7,400 Volunteers to Be Selected for Domestic Vaccine

7,400 Volunteers Selected for Domestic Vaccine 7,400 volunteers to be selected for TURKOVAC booster dose study Ankara City Hospital General Hospital Director Assoc. Prof. İhsan Ateş: - "We will include approximately 7,400 volunteers in the study, consisting of 3,700 TURKOVAC and 3,700 CoronaVac volunteers" "As of now, we have identified that over 100 volunteers meet the criteria for inclusion in the study and we have begun vaccinating" "In our Phase 2-B double-blind randomized controlled study conducted with CoronaVac, our TURKOVAC vaccine was found to be safe and we have positive data on efficacy" ANKARA (AA) - Ankara City Hospital General Hospital Director Assoc. Prof. İhsan Ateş announced that 7,400 volunteers will participate in the booster dose study of the domestic COVID-19 vaccine TURKOVAC. Speaking to media representatives at Ankara City Hospital, Ateş said the open-label booster dose study of TURKOVAC began at the start of the week. Explaining that they moved to active work following Health Minister Fahrettin Koca's announcement on social media yesterday, Ateş said, "This study is a booster dose study for volunteers who have previously received two doses of Sinovac, 90 days have passed since vaccination, and who have not had a COVID-19 infection. The distinctive feature of this study is that it is Phase 3-A, which we call open-label. That means volunteers meeting the eligibility criteria will choose their vaccine. We administer TURKOVAC to volunteers who want it and Sinovac to those who want that." he shared. Stating that approximately 7,400 volunteers will participate in the booster dose study, with 3,700 receiving CoronaVac and 3,700 receiving TURKOVAC, Ateş said, "We began enrolling volunteers yesterday. We have received a large number of volunteer applications. We have now begun selecting volunteers according to the eligibility criteria. As of now, we have identified that over 100 volunteers meet the criteria for inclusion in the study and we have begun vaccinating." he said. Mentioning that work has begun at 41 centers, Ateş said, "We will conduct our Phase 3-A study at 41 centers in our major cities: Ankara, Istanbul, Izmir, Adana, Gaziantep and Bursa."

"We have positive data on efficacy"

Responding to the question "Is there a report on the protective efficacy of TURKOVAC from ongoing studies?", Ateş answered as follows: "Before this study, we conducted Phase 2 and a booster dose study. As mentioned earlier, we planned and completed a double-blind randomized controlled study on 111 TURKOVAC and 111 CoronaVac volunteers. As of yesterday, we obtained our efficacy data by examining the antibody levels of the last volunteer in the first month. Following positive safety and efficacy data from this Phase 2-B study, we started our Phase 3-A study. We can share this good news: in our Phase 2-B double-blind randomized controlled study conducted with CoronaVac, our TURKOVAC vaccine was found to be safe and we have positive data on efficacy." In response to the question "Is TURKOVAC more effective than Sinovac?", Ateş said, "Since it is a comparison vaccine, we examined neutralizing antibodies against Delta, Alpha and the original Wuhan virus. We obtained much better results in some parameters and similar responses in some parameters." Regarding the question "When will TURKOVAC receive Emergency Use Authorization? Can TURKOVAC be administered as a booster dose without Emergency Use Authorization?", Ateş pointed out that the vaccine is not currently in routine use and is being administered in Phase 3 clinical trials under the approval received from the Turkish Medicines and Medical Devices Agency (TİTCK). Prof. Dr. Ateş said that TURKOVAC's Emergency Use Authorization would be granted by the relevant committees after compliance with criteria established by the World Health Organization. Responding to the question "Can TURKOVAC be administered as a booster dose to those who have received two doses of BionTech vaccine?", Ateş said, "Probably within the next week or 10 days, we will also start our Phase 2 study examining the booster dose effect and safety of TURKOVAC against BionTech in the same manner. The sample size determined in that study is 111 cases, with at least 111 volunteers, and we will begin our booster dose study within 10 days for those who are more than 6 months past receiving 2 doses of BionTech, involving 150-200 volunteers." When it was recalled that Minister Koca had stated in yesterday's post "that at least 3,000 volunteers are needed for TURKOVAC", Ateş said, "This is a WHO criterion. If you obtain safety and efficacy data from 3,000 volunteers, you can put this vaccine into routine use with Emergency Use Authorization."

"We expect to enroll volunteers quickly"

Following the question "Haven't 3,000 volunteers been reached so far?", Ateş said the following: "Volunteers are currently being seriously enrolled. Since the previous study was a double-blind randomized study, we don't know how many of those enrolled received TURKOVAC and how many received CoronaVac. Since this study is open-label, conducted at 41 centers, and is accessible to volunteers across Turkey, we expect to enroll TURKOVAC volunteers quickly." In response to the question "When will TURKOVAC move to mass vaccination?", Ateş said, "According to our estimates, it appears we can reach 3,000 volunteers in a short time. Currently, our volunteers can make appointments through e-Nabız and ALO 184 across Turkey to participate in this study and vaccination." Ateş noted that following Minister Koca's post yesterday, there were approximately 7,000-8,000 volunteer applications, and their compliance with criteria was being evaluated.