“R21 will change the face of the fight against malaria in Africa”

After Nigeria and Ghana, Burkina Faso recently became the third country, via its National Pharmaceutical Regulatory Agency (ANRP), to approve the R21/Matrix-M malaria vaccine. The approval of R21 by a third country comes even before the WHO decides on this vaccine. This denotes the urgency of resorting to a vaccine perceived as a salvation. It must be said that the other means of combating the disease (mosquito nets, drugs, etc.) did not prevent the recording, in 2021, of no less than 247 million cases worldwide, of which 95% in Africa.

If anyone remains who thinks that the R21 inspired by another vaccine, the RTS, S, will accelerate the elimination of malaria, it is Pr Halidou Tinto. This pharmacist is the one who was the main actor in the research of phases 2 and 3 of R21. He is director of the Nanoro Clinical Research Unit in Burkina, which has carried out clinical studies since May 2019, in partnership with three other institutions: the University of Oxford in the United Kingdom, the Institut du India and the American firm Novavax.

What will R21 change in the management of malaria in Burkina Faso? How to support the development of tropical disease research? So many questions among others that Professor Halidou Tinto has agreed to answer. In the meantime, this research director in parasitology at the Institute for Research in Health Sciences (IRSS) of the National Center for Scientific and Technological Research (CNRST) of Burkina will have had time to be the 2021 winner of the “The Name in Science” from the Academic Union of Oxford and to be named the best researcher in health sciences of the year 2021, according to the International Achievements Research Center.

Le Point Afrique: The R21 malaria vaccine has just been approved in Burkina Faso in the wake of Ghana and Nigeria. What’s going to change here in disease management?

Pr Halidou Tinto: First of all, it must be said that R21 is 75% effective. This efficacy has never been reported in the history of malaria vaccinology. This means that we must be able, with this vaccine, to reduce malaria by 75%, which is enormous. This vaccine, if introduced, will therefore certainly change the face of the fight against malaria in the sense that it will considerably reduce the cases of the disease and make it possible to accelerate the agenda for its elimination which is projected for the 2030s. The impact will therefore be significant from a public health point of view for our populations.

Can you tell us about the scientific journey of this vaccine developed with the assistance of the University of Oxford in the United Kingdom, the Serum Institute of India and the Clinical Research Unit of Nanoro in Burkina that you lead?

The R21 vaccine protein was manufactured and synthesized by the University of Oxford in the United Kingdom. This was inspired by the RTS, S protein, this other vaccine which was approved in 2021 by the WHO and which will be deployed next year in different countries. Researchers at the University of Oxford were interested in improving the RTS, S.

After achieving this, the university approached the Nanoro Clinical Research Unit of Burkina, as a center specialized in clinical trials, for a partnership so that we can test this vaccine and say if it is good and usable. safely on children. This is how we initiated phase 2 of the vaccine and this resulted, a year later, in the result of 77% effectiveness. We then moved into phase 3, which is the one that precedes the marketing of the vaccine.

And it is in this perspective of placing on the market that the Serum Institute of India intervenes, which is the largest producer of vaccines in the world with no less than 4 billion doses, all diseases combined, per year. Apart from these three players, there is a fourth, namely the American firm Novavax, which owns the adjuvant we used. This adjuvant is called Matrix-M, hence the full name of the R21/Matrix-M vaccine. The role of the research unit was above all the phase of experimentation and demonstration of the efficacy and safety of the use of the vaccine.

How can we explain that it took so long to arrive at this result when malaria has been one of the main causes of death in Africa for a long time?

The time taken is essentially linked to two things.

The first is that we believe, as research actors, that the means made available to research teams working on malaria are not sufficient. Which means you have to put more resources into it. What clinical research can cost is a lot of money. If we take a protein, the RTS, S for example, which was financed by the Bill

The second, which has taken us so long, is the complexity of the parasite. I remind you that this parasite is a microorganism, a very complex pathogen, with 14 chromosomes, or 8,000 genes. It’s a lot. There are hindrances for functions that no one knows about and we must try to dissect all of this.

To this must be added the very cycle of malaria: the mosquito bites you, injects you with the parasite, the parasite passes through the liver, leaves this organ and enters the bloodstream, tries to enter the red blood cells that it leaves before another mosquito picks it up and injects it into a new person.

There are therefore several stages and it is necessary to be able to tackle the parasite at each of these stages. It is this complexity that has since led to research and it is only very recently that we have begun to see the end of the tunnel with in particular the RTS, S which was recommended in 2021 by the WHO and the R21 which has just been approved by three countries for large-scale use.

You talk about the large scale use of R21 by three countries, what does the WHO say about this vaccine?

At the same time as dossiers were being submitted in African or endemic countries for marketing authorization, the Serum Institute of India submitted a dossier to WHO which is in the process of examine it. In principle, a dossier review meeting should be convened shortly and the participants will decide whether to authorize the use of this vaccine, like the RTS, S. This is an ongoing process. and we hope that before the end of 2023 the WHO will recommend R21.

What can you tell us about the circuit that will be put in place to facilitate its availability for the populations but also the industrial process that will accompany it?

The commercial partner in the development process of this vaccine to which the University of Oxford has assigned the production and commercialization license is the Serum Institute of India. As I said, this institute is the largest vaccine producer in the world. This firm has undertaken to produce, per year, between 180 and 200 million doses of R21, if the latter were to be approved.

We hope that with the recommendation of the WHO, the Gavi initiative, like what has been done with RTS, S, can buy doses of vaccine and offer them to countries so that our populations can benefit from the R21 for free. We hope that this will happen very soon, precisely in 2024.

How will R21 cohabit with RTS,S, which has been declared “safe and effective” by the WHO and of which 18 million doses will be shipped to 12 African countries, including Burkina. Isn’t it a bit late for R21?

I don’t think R21 is a bit late in that you’re talking about 18 million doses of the RTS,S for 12 countries. It is insufficient. Take for example Burkina which has a population of around 20 million and where only 1 million doses of RTS,S are announced.

Those who are mainly affected by malaria and who can therefore be affected by this vaccine are less than 60% of children under 5 years old. This means that we have millions of children in Burkina who need the vaccine. However, with 1 million doses of RTSS, only about 250,000 children will be vaccinated since it takes four booster shots of this vaccine to be effective.

This means that R21 will meet the strong demand from African countries that show interest in vaccinating their populations against malaria. I always say that it is better to have two, three or even four vaccines than one. We have also seen with Covid 19 the plethoric number of vaccines used. For malaria, if we have more than one vaccine, this will make it possible to cover the strong African demand very quickly.

Is there still a long way to go to counter malaria now that we have at least two vaccines on the market? If so, what is it?

Two vaccines are better than one. Two vaccines will allow for better vaccination coverage, and this will have the effect of accelerating the malaria elimination agenda that we have been advocating for so many years. The commitment to zero malaria by 2030 was the slogan of the last World Malaria Day in Burkina. The more children we vaccinate, the better we will reduce transmission and the closer we will go towards this zero objective.

What would you, as a researcher, advocate for better support and development of tropical disease research in our countries?

As a researcher, I don’t think I’m in the best position to say how research on tropical diseases should be supported and developed. This is a decision and a political commitment. What I can advocate, in terms of advocacy, is to call on governments in Africa to take more ownership and commitment in the fight against these types of diseases.

With Covid-19, we have clearly seen that when it comes to protecting populations by vaccinating them, Western countries have favored their populations before Africa. Fortunately, the virus has not killed in Africa at the same level as in Europe, otherwise it would be a disaster. Because Westerners took care to have very good vaccination coverage before thinking of giving the vaccine to African countries. From this point of view, I can say that the Covid-19 has certainly been a health scandal, but this pandemic has been an opportunity for us Africans to realize that we must take our destiny into our own hands in terms of research and production of medicines and vaccines in our countries.

This is an opportunity for me to challenge our governments and, above all, the African Union on this challenge. I was glad to know that recently the process that will operationalize the African Medicines Agency has been activated. This will perhaps allow more and more Africans to take ownership of all the research that will be carried out on the continent and make the right decisions to improve the health of our populations.