The World Health Organization (WHO), in collaboration with the African Centre for Disease Control and Prevention and the African Union Commission for Social Affairs, has approved a protocol for phase 3 clinical trials of herbal medicine for Covid-19.
The Regional Expert Committee on Traditional Medicine for Covid-19, which was formed by the 3 institutions, while giving the approval also endorsed a charter and terms of reference for the establishment of a data and safety monitoring board for herbal medicine clinical trials.
The Director Universal Health Coverage and Life Course Cluster at WHO Regional Office for Africa, Dr Tumusiime, said, “Just like other areas of medicine, sound science is the sole basis for safe and effective traditional medicine therapies. The onset of COVID-19, like the Ebola outbreak in West Africa, has highlighted the need for strengthened health systems and accelerated research and development programmes, including on traditional medicines.’’
The technical documents that were approved are aimed at empowering and developing a critical mass of technical capacity of scientists in Africa to conduct proper clinical trials to ensure quality, safety and efficacy of traditional medicines in line with international standards.
This appears to add to the global effort to develop vaccines for the coronavirus disease, which are at different trial stages. The WHO had disclosed that there are well over 100 Covid-19 vaccines currently under development across the globe with about 8 of them at the phase 3 trial stage.
The phase 3 clinical trials are quite crucial in fully assessing the safety and efficacy of a new medical product. The data safety and monitoring board will ensure that the accumulated studies data are reviewed periodically against participants’ safety.
The late-stage trial will also make recommendations on the continuation, modification or termination of a trial, based on evaluation of data at predetermined periods during the study.
Dr Tumusiime explained that if a traditional medicine product is found to be safe, efficacious and quality assured, the WHO will recommend for a fast-tracked, large-scale local manufacturing. The WHO also noted that through the African Vaccine Regulatory Forum, there is now a benchmark upon which clinical trials of medicines and vaccines in the region can be assessed and approved in less than 60 days.
The Expert Committee Chairman, Professor Motlalepula Gilbert Matsabisa said, “The adoption of the technical documents will ensure that universally acceptable clinical evidence of the efficacy of herbal medicines for the treatment of COVID-19 is generated without compromising the safety of participants.”
The 25-member Regional Expert Advisory Committee on Traditional Medicine for Covid-19 was mandated to support countries to improve on research and development of traditional medicine based therapies against the virus.
It is to also provide guidance on the implementation of the approved protocols to generate scientific evidence on the quality, safety and efficacy of herbal medicines for Covid-19.