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Al-Marsad Journal – SPA: The Food and Drug Authority announced today (Thursday) 25 Rabi` Al-Akhir 1442 AH corresponding to December 10, 2020 AD, its approval to register the vaccine against the coronavirus “Pfizer-BioNTech” ( Pfizer-BioNTech COVID-19 vaccine) in the Kingdom of Saudi Arabia, after Pfizer submitted an application for approval for its registration, so that health authorities in the Kingdom can then import and use the vaccine.
The decision to approve the approval of the vaccine and to authorize its use came on the basis of data provided by the company “Pfizer” on November 24, 2020 AD. As soon as the requirements were met, the authority began to review and evaluate the registration dossiers in several aspects, including the evaluation of the efficacy of the vaccine and the safety data illustrated by it. Clinical trials and studies, as well as verifying the quality of the vaccine by reviewing scientific data that shows the build quality and stability of the product, in addition to verifying the manufacturing steps and the manufacturer’s commitment to apply the principles of good manufacturing pharmaceutical (BPF) according to international standards in the pharmaceutical industry.
The authority held several meetings to review the data provided by the company, which included meetings with local and international experts and scientists, in addition to meeting with the manufacturer and their representatives to respond to inquiries submitted by the authority, and the opinion of the Scientific Advisory Team for Infectious Diseases from the Scientific Advisory Committee for Clinical Studies was also taken.
According to the system of pharmaceutical and herbal facilities and preparations, the registration committee of pharmaceutical companies and factories and their products held a meeting to study the scientific data and reports, and after presenting and discussing the matter in all its technical and scientific aspects, the committee decided to approve the registration of the vaccine and allow its use.
On the date of arrival of the vaccine and the start of its use, the authority clarified that based on the approval issued today, the relevant health authorities will begin import procedures in accordance with the standards and requirements of this regard, and the authority will analyze the samples of each incoming shipment of the vaccine before use to ensure its quality, and the Ministry of Health will announce the arrival date of the vaccine. And start using it after fulfilling the import conditions.
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