Local trial of COVID-19 vaccines critical – Clinical Pharmacologist
A clinical pharmacologist, Professor Alex Dodoo, has suggested that Ghana should conduct local clinical trials for COVID-19 vaccines to help settle on a suitable one for the people.
All vaccines, he said, might have side effects, depending on various conditions in the geographical areas they might be used, hence the need to do clinical trials locally.
In an interview with the Daily Graphic in Accra, Prof. Dodoo posed some questions: “Which of them [vaccines] is Ghana going for and what is the global experience? Based on the global experience, should we go for it? Do we use it as intended by other countries or should we blend?”
“The fact that a vaccine is safe doesn't mean it is safe for all conditions,” Prof. Dodoo, who is also the Director-General of the Ghana Standards Authority (GSA), said in an interview in his private capacity as an expert on tropical clinical pharmacology and therapeutics.
Consequently, he said, it was a priori necessity for Ghana to begin discussions on how to deploy COVID-19 vaccines when approved for use in the country.
“We must begin engagements on these things and have upfront discussions because when the vaccine hits, there will be a clamour for it, but there are certain parts of the population who should not take the vaccine, such as those who are immune-compromised with HIV and the rest, those with asthma who could have unacceptable harm when they take the vaccine,” Prof. Dodoo, who also lectures at the Centre for Tropical Clinical Pharmacology and Therapeutics (CTCPT) at the University of Ghana, said.
He said an important consideration the science community should make before approving any COVID-19 vaccine for use in the country was to ascertain its benefits and associated risks on Ghanaians.
Prof. Dodoo was the first Chairman of the World Health Organisation (WHO) Global Vaccine Safety Initiative and the interview was in relation to the global endeavour to create a safe and effective COVID-19 vaccine and Ghana's preparedness to settle on one that would be suitable for use in the country.
Efforts to have a safe COVID-19 vaccine have been bearing fruit, with a handful of vaccines now authorised and many more in development.
About four million United Kingdom citizens had already received their first dosage of the approved vaccine, according to UK officials.
The United States of America (USA) and Europe have also developed and approved their own vaccines for mass usage.
Global efforts, Ghana's steps
President Nana Addo Dankwa Akufo-Addo last Tuesday announced that the government had commenced discussions with some COVID-19 vaccine manufacturing companies, with the goal of ordering the suitable doses of
the vaccines for use in Ghana.
That followed the completion of work by the committee the government set up to recommend the appropriate decision on the COVID-19 vaccine.
He noted that through the advancement of science, some vaccines were already being administered in some countries to help control and eventually end the pandemic.
Prof. Dodoo said considering that West Africa and Ghana had not participated in the development of any COVD-19 vaccine till now, the country would have access to the globally approved vaccines because “the world wants us to have it and not because we deserve it”.
He added that none of the approved vaccines would automatically be suitable for use in Ghana, as vaccines were not made “one fit for all”.
He explained that for a vaccine to be considered suitable for an individual, the associated benefits must far outweigh the risks.
However, Prof. Dodoo said, the public could be assured that there were experts in the country to provide guidance and the necessary technical infrastructure to ensure that any COVID-19 vaccine used in the country was safe and also safely deployed.
The clinical pharmacologist said once the government settled on which vaccine(s) should be used in Ghana, an application would be made to the Food and Drugs Authority (FDA) for registration.
At the time of application for FDA registration, all the data relating to the development and use of the vaccine would be made available to the FDA in a confidential manner, he explained.
“The data will be examined, and if there is the need for quick additional local studies in Ghanaians, these will be done. It is then, and only then, that the FDA and its technical advisory committees will, on behalf of the Minister of Health, give approval for this vaccine to be used in Ghana if the data provide assurance that the vaccine is safe and that the benefits obtained by deploying it in Ghana far outweigh any risk it may pose,” he explained.
On how to get the cooperation of the public that the vaccines to be brought into Ghana would be safe, Prof. Dodoo said the country had one of the strongest pharmacovigilance systems in Africa that could ensure safety.
“For years, the University of Ghana Medical School hosted the WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance and did provide support for several countries in Africa to establish safety monitoring systems for vaccines and medicines,” he indicated.
Again, he said, the FDA had hosted the Ghana National Centre for Pharmacovigilance since 2000 and gained membership of the WHO Programme for International Drug Monitoring in 2001, nearly 20 years ago.
“This year, a WHO Regulatory Assessment exercise carried out on the pharmacovigilance system at the FDA rated it at Level 4 Maturity, the highest attainable level globally,” he said.
In addition to that, he said, the FDA was involved in hands-on vaccine safety monitoring, being one of only three countries to undertake monitoring of the recently deployed malaria vaccine.
“Currently, the roll-out of the malaria vaccine is going well and without any major incidents. The same infrastructure that is used for the malaria vaccine and which has been used for monitoring mass vaccines and medicines administration in Ghana will be used for COVID-19 vaccines, with extra support provided by groups such as the African Collaborating Centre for Pharmacovigilance and Surveillance, which is also based in Accra,” Prof. Dodoo said.