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By KSA Ministry of Health | 8 August 2020
The Ministry of Health (MOH) continues its efforts to combat the COVID-19 pandemic. Its ongoing endeavors aim to develop an effective vaccine for the disease. This is taking place with the tremendous support of the government of the Custodian of the Two Holy Mosques and HRH the Crown Prince, which has spared no effort to preserve the health and safety of citizens and residents in KSA. MOH will continue to conduct experiments and research in this area. Moreover, it has announced that a clinical trial for a vaccine against the virus will be conducted in the Kingdom, within the framework of the cooperation agreement between KSA and China.
An action plan is currently being developed to implement a clinical trial in the third phase of the vaccine against the novel Coronavirus. This will take place in cooperation with the Chinese company ‘CanSino’, which managed to develop a vaccine against the virus.
The first- and second-phase trials were carried out in China. The first phase of the study involved testing the vaccine on 108 volunteers in China during the period from 16 to 27 March.
It included three different doses (low, medium, and high). The second phase of the study also included testing the vaccine on 603 volunteers in China, during the period from 11 to 16 April. It included two different doses (low and medium). These two stages have proven high efficiency of the vaccine, with the emergence of COVID-19 antibodies in the volunteers' plasma, and good immune responses. There were only a few side effects, especially with low vaccine doses. The results of the two studies have been published in the peer-reviewed scientific journal, “The Lancet”.
The third phase will include multi-center clinical studies in several countries and in large numbers after confirming the effectiveness and safety of the vaccine in the first and second phases.
The study will be performed in the Kingdom on a minimum of 5,000 healthy participants above the age of 18 years. They will be divided into two groups: The first will be given a low dose of the vaccine. The second will be a control group given the vaccine without any active ingredients.
Research teams will follow up on participants after they take a dose to ensure that no side effects appear. The follow-up will be through direct visits by the patients to the doctors participating in the study. Patients will also undergo all necessary immunological tests. Furthermore, electronic follow-up methods will be used.
MOH stated that it is working to prepare for these trials in three main cities: Riyadh, Dammam, and Makkah in four health clusters. These clusters are: the first health cluster in Riyadh, the second health cluster in Riyadh, the third health cluster in Eastern Province, and the first health cluster in Makkah.
MOH stressed that the launch of the study will be announced very soon. This step is a continuation of the studies and research that MOH often conducts in this field. It has also recently cooperated with WHO to conduct an advanced multi-center clinical study in seven hospitals in the Kingdom to combat the spread of the novel Coronavirus pandemic.