The regulator unanimously voted on Monday to postpone the import authorization of the Russian vaccine, citing lack of information.
"The decision by Brazil’s National Health Surveillance Agency (Anvisa) to delay the approval of Sputnik V is, unfortunately, of a political nature and has nothing to do with the regulator’s access to information or science," the developers said in a statement.
The developers pointed to the fact that the decision also runs contrary to an earlier one by Brazil’s Ministry of Science, Technology and Innovation, which recognized the vaccine safe and allowed its production in the country.
Earlier this month, governors of Brazil's northeastern states announced their intention to appeal to the Supreme Court if they did not receive a response from Anvisa on the delays in Sputnik V's import approval. On April 13, Supreme Judge Ricardo Lewandowski gave Anvisa until the end of this month to make a decision.
Sputnik V, the world's first registered coronavirus vaccine, has been approved for emergency use in 60 countries across the globe. The efficacy of the vaccine stands at 97.6%, based on the latest analysis of data on the post-vaccination infection percentage among 3.8 million vaccinated Russians. It is higher than the 91.6% efficacy shown in an interim analysis from the trial published in The Lancet in early February.