Dr. Ruth Owusu on World Malaria Day, 2009

New Tools in the Fight against Malaria

 

Good afternoon.

It is a pleasure for me to take part in this briefing in celebration of World Malaria Day.

My name is Ruth Owusu. I am a research physician and scientist from Ghana, West Africa. I work in Kintampo, a predominantly rural area in the middle belt of Ghana.  Malaria is the major cause of death in children under five in this area and, in fact, in the whole of Ghana. It is also the major reason for both in-patient and out-patient hospital attendance in children. You can understand why today I am grateful for this opportunity to talk about the hope and promise of malaria vaccines in the fight against malaria.

This is a great year for malaria vaccine research and development. Never before has the world been so close to having a malaria vaccine. The investment in malaria vaccines from private donors like the Gates Foundation and from governments in the United States and other donor countries is beginning to pay off for the millions of African children whose very lives may be about to change forever!

The world’s most clinically advanced malaria vaccine, called RTS,S, will enter a Phase 3 clinical trial within the next few months. For any vaccine, this is the final stage of testing before licensure. It is the stage of testing where we collect critical information on safety and efficacy of the vaccine. No malaria vaccine candidate has ever come this far. By 2011, if all goes well, this vaccine could be available for licensure and for use. When we do have a malaria vaccine ready for use, it would be a major scientific breakthrough: the first ever human vaccine against a parasite. This is a feat that has eluded scientists for decades.

I can understand if policymakers who are grappling with the global economic downturn do not want to hear about another issue that requires yet more money. However, if it is money we are talking about, it is important to know that vaccines have proven to be the most cost-effective public health tool we have, as has been seen with smallpox, measles, polio, and many other diseases. This vaccine has the potential to save hundreds of thousands of precious young lives, improve the national income of African countries, and increase the world’s chances of achieving important Millennium Development Goals.

Today, my remarks on malaria vaccines will focus especially on GlaxoSmithKline Biologicals' RTS,S vaccine and on the Phase 3 clinical trial. And I will briefly discuss why—despite the availability of effective tools against malaria—we still need malaria vaccines. I hope that by the end of my remarks, I would have managed to have whipped up enthusiasm for malaria vaccines and to have convinced you why NOW is the right time to talk about and invest in malaria vaccine R&D.

Before I do that however, permit me to digress a bit and to take you on a journey with me back to the year 2000 so you can understand why I am here today. January 3, 2000 was when I started work as an intern in the Children’s Department of the Korle Bu Teaching Hospital in Accra, Ghana after graduating from medical school. A few weeks earlier, I had sworn the Hippocratic oath together with other classmates: an oath to save lives. The euphoria of the new millennium and of graduation had filled me with vigor to fulfill my oath. On my first day in the emergency ward, the ward was filled to capacity with children who had malaria, severe anemia, diarrhea, and acute respiratory and other infections. By the end of that first day, the euphoria had vanished—not because of physical exhaustion, but  because I had seen children die from preventable and treatable diseases. Malaria was the major culprit.

One day, three weeks into my internship, I held a little girl in my arms, a child who had been brought to us too late to be saved. I was at the breaking point. For my own sanity, I knew I had to make a choice—either to see each young child’s death as an ordinary, everyday event so I could stop caring so much, or to see each death as a tragedy that did not have to happen.

I chose the latter, and that is why, for me, today and any day and any year is a good day and a good year to talk about malaria vaccines, because an effective malaria vaccine would be a tool with the potential to save lives, like that of the little girl whose face I still see every day.

For more than 70 years, scientists have sought to develop a malaria vaccine without much success. That is why the success of the RTS,S vaccine candidate represents hope in the fight against malaria. Development of this malaria vaccine began about 22 years ago and the journey has had its bumps along the way.

The target group for this vaccine is infants and young children living in malaria-endemic regions of Africa. This is because the majority of deaths from malaria occur in children under five. Every thirty seconds, a child dies from malaria.

The vaccine was first tested in adults in the United States at the Walter Reed Army Institute of Research and in Belgium, and then in adults in The Gambia, West Africa. It was then tested in children in The Gambia, Mozambique, Gabon, Tanzania, Ghana, and Kenya.

These trials were mainly to determine the safety of the vaccine and the immune response it elicited. So far, the vaccine has been found to be safe. The trial in Mozambique enrolled 2,000 children ages one to four years and assessed vaccine efficacy—in other words, whether it protects users against getting malaria or from getting the severe form of malaria. Compared with vaccines in use for other diseases, the vaccine efficacy in this trial was modest—49 percent against severe malaria and 35 percent against clinical infection. However, considering that malaria kills close to one million people and causes up to 250 million episodes of illness each year, this level of efficacy would save hundreds of thousands of lives annually.  

Today, the Phase 3 clinical trial is poised to start in 11 research sites in seven African countries and will involve 16,000 children.

This trial is history in the making. The potential benefits to so many people and countries are breathtaking. 

The trial has been designed to answer key questions and challenges surrounding the development and use of a malaria vaccine:

  • Questions on whether it's best to co-administer it with other childhood vaccines.
  • Questions about its efficacy under different malaria transmission settings.
  • Questions about its potential impact on public health systems and on community welfare.

In addition, the Phase 3 trial will address one of the biggest challenges scientists face in developing an effective malaria vaccine: the lack of understanding of how the immune system fights against the malaria parasite. This knowledge will help us develop next-generation malaria vaccines with even greater efficacy.

There is yet another benefit to these trials. Health facilities at the trial sites receive new medical equipment to improve clinical care for their communities. African scientists at various sites have forged partnerships that extend into other areas of malaria control. These scientists have also acquired new skills to engage policymakers, the media, and community members. Lastly, these trials are a source of hope for people living in malaria-endemic countries—a hope that in the near future, one of their greatest sources of pain and poverty will be conquered.

Scientists agree that we need a wide array of tools to fight malaria. There are reasons why no single tool will win the fight, despite the public health gains from anti-malarial drugs, insecticide-treated nets, and indoor residual spraying with insecticides. I salute all the people and nations that are providing resources to scale up these interventions. However, even with all these tools, the malaria disease burden remains astronomical.

The beauty of a malaria vaccine is that most countries have set up effective immunization programs. Even remote communities receive a visit at least once a month by community health nurses to deliver immunizations. Vaccines are widely accepted, and mothers make an effort to get their children vaccinated. Vaccines, unlike bednets, do not require a daily effort on the part of users.

I am encouraged that there has been a paradigm shift from "malaria control" to "malaria eradication." But please understand: there can be no eradication of malaria without a vaccine. We have examples from small pox, measles, and polio to support this.

Ladies and Gentlemen, I acknowledge the many contributions made by the United States in the fight against malaria; the successful President’s Malaria Initiative is a positive legacy of former President George Bush, and we look forward to President Barack Obama continuing support for this effort. Agencies like the US Agency for International Development and the National Institutes of Health have also made important and appreciated contributions. I would not be here today talking about malaria vaccines at all were it not for charitable foundations like the Bill & Melinda Gates Foundation and the ExxonMobil Foundation, and non-profit entities like the PATH Malaria Vaccine Initiative.

I ask you to continue to support the fight against malaria, and in doing so, please remember the malaria vaccine. Supporting further development of malaria vaccines could be our best shot for transforming lives in Africa. 

If in 2012, we do have a malaria vaccine ready for use, that will not be the end of our responsibility. We must make sure that the vaccine becomes available to the children in Africa who need it.

To conclude, permit me to quote what Bill Gates said in 2005 of his investment in immunization: "Supporting children's immunization is undoubtedly the best investment we've ever made."

Ladies and gentlemen, I hope you'll join me in rising to the challenge and doing whatever you can to be part of the drive for effective malaria vaccines.

Thank you.