Posted 11 августа 2020, 06:40

Published 11 августа 2020, 06:40

Modified 24 декабря 2022, 22:37

Updated 24 декабря 2022, 22:37

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Not to perform heroics: the Ministry of Health urged to postpone the registration of a vaccine against coronavirus

11 августа 2020, 06:40
The state registration of the first coronavirus vaccine developed in Russia should be postponed until the third phase of the clinical trials is completed, the Association of Clinical Research Organizations (AOKI) insists. Roszdravnadzor believes that AOKI is simply not sufficiently informed about the drug.

The document sent to the head of the Ministry of Health Mikhail Murashko notes that no more than a hundred people took part in the trials of a vaccine developed by the National Research Center for Epidemiology and Microbiology named after N.F Gamaleya, and during the third phase of testing, drugs are usually tested on several thousand, RBC reports.

AOKI notes that in the third phase of testing, information is collected not only about the effectiveness of the vaccine, but also about its safety for people with weakened immunity, with concomitant diseases, etc.

- The developers directly state 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, often with a number of comorbidities and often - weakened immunity, - points out in a letter to AOKI.

Note that a number of large biopharmaceutical companies participate in the Association, including Bayer, AstraZeneca, Novartis, etc. AOKI representatives remind that the vaccine will have to be registered as a final product - exactly the way consumers will receive it. However, the mass production of Gam-Covid-Vac has not yet been established and it is not known what the quality of the drug will be.

AOKI said the drive to complete vaccine development as soon as possible is a holdover from the so-called heroic paradigm that characterized the early days of vaccination pioneers. Modern medicine, however, emphasizes AOKI in a letter, adheres to standards that reduce risks to people.

“Many of the daring experiments of vaccine pioneers that no ethics committee would endorse today fit into the heroic paradigm. Judging by the sensational vaccine research on the staff of the Gamaleya Center before the official start of clinical trials, the developer continues to act within the heroic paradigm and considers himself entitled to deviate from the drug testing standards. Unfortunately, the role of heroes in this case is assigned to those who did not plan to play it at all - ordinary citizens of Russia who are at risk for COVID-19, - is indicated in the appeal.

There is no point in chasing the world championship in vaccine development, the association believes:

- Accelerated registration will no longer make Russia a leader in this race, it will only expose end users of the vaccine, citizens of the country of the Russian Federation, to unnecessary danger.

Roszdravnadzor reacted to the letter. Deputy head of the department Valentina Kosenko believes that market participants simply do not have enough information about the developed drug.

- It is unlikely that the vaccine center. Gamalei will not meet the established requirements. Several hundred volunteers were vaccinated with this vaccine, there were no serious adverse reactions ... It is obvious that AOKI, not knowing any results, draws conclusions, - said Kosenko.

Sergey Glagolev, head of the pharmacovigilance organization department of the Roszdravnadzor department for state control of the quality of medical products, noted that laboratory confirmation of the study will take place in the post-registration period, during which thousands of volunteers will be vaccinated. And he called it unacceptable to register the drug in the early stages.

Let us recall that the release of the vaccine developed at the National Research Center for Epidemiology and Microbiology named after N.F Gamaleya is expected this month. According to some reports, the drug may go into circulation as early as August 15.