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The decision to authorize the vaccine to register and authorize its use came based on data provided by Pfizer on November 24, 2020, as the first vaccine approved by Saudi Arabia and then the Kingdom’s health authorities. were able to import and use the vaccine.
The Saudi Commission said that the processes for reviewing and evaluating the registration dossiers included evaluating the efficacy and safety data of the vaccine, which has been demonstrated through clinical trials and studies, as well as the verification of vaccine quality by examining scientific data that shows the quality of manufacture and stability of the product, in addition to verifying the steps of manufacture and the plant’s commitment to apply the principles of manufacture. Good medicine (GMPAccording to international pharmaceutical industry standards, according to the Saudi press agency, “SPA”.
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.
Regarding when the vaccine will arrive and start using it, the authority clarified that, based on the approval issued on Thursday, the relevant health authorities will begin import procedures in accordance with the standards and requirements to this regard, and the authority will analyze the samples of each incoming shipment of the vaccine before using it to ensure its quality, and the Ministry of Health will announce the date. Arrival and start of vaccine use after import requirements have been met.
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