Brazilian regulator denies permission to import Russian COVID vaccine Coronavirus pandemic News

The lack of information to ensure the safety of Sputnik V has been highlighted as “inherent risks” and “serious” errors.

The Brazilian health regulator has denied requests from several states to import the Russian Sputnik V coronavirus vaccine, saying it does not have the data needed to verify the safety and effectiveness of the owner.

The five-member Anvisa committee voted unanimously on Monday not to approve the Russian vaccine after technical staff pointed out “serious” flaws, citing a lack of information to ensure safety, quality and effectiveness.

Ana Carolina Moreira Marino Araujo, the director general of health control in Brazil, said that all the documentation submitted, the data obtained in previous inspections and information from other regulators, said the “inherent risks” were too great.

Russia registered Sputnik Va ahead of large-scale clinical trials last August, and raised medical concerns about the rapid process.

But later reviews have been largely positive. The Lancet medical journal has published results that show it is safe and more than 90 percent effective.

Experts at Anvisa said the medical journal’s investigation had led to another review process with the regulatory body.

“A journal does not have the same goals for determining whether to accept the use of the vaccine,” said Gustavo Mendes, one of Anvisa’s technical directors.

Brazil has recorded more than 390,000 COVID-19 deaths, the second highest in the world after the United States. But the government has tried to get enough vaccines for the country’s 212 million people.

So far it has managed to administer about 38 million doses.

But the country’s outbreaks of more than 14.3 million people have continued to increase, prompting hospitals to break out.

In an attempt to speed up the spread of vaccines, a dozen states in northern and northeastern Brazil signed contracts with Russia to obtain more than 30 million doses of the Sputnik V vaccine.

The federal government promised an additional $ 10 million.

“I hope that the Sputnik V vaccine process will adapt its information and solve compliance problems quickly, as millions of people need to get safe and effective vaccines,” said Meiruze Freitas, one of Anvisa’s directors.

The Brazilian regulator gave the green light to two COVID-19 vaccines in January – AstraZeneca and Coronavac – and also approved the Pfizer-BioNTech and Johnson & Johnson shots that have not yet reached the country.

The Sputnik vaccine has so far been approved for use in 60 countries, including more than 10 in Latin America.

Argentina signed an agreement with Russia to become the first Latin American country to produce Sputnik V earlier this month and will aim to achieve full production in June.