RIO DE JANEIRO, March 28. /TASS/. Brazil’s national sanitary watchdog Anvisa said on Saturday it had postponed indefinitely its review of a registration bid, filed by Russia’s Sputnik V vaccine.
The review process was expected to be completed on April 2. However, according to Anvisa, its experts did not receive about one fifth of documents it had requested.
"Despite postponing the deadline, Anvisa continues to review the rest of the information, submitted by Uniao Quimica," the watchdog’s press service said.
Uniao Quimica, a pharmaceutical company that represents the Russian Direct Investment Fund (RDIF) in Brazil, submitted a new registration request for Sputnik V on March 26. In line with the current legislation, such requests are to be considered within seven days, but the deadline can be put off if some of the required documents were not submitted in time.
This is not the first delay in the Russian vaccine’s review, and Uniao Quimica’s chief had earlier accused Anvisa of deliberate delays for the benefit of other COVID-19 vaccine manufacturers.
On January 15, Uniao Quimica and RDIF submitted a request to the regulator for a temporary limited use of Sputnik V in Brazil for emergency vaccination. On January 16, Anvisa rejected Uniao Quimica's application for simplified registration of the Russian vaccine as "not meeting the minimum criteria." In particular, the regulator pointed out the need for the Phase III of clinical trials of Sputnik V in Brazil. Later, Anvisa waived this requirement. The RDIF explained that this was a standard procedure for requesting additional information, which does not mean the regulator’s final refusal to register the vaccine.