Just when Africans who bear the major brunt of malaria episodes were about to heave a sigh of relief that the much anticipated vaccine in the works would help to reduce their agony, then came the devastating news that the efficacy has reduced somewhat from what it was a year ago during the clinical trials. WINIFRED OGBEBO wonders in this report when the big break would come.
Malaria kills approximately 655,000 people a year worldwide and causes illness in hundreds of millions more. Most of them are children under the age of five in sub-Saharan Africa. It is a huge burden on the health and economic growth of Africa. In the past years, the federal government has made several interventions to fight malaria and yet many cases of the deadly disease are still being recorded.
Even with huge funds from within and outside Nigeria, malaria has continued to be a huge public health problem in the country with high risk of the infection taking its toll on children, pregnant women and the aged. It is estimated that over seventy per cent of the Nigerian population experience at least one bout of malaria attack yearly.
The consequences of these attacks on the nation include disruptions in production, absenteeism from school and work, economic waste and loss of human lives estimated at 225,000 deaths with most of them under five years of age. To assist in eradication the disease in Nigeria, the World Health Organisation (WHO), Global Fund and other international agencies in their programmes to fight HIV/AIDS, Tuberculosis (TB) and Malaria were estimated to be spending over $20 billion yearly in the procurement of drugs for the three diseases alone.
Specifically, Global Fund' grants in Nigeria for the fight against HIV/AIDS, TB and Malaria have hit $ 980 million since its first grant in the year 2004.The major recipients of these grants included Christian Health Association of Nigeria, Association for Reproductive and Family Health (ARFH), National Agency for Control of AIDS (NACA), Institute of Human Virology Nigeria, National Malaria Control Programme (NMCP), Civil Society for HIV/AIDS in Nigeria, Planned Parenthood Federation of Nigeria (PPFN) and Society for Family Health (SFH).
In 2009, Global Fund provided $285 million to Nigeria to facilitate distribution of 61 million insecticide treated nets and provision of antimalarials worth 56 million for malaria treatments. The Round 2 grant was signed on October 22nd, 2004 amounting to $20.9 million to support 12 states including Yobe, Taraba, Plateau, Kwara, Zamfara, Kaduna, Ekiti, Lagos, Ebonyi, Imo, Cross River and Delta States and to strengthen programme management at Federal level.
Some of the objectives of the Round 2 grant was procuring and distributing 3 million ITNs to 2 million under five children and 1 million pregnant women within 2 years and, procuring and distributing 4 million doses of Artemisinin Based Combination Therapy (ACTs) to under five children for treatment of malaria within 2 years, providing 1 million doses of IPT to 500,000 pregnant women through public and private sectors.
It also involves training of 2,220 health care workers (Tertiary, Secondary, Primary and Private Sector) in all the selected states on correct ITNs use and Re-treatment, Intermittent Preventive Treatment and training of 444 store officers on correct drug management.
The Round 4 Grant was signed on December 3, 2004 amounting to $20.47 million aiming to reduce malaria morbidity and mortality in children under five years of age through improving case management of malaria in 6 states including Bayelsa, Borno, Enugu, FCT, Oyo and Sokoto. The Phase 2 of the Round 4 Malaria grant from Global Fund in 2007 totalling $61.67 million was for scaling up malaria control in 18 states in Nigeria. The Principal Recipients of the grant were Yakubu Gowon Centre (YGC) - $31.03 million and SFH - $30.64 million.
The objectives of the grant included provision of 26,881,101 treatment courses of ACT, distributing 4,182,116 long lasting insecticide nets to children under five and pregnant women and improving intermittent preventive treatment of malaria in pregnancy with 4,210,907 treatment courses over the 5 year life time of the project. Other challenges and obstacles encountered by the interventions to eradicate malaria in Nigeria over the years included use of population projections and morbidity data for quantification without taking cognizance of health seeking behaviour, lack of data due non-experience with ACTs resulted in the initial push of the medicines down the supply chain based on population projections and estimates i.e inaccurate forecasts.
There were also challenges in data collection and transmission especially from the health facilities to the LGAs, States and National office, incomplete and delayed reporting from the states. At the occasion, the Chairman of Friends Africa, Mr. Aigboje Aig-Imoukhuede maintained that Global Fund has been extremely effective in mobilizing billions of dollars towards the fight against the three pandemics of HIV/AIDS, Malaria and Tuberculosis in Nigeria.
He said: "As we know, almost a billion dollar has actually been mobilized towards Africa, and Nigeria in particular since the Global fund commenced its activities and with additional over 200 hundred million dollars, we are saying we have crossed the 1billion dollar funding request for Nigeria. I think this is a phenomenal achievement and I think the role of the Friends Africa, an advocate for African countries who benefit from the fund, must be well recorded."
In 2001, the MVI entered into partnership with GSK to study the vaccine candidate's ability to protect young children in sub-Saharan Africa. Over time, the partnership expanded to include the 11 African research centres and, in some instances, associated scientific institutions from Europe and the United States.
RTSS is a scientific name given to this malaria vaccine candidate6 and represents the composition of this vaccine candidate. RTS,S aims to trigger the immune system to defend against Plasmodium falciparum malaria parasite when it first enters the human host's bloodstream and/or when the parasite infects liver cells. It is designed to prevent the parasite from infecting, maturing, and multiplying in the liver, after which time the parasite would re-enter the bloodstream and infect red blood cells, leading to disease symptoms. In the Phase III efficacy trial, RTS,S is administered in three doses, one month apart. A booster dose administered 18 months after the third dose is also being studied in the trial.
The vaccine, based on a protein first identified in the laboratory of Drs Ruth and Victor Nussenzweig at New York University, was invented, developed, and manufactured in laboratories at GSK Vaccines in Belgium in the late 1980s and initially tested in US volunteers as part of a collaboration with the US Walter Reed Army Institute of Research. With more than US$200 million in grant monies from the Bill & Melinda Gates Foundation, MVI contributes financial, scientific, managerial, and field expertise to the development of RTS,S.
GSK takes the lead in the overall development of RTS,S and has invested more than $300 million to date and expects to invest more than $200 million before the completion of the project. However, according to the reports published in the New England Journal of Medicine last week , the trial results show a reduction in malaria by approximately one-third in African infants aged 6 to 12 weeks; this is lower than that seen in the older age group a year ago.
The results also showed there was no overall increase in reporting of serious adverse events in the infants vaccinated with RTS,S, demonstrating an acceptable safety and tolerability profile.However, when administered along with standard childhood vaccines, the efficacy of RTS,S in infants aged 6 to 12 weeks (at first vaccination) against clinical and severe malaria was 31% and 37%,3 respectively, over 12 months of follow-up after the third vaccine dose.
The efficacy observed with RTS,S last year in children aged 5-17 months of age against clinical and severe malaria was 56% and 47%, respectively.
One of the researchers, Dr Abdulla, said, "The efficacy is lower than what we saw last year with the older 5-17 month age category, which surprised some of us scientists at the African trial sites. It makes us even more eager to gather and analyze more data from the trial to determine what factors might influence efficacy against malaria and to better understand the potential of RTS,S in our battle against this devastating disease. We were also glad to see that the study indicated that RTS,S could be administered to young infants along with standard childhood vaccines and that side effects were similar to what we would see with those vaccines." The Director of the PATH Malaria Vaccine Initiative, David Kaslow noted that determining the role of RTS,S in Africa will depend on analyses of additional data.
" We are now an important step closer to that day. Success in developing malaria vaccines depends on many factors: at the top of the list are partnerships and robust evidence, coupled with an understanding that different combinations of tools to fight malaria will be appropriate in different settings in malaria-endemic countries."
Although the co-founder of Bill and Melinda Gates Foundation and one of the major contributors to the vaccine project, Bill Gatest commended the research, he called for more study, saying,"This is an important scientific milestone and needs more study," He, however, noted, "The efficacy came back lower than we had hoped, but developing a vaccine against a parasite is a very hard thing to do. The trial is continuing and we look forward to getting more data to help determine whether and how to deploy this vaccine."
The trial sites are in Burkina Faso, Ghana, Gabon, Kenya, Tanzania, Malawi and Mozambique. The final data is expected in 2014.