SFDA approves registration of Pfizer-BioNTech COVID-19 vaccine

The Saudi Food and Drug Authority (SFDA) approved today, Dec. 10 registration of the Pfizer-BioNTech COVID-19 vaccine in the Kingdom.

The US firm Pfizer applied to register the new vaccine, to allow the Saudi health authorities to import and use the new medication.

The approval was based on the data provided by Pfizer on November 24, 2020.

Upon completion of all requirements, SFDA reviewed the registration documents from several aspects, including evaluating the data on the vaccine's efficacy and safety.

SFDA also verified the quality of the vaccine by reviewing scientific data on the quality of manufacturing and the stability of the product, in addition to verifying the manufacturer's commitment to principles of good manufacturing practice, in accordance with international standards in the pharmaceutical industry.

To study the data provided by the US firm, the authority also held a number of meetings, including with local and international experts and scientists, and with the manufacturer and its representatives.

SFDA also sought the opinion of the scientific advisory team for infectious diseases, which is affiliated to the scientific advisory committee for clinical studies.

In accordance with the Pharmaceutical and Herbal Facilities and Preparations Law, the committee for the registration of pharmaceutical companies and factories and their products held a meeting to study the scientific data and reports, and after reviewing all technical and scientific aspects, it decided to approve the registration of the vaccine and allow its use in the Kingdom.

Following the approval, the competent health authorities will start the import procedures, in accordance with the related standards and requirements, SFDA said.

Samples from each inbound shipment of the vaccine will be tested prior to use to ensure its quality, it added.

The Ministry of Health will announce the date of the vaccine's arrival and the start of its use after completing import requirements.