Kampala, 16th October 2013 -- Delegates from 23 African countries are meeting in Entebbe, Uganda, for the 8th African Vaccine Regulatory Forum (AVAREF) to discuss issues regarding regulation of new vaccines, drugs against infectious diseases as well as ethics.  

The meeting addresses one of the goals of the Global Vaccine Action Plan (GVAP) and is in line with the vision of the World Health Organization (WHO) Regional Director for Africa, Dr Luis Sambo, as recommended by a meeting of the Task Force on immunization (TFI) held in 2006. The delegates are reviewing the implementation of recommendations of the 7th AVAREF held in Gabon last year in addition to the status of the Pan African Clinical Trials Alliance strategy that deals with approval and oversight of trials for medicines and vaccines in Africa. 

Overall, delegates from countries targeted for clinical trials of vaccines will be given information on the different candidate vaccines and on timelines for the trials. The meeting will also strengthen communication and collaboration between National Regulatory Authorities (NRAs) of countries where vaccines are developed and those in countries targeted for clinical trials in the African region.  The meeting will also afford an opportunity  for training in regulation and evaluation of vaccines for  NRAs from participating counties. 

Recent advancements and the growing importance of medical sciences have resulted in a surge in Research and Development, and the availability of new medicines and vaccines that touch the health status of human beings.  

In this regard, Uganda’s Minister of Health Hon Dr Ruhakana Rugunda who officiated at the opening ceremony pointed out that “the main responsibility of drug regulation is to safeguard the availability of good quality, safe and effective medicines to all citizens” and this is critical to any health care system. He added that “a vital part of healthcare is availability and rational use of   essential drugs and vaccines”.

Consequently, the 8th AVAREF provides an opportunity to harmonize the work of the Capacity Strengthening Regulatory Oversight of Novel Vaccines funded by the Bill and Melinda Gates Foundation and that of the African Medicines Regulatory Harmonization project. These efforts are meant to ensure that people in Africa have access to quality essential drugs, efficacious vaccines and basic yet reliable diagnostic technologies. 

Dr Rugunda stated that lack of essential drugs, irrational use of and poor drugs, as well as spurious, substandard or falsified products posed serious health threats to Africa.  “Ten to twenty percent of sampled drugs fail quality control testes in many African countries and counterfeit medicines have been detected in many countries. Up to 75 percent of antibiotics are prescribed   inappropriately”, he said .

WHO and partners such as the US Food and Drugs Administration, Bill and Melinda Gates    Foundation, Health Products Food and Biologicals Directorate of Health Canada, the European Medicines Agency and the Programme for Appropriate Technologies in Health and the European and Developing Countries Clinical Trials Partnership have worked over the years to improve the situation and save lives in Africa. 

Stressing that point, the WHO Country Representative in Uganda, Dr Wondimagegnehu Alemu, said that “by strengthening the capacity of ethics committees and national regulatory authorities through AVAREF, WHO is supporting countries of the region to provide access to new medicines and vaccines which will help them meet global health goals including some of the MDGs and the goals of the Global Vaccine Action Plan”. 

Dr Alemu said that several new vaccines will soon be accessed by African countries and emphasized the critical role of ethical reviews on research for new vaccines and drugs in Africa. In this regard, went on “WHO will continue to support this area of work as enshrined within its mandate”. 

During the meeting, sessions will also be devoted to vaccines against TB, HIV and Malaria which are under development as well as on planned clinical trials of medicines, the African Medicines Agency and vaccine safety, among others.

Participants are from Botswana, Burkina Faso, Cameroon, Central African Republic, Ghana,    Gabon, Gambia, Kenya, Mali, Mozambique, Nigeria, Rwanda, Senegal, Sierra Leone, South Africa, Tanzania, Zambia, Zimbabwe, Democratic Republic of Congo, Equatorial Guinea, Niger and Uganda. 
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Technical contact: Mr Andrew Bakainaga:bakainagaa [at] who.int ( )+256772373231

Media contact: Benjamin Sensasi:sensasib [at] who.int+256772507906 or cam [at] who.int">cam [at] who.int  tel: +47 241 39100