Russian President Vladimir Putin announced the registration of the first vaccine against coronavirus.
Russia has thus become the first country in the world to register the vaccine against the novel coronavirus, the head of state said.
"One of my daughters received the shot. In this sense, she took part in the experiment," Putin said during a meeting with the government, where he announced the state registration of the first Russian vaccine against COVID-19.
The Association of Clinical Research Organizations (ACRO), which unites pharmaceutical companies and research organizations, urged the Ministry of Health of the Russian Federation not to rush with the state registration of the Gam-Covid-Vac2 coronavirus vaccine created by the Federal Research Center for Epidemiology & Microbiology named after N.F. Gamaleya. According to ACRO, the vaccine needs to be registered only after it passes though all stages of critical development successfully.
The hasty registration of the vaccine will not make Russia a leader in the vaccine race, but will rather expose end users to unnecessary danger, representatives of the organisation claimed.
"This is a new vaccine, and its the testing has not been completed, not even with the participation of even hundreds of people, not to mention several thousand participants in phase III of the trials," the letter said.
ACRO noted that even in the face of a non-standard situation and an urgent need for a vaccine against COVID-19, the international community does not abandon the established norms for the development of drugs.
According to the WHO, there are 26 candidate vaccines in the world, of which six have already entered phase III of the clinical trials and are being tested with the participation of thousands and tens of thousands of people with preliminary published results of previous studies.
"Regretfully, we have to admit that the Russian regulator is ready to introduce into civilian circulation the vaccine that meets much lower requirements, and which is less safe and effective," the ACRO said.
The developers of the new vaccine explain the unprecedentedly quick access to the registration stage of the drug with the fact that it is based on the vaccine against the MERS virus, which scientists of the Federal Research Center for Epidemiology & Microbiology named after N.F. Gamaleya have been working for several years already. However, according to the state registry of clinical trials, this vaccine is still in phase I-II of the trials, which is planned to be completed only by December 31, 2020. Therefore, it is too early to speak of its effectiveness.