The Kingdom of Bahrain today approved the emergency use of the Sputnik V vaccine, produced by the Jamalaya National Center for Epidemiological and Microbiology Research of the Ministry of Health of the Russian Federation.
The decision to authorize the Sputnik V vaccine was based on data provided by the manufacturing company, results of an expanded study, and a process of review and evaluation of effectiveness of data conducted by the Kingdom’s National Health Regulatory Authority (NHRA).
The NHRA also reviewed and evaluated the safety of the vaccine, demonstrated by clinical trials and studies, as well as verified the quality of the vaccine by reviewing scientific data showing the quality of manufacturing and the stability of the product.
Additionally, the stages of manufacturing and the manufacturer’s commitment to applying the principles of good pharmaceutical manufacturing (GMP) were verified according to international standards in the pharmaceutical industry and requirements issued by the authority.
The NHRA also took the opinion of the Clinical Research Committee, made up of consultants from a group of academics and physicians responsible for approving clinical trials.
After presenting the technical and scientific data, the Authority took the decision to approve the emergency use authorization of the vaccine and allow its use in the Kingdom.
The Authority stated that based on the approval issued today, the Ministry of Health will start import procedures according to current standards and requirements.
The Sputnik V vaccine becomes the fourth emergency use of a COVID-19 vaccine approved in Bahrain, following the approval of vaccines from Sinopharm, Pfizer/Biontech, and Oxford-AstraZeneca, with citizens and residents free to choose which vaccine they wish to receive, free of charge.