The developers of Russia’s Sputnik V coronavirus vaccine have criticised Brazil’s refusal to import the jab as politically motivated.
Brazilian health regulator Anvisa on Monday rejected importing the Russian-made vaccine requested by state governors battling a deadly second wave of the virus, saying technical staff had highlighted “inherent risks” and “serious” defects.
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“Anvisa’s delays in approving Sputnik V are unfortunately of a political nature and have nothing to do with access to information or science,” the official Sputnik V Twitter account said.
It pointed to a recent US government report that said Washington had tried to persuade Brazil not to use Sputnik.
“The United States Department of Health, in its 2020 annual report several months ago, publicly stated that the United States health attache ‘persuaded Brazil to reject the Russian vaccine against COVID-19,'” the account added.
Russia registered Sputnik V last August ahead of large-scale clinical trials, prompting concern among medical experts over the fast-track process.
But later reviews have been largely positive, The Lancet medical journal published results showing it to be safe and more than 90-percent effective.
Experts at Anvisa said the medical journal’s study had a different scrutiny process from the regulatory body.
“A journal does not have the same objectives of determining whether or not to approve the use of a vaccine,” said Gustavo Mendes, one of Anvisa’s technical managers.
Ana Carolina Moreira Marino Araujo, Brazil’s general manager for health monitoring, said taking into account all the documentation presented, data acquired at in-person inspections, and information from other regulators, the “inherent risks” were too great.
Brazil has recorded more than 390,000 COVID-19 deaths, the second-highest number globally after the United States. But the government has struggled to secure enough vaccines for the country’s 212 million people.
So far, it has managed to administer about 38 million doses.
But the country’s outbreak, which has sickened more than 14.3 million people, has continued to surge, pushing hospitals to the breaking point.
In an attempt to speed up their vaccine rollout, about a dozen states in the north and northeast of Brazil signed contracts with Russia to acquire more than 30 million doses of the Sputnik V vaccine.
The federal government ordered 10 million more.
“I hope that the Sputnik V vaccine process adapts its information and quickly resolves any compliance problems because millions of people need access to safe and effective vaccines,” said Meiruze Freitas, one of Anvisa’s directors.
The Brazilian regulator gave the green light to two COVID-19 vaccines – AstraZeneca and Coronavac – in January and has also approved both Pfizer-BioNTech and Johnson & Johnson shots, which have yet to arrive in the country.
The Sputnik vaccine has so far been approved for use in 60 countries, including more than 10 in Latin America.
Argentina signed a deal with Russia earlier this month to become the first Latin American country to produce Sputnik V and will aim for full-scale production to start in June.