Bahrain has approved the Oxford-AstraZeneca COVID-19 vaccine manufactured at the Serum Institute of India (SII) for emergency use, state news agency BNA reported on Monday, citing the country’s National Health Regulatory Authority.
The vaccine is the third to be approved by Bahrain for emergency use following SinoPharma and Pfizer and Biontech.
Monday’s announced approval was based on the study carried out by the National Health Regulatory Authority with the participation of NHRA’s Clinical Research Committee and the Ministry of Health’s Immunization Committee.
The study considered data from AstraZeneca about the results of studies on the vaccine conducted in several countries, immunity data and the manufacturing data provided by SII to prove the process complies with international standards.
NHRA Chief Executive Officer Dr. Mariam Adhbi Al Jalahma said an in-depth study of all the data submitted by IIS, including the quality of manufacturing and the results of the immunity study had been conducted.
She pointed out that NHRA approved the emergency use in coordination with the manufacturer because it applies to many procedures for controlling the quality, safety and effectiveness of the vaccine.
They include use within a range determined by the health authorities in Bahrain, deciding the numbers of target groups, the dose and the vaccination system, and providing information supporting safety, efficiency and manufacturing.