2022 Emerging Health Technologies Media Award
Month: May 2023
World Malaria Report 2022
Can Monoclonal Antibody Medical Products Boost the Fight Against Malaria in Africa?
Author: Sandra Y. Oketch
Malaria parasite attaching to human red blood cells. Photo credit: NIAID
In 2021, the World Health Organization (WHO) estimated 247 million malaria cases and 619,000 malaria deaths globally. Most of this burden befell Africa, where children less than 5 years of age and pregnant women were the most affected.
Malaria prevention strategies face many threats, including resistance of malaria parasites to antimalarial drugs, vector resistance to insecticides, and missed malaria infections due to the inability of often trusted rapid diagnostic tests (RDTs) to detect the Plasmodium falciparum parasite. An additional threat is the funding gap for malaria, where the money invested in malaria control and elimination efforts is far less than the resources needed. Furthermore, service disruptions from pandemics such as COVID-19 and other humanitarian/health emergencies are major drawbacks in the malaria elimination efforts. Importantly, an invasive mosquito species, namely Anopheles stephensi, entered Africa in the last decade. This invasive species, which is considered an efficient urban malaria vector, is reported to be resistant to many of the insecticides used in public health, thereby posing an added challenge to malaria elimination efforts on the continent.
mAbs recommendation for malaria prevention
The WHO Global Malaria Programme has recommended the need to intensify research and development of new technological tools with the ability to take us to elimination. Among these new tools being developed are monoclonal antibodies (mAbs).Monoclonal antibodies work through preventing the multiplication of the parasites in the blood and decreasing the number of parasites hence averting clinical disease.
Early-stage clinical trials for malaria mAbs conducted in Mali and Kenya have shown promising results, including demonstrated high efficacy, safety and tolerability. For example, the clinical trial conducted in Mali in 2021 found the mAbs to be protective against P. falciparum infection with 88.2% efficacy over a 6-month malaria season without evident safety concerns.
Potential gains for mAbs use in malaria prevention
There are several reasons why the addition of mAbs to the malaria control arsenal will be a good thing. First, mAbs could be used to provide protection from malaria in cases where there is increased antimalarial drug resistance. Secondly, being a single-dose application coupled with the fact that they will potentially confer protection over a longer period of time (up to 6 months or more) gives mAbs an edge over currently used antimalarial drugs, which have a complex drug regimen with potential adherence issues. Thirdly, mAbs offer higher efficacy (88.2%) in comparison to the current WHO-recommended RTS, S/AS01 vaccine, which has moderate efficacy of approximately 30%. Additionally, mAbs compare better to the next generation R21/Matrix-M vaccine, which recorded a 74% efficacy rate from a randomised control trial. What is more, is that mAbs have a single-dose regimen compared to the three-dose regimen for the R21 malaria vaccine.
Barriers to mAbs use and access in Africa
Globally, there is only a handful of licenced mAbs for infectious diseases such as scabies, Ebola and respiratory syncytial virus (RSV). However, there is very limited access to mAbs in Africa, with the continent having only 20% of the mAbs market compared to 80% in high-income countries in other continents. The challenges hindering access to mAbs in Africa include: (a) lack of awareness by governments and policymakers on the broad potential that mAbs offer to treat and prevent diseases, (b) lack of capacity by drug and pharmaceuticals regulators in evaluating the mAbs for market authorization, (c) variation in the drug and pharmaceuticals registration requirements with very long wait times across national authorities, making the African market unattractive for manufacturers, and (d) high prohibitive costs occasioned by expensive manufacturing processes limit mAbs availability to the small segment of the population can afford them.
Increasing mAbs access in Africa
There is an urgent need to increase awareness of the potential of mAbs in preventing and treating malaria. Engaging in advocacy efforts will potentially lead to deliberate conversations and actions on prioritisations, commitments and investments in mAbs by African governments and policymakers.
To address the regulatory capacity constraints, collaborative partnerships with accomplished regional institutions such as the African Vaccine Regulatory Forum (AVAREF) will serve to strengthen and sustain the regulatory capacity of biological products through training and harmonization of drug and biopharmaceutical product assessments prior to market authorization.
Strategies to lower the high cost of mAbs include the inclusion of mAbs into the WHO Essential Medicines List (EML), which is a prerequisite step for the WHO prequalification that is used by many countries to guide bulk purchases. This then makes the products available through the national public health systems. Additionally, utilizing business models such as public-private partnerships may bolster local manufacturing and increase investments needed to stimulate industry focus on delivering affordable and accessible mAb products in Africa.
Zero Malaria Is Possible: Ending the Malaria Burden in Africa
In 2015, member states of the World Health Organization (WHO) set an ambitious target of reducing the global malaria burden by 90% by 2030. This target is outlined in the Global Technical Strategy for Malaria 2016-2030, which provides guidance to member states and development partners in scaling up malaria control efforts towards elimination.
Current progress shows that this goal will not be met. With seven years to go, it is important that governments, development partners and communities intensify implementation efforts focusing on most effective malaria control measures and share lessons to enable continuous learning and improvement. A five-part webinar series titled “How Do We End Malaria in Africa?” hosted by the African Institute for Development Policy (AFIDEP), through the Platform for Dialogue and Action on Health Technologies in Africa (Health Tech Platform), sets out to facilitate the sharing of lessons on effective strategies that have potential to accelerate Africa’s progress towards malaria elimination.
The first webinar, held on World Malaria Day April 25, 2023, focused on actions needed to reduce malaria significantly in Africa. The webinar presentation and panel discussion featured government policymakers, political leaders, and malaria experts. Prof. Richard Mukabana, Senior Research and Policy Analyst at AFIDEP, gave a keynote address outlining the status of malaria control efforts and emerging threats, which was followed by a moderated panel discussion featuring: Mr. Shija Joseph Shija, Head of Zanzibar Malaria Elimination Programme (ZAMEP); Dr. Fredros Okumu, Director of Science at the Ifakara Health Institute; Hon. Dr. Timothy Batuwa, Chair of Uganda Parliamentary Forum on Malaria (UPFM); and Dr. Susan Imbahale, Senior Lecturer at the Technical University of Kenya.
Ownership and leadership in elimination efforts
Prof. Mukabana highlighted lessons learned in eliminating malaria from countries in Africa certified as malaria-free by the WHO, with a particular focus on lessons that can be gleaned from Algeria. The country reported its last indigenous case of malaria in 2013 and achieved its certification in 2019. With an estimated 80,000 cases reported annually, malaria had become the country’s main health issue by the 1960s. Over the subsequent 40 years, this number decreased to 28,000 cases per year. A further decline in cases was reported in the 2000s, with just 189 local cases reported between 2000 and 2013.
Among the key things that the Algerian government did was to invest heavily in its malaria programme. Algeria invested in better diagnostic tools and laboratory infrastructure to improve the quality and coverage of case reporting, enabling health officials to track the spread of the disease and respond quickly to outbreaks. Further, it invested in vector control measures such as indoor residual spraying (IRS) and insecticide-treated bed nets (ITNs) to reduce the transmission of malaria. This was complemented by extensive awareness-raising campaigns to educate the public about these measures and deploying trained health workers in communities to improve access to diagnosis and treatment.
Zanzibar is walking a similar path to Algeria with very few or even zero occurrences of local transmission recorded on the Tanzanian island. According to Mr. Shija, Zanzibar has implemented a strong surveillance system to detect and respond to new malaria cases quickly. It has also invested in community engagement to encourage active participation in malaria prevention and control efforts. There is still a significant challenge in addressing imported malaria cases due to its large tourism industry, and Zanzibar is strengthening screening and treatment protocols for travellers, especially those arriving by boat from mainland Tanzania.
In light of this challenge, Dr Okumu stressed the importance of a continental approach to controlling malaria rather than individual efforts by countries. He stated that achieving zero malaria cases will be challenging for countries if their neighbouring countries have not reached zero cases.
It is important to note that most countries that have eliminated malaria in Africa are those with low malaria rates. High-burden countries face challenges such as rising parasite and vector resistance to drugs and insecticides. Hon. Dr. Batuwa, who is leading parliamentarians in fighting malaria in Uganda, noted the value of strong relationships with other stakeholders such as malaria scientists and media. He said that the efforts of the Uganda parliamentary caucus on malaria have benefited greatly from close collaborations with malaria scientists and media.
Larval source management, a demonstrated effective strategy in reducing malaria, has not been prioritised in Africa
Dr. Imbahale noted that in Africa, there is a disproportional focus on indoor vector control interventions (IRS and ITNs), yet these are becoming ineffective due to resistance. She noted that the larval source management (LSM) strategy, which includes methods such as larviciding aquatic habitats where mosquitos breed, was successful in eliminating malaria in other world regions. While the WHO recommends the use of LSM as a supplementary measure for malaria vector control, the strategy has not been prioritised in Africa.
The recently approved malaria vaccine also provides a good avenue for accelerating malaria elimination efforts. Scaling up the roll-out of the vaccines in Africa as well as enabling the local manufacturing of vaccines and other medical products, will help prevent millions of malaria cases and save countless lives. Local manufacturing can help to ensure a reliable supply of vaccines, making it easier to sustain vaccination programmes over the long term. It can also help to build local capacity for research and development. Capacity is also needed in harnessing emerging tools with the potential to eliminate malaria such as gene drive technology for malaria control, which has been prioritised by the Africa Union.
Partnerships and multisectoral approach to elimination efforts
Most African countries are still struggling to eliminate malaria. The discussions from this first webinar highlight the need for countries to employ a multisectoral approach towards malaria control, involving partnerships between different sectors and among stakeholders. The agricultural sector, for instance, contributes to increased malaria transmission through irrigated croplands that enhance the breeding of mosquitoes. Therefore, malaria should no longer be treated as an individual disease case, but a comprehensive development case, with each country applying a suite of complementary and integrated elimination approaches suitable to its context.
But more importantly, as Dr. Okumu challenged, the work must go beyond zero malaria. The goal should be resilient and sustainable health systems, not only for continued malaria-free societies but healthy communities contributing to socioeconomic development.
This is the first of a five-part series on the webinars. Watch the first webinar recording here: https://bit.ly/3LtMP8B (French translation available)