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The Firmasınca coronavac Sinovac vaccine produced in China has been completed, Coordinator of Hacettepe University Phase 3 study conducted in 24 centers in Turkey. In a written statement from Hacettepe University, it was stated that the purpose of the Phase 3 clinical study conducted with healthy volunteers was to evaluate the safety of the CoronaVac vaccine developed against the Covid-19 pandemic and its protection against RT-confirmed disease. PCR.
This study was noted to be a double-blind, placebo-controlled, randomized clinical trial, meaning that some of the volunteers received the actual vaccine and the other part received a placebo. In the statement, “In the study protocol, it was planned to include 12,450 volunteers in total, in two stages, such as health workers (Cohort K-1) and normal-risk volunteers (Cohort K-2). While vaccinated, 2 applications out of 3 vaccination applications made in the department of normal-risk volunteers were randomly assigned to the actual vaccine arm, meaning the probability that volunteers are vaccinated is 2/3 “ It was said.
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“57 PERCENT OF MEN AND 43 PERCENT OF WOMEN”
Stating that the clinical study began with the inclusion of the first volunteer on September 14, 2020, “Volunteers between the ages of 18-59 were included in two arms, namely the real vaccine arm and the placebo arm. 10,216 people from 24 centers received at least 1 dose of real vaccine or placebo. 6,648 of these volunteers were included in the real vaccine arm. A total of 25,937 doses were administered, the placebos being re-vaccinated with the real vaccine. 57.8 percent of the volunteers included were men and 42.2 percent women. expressions were used.
EFFICIENCY CALCULATED AT 83.5 PERCENT
Within the scope of the study, it was stated that blinding began to break down in healthcare workers on January 14, 2021 due to the approval of emergency use.
Then, according to the capacity of the centers, the blindness of the volunteers continued until February 12, 2021. On February 12, the blindness of all the volunteers was broken. With Covid-19 symptomatic and confirmed by RT-PCR In the cases seen to date, the effectiveness of the vaccine was calculated at 83.5 percent. The most common side effects were fatigue 9.8 percent, headache 7.6 percent, muscle pain 3.8 percent, fever 2.5 percent, chills 2.4 percent and localized. The effect is pain at the injection site, 1.6 percent. The median follow-up period after the first dose of the vaccine is 70 days, and the median follow-up period of 14 days after the second dose of the vaccine is 42 days.
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