Rector of the Russian Medical Academy of Continuing Professional Education, Corresponding Member of the Russian Academy of Sciences Dmitry Sychev found it difficult to explain what caused the claims of the International Association of Clinical Research Organizations (AOCI) to the registration of a Russian vaccine against a new type of coronavirus.
In an interview with Izvestia, the expert noted that “elements of competition periodically appear in the media, because many companies are engaged in the development of vaccines and drugs for COVID-19.” He also recalled that many foreign regulators previously issued emergency permits for the use of drugs that have not even passed full clinical trials.
“These include monoclonal antibodies and hydroxychloroquine. The approvals were based on individual clinical observations. As far as we know, the third phase of clinical trials of the Russian vaccine against coronavirus is now planned. When the vaccine is registered, a vaccine recipient register will likely be created. This is what will allow active monitoring of vaccine safety, ”he concluded.
On August 10, AOKI published an open appeal, in which the association called on the Ministry of Health to postpone the registration of the coronavirus vaccine developed by the Gamaleya Center until the completion of the third phase of clinical trials. The deputy head of Roszdravnadzor, Valentina Kosenko, responded by saying that the organization’s claims were related to ignorance of the research results.
Read more in the material:
Ignorance is power: who is delaying the registration of the Russian vaccine against COVID-19