The decision comes following extensive research conducted by Bahrain’s National Health Regulatory Authority (NHRA) and the Immunization Committee at the Ministry of Health, which considered the results of clinical trials held in several countries as well as information shared by the Serum Institute of India, covering manufacturing processes and batch analyses, the official Bahrain news Agency (BNA) reported.
The authority has undertaken “comprehensive evaluation of the information submitted by the manufacturer”, including the quality and consistency of the vaccine as well as immune response results, said Dr Maryam Athbi Al-Jalahmah, CEO of the NHRA.
Data collected by Oxford-AstraZeneca shows a 70.42 per cent efficacy rate with minor side effects, such as headache, fatigue, chills, and injection site pain.
The manufacturer has also “undertaken rigorous randomised studies to uphold the high safety standards required by Bahrain”, which requires its testing on broad demographic groups, as well as collecting additional information on effectiveness, safety and efficacy data, added Al-Jalahmah.
The Serum Institute of India is also registered as a manufacturer of medicines and vaccines in Bahrain, and currently produces other key vaccines authorised by the World Health Organization, such as BCG, hepatitis, measles, polio and influenza vaccines.
“The rescheduling of the delivery of Pfizer–BioNTech vaccine shipments will not affect citizens and residents receiving the second dose of the vaccine over the upcoming period, according to current scheduled dates and the availability of the needed quantity for them,” the ministry of health said at the time.
The latest decision to approve Covishield is aimed at supporting Bahrain’s national efforts towards vaccinating vulnerable members of the public at risk of developing complications from the virus, including the elderly and people with chronic diseases, the BNA report added.