The curious Phase-3 study results of TURKOVAC, which was approved for emergency use in the past few days and started to be administered as the third dose, have been announced.
Vaccination against the coronavirus, which Turkey has been fighting since March 2020, continues all over the world and in our country. While domestic vaccine studies against coronavirus have been going on for a long time, it has been developed by Erciyes University in the past weeks. TURKOVACIt had been approved for immediate use. TURKOVAC is currently as the third dose It can be applied to any citizen who wishes.
Today, the results of the highly anticipated Phase-3 study of the TURKOVAC vaccine are shared. Hacettepe University Prof. Dr. Serhat Unal and Prof. Dr. Mine Durusu Tanrıöver, at the press conference in Ankara, the TURKOVAC vaccine In the statements regarding the results of the phase-3 studies found. Phase-3 results of the vaccine have also been announced.
TURKOVAC’s follow-up period is 108 days:
prof. Dr. Ünal explained that the vaccine used for comparison in Phase-3 studies of the TURKOVAC vaccine is CoronaVac (Sinovac), as it is an inactivated vaccine in the same way as TURKOVAC. Ünal stated that the follow-up period, which was 43 days in CoronaVac, was 108 days in TURKOVAC. team, then Conclusions on the last assessment on 27 December They started to share. prof. Dr. Ünal continued his words as follows:
“Our benchmark product is both due to inactivated vaccine CoronaVac. It was decided to compare it with this vaccine. On one side there are CoronaVac values, on the other hand there are TURKOVAC values. The period when CoronaVac was developed was when the virus was at its prime. In the TURKOVAC period, there were many variants such as delta. In the Coronavac era, there was no vaccine. During the TURKOVAC era, there were many vaccine opportunities.
Our follow-up period at TURKOVAC is 108 days. It has been studied more closely and for a long time. On August 4, we reached 400 volunteers. An interim security analysis was conducted on 21 October. The ethics committee specifically requested this. Despite reaching the end point, on November 23, 2021, the sponsor of the study, the Presidency of Turkish Health Institutes (TÜSEB), requested the results up to that date be reported in a letter. On December 22, 2021, it was decided that TURKOVAC should receive an emergency use approval. We started our review again.”
prof. Dr. Mine Durusu Tanrıöver: We conducted research on 182 volunteers
“We had a group of volunteers who didn’t have any disease. Half of the applicants to us were referred to the CoronaVac arm and half to the Turkovac arm. When we recruited the first volunteer, the number of cases was 6 thousand, and when we made the first trial, it was 26 thousand. There was more than 4 times the increase in cases. Incidence values increased because of this. We will share the findings of the volunteers from June 22 to December 27.
Within the scope of the study, we administered one dose of research vaccine to 1286 people. CoronaVac and TURKOVAC We vaccinated 2444 people, including. When excluding those who do not follow the protocol We conducted research on 1182 volunteers.. Istanbul Çam and Sakura Hospital provided the most volunteers. Ankara City Hospital and Hacettepe also followed this hospital. That’s how the first three were. We analyzed our CoronaVac and TURKOVAC volunteers separately to do our analysis.”
Out of 1008 people, 69 were diagnosed with COVID-19, 23 were volunteers with the TURKOVAC vaccine:
“Our total follow-up period is 108 days. Our primary point was patients who had coronavirus after 14 days. Our follow-up period of 14 days after the second dose was also calculated. This was 69 days. I can say that we have a rather long study period compared to the Coronovac study period. We identified 69 cases of COVID-19 out of 1008 people whose activity we analyzed. 23 of these were in the TURKOVAC arm. The rate of corona in TURKOVAC was determined as 4.55 percent.”
Side effects are more than CoronaVac:
“Almost half of those diagnosed with COVID-19 do not report symptoms or do not experience serious illness despite reporting symptoms. There were only three patients hospitalized. These were also caught before the protection period of the vaccine. We follow our safety data as expected and unexpected ones separately. We found that the expected side effects in the TURKOVAC arm were slightly higher than in CoronaVac.
We stage side effects. We are looking at whether it has caused damage or loss of function in the person. The stage-3 effect occurred in one person. It’s also a case of nausea and vomiting. CoronaVac happened on your arm. We can say that there is pain at the injection site. Nothing serious happened with either vaccine. TURKOVAC is at least as effective and safe as CoronaVac. Our studies and researches continue.”