TMA-19 Covidien Announces Emergency vaccination in Turkey Terms of Use

Officials of the Turkish Medical Association Monitoring Committee, stating that the "Regulation on the Amendment of the Registration Regulation for Medicinal Products for Human Use" has been published in the Official Gazette today (18.12.2020), the "Emergency Use Approval" for the amendment vaccines and in article 10 / A For vaccines for which comprehensive data on efficacy, safety and quality have not yet been provided, the Emergency Use Approval (ECHO) is given until this data is available. We find this arrangement very sensitive and important. We particularly emphasize that AKO is not actually a license ”.

"We would like to share our strong reservation with the public with our approach that prioritizes scientific care and public health," said the officials and stated that they found it necessary to provide the following conditions in order for a vaccine to be given Emergency Use Approval. TTB explained the required conditions as follows,

• The Phase1, Phase2 and Phase3 studies of the vaccine must be published as a scientific report and publicly accessible,
• These reports should prove that the vaccine is "safe" and "effective", and if it has been evaluated by the Scientific Committee, the result should be shared with the public quickly,
• All information of the production process related to the vaccine, including quality assurance and data -if if / completed if the country belongs to our study results özellikle- Turkey drug should be given to the Medical Devices Institution, must not ignore the usual examinations reasons, such as when the narrow absence or urgency and should be done in all circumstances,
• Turkey Pharmaceuticals Medical Devices Agency vaccine "Emergency Use Authorization" competent pharmacology in the subject to give, immunology, virology, microbiology, infectious diseases, public health and consisting of epidemiologists and no conflict of interest should establish a committee composed of scientists who are not concerned,
• Prior to the decision process, Turkey Pharmaceuticals and Medical Devices Agency by all the information data should be disclosed to the public (as was done by the US Food and Drug Administration)
• The board meeting must be publicly available online (again in the USA by the Food and Drug Administration).

Vaccination is very important on our way out of the COVID-19 pandemic. Regulations and practices that may shake the trust of the society regarding vaccines that we can use against the disease and cause vaccination hesitation should be avoided and transparency should be prioritized.

Source: BSHA