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The Saudi Food and Drug Authority (SFDA) announced the approval of the registration of the Pfizer-BioNTech Corona virus Vaccine for the emerging corona virus, to be the first vaccine registered in Saudi Arabia.
The approval came after Pfizer submitted the request for approval of its registration. 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 it available for use was based on the data provided by Pfizer on November 24th, 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 demonstrated 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, 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 send out from the Scientific Advisory Committee for Clinical Studies was also taken.
– According to the law 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.
– Regarding the date of arrival and use of the vaccine, 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.
Source: Saudi Expatriates