Anvisa rejects import of Russia’s vaccine

Anvisa has rejected the import of the Russian Covid-19 vaccine, Sputnik V stating that it lacks consistent and reliable data. The coronavirus vaccine was requested by state Governors to fight against the second Covid-19 wave that hit the country.

The vaccine was developed by the Gamaleya National Center of Epidemiology and Microbiology it is based on a human adenoviral vectors platform. The Brazilian National Health Surveillance Agency Anvisa has a five-strong board who voted unanimously against the Russian vaccine. It has approval as technical staff had emphasised ‘inherent risks’ and ‘serious’ defects, pointing out the lack of data ensuring the safety, quality and effectiveness of the shot.

The health monitoring general manager Ana Carolina Moreira Marino Araujo has said that data obtained at in-person inspections and information from other regulators indicate greater inherent risk. Gustavo Mendes, Anvisa medicines and biological products manager said  that the major problem with the vaccine was the adenovirus’ presence that could reproduce which is a serious defect. The EU had expressed similar concern and has not approved the vaccine so far as it required more data on the tests and manufacturing methods.

Last month, the European Medicines Agency’s Committee for Medicinal Products for Human Use initiated a rolling review of the Russian Covid-19 vaccine, Sputnik V. Russia’s coronavirus vaccine is approved in many countries across the globe.

Recently, the Gamaleya National Research Center of Epidemiology and Microbiology and the Russian Direct Investment Fund reported that the vaccine showed a 97.6% efficacy against Covid-19. The infection rate of 0.027% starting from the 35th day on administering the first dose. These results are from a real-world assessment based on data from 3.8 million people who received the two shots of the vaccine.Since the pandemic onset, 14.4 million confirmed Covid-19 cases and around 400,000 deaths were reported in Brazil. Estimates from the health ministry data show that 13% of the country’s population have received the first dose.