12 January, 2022 274

Europe Accepts Sputnik V Vaccine Production Standards

The European Medicines Agency (EMA) has recognized the production standards for the Russian Sputnik V vaccine and issued a corresponding positive conclusion.

This was reported by the BBC Russian Service with reference to the deputy head of the Gamaleya Center Denis Logunov.

Logunov emphasized that the EMA specialists had no critical remarks and their conclusion also concerns the conduct of clinical trials of the Russian drug.

The Russian Academy of Sciences (RAS) said that now there are no serious obstacles to the recognition of Sputnik V by Europe. The conclusion of the EMA means that they examined the enterprises where the Russian vaccine is produced, and the experts recognized them as meeting European requirements. As the well-known virologist, academician of the Russian Academy of Sciences Vitaly Zverev said, “this is one of the main stages, after which only formalities will remain. Now there are no serious obstacles to the recognition of our vaccine.

Earlier, the Russian Foreign Ministry spoke about “encouraging signals” from the WHO. WHO spokeswoman Margaret Harris said at the end of December that the delay in the organization’s recognition of the Russian vaccine was due precisely to the “verification of technological processes.”

To include the drug on the official list of emergency drugs, WHO is asking for safety and efficacy data, as well as manufacturing technology documentation, she said.

The Sputnik V vaccine was registered in Russia in August 2020. The development of the Gamalea Center became the world's first registered vaccine against COVID-19. As stated by the Russian authorities, the drug was approved in 70 states “with a total population of over four billion people.”


Новостной портал – ATPress