SAUDI ARABIA

SFDA approves Moderna COVID-19 vaccine for use in Kingdom

July 09, 2021
The Saudi Food and Drug Authority (SFDA) announced on Friday that the nod was given after the US-based pharmaceutical company submitted a request for approval and registration in the Kingdom.
The Saudi Food and Drug Authority (SFDA) announced on Friday that the nod was given after the US-based pharmaceutical company submitted a request for approval and registration in the Kingdom.

Saudi Gazette report

RIYADH — Saudi Arabia has approved the Moderna coronavirus vaccine for emergency use, making it the fourth jab to be administered in the Kingdom along with Pfizer-BioNTech, Oxford-AstraZeneca and Johnson & Johnson.

In a statement on Friday carried by the Saudi Press Agency, the Saudi Food and Drug Authority (SFDA) announced that the nod was given after the US-based pharmaceutical company submitted a request for approval and registration in the Kingdom.

The decision to approve the registration and allow the use of the vaccine was made based on the data provided by the company, the statement added.

Once the requirements were completed, the authority began reviewing and evaluating the registration files from several aspects, including evaluating the effectiveness and safety data shown in pre-clinical trials and clinical studies, the SFDA said.

It also verified the quality of the vaccine by reviewing the scientific data that shows the quality of manufacturing and product stability in addition to verifying the manufacturing stages and the factories’ commitment to applying the principles of good pharmaceutical manufacturing (GMP) according to international standards in the pharmaceutical industry.


July 09, 2021
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