Today.Az » World news » Turkey’s coronavirus vaccine awaits final approval
02 December 2021 [16:35] - Today.Az
By Vugar Khalilov
Turkey’s coronavirus vaccine Turkovac is in the final stage of approval for mass production, Yeni Shafak has reported.
The domestic inactivated vaccine developed during the pandemic successfully passed the phase studies and was sent to the Turkish Medicines and Medical Devices Agency (TMMDA) laboratories in late November for emergency use approval, the report added.
The infrastructure has been created for the serial production of Turkovac at two facilities and following the mass production, the vaccines will undergo another 14-day test and be released to the market.
Taking into account the approval process of Biontech and Sinovac, a permit is expected to be issued for Turkovac’s immediate use in mid-December. Along with the phase studies, infrastructure works for mass production have also been carried out. The production capability of the facilities has been inspected and the relevant certification has been provided.
Furthermore, a second facility has been established for the mass production of the vaccine, which will start following the immediate use approval. Each of the vaccines will have a usage barcode and samples taken after mass production will be sent to TMMDA laboratories for analysis.
The analysis of the samples will be carried out in line with the routine quality control processes applied all over the world. As a result of the analysis, the expected quality, efficacy, and reliability of the vaccine will be checked under the required conditions. In this phase, the vaccine will undergo at least 14 days of testing as well and after the positive results, it will be released to the market.
Like Sinovac, the inactivated Turkovac vaccine was developed by Erciyes University in cooperation with the Turkish Health Institutions (TUSEB). The first study phase of the vaccine started in November 2020, and the second phase in February 2021. Vaccination of volunteers in Phase-2 studies was completed in April. Within the scope of third phase clinical studies, volunteers were vaccinated in June and Phase-3 studies were completed in November.