CLINICAL PHASE STUDIES OF VLP AND INACTIVE VACCINES CONTINUE SUCCESSFULLY

TÜBİTAK Marmara Research Center (MAM) Genetic Engineering and Biotechnology Institute (GMBE) Director and Turkish COVID-19 Platform Coordinator Prof. Şaban TEKİN gave an interview to A News and made important explanations about the vaccine and drug development studies conducted by the Platform under the coordination of TÜBİTAK MAM GMBE.

Stating that 7 different national vaccine studies are conducted against the virus and 2 of the vaccines are expected to be ready for use by November-December, TÜBİTAK MAM GMBE Director Prof. Şaban Tekin added “The studies for developing national vaccines under the Turkish Covid-19 Platform are coordinated by TÜBİTAK MAM GMBE. We have 7 vaccine candidates. 1 of them, which is a VLP, has completed the Phase-1. The Phase-2 will start in the first week of June, and then we will proceed to the Phase-3. In another inactivated vaccine study conducted by Prof. Osman Erganiş, we keep working on the Phase-1 studies, and the clinical studies continue at Ankara City Hospital. As soon as this phase is completed, necessary actions will be taken for the Phase-2. In our third vaccine, which is an Adenoviral-based Covid-19 vaccine, Phase-1 and Phase-2 productions were made in the GMP environment. We have submitted our application on this to Turkish Medicines and Medical Devices Agency (TİTCK). As soon as we get the approval, Phase-1 studies will start.”

TÜBİTAK MAM GMBE Director Prof. Şaban TEKİN stated that, on TÜBİTAK’s part, the vaccine closest to use is the VLP vaccine developed by METU-BİLKENT team which is prepared at Nobel facilities by Prof. Mayda Gürsel, that it is about to pass to Phase-2, and that it is possible to get emergency use authorization towards the end of the year depending on the consent of Turkish Medicines and Medical Devices Agency (TİTCK).

Reminding that there are vaccine studies other than that of TÜBİTAK and giving information about the study of Erciyes University, Prof. Şaban Tekin said, "As no publication is available at the moment, we are not sure, but we hear that the Phase-2 of the vaccine study by Erciyes University is complete. Phase-3 studies will start in June. Of course, it is possible also for them to get emergency use approval in this year. I can say that currently these 2 vaccines are actively studied and have the possibility to get into use within the year. If we do not encounter any problems in these studies and the production process, at least 2 vaccines may be ready in Turkey in the worst case.” 

TÜBİTAK MAM GMBE Director Prof. Şaban TEKİN added “When we started these studies under Turkish COVID-19 Platform, unfortunately there was no vaccine production in Turkey, neither in terms of facilities, nor in terms of human vaccine production, except veterinary products. Teams were conducting studies in a disorganized way in their own laboratories. R&D studies had been conducted, however, unfortunately, previous vaccine making capabilities had been lost. We have revitalized these capabilities, brought together these teams and allowed the creation of 7 vaccine projects under this platform. We set out with the motto to co-achieve and co-develop with a stunning effort. We emphasized the importance of achieving together. We have figured out that it is really possible. Because our platform allows working on the basis of mutual cooperation. The whole platform is coordinated by TÜBİTAK MAM GMBE. We provide all kinds of support to these teams. When they request, we provide purchasing support, supply support, experimental challenge essays, neutralizing essays, etc. Besides, we allow them to use our laboratories when they need. Both companies and teams can come to our facilities and make use of them as they wish. Thanks to the solidarity created, the teams not only worked here, but also opened their labs to each other, helped each other and brought about a great collaboration. Platform structure worked well and we think that it can be used also in future TÜBİTAK projects, because the platform model attracted attention both from Turkey and foreign countries, and we provided information on it. Consequently, we achieve and develop together. There is a great effort from each participant; we have 436 research specialists from various institutions, universities, companies and public research centers, and more than 200 of them are young researchers spending a great deal of effort. Along with the ongoing studies, a significant capacity has been created. Our academics and teams will hopefully produce the vaccines that might be needed by Turkey in the future. Turkish government also gives significant supports in this field. In this regard, we establish a vaccine production center here.”

Stating that the all national vaccines are produced under the control of Turkish Medicines and Medical Devices Agency (TİTCK) at GMP conditions in maximum hygienic and comfortable environments, Prof. Şaban TEKİN said that national vaccine studies follow the same, or even more meticulous pathways as the World Health Organization, that the studies are investigated by TİTCK, and that the progress of the studies are determined depending on these investigations.

Click here to access the interview video.

 

 

01.06.2021
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