Google Translation of SFDA’s Arabic Announcement
The Food and Drug Administration allows the import and use of the “AstraZeneca” vaccine for Coronavirus
Today, Thursday, February 18, 2021 AD, corresponding to Rajab 6, 1442 AH, the Food and Drug Authority authorized the use of the British company “AstraZeneca” anti-corona virus (Covid-19) vaccine, which was developed by the company in cooperation with the University of Oxford. It was submitted to it and which has been reviewed in all its details according to an accurate scientific methodology, and accordingly the health authorities in the Kingdom will start the procedures for using the “AstraZeneca” vaccine in accordance with the standards and requirements for this. The Authority will also analyze samples from each incoming shipment of the vaccine before using it.
The “authority” indicated that it is working according to a scientific mechanism to approve the use of vaccines as it studies the safety, effectiveness and quality of vaccines through clinical trials and studies, and scientific data that show the quality of manufacturing and product stability, in addition to verifying the stages of manufacturing and the factory’s commitment to applying the principles of good pharmaceutical manufacturing (GMP). According to international standards in the pharmaceutical industry, as the authority’s procedures included holding several meetings with experts and specialized scientists – local and international – to take their views, in addition to meeting with the manufacturer and its representatives to answer the inquiries submitted by the Authority and the scientific advisory team for infectious diseases emanating from the advisory committee Scientific Clinical Studies.
Note that the “authority” has developed a special path for registering the new Corona vaccines that depends on the principle of presenting the ready parts of the files first, and they are reviewed immediately until the file data is completed, because some vaccines are still in the stages of clinical studies and their data has not been completed, and this mechanism Speed up the process of approval and entry of vaccines into the Kingdom, and the authority assures that if any other vaccine is approved, it will be announced in a timely manner.