Director General of the state scientific center “Vector” of Rospotrebnadzor Rinat Maksyutov said that the Ministry of health has not yet issued a permit to anyone to conduct clinical trials of vaccines from COVID-19. In addition, volunteers are also strictly selected. “There are more than 22 contraindications for COVID-19 vaccines,” Maksyutov said, naming those for whom testing the vaccine is prohibited.
Earlier, it was reported that the Russian vaccine against COVID-19 is already being unofficially tested on humans. Director General of the state scientific center “Vector” of Rospotrebnadzor Rinat Maksyutov clarified that none of the developers has yet received the necessary permission from the Ministry of health to conduct clinical trials of vaccines against a new coronavirus infection.
The expert also stressed that receiving the laboratory version can not be considered as receiving the vaccine itself. He also noted that in his organization, the laboratory version of the prototype of the vaccine was received in March of this year.
In an interview with Izvestia, Maksyutov explained that without permission from the Ministry, it is impossible to conduct clinical research, and compliance with strict Protocol is necessary to avoid risks.
There are restrictions on volunteers who will test the drug on themselves. They must be absolutely healthy. According to Maksyutov, “there are more than 22 contraindications for COVID-19 vaccines.” Among those that he listed, there is a ban on both pregnancy and chronic diseases. Even the weight of the volunteer is taken into account.
The clinical study will include volunteers with a verified diagnosis of “healthy” according to standard clinical, laboratory and instrumental methods of examination. Even the body mass index is taken into account. The clinical study does not include persons who have contraindications to the introduction of vaccines. For COVID-19 vaccines, there are more than 22 contraindications, including pregnancy, breast-feeding, chronic diseases in the acute stage and others,” he told TASS in an interview.