Home / World / WHO Suspends Approval of Sputnik V due to Manufacturing Infringements
The approval of the Russian Sputnik V coronavirus vaccine at the World Health Organization has been suspended pending a new inspection of the manufacturer's plant. This was announced by the deputy head of the Pan American Health Organization, Dr. Jarbas Barbosa. "Vaccine manufacturers must confirm that the locations where vaccines are produced agree with good manufacturing practice standards. The process for Sputnik V’s emergency use listing was suspended because while inspecting one of the plants where the vaccine is being manufactured, they found the plant was not in agreement with best manufacturing practices," Barbosa said. He did not specify what plant he was talking about. The Pan American Health Organization is an international agency in the Americas that does not have the authority to approve drugs, but acts as a regional office for WHO. In mid-June, a WHO expert group revealed irregularities in the production of Sputnik V in Ufa at the Pharmstandard-UfaVITA enterprise. The claims were related to environmental protection and emission monitoring. The experts had no comments on other enterprises. WHO expressed concern about:
- the integrity of data and test results during microbiological and environmental monitoring during production and quality control;
- implementation of an environmental monitoring program to monitor aseptic handling and filling of vaccines;
- completeness of traceability and identification of lots of vaccines and medicinal substances of its components;
- introduction of measures to prevent cross-contamination;
- compliance with the necessary sterility on the filling lines, as well as on the issue of wearing personal protective equipment by operators;
- checking the sterility of filtration of the vaccine.