The process of evaluating and researching the Turkish-developed inactivated coronavirus vaccine Turkovac before approval for emergency use is expected to take at least three weeks.
Health Minister Fahrettin Koca said Thursday that an application for approval of the emergency use of Turkovac has already been sent to the Turkish Agency for Medicines and Medical Devices (TITCK).
If the use of the vaccine is approved, the serial production of the drug will begin. According to the Ministry of Health, the serial production of Turkovac will be carried out at two enterprises in Turkey.
1. When did the research of the domestic vaccine begin?
The Turkovac vaccine was developed by scientists from Erciyes University in collaboration with the Turkish Institutes of Health Administration (TÜSEB) under the Turkish Ministry of Health.
The first phase of research started on November 5, 2020. The study involved 44 volunteers, whose first dose was administered on February 10. In the second phase of the study, the vaccine was administered to 250 volunteers. Both phases gave positive results.
The third phase of the vaccine study, which involves administering the drug to more volunteers, began on June 22nd. It was attended by thousands of volunteers both domestically and internationally. The vaccine is administered to people who have not previously had a coronavirus and have never been vaccinated.
2. Why is the Turkovac clinical trial important?
Turkovac is the most comprehensive vaccine development project in Turkey with 8 simultaneous clinical trials.
In October, the last clinical trial was conducted, in which volunteers were given a booster dose of the vaccine. The process covered 41 hospitals in 28 provinces of Turkey.
The study involved persons aged 18-59 who had not previously had a coronavirus and were vaccinated with two doses of Sinovac vaccine. Half of the volunteers received the Turkovac vaccine as a booster dose, and the other volunteers received the Sinovac vaccine.
Clinical trials supported by TÜSEB are nearing completion. The results will be announced shortly.
3. How is the emergency application and assessment process going?
The authorization for the use of a vaccine in an emergency is issued by an authorized body. Thus, the drug is allowed to be used against diseases recognized by WHO and the Ministry of Health as infectious and posing a serious threat to public health.
In Turkey, vaccines receive TITCK approval following a study conducted in accordance with the Emergency Application and Evaluation Guidelines.
4. Is Turkovac effective against new strains?
Research is ongoing to determine the effectiveness of the domestic Turkovac vaccine against various strains of coronavirus.
The vaccine has been found to be 100 percent effective against the alpha strain, and research on the delta strain is ongoing.
5. Does Turkovac have any side effects?
Turkovac’s developments are carried out in accordance with global standards for inactivated vaccines GLP, GMP and GCP. To date, no serious side effects have been reported in the volunteers.