‘Sinovac’ will be used instead of ‘placebo’ in Phase-3 phase of the domestic vaccine


gave | Monday, May 17, 2021 – 17:11 | Last Updated: 17 05 2021 – 17:11

Among the domestic vaccines developed against coronavirus in Turkey, the Sinovac vaccine will be used instead of placebo (empty vaccine) in the Phase-3 phase of the Covid-19 vaccine, which was the first to start human trials and completed Phase-1 and Phase-2. Thus, in addition to the effectiveness of the domestic vaccine developed by Kayseri Erciyes University (ERU) against coronavirus, its protection compared to the Chinese vaccine will be compared.

Phase-1 study of Covid-19 domestic vaccine developed against coronavirus by the Vaccine Research and Development Center (ERAGEM) and Good Clinical Practice and Research Center (IKUM) under ERU and supported by the Ministry of Health and the Presidency of Turkish Health Institutes (TÜSEB), was conducted on 44 volunteers. done. The Phase-2 study of the inactive vaccine, which started in February, was completed on April 9. In the reporting of Phase-2, which was conducted on 250 volunteers, the final stage was reached. Phase-3 study of the domestic vaccine is planned to begin at the end of this month.

SINOVAC WILL BE USED

In the Phase-3 phase of the domestic vaccine, some of the volunteers will use China’s Sinovac vaccine, which is widely used in Turkey, instead of plosebo. Some of the people in the similar group who will volunteer in the study will be given the local vaccine and the Sinovac vaccine will be applied to some. Thus, in addition to the effectiveness of the domestic vaccine, its protection against the inactive Sinovac vaccine will be compared. At the same time, everyone who volunteers in the Phase-3 phase will be vaccinated.

‘AN ACCEPTABLE METHOD’

Head of the Division of Pediatric Infectious Diseases, Hacettepe University Faculty of Medicine. Dr. Mehmet Ceyhan evaluated this decision of the Ministry of Health to DHA. Noting that this work is a normal thing, Prof. Dr. Ceyhan said, “We are making an inactive vaccine similar to Sinovac. It is an acceptable method to compare it with another inactivated vaccine. You can even give Biontech vaccine to a group if you have the vaccine. You have to use tens of thousands of cases in phase-3 studies, 30-40 for each group. “You need to apply a thousand vaccines. A decrease in the number of cases reduces its reliability,” he said.

‘IF I WERE IT, I WILL COMPARE IT WITH THE FIRST PLASEBO’

Prof. Dr. On the other hand, Ceyhan emphasized that his personal opinion is that a newly released vaccine should be compared with a placebo, “So you have developed a vaccine and it will be used for the first time. Here you need to prove whether this vaccine is effective. We prefer studies because its efficacy is unknown. However, after using it for a while, if we wonder ‘Sinovac is it effective or effective, whether there is a difference in effect’, we will make a study by comparing it with Sinovac. It can be compared with another vaccine after starting use and obtaining a license. It is not very correct to do the Phase-3 study with Sinovac, saying ‘Let’s find answers to two questions at the same time.’

‘NOT ENOUGH’

Prof. Dr. Ceyhan stated that in order to determine the effectiveness rate of the vaccine produced and to determine which vaccine is more effective, 3 groups can be formed as placebo, Sinovac and local vaccine group. Ceyhan said, “In order for the results to be reliable, there should be more than 100 thousand volunteers.” Prof. Dr. Ceyhan noted that if there is a target to start mass production of the local vaccine and sell it to other countries, the researches with Sinovac will not be sufficient.

It was stated that the domestic vaccine will start to be widely used after the Phase-3 phase is completed, with emergency use approval as in autumn.