Health Ombud – Appointment to the Data and Safety Monitoring Board
THE HEALTH OMBUD, PROF MAKGOBA APPOINTED TO SERVE ON THE USG DATA AND SAFETY MONITORING BOARD FOR THE FIRST COVID-19 VACCINE CLINICAL TRIALS
The Health Ombud, Professor Malegapuru Makgoba is ‘honoured and inspired’ to be invited by the United States of America (USA) Government (USG) to serve on the 12-Member expert panel of the Data and Safety Monitoring Board for the first COVID-19 vaccine clinical trials.
The Data and Safety Monitoring Board is responsible to ensure the safety of participants, the efficacy and the immunogenicity of the candidate vaccine being tested or on trial and it is the final structure to pronounce on the vaccine approval.The 12-member expert panel currently consists of 9 USA scientists, physicians, ethicists and biostatisticians, with 3 non-USA experts from South Africa, Brazil and the United Kingdom (UK). Members are selected based on their expertise and experience.
The committee is independent of investigators, organizations, and institutions conducting the vaccine clinical trials. The Data and Safety Monitoring Boards has the authority to recommend that a trial be stopped early should there be concerns of participant safety.
The race to develop a safe and efficacious vaccine is on globally. Finding a safe and efficacious vaccine is the ultimate goal that has become a global emergency, to significantly impact to change the course of the Covid-19 pandemic, that has caused so much damage and misery to the whole of humankind and the future of the world.
The recommendations of the Data and Safety Monitoring Board will have an enormous impact on the overall global response to the COVID-19 pandemic.
“I feel greatly honoured and inspired to be a member of this Data and Safety Monitoring Board. I shall do my best to make a meaningful input and contribution to the task,” said Prof Makgoba.
ISSUED BY THE OFFICE OF THE HEALTH OMBUD
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