Public health experts in Africa are hailing the recent approval of the R21 Malaria vaccine in Ghana and Nigeria which was developed by the Oxford University’s Jenner Institute in the UK and partners around the world.
Some say the move could put the continent on a path to eradicating the disease, although that will take a long time to achieve.
“It is the beginning of the journey to eradication. But we are nowhere near that yet because eradication should take us to a point where we have herd immunity among the general population…But this is a step towards that,” renowned Ghanaian pharmacist and Development Fellow in Health with the Ghana Centre for Democracy and Development Dr Kwame Sarpong Asiedu, told Joy News in an interview.
He says expanded access to malaria vaccines will help reduce the cost of health care on the continent because the use of vaccines to prevent malaria will be less expensive than the huge amounts spent on treating the disease.
“That is a key thing this vaccine will do and that is why people like myself are excited about it,” he said.
Dr Hubert Amu of the School of Public Health of the University of Health and Allied Sciences in Ghana agrees that the approval is a good move for Africa.
“Malaria has been a problem for sub-Saharan Africa over the decades. So, it is great news that finally a vaccine has been approved for use in Ghana and Africa to prevent the disease,” he told Joy News.
Malaria and deaths
Malaria is difficult to control as it is spread through the bites of infective female Anopheles mosquitoes in poor sanitary conditions.
According to the World Health Organization, more than 247 million people are infected by malaria annually, with associated deaths hovering around 619,000. 95% of all malaria cases worldwide are recorded in Africa.
Africa also accounts for an estimated 96% of all deaths from the disease with 80% of the deaths happening among children below the age of 5.
Symptoms of malaria include fever, headache, and chills. In more severe cases, malaria causes yellow colouring of the eyes and skin (jaundice), as well as anaemia and respiratory challenges.
In worse cases, the disease causes failure of body organs like the kidney, as well as seizures, coma, and eventually death.
Preventing the spread of mosquitoes and malaria treatment medications are used to avoid deaths from the disease but mortality still remains high. Work on malaria vaccines began in the 1960s but they are still not widely available.
Approvals in Ghana and Nigeria
Ghana’s Food and Drugs Authority (FDA) announced last week that it has granted approval for the R21 Malaria vaccine following an extensive series of reviews of non-clinical and clinical data.
Chief executive officer of the authority Delese Mimi Darko said the vaccine has been approved for the immunization of children aged five months to 36 months against malaria caused by Plasmodium Falciparum, which is the deadliest malaria parasite.
The FDA says the evaluation and approval process considered the safety, immunogenicity, and efficacy data generated from five main clinical trials conducted in the United Kingdom, Mali and Burkina Faso, and Tanzania.
The authority says approval of the vaccine was based on a satisfactory evaluation outcome of the quality, safety, and efficacy data submitted to the FDA.
The evaluation of the submission concluded that the benefit of the vaccine significantly outweighs the risk associated with the use of the vaccine. Again, the vaccine has the potential to reduce children under 5 mortality caused by malaria in Africa, the FDA said.
Days after the approval in Ghana, Nigeria’s National Agency for Food and Drug Administration And Control (NAFDAC) also announced it has given provisional approval for the use of the R21 Malaria vaccine. Director-General of NAFDAC Prof. Mojisola Christianah Adeyeye said in a statement that the dossier of the R21 Malaria was subjected to independent review at 2 levels using standards of the World Health Organization before approval.
NAFDAC’s Vaccine Advisory Committee (NEVAC), which is made up of four highly recognized experts scored the dossier as adequate and fully compliant with standards.
The in-house NAFDAC’s Vaccine Review Committee also independently scored the vaccine dossier as satisfactory.
A joint review by members of both committees agreed that overall, the R21 Malaria Vaccine dossier complied substantially with best international standards.
The review also concluded that the data on the R21 Malaria vaccine were robust and met the criteria for efficacy, safety, and quality. It was also adjudged that the vaccine’s known and potential benefits outweigh its known and potential risks, thereby supporting the manufacturer’s recommended use.
The authority says the vaccine will be an additional interventional tool to help the country fight malaria.
The authority however recommended an additional phase 4 clinical trial study in-country given the peculiarity and heterogeneous nature of malaria in Nigeria.
The latest trials show that the vaccine has a 77% efficacy rate. Ghana and Nigeria have approved the vaccines even before data on the final stage of trials being done by the developers are published. But Dr. Sarpong Asiedu says that is not a big issue.
“I don’t think the process is strange. Knowing that work on this span from about the year 2000, there is nothing strange about it…The FDA has seen all the data dating back to 2004 and 2005 because they have been embedded in the process,” he said.
Expected impact of vaccine
A statement from Oxford University’s Jenner Institute following the approval said: “It is hoped that this first crucial step will enable the vaccine to help Ghanaian and African children to effectively combat malaria.”
This breakthrough is a critical step towards reducing over half a million malaria-related deaths annually and improving the health outcomes of millions of people in Africa and beyond, the statement said.
The project’s chief investigator Professor Adrian Hill said the vaccine is a low-dose vaccine that can be manufactured at a mass scale and modest cost, enabling as many as hundreds of millions of doses to be supplied to African countries which are suffering a significant malaria burden.
Serum Institute of India which will manufacture the vaccines says it has already established potential manufacturing capacities of more than 200 million doses annually.
Because of its lower cost, it is expected that the R21 malaria vaccine will be used more popularly than the first approved malaria vaccine, Mosquirix, developed by British firm GSK.
Dr Sarpong Asiedu doesn’t expect the malaria vaccine to suffer the kind of vaccine hesitancy that the Covid-19 vaccine for example suffered in Ghana.
“Ghana has had a very strong and extended program for immunization for childhood diseases… Malaria will just piggyback on those vaccination programs. In that sense, I don’t think there will be a lot of vaccine hesitancy. But we still need a lot of communication,” he said.
Dr Amu says vaccine hesitancy is usually caused by rumours and myths, lack of trust in the health system and healthcare personnel, and difficulty in accessing vaccines.
“To reduce hesitancy level, we need to work with community leaders, pastors, imams… We need to have stakeholder engagement. It shouldn’t be a top-bottom approach where everything is damped on the people. We need to work with the leaders so they can communicate with the people,” he said.
“We need to ensure social education. Education on vaccines should go to the right place,” he added.
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