Brazil again rejects approval of Russian vaccine 'Sputnik V'

[Image source=Yonhap News]

Brazilian health authorities have once again rejected approval of the Russian-made COVID-19 vaccine 'Sputnik V.'

According to TASS news agency on the 27th (local time), the National Health Surveillance Agency (Anvisa), Brazil's regulatory body for health, decided to deny approval with the unanimous consent of all five directors during a meeting held the previous day to review the introduction and domestic use approval of Sputnik V.

Antonio Barra Torres, director of Anvisa, explained, "This decision reflects the current situation and was made based on what we have analyzed up to today."

The head of Anvisa's Office of Medicines and Biological Products Supervision stated, "One of the critical factors that caught our attention is that this vaccine contains replication-competent adenoviruses."

This points to the safety risk that the adenovirus, which acts as a vector to carry the COVID-19 virus gene, can replicate on its own.

Another Anvisa official said, "Most countries that have approved the Russian vaccine do not have international authority," adding, "Sputnik V has not yet been approved by European and U.S. authorities."

Sputnik V is a vector-based vaccine that uses human adenovirus types 26 and 5 as vectors. Vector vaccines insert the gene for the COVID-19 spike protein into a vector virus that has been treated to be harmless to the human body and then inject it into the body.

When the vector virus enters the body, human cells read the gene for the spike protein and synthesize the antigen protein, which induces the production of neutralizing antibodies against COVID-19. Sputnik V, AstraZeneca (AZ), and Janssen vaccines all use adenoviruses, which cause the common cold, as vectors.

Recently, cases of rare thrombosis accompanied by thrombocytopenia have been reported with AZ and Janssen vaccines, and some interpretations suggest that the vector adenovirus may have triggered an excessive immune response in the body.

Earlier, the Russian Direct Investment Fund (RDIF), responsible for supporting the development, overseas supply, and production of Sputnik V, requested approval from Anvisa in mid-January through the Brazilian pharmaceutical company Uni?o Qu?mica. However, Anvisa rejected the approval, stating that the Sputnik V vaccine did not meet requirements such as undergoing phase 3 clinical trials.

This content was produced with the assistance of AI translation services.