Comments calling for the postponement of registration of the Russian vaccine against COVID were sent by associations that unite commercial business entities, Sergey Glagolev, chairman of the Committee of the Parties to the Medicrim Convention, vice-chairman of the WHO Mechanism for Counterfeit and Substandard Medicines, said on August 11.
“I cannot identify the customers of the publication of this information. We did not receive comments from academic institutions; comments came from associations of commercial business entities. Including foreign commercial farms. Accordingly, when reading these comments, one should keep this fact in mind, ”Glagolev said.
According to him, the association did not take into account the conditions in which the vaccine is created. The deputy head of Roszdravnadzor, Valentina Kosenko, already said on August 11 that conducting clinical trials at the third, post-registration stage, is permissible during a pandemic.
In addition, the Russian regulatory system is based on the priority of patient interest, the expert recalled. The country has created mechanisms for the release of the drug in a pandemic, as in all economically developed countries. When risks permit, a drug can be released at an early stage of study, followed by monitoring of the use and further study.
On August 10, it became known that the International Association of Clinical Research Organizations (AOCI), whose members are a number of large (mainly Western) pharmaceutical companies, including Bayer, AstraZeneca and Novartis, sent a letter to the Ministry of Health of Russia in which it asked to postpone state registration vaccine “Gam-Covid-Vac”, developed by the National Research Center for Epidemiology and Microbiology named after N.F. Gamalei (NITsEM).
The reason for this, according to the organization, is that the third phase of drug testing has not yet been completed.