RIO DE JANEIRO — Brazil’s health authority said late Monday that it would not recommend importing Sputnik V, the Covid-19 vaccine developed by Russia.
The need for vaccines is urgent in Brazil: It has been battered by one of the world’s worst outbreaks, driven by the highly contagious P. 1 virus variant.
But the health authority, Anvisa, said that questions remained about the vaccine’s development, safety and manufacturing. All five of its directors voted against the vaccine.
Data about the vaccine’s efficacy was “uncertain,” Gustavo Mendes Lima Santos, Anvisa’s manager of medicine and biological products, said in a lengthy late-night presentation which noted that “crucial questions” had gone unanswered, including about potential adverse events.
Russia is using Sputnik V in its mass vaccination campaign, and it has been approved for emergency use in dozens of countries. A peer-reviewed study published in The Lancet in February said it had an efficacy rate of 91.6 percent.
The official Sputnik V Twitter account pushed back on Monday in Portuguese, saying that the vaccine’s developers had shared “all the necessary information and documentation” with Anvisa. In another tweet, it said Anvisa’s decision “was of a political nature” and had “nothing to do with access to information or science.” It alleged that the United States had persuaded Brazil to deny approval.
Anvisa officials were under immense pressure to deliver a decision on Sputnik V: Brazilian states had contracts to buy almost 30 million doses. The Supreme Court ordered Anvisa to make a decision.
“The days of yes to the vaccine and to treatments are celebrated,” Alex Machado, an Anvisa director, said. “There will inevitably be days of no.”
Gov. Camilo Santana of Ceará, one of the states with a Sputnik V contract, said on Twitter that he respected Anvisa’s decision but found it strange, given that the Sputnik V had been used in several countries. “I will keep fighting for this authorization, in a safe manner, following all the rules,” he said, adding that the federal government had been slow in distributing vaccines.
The Gamaleya Research Institute, part of Russia’s Ministry of Health, developed the vaccine, also known as Gam-Covid-Vac. The shot has been entangled in politics and propaganda, with President Vladimir V. Putin announcing its approval even before late-stage trials began.
Ana Carolina Moreira Marino Araújo, the general manager of the Anvisa department that inspects vaccine development, said at the meeting that Brazilian officials could not perform a full inspection of the Russian facilities.
She said officials who were in Russia last week were denied access to the Gamaleya Institute and inspected only two factories, finding problems in one of them. She also said Russian officials had tried to cancel the agency’s visit days before.
“At this moment, the inherent risk in manufacturing couldn’t be overcome,” Ms. Araújo concluded.