Registration of the vaccine is based on two components of an expert assessment. First, in order to assess the balance of benefits and risks when using a new drug experts are studying the data of animal experiments and clinical studies involving humans.
during clinical studies of the vaccine Center Gamalei was confirmed by its ability to form a strong immunity to COVID-19. Serious complications of the vaccine have been identified. It should be emphasized that during the examination were evaluated and the statistical reliability of the data about vaccine efficacy.
a Second pillar of expertise is the establishment of quality parameters and confirm compliance with these requirements of the registered drugs. This is particularly important for vaccines, biological products, since the slightest deviation in terms of their quality can strongly affect the profile of efficacy and safety. Moreover, vaccines are used in millions of people and in a short time. Registration of the drug is possible only if benefits of its use outweigh the potential risks, and quality parameters ensure safe use.
In the case of vaccine COVID-19 we were in a unique situation: current level of development of biotechnology has allowed deciphering the genome of the virus in a matter of weeks to design a vaccine, and a little more than six months to carry out all necessary stages of testing, first in animals and then in healthy volunteers. To protect the health of patients during a pandemic, Russia, the EU and the USA, have developed mechanisms to fast-track the registration of drugs for the prevention and treatment of new infections. In Russia and abroad, registration of such drugs, including vaccines, is on particular conditions.
In particular, the developer of the drug shall conduct a further clinical study of its effectiveness and safety and after registration.
In the case of vaccine Center Gamalei it is foreseen to conduct further clinical studies involving two thousand patients of different sex and age, with different health features. Will continue this phase for a long time – within six months, all indicators of the health of the volunteers will be closely monitored by physicians. In addition, each participant of the third phase of the research will be included in a special digital register vaccinated, which also will gather data about the efficacy and potential complications of vaccination.
Another innovation: for rapid communication with physicians, all participants of the third stage will receive the mobile application, they will be able to quickly transmit the slightest changes in their health status. Thus, the safety profile and effectiveness of a new drug would be controlto aromatise in real-time. Uncontrolled use of vaccines no permit.Make no mistake, and now, when recruiting participants for the third phase of the research, and in the future vaccination will be strictly voluntary.
it is also Important to say: in contrast to “synthetic” drugs and for vaccines in Russia and in the EU, provides for a special procedure of issuance. Each batch of the product is required to be monitored kolaborator regulatory authority. And it additionally guarantees quality.
the Global vaccines market COVID-19 is in the focus of attention of many pharmaceutical companies. A significant number of foreign countries have shown interest in the vaccine. Therefore the recent statements by non-core agencies, which are backed by foreign companies, postponement of registration, you need to take, mindful of the competition.
