The Brazil National Health Surveillance Agency (Anvisa) declined the request to approve the Russian-developed Sputnik V vaccine against COVID-19 for emergency use in Brazil. While, emergency use of COVID-19 vaccines from China’s Sinovac Biotech Ltd and Britain’s AstraZeneca have been approved by the regulator.
Citing the agency, TASS reported that the request does not comply with the minimal criteria for this task.
"The request was returned to Uniao Quimica, because it does not comply with the minimal criteria in particular, due to lack of permission for third phase of clinical trials, as well as in regards to issue dealing with the advanced production methods," TASS quoted the Anivsa.
This comes after, Uniao Quimica, a partner of the Russian Direct Investment Fund (RDIF), contacted Anvisa, last year in the month of December, requesting permission to conduct the third stage of clinical trials for the Sputnik V vaccine in Brazil.
Anivsa stated that, considering previous experience of reviewing such applications, the decision could have been provided within 72 hours. However, later, the agency requested additional information on the vaccine.
On Friday, Uniao Quimica and the Russian Fund filed a request for emergency use of 10 million doses of the Sputnik V in Brazil.
"Uniao Quimica believes that, in response to the COVID-19 pandemic escalation in Brazil and the rest of the world, the state and the business must take all efforts to fight it, including by taking measures of emergency and exceptional nature, justified by the urgent need and the importance of the current moment," TASS quoted the company statement.
According to TASS, in January, Uniao Quimica received cellular material for the production of the vaccine.
(With ANI inputs)