The government has approved the first Kovid-19 vaccine trials to be conducted in the country. The approval approved by the Pharmacy and Poison Board on Tuesday allows for testing in Oxford University-developed vaccine in Kenya. The tests, conducted by the Kenya Medical Research Institute (CAMERI), will recruit 400 health workers in Kilphy and Mombasa counties. The next step, though usually formal, would be final approval by the National Commission for Science, Technology and Innovation (Nacosti).
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This makes Kenya the second country in Sub Saharan Africa after South Africa to conduct clinical trials for the Kovid 19 vaccine. South Africa began testing for the same Oxford University vaccine, known as ChAdOx1 nCoV-19, in June. Last Tuesday, global trials of the vaccine were halted due to severe and unexpected adverse reactions in a participant in the UK. The vaccine co-developers, AstraZeneca, said the test was suspended worldwide to allow for the review of safety data by an independent committee. Locally, however, the test will determine the safety of the vaccine, its ability to generate protection, and its efficacy against new viruses in adult canines. “The study will only recruit 400 health workers, including doctors, nurses, clinical officers, pharmacists, morgue attendants, and allied health professionals,” the protocol says.
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Health workers are preferred because of the high risk of occupational exposure to Kovid-19, so their safety is urgently needed. Participants who will be given one dose of the vaccine will be followed for 12 months. Justifying the vaccine testing in Kenya, the protocol says this is important because studies in other populations may have demonstrated vaccine performance differently in Africa. On Monday, Health Administrative Cabinet Secretary Rashid Aman said seven applications for the Kovid-19 drug study had been received by the Poison Board so far. “Four of them have been approved,” he said during the daily Kovid-19 status update. Those most recently approved include a study for the experimental use of chloroquine / hydroxychloroquine for the prevention of Kovid-19 in healthy adults. The study, named COPCOV, will be conducted by Camry at four sites in Kilfi, Mombasa, Nairobi and Kisum, targeting 1,600 health workers. Globally, the study targets 40,000 participants.
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While chloroquine / hydroxychloroquine has been discounted as ineffective against covid-19, some experts have argued that this is not supported by evidence. There is also a request to seek approval by Kenyatta University Teaching, Referral and Research Hospital for the experimental use of blood plasma in Kovid-19 patients. “The study is in the regulatory approval phase. As soon as all these arrangements are in place, we will tell you, “Dr. KU Deputy Director of Research. Marian Kiguya-Njou told standard Last week. “The primary objective of this test is to look at the safety and efficacy of convulsive plasma therapy in critically infected patients,” the study says. Potential donors will be required to meet standard criteria for blood donation. However, they should confirm previous infection with SARS-CoV2 and also test negative to show when they have recovered. Earlier, the Pharmacy Board approved the World Health Organization-sponsored Solidarity Trial and another study in which Aga Khan University Hospital, Nairobi, is experimenting with cyanide-drug, tocilizumab in cybid-19 patients. During the Kovid-19 briefing yesterday, Aman said that the ministry is not yet aware of the suspension. He said that plans were already underway to begin trials of the vaccine, as necessary approvals were given. “This new information has not come to my attention,” he said, as he announced 104 new cases and eight deaths, increasing the case load to 35,460 and fatal to 607. The clinical trial of the vaccine, in phase three, targets 30,000 individuals. In the United Kingdom, and as noted by the CAS, more people from inter-ethnicity backgrounds, among them Africans, had to be recruited. Aman said plans to go along with the trials in Kenya were still ongoing.