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Bahrain authorizes emergency use of ‘Sputnik Light’ single-dose vaccine

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Bahrain approved the new single-dose Sputnik Light vaccine for emergency use. Sputnik Light vaccine is the sixth vaccine approved in the kingdom for emergency use, following Sinopharm, Pfizer-BioNTech, AstraZeneca, Johnson and Sputnik V.

This vaccine is produced by the Gamaleya National Center for Epidemiological and Microbiology Research, at the Ministry of Health of the Russian Federation.

The decision to approve the new Sputnik vaccine and allow its use was based on the thorough analysis data provided by the manufacturing company.

On receipt of the vaccine files and the results of the expanded study, the National Health Regulatory Authority (NHRA) undertook a review and evaluation process, including the evaluation of efficacy data, safety throughout the clinical trials and vaccine manufacturing quality and product stability, noting the manufacturer’s commitment to applying the principles of good pharmaceutical manufacturing (GMP) according to international standards.

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The NHRA also took the opinion of the Clinical Research Committee, academics and physicians responsible for approving clinical trials.

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Following approval by the Immunization Committee at the Ministry of Health, who considered technical and scientific data, the NHRA took the decision to approve the Sputnik light vaccine for emergency use.

The new Sputnik Light vaccine uses the first dose of the previously approved Sputnik V vaccine, with a high efficacy level and proven effectiveness against all new strains of COVID-19, evident during laboratory testing at the Gamaleya National Centre.

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The NHRA confirmed that based on the approval issued today, the Ministry of Health will commence import procedures.

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BNA

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