Vaccine & Diagnostics Production

Vaccine and Diagnostics Production Research
About the Directorate

Infectious diseases are thought to account for nearly 25% of all deaths worldwide, and extract a disproportionate toll in developing countries. Moreover, infectious disease are now appreciated to be major causes of the poverty and economic under development that characterize the world’ poorest countries. Development and deployment of vaccines to prevent infectious diseases in developing countries have therefore become a high priority in the global health agenda. Of the major infectious disease that can easily prevented with vaccination are rabies, yellow fever, meningitis, cholera, tetanus, typhoid fever and Diphtheria. Vaccination offered the best chance to avoid the disease: only individuals who lack antibodies against the circulating virulent strain develop a disease.

However, mass vaccination with the vaccine in the developing country is impractical or of limited use because vaccination is usually started too late because of the obstacles in this region to allocating vaccine supplies and logistic resources faster than the spread of the epidemic. Research for developing vaccines is carried out mainly in developed countries. And there are very few vaccine manufacturers to meet the global demand. This leads to shortage and high cost of vaccines for use in developing countries where the need is very dire.Local capacity to produce these vaccines will have a significant contribution to minimize the impact of epidemics. Countries like Cuba showed us that this approach is feasible for developing countries where there is commitment from government.

According to 2008 data from FMoH, Ethiopia is investing more than 48 million US dollar, at the minimum estimation for the purchase of essential vaccines annually. If we are able to produce these essential vaccines locally, we can avoid not only importing with hard currency but also minimizing the usual shortage in the event of epidemics. Moreover, the capacity to produce vaccines locally will create job opportunities for young Ethiopians in addition to generating hard currency by supplying to neighboring countries.

In the Ethiopian context, EPHI has previous experience in producing bacterial and viral vaccines. For instance, during cholera epidemics in the 1960s, the Institute used to produce a parenterally administered killed whole cell vaccine. The Institute also produced smallpox and typhoid fever vaccine in early 1950. Furthermore, Fermi type rabies vaccine has been produced by the Institute for over four decades both for human and animal use and it is still in use in the country. To replace this outdated vaccine with cell culture based rabies vaccine. EPHI adapted this new technology and has transferred the cell culture based rabies vaccine production to NVI destined for mass vaccination of source animals.

Currently, our directorate is renovating the facilities to meet the GMP for the API production. State of art equipment like water for injection, labeling machine, Bioreactors, vaccine mixing tank and storage tanks, purification systems (ultrafiltration, tangential flow filtration, membrane filtration) were procured.

Missions

Produce safe and efficacious traditional human vaccines for priority diseases and diagnostics for diagnostic purposes.
Act as focal point within Ethiopia on interaction on human vaccine R&D with external partners and organizations which collectively play a vital part enriching the global vaccine research, development and utilization.
Participate in the harmonization of internationally accepted standards and regulatory requirements for human vaccine R&D.
Independently evaluate the safety and efficacy of imported human vaccines.
Conduct appropriate implementation research; develop policies and strategies for rational (optimal) use of vaccines and technologies.
Objectives

Produce vaccines for rabies, meningitis, yellow fever, cholera and typhoid fever the coming 5 years
Produce rabies immunoglobulin/monoclonal antibodies and polyvalent antivenom in the coming 5 years
Map the geographical distribution of rabies disease and identification of new strains of the virus
Conduct research on genetic mapping of circulating rabies virus and production of attenuated rabies vaccine from the circulating rabies virus
Initiate and implement collaborative Research and Development platforms for vaccine
Establish quality control setup for imported human vaccines
Collaborate on clinical trials of vaccines
Partnership

Partnerships are the keys to our success. Especially in the fields of vaccine and diagnostic production which are well known for their complexity. EPHI and FINLAY Institute, the Republic of Cuba signed a bilateral agreement. This includes training of EPHI experts in FINLAY Institute and the onsite training for EPHI staffs by FINLAY experts. As well as transfer of technology for the production of traditional vaccines.

The Directorate has two case teams

1. Production and Research Case Team

2. Quality Control Case Team

Members of the Directorate

Kelbessa Urga (Lead Researcher)
Birhanu Hurisa (MSc)
Abebe Mengesha (MSc)
Mekoro Beyene (BSc)
Dereje Nigussie (MSc)
Hailu Lemma (MSc fellow)
Gashew G/Wold (MSc fellow)
Anberbir Alemu (BSc)
Tihitina Tesfaye (BSC)
Nishanwork Wondaferaw (Dr.)