What you need to know:
- A vaccine would be a game-changer against the Covid-19 pandemic, which has killed more than 1,400, infected more than 81,000 and crippled the economy.
- After the Oxford team established in phase 1 that the vaccine could trigger an immune response, it was allowed to be used on healthcare workers, the people most exposed to the virus.
The earliest African countries can get the Covid-19 vaccine is July 2021, the Africa Centres for Disease Control and Prevention has said.
That— the shortness of time for scientists developing a vaccine— is not the only headache that the team at Kenya Medical Research Institute (Kemri) Wellcome Trust Programme will have to endure on the path to getting a vaccine.
Instead, the Sunday Nation lays out how Kenyan scientists have had to wade through the muddy waters to get a vaccine that the country so desperately needs.
Apart from the usual unpredictability of science in vaccine evaluation, distributing them on cold chain, there is also the deliberate delaying of ethic approvals and politicians’ careless statements that turn an already sceptical community into anti-vaccines.
On October 28, the Kemri-Welcome Trust Research programme based in Kilifi started the vaccine trials of the ChAdOx1 nCoV-19, developed by the University of Oxford in partnership with the pharmaceutical company AstraZeneca.
Kenya’s participation in this trial is a big deal — there are 13 vaccines on trial. Kenya and South Africa are the only African countries participating.
The man behind the trials, Oxford University associate professor George Warimwe, was thrust into the public eye and he is acutely aware of the load on his team’s shoulder.
A vaccine would be a game-changer against the Covid-19 pandemic, which has killed more than 1,400, infected more than 81,000 and crippled the economy.
The Sunday Nation visited the team in Kilifi, where they are recruiting 40 frontline workers.
Once the safety is confirmed, the study will recruit another 360 and expand the research to 400.
This is a Phase 2 trial, where it is tested on hundreds to check the safety of the vaccines.
After the Oxford team established in phase 1 that the vaccine could trigger an immune response, it was allowed to be used on healthcare workers, the people most exposed to the virus.
Prof Warimwe told the Sunday Nation that “everything is going on as expected”. However, Kenya started its trials nearly five months later than its counterparts in the United Kingdom, South Africa and Brazil. From the sources at the Health ministry, the Sunday Nation established that the ethical procedures needed to start the vaccines — a very standard procedure in any human medicine — was delayed due to internal disagreements at the ministry.
Each agency, or those that head them, do not want to miss out on this opportunity to save lives. However, they delay the approvals if they do not get their pound of flesh in glory. Eventually, after other countries started reporting preliminary results of their trials and seeing how popular those governments became among their citizens, the Kilifi team got the go-ahead to start the research.
Health secretary Mutahi Kagwe told the Sunday Nation that the team in Kilifi “deserved real credit”.
These petty wars have plagued not just the ChAdOx1 nCoV-19 trials in Kilifi but another study to follow up patients from hospitals to see whether there are long-term effects of the virus on the body after one is cured of Covid-19.
A renowned scientist is on record lamenting that the former Kenyatta University Teaching Referral and Research Hospital chief executive, Dr Wekesa Masasabi, “refused to allow that we follow up on patients yet that centre holds a large number of Covid-19 patients”.
In a country where regulatory bodies are not autonomous and independent of political interference, it did not help ChAdOx1 nCoV-19 trial when several popular politicians said on the social media the vaccine was a ploy to use Kenyans as guinea pigs.
After working on vaccines for a while, Prof Warimwe has been here before, and he was ready. At the KEMRI Wellcome Trust hospital, getting the vaccine jab is not a one-day affair for a patient.
The volunteers have a designated gate, where they meet the first nurse to take their temperatures, contact details and history. They are moved to another room, where a counsellor will explain how the vaccine will be administered — a jab on the upper arm that one does not use often, the tests that they will go through and give the volunteer a chance to bow out.
Once they consent, the volunteers are then moved to three other rooms for through investigations where the doctors test their kidneys and blood.
The trial’s project manager nurse Irene Njau told the Sunday Nation: “if they are found to have been infected with the virus, or are pregnant, or have any chronic conditions or are lactating, they are ineligible to participate in the trial.”
If any volunteer is found with medical conditions that need attention, the Kilifi programme takes the volunteer to the hospital. As all of this goes on, Prof Warimwe has to report every detail of the vaccine activities to numerous regulatory bodies, as dictated by the World Health Organisation that gives guidelines.
“The protocols include the initial document that was approved to guide the study and it is the same to every detail with the Pharmacy and Poisons Board, the World Health Organisation, Kemri… everyone,” he says.
Prof Warimwe said this is to protect the wellbeing of the participants, and that the evaluation is standard.
“It is so strict that should I want to add even a name of a scientist to the team, I have to apply for another approval,” he told the Sunday Nation.
Prof Warimwe is not starting from a blank slate. In June, the Oxford team reported that the phase I and II peer-reviewed trial results showed that the ChAdOx1 nCoV-19 vaccine induces strong antibody and T-cell immune responses across all age groups, including older adults.
The Phase 3 trials — the only stage of vaccine development where any rare side effects are seen because thousands are tried and some given a placebo — has returned positive results: it offers 70 per cent protection collectively but higher (90 per cent) when they give lower dose the second time.
The results came days after Pfizer and Moderna vaccines showed 95 per cent protection.
@VerahOkeyo, [email protected]