‘Decision to suspend Ebola vaccine trials regrettable’

"Ironically, the trial of the VSV Ebov vaccine was rejected by several countriesincluding USA, Italy, France, United Kingdom, Russia, Germany and Canada for its unspecified adverse effects."

Source: GNA  -  The Chairman of Global Vaccine Safety Initiative of the World Health Organisation, on Wednesday described the directive of Mr Alex Segbefia, Minister of Health to suspend the Ebola vaccine trials as a very regrettable decision.

Professor Alex Dodoo said the phase 1 study of the Ebola vaccine trial is being undertaken in Hohoe and surrounding areas in the Volta Region.

The Associate Professor in Clinical Pharmacology at the School of Medicine and Dentistry, University of Ghana, Legon told the Ghana News Agency in Accra that the decision by activists of the ruling National Democratic Congress (NDC) and some member of parliamentarians of both the NDC and main opposition New Patriotic Party to take to the streets if the vaccine trials are not halted is also ill-informed.

“These hostile decisions will eventually go against the national interest because the reasons for the uneasiness are unfounded and very strange,” he said.

Prof Dodoo said all vaccines used by the Expanded Programme on Immunisation were tested before they were brought into the country.

“US and Canada had no local cases of Ebola but they developed drugs for the disease for which the whole world is benefiting. To develop vaccines against Ebola is therefore of national interest and stopping the phase 1 trial may hurt our national security and healthcare interests.”

Prof Dodoo said the proposed phase 1 study involves 36 recruited volunteers, in line with the protocol for the clinical trial, which has undergone rigorous evaluation by local and international independent experts and professionals and has been approved by the Food and Drugs Authority (FDA), the body legally mandated by the Public Health Act of Ghana 2012, to authorise clinical trials.

He said Ghana has the capacity to undertake clinical studies of vaccines and has been involved in a number of vaccine trials.

Prof Dodoo said: “The current brouhaha about the vaccine trials is a dent on the integrity and the professionalism of the several world renowned professionals in the country who have been providing technical assistance to countries all over the world including some developed countries.

“It is wrong on the path of the Minister to suspend the trials since the FDA is the agency mandated by law to give approval for clinical trials” adding that the decision undermines the independence and integrity of the FDA, which is a respected African national regulatory authority.

Prof Dodoo said all ethical protocols were pursued with the ultimate aim of protecting the lives of the volunteers in the trials in line with the Declaration of Helsinki and according to Good Clinical Practice guideline.


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