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Scientific Committee member Tezer said that the Sinovac vaccine has not yet been licensed in China and that Phase 3 studies have not been carried out as there is no disease in the country since May, and these data are necessary to obtain a license.
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Current
Member of the Scientific Committee of Coronavirus of the Ministry of Health and Specialist in Childhood Infectious Diseases of Gazi University, Prof. Dr. Hasan Tezer said that Phase 3 studies are needed for the vaccines to be authorized.
Stating that the efficacy of the vaccines was examined in phase 3 studies, Prof. Dr. Tezer said: “Last week, provisional data on the coronavirus vaccine originating from China were announced in our country. Within the scope of Interim data studies involving volunteers from the 18 to 59 age group, it was announced that the protection effectiveness of the vaccine was 91.25 percent. Studies continue. “It is an important piece of data for us to be above 90 percent. We know that there have been temporary approvals for Moderna, Pfizer / BioNTech, AstraZeneca vaccines around the world. “
‘700 THOUSAND DOSES APPLIED IN CHINA’
Prof. Dr. Tesis, Turkey is also related to the discussion about the safety of imported vaccine from China, said:
“We know that the coronavirus vaccine developed by the China-based company Sinovac was administered in China in approximately 700,000 doses. These were used in China subject to emergency use permits.
However, China is waiting for the data in our country with great care and curiosity. Because phase 3 studies cannot be done in China at the moment. Why is that? There have been no illnesses in China since May. A patient is needed to conduct a phase 3 study and obtain a license; but there is no coronavirus patient, Covid-19 circulation in China. In other words, patients must be able to get vaccinated and see how well the vaccine works. These vaccinated people need to contact. In this case, if they were vaccinated, they would be 100 percent effective.
There is no very precise data on such a thing. Therefore, since China is not sick in its own country, it is working in countries where the disease is intense. According to the results of these studies, it will be applied to your institutions for the license application. The vaccine has “emergency use permits.”
Phase 3 studies are required for licensing approval. China will also apply for license approvals, considering the results of studies outside its home country. If the results of the toxicological analysis to be carried out in the laboratories of the Ministry of Health are positive, the institutions of the Ministry of Health will approve the vaccine and the vaccines will be used. ” (DHA)
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