First Vaccine Approved by the Saudi Food and Drug Authority

First Vaccine Approved by the Saudi Food and Drug Authority. Corresponding to December 10, 2020 AD, that it has approved the registration of the “Pfizer-BioNTech” Coronavirus ( Pfizer-BioNTech COVID-19 Vaccine ) in the Kingdom of Saudi Arabia after the company “Pfizer” submitted to request approval to register it so that the health authorities in the Kingdom can then import the vaccine and use it.

First Vaccine Approved by the Saudi Food and Drug Authority

The decision to approve the registration of the vaccine and to allow its use came based on the data provided by the company, “Pfizer” on November 24, 2020 AD. As soon as the requirements are completed, the authority began the process of reviewing and evaluating the registration files from several aspects, including the evaluation of the vaccine efficacy and safety data shown by it. Clinical trials and studies, as well as verifying the quality of the vaccine by reviewing 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.

Continue

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 the data and scientific reports, and after presenting and discussing the issue 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 starting to use it, 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 start using it after completing import requirements.