On (Thursday) December 10, 2020, the Food and Drug Authority announced its approval to register the Pfizer-BioNTech COVID-19 Vaccine vaccine in the Kingdom of Saudi Arabia, after Pfizer submitted a request for approval to register it. So that the health authorities in the Kingdom could then import and use the vaccine.
The decision of the authority’s approval of registering the vaccine and making its use available was based on the data provided by Pfizer on November 24, 2020, as the authority - upon completion of the requirements - began reviewing and evaluating the registration files from several aspects, including the evaluation of the vaccine efficacy and safety data illustrated by experiments and studies. Clinical, as well as verifying the quality of the vaccine by reviewing the scientific data that shows the quality of manufacturing and the stability of the product, in addition to verifying the manufacturing stages and the manufacturer's commitment to applying the principles of good pharmaceutical manufacturing (GMP) according to international standards in the pharmaceutical industry.
The authority held several meetings to study the data provided by the company, which included meetings with local and international experts and scientists, in addition to meeting with the manufacturer and its representatives to answer the inquiries submitted by the authority, and the opinion of the scientific advisory team for infectious diseases emanating from the Scientific Advisory Committee for Clinical Studies was also taken.
According to the system of pharmaceutical and herbal facilities and preparations, the committee for registering pharmaceutical companies and factories and their products held a meeting to study data and scientific reports, and after presenting the subject and discussing it 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 concerned health authorities will start import procedures according to the standards and requirements for this, and the authority will analyze samples from each incoming shipment of the vaccine before using it to ensure its quality, and the Ministry of Health will announce the date of the arrival of the vaccine and the start Use it after completing import requirements.