SFDA ratifies registration of AstraZeneca COVID-19 vaccine

Logo of Saudi Food and Drug Authority

The Saudi Food and Drug Authority (SFDA) authorized today, Feb. 18, 2021, the use of the British AstraZeneca's COVID-19 vaccine, developed in cooperation with the University of Oxford.

The decision was taken based on the data provided to permit importing and using the vaccine, which has been reviewed in details according to an accurate scientific methodology, the authority said in a statement.

Accordingly, the health authorities will conduct the procedures of using the AstraZeneca vaccine as per the standards and requirements set for its use. It will also analyze samples from each incoming shipment of the vaccine before use.

SFDA follows a scientific mechanism to approve vaccines' use, as it studies the safety, efficacy, and quality of vaccines through clinical trials and studies.

It accesses the scientific data that shows the manufacturing quality and product stability, in addition to verifying the manufacturing stages and the factory's commitment to applying good manufacturing practice (GMP) as per international standards in the pharmaceutical industry.

The authority held several meetings with experts and specialized scientists - local and international - to take their views.

It also met with the manufacturer and its representatives to seek answers on the inquiries submitted by SFDA and the scientific advisory team for infectious diseases emanating from the scientific advisory committee for clinical studies.

SFDA created a special pathway to register the new coronavirus vaccines, based on presenting the ready-made parts of the files first that are reviewed immediately until the rest of file data is completed.

This is because some vaccines are still in the clinical studies phase and their data has not been completed. Thus, this mechanism speeds up the approval process and entry of vaccines into the Kingdom.

The authority confirmed that it would be announced in a timely manner if any other vaccine is approved.

According to the data compiled by Argaam, this is the second vaccine approved by SFDA, after it agreed last December to register the Pfizer-BioNTech vaccine in Saudi Arabia.