1/ I have noted that a lot of Zimbabweans have a number of questions about the Sinopharm vaccine. I have also noticed that there is also a lot of myths l, conspiracies and outright #Fakenews on this vaccine. Let me attempt to address these in this thread.
2/ No Zimbabwean will be used as a guinea pig for the Vaccine #Fact. This vaccine has been proven to be very safe in millions around the World. The safety studies are conducted in Phase 1 of Clinical Trials and any substance that fails those studies never ptogresses
3/ What about the elderly and the young? There is not enough evidence on safety of this vaccine in those under 18 or over 60. As a result some authorities have recommended this vaccine for those between the ages of 18 and 60.
4/ There are many adults over 60 years who have received this Vaccine in China and elsewhere with no reported adverse events. The authorities in Zimbabwe will consider the data from elsewhere when deciding on vaccinating those over 60 years.
5/ Why is this vaccine approved for use in Zimbabwe when Phase 3 Clinical Trials have not yet been completed? This is by far the most important question. There is just one problem: The vaccine has not been approved for use. It has been granted an emergency authorization permit.
6/ It is important to realize that clinical trials occassionally schedule interim analyses where an independent safety monitoring board evaluates the results and make decisions on weather the is enough evidence regarding the efficacy and safety if the agent under study.
7/ Almost all other Covid 19 vaccines were found to be efficacious during such interim analyses. The studies usually continue and additional data may strengthen, diminish or confirm the findings at interim analysis.
8/ Are Sinopharm Covid 19 vaccine recipients participating in a clinical trial? This question arises from some of the utterances of Senior Government officials. My emphatic response to this question is that recipients of this vaccine are not Clinical Trial participants.
9/ Clinical Trials go through a rigorous approval process and participants have to formal consent to the studies. What the Senior Government Officials were referring to is standard data collection for any newly introduced therapeutic agent.
10/ What about the mention of the Clinical Trials Committee by the Senior Health Officers? What was that about? I must admit that this was probably not well communicated. The MCAZ has a Committee that is responsible for Clinical trials This is the committee being mentioned here.
11/ Their involvement in the vaccine roll out is mainly to look at the safety data and make a determination if the emergency authorization for this vaccine be maintained, revoked or upgraded into a formal approval. They are not doing any clinical trial.
12/ What about this @ZLHRLawyers letter below? As highlighted above, the Communications by Senior Health Officers could have been misinterpreted as suggesting that the Sinopharm Vaccine will be provided as part of a clinical trial.
13/ I am confident that @MoHCCZim will be able to provide a comprehensive response to @ZLHRLawyers explaining why this is not a clinical trial but good clinical practice when managing newly introduced vaccines.
14/ Finally let me reassure those who will volunteer to participant in this vaccine roll out that their safety is guaranteed. Their participation may help the Country to get back to normal again.
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