ScienceThe COVID-19 reporting is supported by the Heising-Simons Foundation.
Despite safety concerns, the Brazilian Health Regulatory Agency (Anvisa) reversed itself last week and voted to allow a trickle of Sputnik V, the Russian-made COVID-19 vaccine, into the country. Only 928,000 doses will be imported – just a fraction of the total requested by a group of state governors – and the agency has imposed strict measures to reduce supposed health risks and monitor the safety and effectiveness of the vaccine. .
In April, as Brazil faced a massive wave of COVID-19 and a vaccine shortage, Anvisa vetoed a previous import request, fearing the vaccine might contain adenoviruses that could replicate and harm vaccinated people. The move sparked a threat of lawsuit by the maker of Sputnik V, the Gamaleya Research Institute in Epidemiology and Microbiology, and drew criticism from some scientists. But on June 4, four of Anvisa’s five directors decided to authorize the importation of Sputnik V, influenced by a new law and the continuing and worsening crisis in Brazil. “The health context that our country is going through makes us face the need to make as many vaccines and medicines as possible,” said Alex Machado, one of the four directors. Brazil has one of the world’s highest burdens of COVID-19, but has only vaccinated around 15% of its population with a first dose.
The two doses of Sputnik V use two different adenoviruses to deliver genes encoding the spike protein in the pandemic SARS-CoV-2 coronavirus. Adenoviruses are believed to be unable to make copies of themselves. But Anvisa’s director general of drugs and biologics, Gustavo Mendes, said the latest documents received by the agency, describing tests carried out by Russia’s health minister, placed the number of adenoviruses capable of seeding. reply to “no more than 50 per dose”. This is less than what previous documents suggested, but still “unacceptable”, he adds. “It is not clear to us what the rationale was used to endorse this specification or how the presence of these viruses can be certain.”
Some scientists outside the fray have already said that Anvisa misreads this Russian documentation. They argue that this does not indicate the presence of a live virus, but rather the detection limits of testing for such a virus.
According to a Brazilian law enacted in March, the country can selectively import vaccines already approved for emergency use by some countries, including Russia. So Anvisa’s staff members and governors had several meetings to discuss ways to get the vaccines out and, at the same time, to “minimize the risks” associated with the vaccine, Mendes says.
Anvisa has so far limited imports of Sputnik V to a number sufficient to cover just 1% of the population of the six northern states that filed the initial vaccine request, which called for 67 million doses. Lots will need to undergo analysis by a public laboratory to show that they are safe and do not contain replicative adenoviruses, and only healthy adults will be eligible for injections.
In addition, states administering the vaccine must disclose to the public that the regulatory agency has not authorized the products for quality, safety or efficacy. And in an approach proposed by the Brazilian governors, the States will have to conduct a Sputnik V efficiency study under the supervision of Anvisa.
“It was a victory for us, and we will work together to meet all the conditions,” said Sergio Rezende, the former Brazilian science minister, who is part of the scientific council supporting the governors who requested the vaccine. Rezende argues that Anvisa initially vetoed the import for political reasons, as Brazilian President Jair Bolsonaro criticized COVID-19 vaccines, especially those made by ‘communist countries’, such as China and Russia .
The temporary use permit for Sputnik V can be suspended at any time if Anvisa or the World Health Organization denies it a formal authorization for emergency use (still under evaluation in Brazil), or if problems arise during laboratory tests or vaccination. There is no prediction of when the approved doses will arrive, but Brazilian governors, Anvisa and the manufacturer are already discussing the rollout of the vaccination.
For immunologist Jorge Kalil, a vaccine expert on the main campus of the Federal University of São Paulo, Anvisa’s compromise was a smart strategy. “We are not able to throw away vaccines, and it was a good solution to see if, indeed, in the eyes of Brazilians, this vaccine works well and can be distributed to the whole population.”