Conclusions about the undesirability of registering the first vaccine developed in Russia against coronavirus infection COVID-19 before the end of the third phase of its clinical trials are based on ignorance of the research results. Judging by the biography, the author of the loud statement – the executive director of the Association of Clinical Research Organizations Svetlana Zavidova – has a legal education, which is not enough for an accurate understanding of the processes that accompany the creation of drugs. This was stated by experts interviewed by Izvestia. The letter that AOKI sent to the head of the Ministry of Health, Mikhail Murashko, became known on August 10. In the document, the association, whose members are a number of large (mainly Western) pharmaceutical companies, including Bayer, AstraZeneca and Novartis, asked to postpone the state registration of the Gam-Covid-Vac vaccine, which is being developed by the National Research Center for Epidemiology and Microbiology named after N.F. Gamalei (NITsEM).
AOKI bases its argument on the fact that, according to it, fewer than a hundred volunteers took part in the vaccine trials. Usually, in the third phase of studies, the drug is tested on thousands of people – this way information is collected about the effectiveness of the vaccine and its safety for patients with concomitant diseases and weakened immunity.
“The developers directly declare that they want to vaccinate first of all, including retirees as belonging to the risk group for COVID-19. Although to date there is no data on the safety of this vaccine for the elderly, who often have a number of concomitant diseases and often weakened immunity, ”RBC quotes a letter from AOKI.
At the same time, the association did not take into account the conditions in which the vaccine so necessary for Russians is being created. As the deputy head of Roszdravnadzor Valentina Kosenko said on August 11, extensive clinical trials are expected to be carried out at the third, post-registration stage, which is allowed during a pandemic.
At the same time, the author of the letter – executive director of the Association of Clinical Research Organizations Svetlana Zavidova – judging by open data, graduated from the Moscow Institute of Economics, Management and Law (specialty “jurisprudence”, qualification – lawyer). In her early years, she worked as a consumer hotline legal consultant for the Bureau of Business of the Future Association of Conscientious Entrepreneurs. This, of course, has a rather distant relationship to pharmaceuticals.
– Several hundred volunteers were vaccinated with this vaccine, there were no serious adverse reactions to this vaccine. It is obvious that AOKI, not knowing any results, draws conclusions, – said Valentina Kosenko.
Moreover, as Sergey Glagolev, head of the pharmacovigilance organization department of the department for state control of the quality of medical products of Roszdravnadzor, explained, the clinical trial protocol was agreed upon based on the results of an expert assessment.
“It is permissible to register a drug in the early stages of a clinical study, and similar schemes exist in the EU and the USA,” he said. “During the pandemic, countries resorted to drug approval in the absence of normal randomized trials, the case of the Gamalea vaccine is not.
In the case of the Gamaleya Center vaccine, it is about early market admission under tightly controlled conditions, he stressed.