ADP BlogEnsuring the safety of the new malaria vaccine in Ghana and Malawi

Blog By ADP On 22 Apr 2021 Read 964

Health workers with the Ghana Health Service organize a community immunization session where the RTS,S vaccine is delivered alongside other routine vaccines.


Malaria-related illness and death still threaten millions of people around the world.

After modest declines in malaria cases – from 238 million in 2000 to 229 million in 2019 – progress has stalled over the past few years. Only a 3 percent reduction in incidence was achieved in 2019 compared to the 2015 baseline. This is far from the World Health Organization (WHO) Global technical strategy for malaria 2016–2030 milestone of 40 percent reduction by 2020 and much too slow to reach the Sustainable Development Goals (SDGs) target of at least 90 percent reduction by 2030.

An estimated 90 percent of malaria cases occur in Africa, with African children among the most vulnerable to the disease. In 2019, over 250,000 African children under five years of age died of malaria—more than half of all malaria-related deaths worldwide that year.

During the health and economic crises caused by the COVID-19 pandemic, implementation of routine malaria prevention and control activities has been even more challenging. Modelling analysis has predicted a more than 20 percent rise in malaria incidence and a 50 percent increase in malaria-related deaths in sub-Saharan Africa as a result of pandemic-related reductions in routine malaria control measures, such as bed net distribution and shortages of anti-malarial medicines.

Fortunately, a powerful new tool in the global fight against malaria has the potential to save millions of children’s lives. After decades in development, malaria vaccines offer huge promise in combatting one of the world’s oldest diseases. RTS,S is the first malaria vaccine to demonstrate significant reductions in malaria deaths among young children in a large-scale trial. Through an ongoing pilot roll-out programme assessing the vaccine’s efficacy and evaluating its safety, the global health community is one step closer to controlling malaria in sub-Saharan Africa and around the globe.

Of the 10 countries that expressed interest in participating in the pilot, WHO selected Ghana, Kenya and Malawi. Central to this selection was the countries’ ability to closely monitor and report on the safety of RTS,S – which is essential to safeguarding children being vaccinated and to guiding future use of the vaccine.

The pilot is part of the Malaria Vaccine Implementation Programme, MVIP, which was established to support the country-led introduction of the vaccine through their routine immunization programmes.

In each of the countries, the malaria vaccine introduction is being led by the ministries of health, with support from WHO and in-country and international partners including PATH and GlaxoSmithKline, the manufacturer of RTS,S.

Since 2019, 1.7 million doses of the vaccine have been administered to over 650,000 children across the three pilot countries. The pilot seeks to reach 1 million children with the full immunization course of four vaccine doses in the initial 3-year phase.

ADP’s role in ensuring safety in Ghana

It is no small feat to collect data on a four-dose vaccine delivered to hundreds of thousands of children. The UN Development Programme-led Access and Delivery Partnership (ADP) has been helping to strengthen monitoring and evaluation capabilities across varied disciplines and sectors.

During roll out of the RTS,S vaccine in Ghana, monitoring and supervision was provided by district officers to valid RTS,S data and coach staff.
“Within each country, the ADP approach is bringing different institutions together to address common implementation challenges and using multiple approaches,” said Professor Margaret Gyapong, Director of the Institute of Health Research at the University of Health and Allied Sciences. “In Ghana – through the ADP-supported SAVING Consortium – we are building implementation research capacity for pharmacovigilance and related areas to ensure that challenges to access and delivery of new health technologies are identified and addressed.”

Implementation research (IR) is critical to ensuring the safe, effective and timely roll out of the RTS,S vaccine using approaches that are adapted to varying local contexts. ADP has helped to strengthen key institutional capacities for IR in Ghana and development of related research tools.

Another critical aspect of RTS,S rollout is pharmacovigilance, also known as drug safety monitoring. This is the monitoring, assessment and prevention of adverse effects, particularly with new medicines and vaccines. ADP has helped Ghana improve its ability to monitor the safety of the RTS,S vaccine.

During the RTS,S roll out, immunization centres need to anticipate and address the challenges of administering four doses of the vaccine over a period of 18 months. They must also understand how to best conduct safety monitoring for such a complex dosing regimen.

With ADP’s support, Ghana introduced a digital system for drug safety monitoring and trained nearly 1,000 health service staff across the country to ensure the system’s effective use.

“We have been supported in various ways to review our national medicines policy and implementation plan, and to strengthen capacities to monitor and respond to safety issues,” said Prof. Gyapong. As a result, Ghana’s Food and Drug Authority can now effectively monitor the safety of medicines and vaccines, including the new malaria vaccine.

Expanding safety systems in Malawi

In Malawi, the malaria vaccine programme spearheaded the development and integration of national pharmacovigilance capacities. A strong drug safety monitoring system was set up in support of the malaria vaccine pilot before similar systems were in place in other health programmes. ADP was able to build on the pharmacovigilance mechanisms developed for the RTS,S vaccine to help expand Malawi’s drug safety monitoring systems across the wider health system.

As part of its broader support to strengthen the Malawi regulatory system, ADP has worked with the Pharmacy and Medicines Regulatory Authority to establish a national pharmacovigilance centre, strengthen its safety monitoring, and improve reporting channels and tools for health care providers.

In both Malawi and Ghana, ADP ensured full consideration of the cultural, geographic and infrastructure-related pharmacovigilance challenges specific to each country.

“Once WHO provides its recommendation for the widescale use of the RTS,S vaccine (the RTS,S vaccine is currently only recommended for use in pilot programmes), its implementation will pose significant challenges for national malaria programmes,” explained Dr Corinne Merle, a scientist with ADP partner the Special Programme for Research and Training in Tropical Diseases (TDR). “The lessons learned from Ghana and Malawi will be invaluable for other countries to address these challenges and prepare for the mass introduction of the vaccine.”
Effective monitoring and supervision is key to the successful introduction of new health technologies.

ADP plans to widely share the lessons from Ghana and Malawi’s experiences with national malaria programmes across the African continent, so that they have a better understanding of the barriers to scaling up the use of the RTS,S vaccine. All activities to improve vaccine safety conducted by ADP in the African region, as well as the strengthening of implementation research capacities of the ministries of health in these countries, should help facilitate vaccination scale-up across the region. Indeed, many of the lessons being learned from the RTS,S vaccine rollout can inform the planning and implementation of COVID-19 vaccination campaigns that are just now starting in most low- and middle-income countries around the world.

When she considers how ADP, the Ministry of Health, the Food and Drugs Authority worked together to improve Ghana’s safety monitoring, leading to the country being selected as a pilot vaccination site, Prof. Gyapong is effusive about the benefits of working with others.

“So what have we learned? If you want to go fast, go alone; if you want to go far, go together.”

The long road to a malaria vaccine

The RTS,S vaccine was decades in the making, with scientists working on a malaria vaccine since the 1980s. This long-term research would not have been possible without the sustained efforts of the global health community. The collaboration involved global health funding bodies (the Global Fund, Unitaid and Gavi, the Vaccine Alliance), health and development organizations (WHO, PATH and UNICEF) and the pharmaceutical company GSK.

“The malaria vaccine is an exciting innovation that complements the global health community's efforts to end the malaria epidemic,” said Lelio Marmora, Executive Director of Unitaid at the launch of the Malaria Vaccine Implementation Programme. “It is also a shining example of the kind of inter-agency coordination that we need.”

Trials conducted from 2009 to 2014 showed the vaccine provides partial protection against malaria in young African children. Specifically, results showed that four doses of RTS,S prevented about four in ten cases of malaria over four years. It also prevented about three in ten cases of severe malaria, and contributed to a significant drop in hospital admissions.

  
Following the successful trial, vaccinations under the pilot programme began in Malawi on 23 April, in Ghana on 30 April and in Kenya on 13 September, 2019.

Based on evaluation of the trial results, WHO published a position paper for RTS,S in January 2016, adopting the joint recommendation of the Strategic Advisory Group of Experts on Immunization and the Malaria Policy Advisory Committee. WHO recommended that a pilot be conducted in 3-5 epidemiological settings in sub-Saharan Africa with moderate-to-high transmission.

Such a pilot provides more information on the vaccine’s role in reducing childhood deaths, confirms its safety for routine use, and allows for close monitoring for any adverse events following immunization. This data will inform recommendations for its wider use.

Photo credit: Ghana Health Service.

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