Sputnik V has only limited import authorization given by Brazil‘s health regulator to the nine Northeast states that have contracted with the Russians.
Brazil‘s regulator authorized the importation of approximately 4 million doses that could be used in Brazil, on a limited basis, as long as the states signed a commitment to conduct studies to verify the safety and efficacy of the vaccine and collect data that, to date, the manufacturer– Gamaleya Institute –has not provided, according to Brazil‘s regulator Anvisa.
In addition, all batches of Sputnik that arrived in Brazil would have to be tested by the National Institute for Quality Control in Health of the Oswaldo Cruz Foundation (Fiocruz), to verify safety and efficacy.
In June, Anvisa approved the importation of Sputnik with 22 conditions. At the time, the decision was celebrated by the governors, who accepted the commitment. However, so far, only four of the nine states have signed the term.
A source that follows the process told Reuters that the state governments, which began negotiating directly with the Russians for the delivery of documents and information necessary to conduct the studies, also began to have difficulties receiving them, which would prevent the studies from the beginning.
The Minister of Health, Marcelo Queiroga, has already stated that the federal government does not intend to include Sputnik V in the national immunization program because there is no longer any need since the country already has contracts for the acquisition of sufficient vaccines among those that already have authorization for use in Brazil.
(Translated by LABS)