Almaty. August 27. Information Center - The
influential UK medical magazine The Lancet has published an expert
review which gives a positive report on the effectiveness of the Kazakh produced
Covid vaccine QazCovid-in®, EU Reporter reports.
its EClinicalMedicine online review published in the middle of
August, it concluded that: “QazCovid-in® is an inactivated aluminium adjuvanted
whole-virion vaccine against COVID-19. Our phase 1 and 2 clinical trials have
proved the QazCovid-in® vaccine to be safe and well-tolerated by adults aged
from 18 to 70 years, who receive one or two doses.
reported local and systemic AEs, associated with intramuscular administration of
the inactivated vaccine, are predominantly mild and classified as foreseeable.
the vaccine and placebo groups, no statistically significant difference has
been shown in the level of total serum IgE antibodies which are known as
specific triggers of allergic reactions .
good safety profile is a big advantage of the QazCovid-in® vaccine which does
not induce acute allergic reactions.”
19-23 September 2020, 104 potential participants aged 18–50 years were
screened, of whom 44 were enrolled into the phase 1 clinical trial and randomly
assigned to receive the QazCovid-in® vaccine or placebo.
states: “Participants were recruited through ethics-approved advertising on the
study site's website. Eligible participants were male or female adults aged 18
years and older who were healthy at enrolment based on their medical history,
vital signs, and physical examination. Participants were screened to meet the
were enrolled in the trials if they had no history of COVID-19, their serology
tests for IgM and IgG antibodies to SARS-CoV-2 were negative, and if they had
no close contact with individuals suspected of being infected with SARS-CoV-2
14 days before the enrolment.
participants of childbearing potential had to agree to use reliable forms of
contraception throughout the whole study period. Volunteers were screened for
the absence of chronic viral infections, such as human immunodeficiency virus
(HIV), hepatitis B (HBV) and hepatitis C (HCV) viruses.
biochemical blood test, hematology test panel, electrocardiogram (ECG), and
pregnancy test for women were also performed. Main exclusion criteria included
allergic history, drug intolerance including hypersensitivity to any vaccine
component, an axillary temperature of more than 37·0 °C, abnormalities in
laboratory tests, and positive urine pregnancy test for women.
with any mental disease or serious chronic illness were also excluded. A
detailed list of the inclusion and exclusion criteria can be found in the
were approved by the National Regulatory Authority and the ethics committee of
the National Scientific Centre for Phthisiopulmonology of the Republic of
Kazakhstan (No. KZ78VMX00000211) and conducted in compliance with the
International Council for Harmonization Good Clinical Practice guidelines.
investigator or a staff member explained the investigational nature and the
purpose of the study to a subject in sufficient detail to allow the subject to
make an informed decision about participating. Written informed consent was
obtained from the study subjects before enrolment and before any study
procedure, including screening. The trials were registered with
sample size was not based on any statistical hypothesis, it was adjusted to
adequately assess the vaccine's safety in each study group. Qualitative
characteristics of a study group were presented as percentages; quantitative
parameters were presented as median with interquartile range (IQR) and min-max
analysis set included all randomised participants who received at least one
dose of the study vaccine or placebo. Descriptive summary data were provided as
numbers and per group percentages and included the participants who reported at
least one solicited local reaction or systemic adverse event, any unsolicited
adverse events, serious adverse events, or adverse events of special interest
after the first or second dose.
attributable risk was calculated for particular groups and presented with 95%
CI calculated by the Newcombe-Wilson method with continuity correction
was funded by the Science Committee of the Ministry of Education and Science of
the Republic of Kazakhstan. The sponsor had no role in the design of the study,
as well as in the collection, analyses, or interpretation of data, or in the
writing of the manuscript, and in the decision to publish the results.
6,183,445 people have received their first dose of the COVID-19 vaccine.
4,819,587 citizens of the republic have been fully immunized.
population of Kazakhstan is 19 million.