Brazil's Health Regulator Decides Against Approving Import Of Sputnik V

MEXICO CITY (UrduPoint News / Sputnik - 27th April, 2021) The Brazilian Health Regulatory Agency, Anvisa, has rejected a regional government request on the import of Russia's Sputnik V coronavirus vaccine.

During a Monday meeting of the Collegiate Board, broadcast on Anvisa's website, the regulatory body unanimously decided (five votes in favor) to veto the import of Sputnik V.

Earlier on Monday, the National Technical Commission on Biosafety (CTNBio) of Brazil's Ministry of Science, Technology and Innovation (MCTIC) recognized Sputnik V as safe and approved its commercial release in the country.

According to the ministry, the decision was made after evaluating complementary documents provided by the Uniao Quimica pharmaceutical company, which plans to produce Sputnik V in Brazil, under the name of Gam-COVID-Vac.

Coordinator of CTNBio's Executive Secretariat, Rubens Jose Nascimento, said that the safety assessment of the Russian vaccine issued on Monday would allow Anvisa to decide on the import of Sputnik V.

Anvisa said last week that it was going to make a decision on permitting the import of Russia's Sputnik V vaccine against the coronavirus on Monday, after a meeting of the Collegiate board that would review requests from states and municipalities for the import of Sputnik V.

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 import approval of Russia's Sputnik V. On April 13, Supreme Judge Ricardo Lewandowski gave Anvisa until the end of this month to decide on the import of Sputnik V doses.

Anvisa has said that it needed more time to collect data on the effectiveness and safety of Sputnik V.

In August 2020, Russia became the first country in the world to register a vaccine against the coronavirus, dubbed Sputnik V, and developed by the Gamaleya research institute. The vaccine has been approved for emergency use in 60 countries worldwide.

According to an interim analysis from a trial published in The Lancet medical journal, the vaccine has 91.6 percent efficacy. Meanwhile, the Gamaleya National Research Center of Epidemiology and Microbiology and the Russian Direct Investment Fund (RDIF) have reported that Sputnik V has 97.6 percent efficacy.