Association of clinical research (AOKI) is a non — profit organizationuniting about 20 pharmaceutical companies — has urged the health Ministry to postpone the registration of vaccines against coronavirus infection, developed by the Center of Gamaliel, before the completion of the third phase of clinical trials. This is stated in an open letter the Association sent to the editors of N + 1. According to AOKI, the registration of the drug until the completion of phase III creates high risks.
In late July, the Center of Gamaliel together with the University medical Academy and military hospital named after Burdenko made a combined I-phase II of clinical trials involving 76 volunteers. The results of these tests, as stated by the Ministry, may be decided on a “conditional” registration of the vaccine, which will allow the use of the vaccine for risk groups. The decision on the confirmation of registration and its output to the General public will be accepted at the end of phase III.
Standard practice requires that clinical trials be done to check the three phases of checks. During the first phase of the healthy volunteers tested the safety of the vaccine during the second — immunogenicity, i.e. the ability to induce an immune response. During the third vaccinated a large group of volunteers (and some of them gets the placebo), after which over a long period tracked the incidence in the placebo group and the group vaccinated. According to the MoH, a phase three trial of the vaccine created in the Center of a name of Gamalei, will begin after the registration, they must take part about two thousand volunteers. According to the results of the third phase of registration may be confirmed or revoked.
AOKI criticized the arguments in favor of “fast registration”, in particular, the indication that a new vaccine based on vaccine another coronavirus causing middle East respiratory syndrome (MERS). However, this vaccine is still in development. “It can not be considered a basis for expedited registration of new vaccines other unregistered vaccine, which is still collecting data, and therefore there are no grounds to make conclusions about its effectiveness”, — the statement says. Link to registration of a vaccine against the Ebola virus, also developed at the Center for Gamalei, according to AOKI, is untenable, as the circumstances of its registration previously raised questions.
The Association notes that in other countries, despite the non-standard situation, do not go “the way of rejection of the prevailing standards of drug development”.
“Today, when according to who, there are 26 vaccine candidates, of which 6 have already moved to phase III and tested with participation of thousands and tens of thousands of people, and with previously published results of the previous phases of the research, there is no reason to force development. Express registration will not make the leader in this race, it will only put unnecessary risk to end consumers of vaccines, citizens of then Federation”, — the statement says.
The representative of the Ministry of health in response to the request of the publisher announced that the Agency will comment on the appeal AOKI later.
What options vaccines against coronavirus infection developed in our country and in the world, read our article “On the tip of the needle”.