The production of a vaccine against the SARS-CoV-2 coronavirus has begun, the Russian Ministry of Health said. The pharmaceutical market urged to postpone the registration of the drug developed by the Gamaleya Center.
The first batch of the SARS-CoV-2 coronavirus vaccine has been released in Russia, Russian media reported on Saturday, August 15, citing the press service of the Russian Ministry of Health. We are talking about the development of the National Research Center named after Nikolay Gamaleya. The director of the medical center said earlier that by the end of January 2021, the production of the vaccine, dubbed Sputnik V, could reach the level of 5 million doses per month.
On August 11, Russian President Vladimir Putin announced the registration of the drug. The vaccine "forms a stable immunity" and "passed all the necessary tests," he assured.
Skepticism of experts in Russia and Germany
Meanwhile, the Association of Clinical Research Organizations (AOCI), which unites pharmaceutical companies and participants in the Russian market for clinical trials, previously urged the Ministry of Health of the Russian Federation to postpone the state registration of the vaccine developed at the Gamaleya Center. The new drug has not yet "completed testing with the participation of even hundreds of people, not to mention the several thousand participants in the study taken in phase III," said representatives of the pharmaceutical market.
A number of German experts were also skeptical about the vaccine. Premature vaccination of millions of people without the third phase of clinical trials involving thousands of volunteers "can be dangerous," said German Health Minister Jens Spahn. Russian colleagues "bring to the attention of European experts" too little information ", and the developments themselves are" insufficiently tested ", the minister complained. The head of the Paul Ehrlich Institute (PEI) Klaus Cichutek also highlighted the lack of transparency in the development of the drug.
The World Health Organization (WHO) has spoken reservedly about the Russian vaccine. according to a WHO spokesman, all data on the safety and effectiveness of a new drug should be carefully checked.