FDA gives approval for Ebola Vaccine Clinical Trials

Accra, June 10, GNA – The Food and Drugs Authority (FDA) has given approval for the commencement of clinical trial of Ebola Vaccine in Hohoe in the Volta Region.

The test is intended to prove its safety, effectiveness and prevention against deadly Ebola Virus Disease.

It would also give vital information about whether the tested vaccine is well tolerated and capable of stimulating adequate immune responses of Ghanaians or not.

Briefing the media in Accra, Mr Hudu Mogtari, the FDA’s Chief Executive Officer, explained that after being satisfied with all the measures to ensure complete participation and protection, the trial would be conducted with the highest ethical standards as operated globally.

Mr Mogtari explained that the vaccine to be tested in Ghana was made using the common cold virus called adenovirus and did not make people sick.

‘The Vaccine contains extracts that do not cause diseases from the Ebola virus,’ he stressed.

He said the FDA gave the approval based on discussions with its international partners and support from its Expert Technical Advisory Committee after Ghana had been selected as the Regional Centre of Regulatory Excellence for Clinical Trials Oversight in Africa, designated by the NEPAD Africa Medicines Regulatory Harmonisation.

‘Ghana has, therefore, joined the UK, USA, and seven other African countries where these hugely important trials are taking place,’ he said.

The trial, to commence later in the year, would be organised by the School of Allied Health Sciences in collaboration with the Noguchi Memorial Institute into Medical Research.

Volunteers for the trial would be healthy individuals between the ages of 18 and 49.

As a form of compensation, they would receive a mobile phone to facilitate communication and monitoring as well as GH¢ 200.00.

The clinicians to be used for the trial are being trained.

He said though Ghana had not yet recorded any case of Ebola virus, the country was a neighbor to endemic areas in the sub region thus placing Ghanaians at a high risk of contracting the disease due to the high passenger flow.

Dr Ama Kyerewaa Edwin, a Clinical Psychologist, and a member of Ghana Health Service (GHS) Ethical Review Committee, which reviewed the Protocol, said the protocol had met all the ethical requirements and assured Ghanaians of its safety.

GNA


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