FDA okays Ebola vaccine trial
The Food and Drugs Authority (FDA) has given approval for an Ebola vaccine trial to be undertaken in the country.
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The 18-month-long trial which would be undertaken at Hohoe in the Volta Region is expected to help find a vaccine for the Ebola viral disease (EVD) which infected more than 8,000 people, especially in Liberia, Sierra Leone and Guinea, killing more than 4,000 people.
At a news conference in Accra yesterday to brief the media on happenings so far, the Chief Executive of the FDA, Mr Hudu Mugtari, said “although Ghana has not yet recorded any case of EVD, the country is neighbour to the epidemic areas in West Africa, and people living in Ghana are at risk of contracting the disease due to high passenger flow and risk of animal transmission”.
In all, Ghana and Kenya are to, in the first phase of the trial, enrol a total of 72 participants. Kenya has already started with its trial.
Participants who are expected to be fit and healthy would be recruited from ages 18 to 50. Pregnant women, lactating mothers, the elderly and children would not be involved. The participants, who would sign an informed consent form, must also be literate in English, Twi or Ewe.
The FDA, after discussions with international partners and with support from its Expert Technical Advisory Committees, granted approval for the trial to test the safety and immunogenicity (indication of how the body will recognise and defend itself against substances that are foreign and harmful) of a potential anti-Ebola vaccine.
Vaccine Trial
Ghana, therefore, joins the United Kingdom (UK), the United States of America (USA) and other seven African countries, including Tanzania, Uganda and Kenya, in search of an effective Ebola treatment.
According to Mr Mogtari, “these trials are being conducted to the highest ethical standards as operated globally and the FDA is satisfied that all measures to ensure complete participant protection are in place”.
He said “Ghana is a leader in drug regulation in Africa, and we are pleased that the global community is calling on us to assist Africa in a time of great need”.
He, therefore, encouraged the academic and clinical research community in the country to take advantage of those studies to contribute to science.
He said the FDA had lots of experience in regulating clinical trial since 2004 where it had received 54 applications and approved 42. Out of those approved, he said 26 were on drugs, while 14 were on vaccines for malaria and HIV.
Protection of populace
A doctor of bioethics who is also a Member of the Ghana Health Service Expert Technical Advisory Committees, Dr Ama Kyerewaa Ampofo, said the vaccine would not cause Ebola as was being circulated.
She said participation in the trial would be voluntary and all those involved would be protected by law.
She said the technical committee had been to the site where the trial would be conducted to ensure the safety of all participants.
A detective who is part of the team to undertake the trial, Dr Rita Baiden of the University of Health and Allied Sciences, said participants would be compensated for their time and the risk involved.
The Deputy Minister of Health, Dr Victor Asare Bampoe, said the ministry was pleased with work so far done by the FDA on the vaccine trial.
He expressed the hope that the trial, when undertaken, would help find a lasting solution to the EVD.