At a time when the world is scrambling to find a cure, a vaccine or some sort of viable treatment for the Novel Coronavirus that is rocking the globe, the Ethiopian Ministry of Health (MoH) and the Ministry of Innovation and Technology (MoIT) have disclosed that they have an effective treatment in the pipeline that enhances natural immunity in the fight againt the virus.
Although the details of the ingredients as well as the laboratory procedure and testing were not presented in detail, the two ministries said that a treatment drug has been discovered from the traditional medicines in the country.
The statement that the MoIT issued on March 27, 2020, indicated that the medicine has passed the basic research procedures and was successful in the laboratory modeling processes.
“The research had been conducted by different Ethiopian scientists both in the country and abroad since the pandemic was known to the global society. It has passed through various testing stages and now green light has been given for animal and clinical trial,” the statement announced.
The whole researching and treatment are said to follow local and World Health Organization’s procedures, according to the press briefing the two ministries gave only to selected government media houses.
According to the United States Food and Drug Administration (FDA), drug development has five processes. The first stage involves discovery and development where researchers “identify a promising compound for development, they conduct experiments to gather information on how it [the drug] is absorbed, distributed, metabolized, and excreted; its potential benefits and mechanisms of action; the best dosage; the best way to give the drug (such as by mouth or injection); side effects or adverse events that can often be referred to as toxicity; how it affects different groups of people (such as by gender, race, or ethnicity) differently; how it interacts with other drugs and treatments and its effectiveness as compared with similar drugs.”
The second stage, which the newly developed drug in Ethiopia is said to have passed, is preclinical research. This involves preclinical research that is “before testing a drug in people, researchers must find out whether it has the potential to cause serious harm, also called toxicity.”
“Usually, preclinical studies are not very large. However, these studies must provide detailed information on dosing and toxicity levels. After preclinical testing, researchers review their findings and decide whether the drug should be tested in people,” states the FDA website.
The Ethiopian government has announced that the new COVID-19 treatment drug has been proved not to cause harm in humans or not to be toxic.
The third step that the new drag entered is clinical research to answer “basic questions about a drug’s safety, it is not a substitute for studies of ways the drug will interact with the human body” according to the FDA.
The two remaining steps are reviewing and post-marketing safety monitoring which is, “examine all of the submitted data related to the drug or device and make a decision to approve or not to approve it,” and “monitoring all drug and device safety once products are available for use by the public.”
The Reporter approached the Ministry of Health and the Ministry of Innovation and Technology to get details of the new COVID-19 drug research about these procedures but could not get replies from both entities. Questions relating to the research team profile, the time and money spent for the research, the ingredients of the new drug, the patent right, the involvement of the WHO or any other global entity, as well as the registration process, still remain unanswered.