Saudi Arabia: The Food and Drug Authority Approves The Tegistration of The Coronavirus Vaccine “Pfizer-Biontec”

The Food and Drug Authority announced today that it has approved the registration of the “Pfizer-BioNTech” Corona virus (Pfizer-BioNTech COVID-19 Vaccine) in the Kingdom of Saudi Arabia, after the company “Pfizer” submitted To request approval for its registration, so that the health authorities in the Kingdom can then import the vaccine and use it.

The authority said that the decision to approve the registration of the vaccine and make its use available was based on the data provided by the company, “Pfizer” on November 24, 2020 AD. As soon as the requirements are completed, the authority began reviewing and evaluating the registration files from several aspects, including evaluating the data on the effectiveness and safety of the vaccine. As shown by 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.

It indicated that it had 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 studies was taken.

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