Association of clinical research (AOKI) has written to the Minister of health of Michael Murashko, the letter, which referred to the need to postpone the state registration of the first national vaccine against coronavirus infection. The desire to expedite vaccine development from COVID-19 AOKI considered a kind of relic of the so-called heroic paradigm, RBC.
In AOKI noted that the state registration of vaccines should be deferred until successful completion of the third phase of its clinical trials. In the document signed by the Executive Director AOKI Svetlana Zavidova stated that participation in the tests developed by the National research centre of epidemiology and Microbiology named after N. F. Gamalei (NICAM) “Gam-Covid-Wack” was attended by less than hundred people, when in the course of the third phase of testing, drugs are usually tested on several thousand people. This is the third test phase to gather information not only about the vaccine’s effectiveness, but its safety for individuals with weakened immune systems, with concomitant diseases, etc.
“The developers just say they want first and foremost to instill in the number of pensioners as at-risk for COVID-19. Although to date there are no data on the safety of this vaccine for the elderly, often having a number of comorbidities and the often — weakened immune system”, — stated in the letter, AOKI.
The Association, which involved a number of major biopharmaceutical companies, including Bayer, AstraZeneca, Novartis, etc., also recalled that the procedure for state registration of vaccine should be held as the final product will be to consumers. Meanwhile, mass production of the vaccine Gam-Covid-VAK has not been completed and what will be the quality of the drug is unknown.