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Bahrain approves registration for Sinopharm COVID-19 vaccine
Published in The Saudi Gazette on 13 - 12 - 2020

The National Health Regulatory Authority (NHRA) on Sunday announced it has officially approved the registration of Sinopharm's COVID-19 vaccine after the submission of all related documentation by G42 Healthcare, the company's exclusive distributor in the Middle East and North Africa.
The NHRA's decision to approve and use the vaccine is based on the clinical trials data conducted across several countries, which was thoroughly reviewed and evaluated by the Authority.
Results from Phase III clinical trials showed an 86% efficacy rate, a 99% seroconversion rate of neutralizing antibody and 100% effectiveness in preventing moderate and severe cases of COVID-19, following testing on 42,299 volunteers
The NHRA further verified the quality of the vaccine by reviewing the scientific data behind the manufacturing process and the stability of the product, in addition to ensuring the manufacturer's commitment to applying the principles of Good Manufacturing Practice (GMP), in accordance to international standards in the pharmaceutical industry and requirements issued by the NHRA.
Additionally, the NHRA also consulted with its Clinical Research Committee, comprised of medical specialists, researchers, academics and doctors, also responsible for approving clinical trials, as well as the approval of the immunization committee.
The Kingdom of Bahrain has participated in Phase III clinical trials of the vaccine as part of the 4 Humanity campaign, in which more than 7,700 volunteers signed up.
The Authority had previously authorized the emergency use of Sinopharm's vaccine based on preliminary results, which was provided to frontline professionals in contact with COVID-19 patients.
The statement did not specify which vaccine among the two being developed by Sinopharm, but cited data from Phase III clinical trials that showed an 86% efficacy rate and said Bahrain had participated in those trials.
The data cited was the same as what was announced earlier this month by the United Arab Emirates from interim analysis of late-stage clinical trials for an inactivated vaccine developed by Beijing Institute of Biological Product, a unit of Sinopharms' China National Biotec Group (CNBG).
Bahrain, which earlier this month granted emergency use authorization for the Pfizer/BioNTech COVID-19 vaccine, had said on Dec. 10 that it would provide COVID-19 vaccine for free for all citizens and residents.
In fellow Gulf Arab state Kuwait, the Ministry of Health on Sunday granted emergency use authorization for the Pfizer/BioNTech vaccine, Kuwait news agency (KUNA) said. — Agencies


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