A Kenya made ventilator for treating Covid 19 patients has for the first time been cleared for human clinical trials at a local hospital.
The ventilator ‘KU TIBA VENT’ developed by students at Kenyatta University will be tested for safety, effectiveness and patient comfort in the next few days.
The trials approval by the Pharmacy and Poisons Board indicate they will take about 14 days, and initially conducted among at least four adult patients.
The trials sponsored by the university will be carried out at Kenyatta University Teaching, Research and Referral Hospital and overall will sample up to 30 patients.
The trials if successful will bring closer the commercialization of the first locally made ventilator in Kenya, which currently has to depend on expensive and hard to come by imports.
“The main objective of this clinical validation is to assess the dependability and reliability of the device when connected to patients in the intensive care Unit,” says the protocol approved on 25th May 2021.
The trials will also asses the ease of use of the device for doctors and medical staff.
The information obtained, says the application by principal investigator Dr Gordon Oluoch Ogweno of Kenyatta University will assist in design modifications before commercialization.
The trial will involve connecting the device to patients with breathing problems in the hospital critical care unit and assessing its performance.
“As a safety measure, the already certified mechanical ventilators in the hospital will be on standby throughout.”
The good news is however dampened by reports that a major study to test the Moderna and Pfizer Covid 19 vaccines in Kenya and seven other African countries has stalled.
In Kenya the study is planned for Jaramogi Oginga Odinga, and Moi teaching and referral hospitals in Kisumu and Eldoret respectively. The study has already been funded by the US government at $130 million (about Sh14 billion).
The study is meant to assess whether the two mRNA vaccines work against variants of concern in the continent, and their performance in HIV infected persons and pregnant women.
The study planned to recruit 14,000 adult volunteers from Malawi, Zambia, Zimbabwe, Kenya, Botswana, Uganda, Swaziland, and South Africa which is also coordinating the event in the continent.
A report published in the journal Science last week said the initiative has stalled with the manufacturers of the two vaccines, indicating unwillingness to provide their shots.
“A Pfizer spokesperson says it considers the study unnecessary because evidence shows its vaccine works well against the Beta variant, and the company has an international study underway in pregnant women,” said Science.
On the other hand the journal said Moderna is concerned over liability issues and several complex aspects of the study design.
Consequently a group of prominent HIV advocates and activists in South Africa have since written to the US government asking it to intervene in unlocking the stalemate.
If this study goes ahead it will be the fourth Covid 19 vaccine clinical trials planned for Kenya.
Others include the University of Oxford/Astra Zeneca trials already completed, a Sanofi/GlaxoSmithKline candidate which might start later this year and the ready to take off Chinese made recombinant COVID-19 vaccine (Sf9 cells).
By Gatonye Gathura