Let�s Find Permanent Medical Solution To Ebola - Segbefia

Minister for Health (MOH), Mr Alexander Segbefia, has stated that it will be prudent for all to do their part to find permanent medical solution to overcome Ebola and to minimise its adverse effects.

According to Mr Segbefia, the epidemiological history of the disease in East and Central Africa points to its return even if the current wave is overcome.

Briefing Members of Parliament (MPs) on the suspended phase one Ebola vaccine trial in the Volta Region, he said the disease was still a major public health, social and economic threat to West Africa in particular and Africa and the world in general.

The MOH suspended the trial of the vaccine in the Hohoe Municipality in the Volta Region due to public reservations and those from MPs.

He said until the last case of Ebola was found and dealt with, there was still a clear and potential danger of spread. Efforts in West Africa

The minister explained that Ghana had led the efforts in West Africa to fight and defeat the disease by the examples of President Mahama visiting the three affected West African countries on September 15, 2014 to break their isolation.

Besides, the President gave a speech at the United Nations calling for the world’s support and attention; and Ghana hosted the United Nations mission on Ebola Emergency Relief in Accra.

Mr Segbefia said the country had the intellectual capacity, infrastructure and track record to support such a clinical trial with strength in institutions such as Parliament, the MOH and the Food and Drugs Authority (FDA), as well as in implementation and research with numerous health research centres throughout the country to be used.

He, however, explained that for every clinical trial, there were potential risks and so the country must take that into account and make every effort to identify the risks early and abort the trial if need be.

He said it was for such reason the FDA had put in place extra measures, over and above the usual measures they employed to make sure that in the event that the trial was to proceed, things would not get out of hand.

Safety of Ghanaians

He gave the assurance that ‘’we will do what has to be done to make sure the good people of Ghana are protected, and we will do what is right to ensure that in the medium and long term Ghanaians are safe from emerging diseases such as Ebola.’’

Giving the background to the trial of the vaccine in the country, Mr Segbefia told the House that following the outbreak of the disease in the sub-region and appeals to the international community to find a vaccine for the disease, the World Health Organisation (WHO) in October 2014 facilitated a meeting of the African Vaccine Regulatory Forum in South Africa to consider how to accelerate the process of approving prospective candidate medicines or vaccines.

He said considering the urgency of the situation, participating countries agreed to undertake joint reviews of clinical trial applications in order to reduce the time usually taken to process applications.

The final decision as to whether to approve clinical trials or not, however, rested with the regulatory agencies in individual countries.

He said subsequent to the meeting in South Africa, the WHO wrote to regulatory bodies of Ghana and four other West African countries, namely Nigeria, Senegal, Cameroun and Mali, notifying them of the intention of Glaxo Smith Kline (GSK), one of the world’s leading pharmaceutical companies, to submit a candidate vaccine for clinical trials in respective countries.

WHO review meeting

He said the WHO subsequently convened a joint review meeting in Geneva on December 14 and 15 last year, which was attended by a number of international health regulatory bodies, including Health Canada, Swissmedic, European Medicines Agency and the United State of America (USA) Food and Drugs Administration.

He indicated that following the Geneva meeting, GSK submitted an official application on December 17 to the Ghana Food and Drugs Authority for authorisation to conduct clinical trials.

In February 2015, the FDA received another application from Johnson and Johnson to conduct clinical trials in the country. Similar applications were made to Kenya, Tanzania and Uganda by Johnson and Johnson.

He said since 2004, the FDA had dealt with 54 applications for clinical trials out of which 43 were approved with the other 11 applications not approved due to insufficient evidence of safety and efficacy.

Mr Segbefia said out of the 43 approved clinical trials, 14 were for various types of vaccines, 26 were for drugs and three were for medical device trials and that most of the clinical trials conducted in the country over the years had been at Navrongo, Kintampo and Hohoe.

Monitoring of clinical trials

The minister said the FDA monitors the clinical trial research centres and perform pre-trial inspection of sites to ascertain suitability and capability for particular trials.

He said owing to the enviable capacity which the FDA had developed over the years, it was nominated by the WHO to host and assist its counterpart organisation in Sierra Leone to review a protocol for phase three of an Ebola vaccine trial by Janssen, a subsidiary of Johnson and Johnson in April 2015. Mr Segbefia said as recently as June 9, 2015, the FDA provided similar advisory capacity building support for a pending phase two Ebola trial for Burkina Faso, La Cote d’Ivoire, Kenya and Uganda.

The FDA has also been designated as a regional centre for regulatory excellence with oversight responsibility for clinical trials as well as medicines evaluation and registration in the sub-region.

He said the first application received for Ebola vaccine trial in Ghana was in December 2014 and was sponsored by GSK and it involved phase two clinical development trial with safety and immunogenicity in healthy humans in Ebola-free countries as its main objective.

He explained that when the vaccine is injected into healthy humans, antibodies against the Ebola virus would be produced which could lead to the prevention of the EVD and that it could not cause EVD since it did not replicate in humans due to deletion of its replicating gene., stressing that it did not contain the Ebola virus and could not cause the disease. Phase two trial

According to the minister, the countries involved in the proposed phase two trial of the GSK vaccine are Ghana, Nigeria, Cameroun, Senegal and Mali and that they were chosen because they border the affected countries. The design of the phase two trial will be such that in the event of an outbreak, persons already vaccinated would be already protected.

He said the studies of the trial vaccine had been conducted with different dosages of the vaccine to assess its safety and immunogenicity in humans and that the studies were conducted in the National Institutes of Health, Bethesda Maryland, USA, Oxford University in the UK and the Centre for Vaccine Development in Mali.

Hohoe research centre

He stated that the Hohoe Centre started in 1986 by the WHO and for nearly 30 years now over 30 clinical trials, including phases one to three studies of oncho drugs, malaria drugs and others have been conducted according to internationally recognised standards at the centre.

Mr Segbefia said the current use of other combinations of drugs recommended by the WHO for all the Oncho affected countries was developed following trials at Hohoe.

He conceded that the implementation of the programme for stakeholder consultations and community engagement had not been as thorough as one would have expected, hence the decision to suspend the exercise.

He said it was in the country’s enlightened self-interest to contribute to the global quest for an Ebola cure or vaccine and would not compromise the people’s safety and interest.