprising dynamics of the spread of the virus that caused the pandemic.”

Lewandowski also stated that should ANVISA fail to decide on the import within the imposed deadline, vaccination of the population of Maranhão with Sputnik V will be made under the “exclusive responsibility” of the state government.

According to the Justice, the deadline granted is compatible with the dates the regulator scheduled to inspect the Russian vaccine plants.

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