WHO Suspends Approval of Sputnik V due to Manufacturing Infringements

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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.
The inspectorate's findings were sent to the vaccine manufacturer, its developer and the Russian regulatory authorities. Sputnik V is produced in Russia at seven sites - Medgamal of the Gamaleya Center, Binnopharm, R-Pharm, Biocad, Generium, Lekko and Pharmstandard-UfaVITA. The WHO audit was carried out in connection with the application of the Sputnik V manufacturer for an emergency vaccine registration. In April, WHO announced that it would conduct an inspection in conjunction with the European Medicines Agency (EMA). On June 13, EMA spokesman Marco Cavaleri said that the agency has completed an inspection of the sites where Sputnik V is being produced. The vaccine is now undergoing a rolling review process; the developers have not yet applied for a marketing authorization. This was reported by the EMA in response to a request from the "Pharmvestnik" publication. The EMA's website states that the agency is using rolling review to "expedite the evaluation of a promising drug during a public health emergency." During this process, the EMA's Committee on Human Medicines (CHMP) reviews drug data as it emerges from various studies. Once the CHMP decides that it has sufficient data on a drug, the manufacturing company can file a formal registration application for the drug. In July, Reuters reported that Sputnik V's developers were having difficulty submitting data to the EMA. The agency wrote that the creators of the drug could not confirm that the main cell bank of the vaccine meets EU standards for the prevention of infections. The publication also noted that the EMA lacks individual registration cards, which would describe the side effects recorded during the trials, and also expressed doubts about how specialists tracked the results of patients who received placebo. Over the past day, 19,594 people have been confirmed infected with coronavirus in Russia, it follows from the data of the operational headquarters to combat the spread of infection. This is the first time since August 29, when the daily increase was more than 19 thousand - 19 286 cases were identified at that time. The total number of confirmed cases of COVID-19 in the country reached 7,214,520. Also, the daily number of deaths in Russia is 794.