On Monday, Anvisa, which is the health regulator in Brazil, rejected a request by state governments to import Sputnik V, the COVID-19 vaccine made in Russia. All five board members voted against its approval saying it has “inherent risks” and “serious defects.” The Russian Direct Investment Fund (RDIF) who markets the vaccine said that this may be a politically motivated decision as 61 countries have approved its use and it has a high efficacy rate.
The general manager for health monitoring, Ana Carolina Moreira Marino Araujo said that they had reviewed the documentation presented as well as checked in-person data and obtained information from other regulators. They concluded that the “inherent risks” in Sputnik V were too great to be used in Brazil.
Brazil’s vaccination program has been beset with delays. The country is a hotspot for COVID-19. The health system is unable to cope with the daily rising numbers. A judicial enquiry on the lapses to procure oxygen is also underway.
According to data from the health ministry about 13 percent of the population which amounts to 27.3 million people has received a first dose of a COVId-19 vaccine. The country registered 14.4 million confirmed COVID-19 infections. The total death toll has also been one of the highest in the world and is reported to be almost 400,000.
Sputnik V is an adenovirus vaccine similar to vaccines produced by AstraZeneca and Johnson and Johnson. Clinical trials put its efficacy at almost 92 percent. A statement released by Moscow’s Gamaleya Institute where the vaccine was developed and the Russian Direct Investment Fund said that the real-world assessment produced better results. Data procured from 3.8 million who have taken the vaccine showed that Sputnik V was 97.6 percent effective.
European Medicines Agency, which is the European Union’s regulator, is reviewing Sputnik V. It is expected to decide whether it will use this vaccine by May or June.