From the Scientific and practical center of interventional Cardioangiology sechenovskiy medical University was discharged volunteers who participated in the first phase of clinical trials of vaccines against coronavirus infection — vaccine on the base adenovirus vector, was developed in NRC epidemiology of Gamaliel (about this and other vaccines, we wrote in the material “On the tip of the needle”).
38 subjects (the youngest 18, the oldest 60, 17 men, 21 women) conducted in hospital exactly a month, where they experienced one of the dosage forms of the vaccine.
“The volunteers were divided into two groups, — says Elena Smolyarchuk, head of the Center clinical study of drugs sechenovskiy University. The first group received vaccination only once, the second twice. This so-called booster circuit, which accentuates the effect of the first vaccination”.
The first phase of clinical testing, strictly speaking, says nothing about the effectiveness of the test drug. It is performed only for security check. The most that you can say definitely in its end — harmed if the drug is subject. What discharged the day before yesterday, the volunteers feel good, in fact, is the answer to the question, can it be considered successful this phase.
Speaking about side effects from trial participants, Smolyarchuk said that all the responses from volunteers did not differ from those that are after the introduction of other vaccines: someone had a fever, someone headaches.
“No way our volunteers did not differ. But these data are comparable with the reactions to the introduction of any other vaccines, absolutely,” said the interviewee ,N+1, no exact numbers, however, are not calling.
The effectiveness of the vaccine say on the outcome of the first phase prematurely. To check the efficacy of the drug need a second phase of the research, and efficiency third (read more about the phases of clinical trials, read our article “Last check”). However, some data about the immunogenicity of a vaccine that is, if she generates in humans the immune response to the virus, harvested of course, and during the first phase.
“There were tests on humoral and cellular immunity. These analyses holds [the developer of the vaccine] Institute Gamalei,” says Smolyarchuk, adding that “immunity” is generated.
All of the subjects he has formed, and what is its strength, the data from Smolyarchuk no.
The center of Gamaliel will have to provide to the Ministry of health the test report, where, in fact, are processed as data on safety and preliminary data on vaccine efficacy. According to Smolyarchuk, this should happen somewhere in August, so detailed information about the success of the vaccine will have to wait for some time.
Commenting on the completion of the first phase of testing, Minister of health Michael Murashko has mentionedthat in two weeks I will complete the second phase of clinical trials of the vaccine. The representative of then direct investment Fund, an organization that supports the development of a vaccine, said N+1, the second phase began almost simultaneously with the first — June 18 (officially, the first phase started on 16 June).
Smolyarchuk recognizes that the phases of clinical trials are sometimes combined “for various reasons”.
“It is generally accepted that the later phases include more people, hundreds of volunteers, — he says. — Secondly, it is a longer period of observation. The first phase is 28 days, the period of observation in the later phases of is months.”
Perhaps the second phase of the tests conducts the Main military clinical Burdenko hospital, where she tested on 50 soldiers.
Thus, the second phase of clinical trials coronavirus vaccine development Centre Gamalei will last about a month and a half and the new data should be expected in August (possibly simultaneously with data on the results of the first phase).
According to the head RFPI Kirill Dmitriev, the second test phase will end on 3 August, and immediately after the start of the third phase of the vaccine trials. The third phase will be conducted not only in our country but also in other countries in the middle East to provide “mnogocentrowoe” tests. Approval of the vaccine by the regulator planned to record time — in September. Whether this will happen before the end of the third phase or even before it — is unclear.
“We expect regulatory approval to start using then vaccine is literally in the August-September… She may become the first registered vaccine against coronavirus infection,” — said Dmitriev.
Reason for optimism, according to Dmitriev, gives the fact that the adenovirus platform has already been validated on a vaccine for Ebola. In addition, the booster circuit — two injections — allows you to provide long-term immunity of up to two years, according to the head RFPI.
Earlier in the same record time was approved for use by then generic of favipiravir aviewer. To register drugs under the accelerated procedure allows the RF government decree of April 3, 2020 No. 441, which States that “the reduction … of expertise” permissible “under the threat of occurrence and liquidation of emergency situations”.
Earlier, Deputy Prime Minister Tatiana Golikova saidthat the production of the vaccine could be launched in September. In turn, Dmitriev said that the production of vaccine are already beginningn company “R-Pharm” and “in Durban”. It is expected that in our country until the end of the year will be produced 30 million doses of the vaccine. In addition, it is assumed to arrange the production of vaccines in other countries — in this case, the volume of production could reach 200 million doses before the end of the year. Talks about the start of production, according to the head RFPI, is underway with five countries.
Officials demonstrate optimism, promising that the production and use of vaccines could begin in early autumn, but on what is based this optimism is not clear. The results of the first phase – accurate data about the side effects of immune response are not yet public, it is unclear exactly how organized the second phase of the test, how and in what time frame will be the third phase. It seems that the launch and registration will take place before the completion of the third phase in emergency mode.