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Minister Koca, to report on the results of the phase 3 study, was carried out by the member of the Scientific Committee Prof. Dr. He left it to Serhat Unal.
Unal made a presentation in his speech, China sinovac virus inactivated vaccine produced by the signing of phase 3 studies began in Turkey of coronavac recalled that on September 14.
Ünal said that, according to the evaluation by the Independent Evaluation Committee, 7,371 of 9,150 volunteers screened at 24 centers were included in the study as of December 23, 4,759 of them were in the vaccine arm and 2,612 of them were in the arm. of placebo.
Remembering that health professionals were vaccinated first and citizens were vaccinated as of November 18, Ünal affirmed that the first group received a vaccine, a placebo and the second two vaccines and a placebo.
Unal said: “When all were evaluated, 10,828 doses were administered to 7,371 volunteers within the scope of the study. Two doses were administered to 3,457 volunteers within the scope of the study.” said.
Noting that the CoronaVak vaccine arm was evaluated in 1,322 people, 752 volunteers and 570 volunteers in the placebo arm, Ünal said: “While there were only 3 patients in 752 vaccinated people, 26 diseases occurred in 570 placebo arm “. I speak.
Emphasizing that the vaccine in question is in accordance with the confidence interval determined by the World Health Organization, Ünal stated that the total efficiency of the vaccine was calculated at 91.25 percent. Expressing that this rate will increase even more in the coming days, Ünal said: “Because the number of patients is lower in the placebo arm, the number of patients will increase. Although there are more cases in the other arm, it happened like this” . used the expression.
Providing information on the table, Ünal said: “The difference between the two groups appears as of day 21, including the number of patients in the red vaccine arm and the number of patients in the placebo arm. Spoke.
Ünal noted that 6 of 26 cases in the placebo arm were treated as a severe corona infection that required hospitalization, while 3 people in the vaccine arm had no symptoms and the disease did not occur.
Referring to the side effects of the vaccine, Ünal said that the vaccine safety analyzes were conducted with data from 2,964 people and that 593 side effects occurred. Ünal stated that the most common side effects were fatigue, headache, pain at the injection site and the same effects were found in the second vaccine.
Ünal said: “Our vaccine appears safe in terms of safety data, 91.2 percent in terms of efficiency. We have submitted our pre-evaluation and mid-term evaluation with 29 cases due to the emergency requirement. We have a plan to continue until 40.” . said.
“It will be a data, data that is announced to the world today in this sense”
Minister Koca said that these results are the first data, the first data announced in the world about the vaccine.
Expressing that the world and China will use this data as a state, Koca said: “The protection of the vaccine will increase by 91.25 percent in this initial period. Because it was a situation that we normally think to explain when there are 40 infected people.” Therefore, this work will continue until the period when 40 people are infected. We can say that this result will increase even more ”. I speak.
Stating that some of those who volunteered for the vaccination studies received a placebo and some were vaccinated, Koca said:
“29 people were infected. 26 of 29 people were not vaccinated, 3 people were vaccinated. These 3 people were health workers, that is, the risk group. We know that there are no other vaccines that include the risk group in these studies. We see that it is a very mild condition without fever or respiratory problems, without lung involvement. In summary, we can easily say that these 3 people had a very mild illness despite being risky and vaccinated. In the next few days, we will be able to raise this picture more clearly.
Therefore, it can be said that we can use the vaccine very easily because the safe area is high, more than 50 percent. This will be a data, data that today is announced to the world in this sense. It will be the first data on the Chinese vaccine, I say about Sinovac. We believe this data will likely be used from now on with respect to usage. “
