Earlier this month, STF Judge Ricardo Lewandowski established a deadline (through the end of April) for ANVISA to decide on ‘the exceptional and temporary imports’ of Sputnik V vaccine doses.
The decision came after a lawsuit filed by the Government of Maranhao that reported negotiating 4.5 million Sputnik V doses.
Lewandowski authorized, in addition to Maranhao, that the states of Ceara, Piaui and Amapa can also import the Russian vaccine if the agency does not adopt the protocol.
ANVISA argued that it is necessary to attach the quality, efficacy and safety data to the purchase order to decide on the ‘exceptional and temporary imports’ of Sputnik V vaccine doses.
According to Lewandowski, the deadline has a legal provision to guarantee a swift immunization.
He noted that the eventual denial of Sputnik V has to be technically justified, not being admissible to resort to bureaucratic issues, and ANVISA cannot just invoke the lack of documents in order not to analyze the request.