The National Health Regulatory Authority (NHRA) today granted approval for the Oxford/AstraZeneca COVID-19 vaccine, manufactured by the Serum Institute of India under the name ‘Covishield’.
The Oxford/AstraZeneca vaccine will support national efforts towards vaccinating vulnerable members of the public at risk of developing complications from COVID-19, including the elderly and people with chronic diseases, as well as other vulnerable groups identified by the Ministry of Health.
The decision comes following extensive research conducted by the NHRA in cooperation with the Clinical Research Committee at the NHRA and the Immunization Committee at the Ministry of Health, which considered the results of clinical trials held in several countries published by Oxford/AstraZeneca as well as information shared by the Serum Institute of India, covering manufacturing processes and batch analyses.
Dr. Maryam Athbi Al-Jalahmah, CEO of the NHRA, stated that the Authority has undertaken comprehensive evaluation of the information submitted by the manufacturer, Serum Institute of India, which included the quality and consistency of the vaccine as well as immune response results.
Dr. Al-Jalahmah went on to note that the manufacturer has undertaken rigorous randomised studies to uphold the high safety standards required by Bahrain, which requires its testing on broad demographic groups, in addition to collecting additional critical information on effectiveness, safety and efficacy data.
Data collected by Oxford/AstraZeneca shows a 70.42% efficacy rate with minor side effects, such as headache, fatigue, chills, and injection site pain.
‘Covishield’ from Oxford/AstraZeneca is the third vaccine to receive emergency authorization in Bahrain following Sinopharm and Pfizer-BioNTech.
It is worth noting that the Serum Institute of India is registered as a manufacturer of medicines and vaccines in the Kingdom of Bahrain, and currently produces other key vaccines authorized by the World Health Organization, such as BCG, hepatitis, measles, polio and influenza vaccines.