The Brazilian National Health Surveillance Agency (Anvisa) has rejected the import of the Russian Covid-19 vaccine, Sputnik V, citing a lack of consistent and reliable data.
The vaccine was requested by state Governors to fight against the second Covid-19 wave that hit the country.
Developed by the Gamaleya National Center of Epidemiology and Microbiology, the vaccine is based on a human adenoviral vectors platform.
Anvisa’s five-strong board voted unanimously against the Russian vaccine 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, Reuters reported.
The news agency quoted health monitoring general manager Ana Carolina Moreira Marino Araujo as saying that data obtained at in-person inspections and information from other regulators indicate greater ‘inherent risks’.
Anvisa medicines and biological products manager Gustavo Mendes said a major problem with the vaccine was the adenovirus’ presence that could reproduce, which is a ‘serious’ defect.
The EU also 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 (EMA) Committee for Medicinal Products for Human Use (CHMP) initiated a rolling review of the Russian Covid-19 vaccine, Sputnik V.
Currently, Sputnik V 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.
Furthermore, an infection rate of 0.027% starting from the 35th day on administering the first dose was observed.
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.