12 November 2025
Respiratory syncytial virus (RSV) is the leading causes of lower respiratory tract infections and mortality among young children across the world. Estimates suggest it causes over 100,000 deaths and 3.6 million hospitalisations each year among children younger than five years old.
But about 97 per cent of all RSV deaths occur in low- and middle-income countries (LMICs), with nearly half of RSV deaths occurring among infants younger than six months.
Supportive care, including hospitalisation and oxygen support, is the main strategy for managing most children with RSV complications. There is no specific approved treatment for the condition – although several phase 2 and 3 trials are ongoing – which highlights the absolutely vital importance of preventative measures.
But the shocking truth is that many healthcare professionals in LMICs, especially in Africa, are simply not aware of the prevalence of RSV. MPP spoke to Pablo Rojo, a paediatrician and clinical researcher at the Hospital 12 de Octubre in Madrid, and member of the Penta and GAP-f networks, about progress and opportunities in RSV prevention.
“We know that many LMICs are not even aware of RSV. As one Rwandan nurse in Cameroon explained ‘We don’t have it in Cameroon. It’s not a problem here. Oh, we don’t have it in Rwanda either. We give the children antibiotics,[1] and that’s about it.’ So I realised then that we were dealing with a disease that medical professionals in LMICs don’t know about.”
There can be no doubt that RSV is a great challenge in LMICs, a challenge that cannot remain unaddressed[2]. Greater awareness about RSV is an obvious first stepping-stone. No antiviral has yet been approved to treat RSV, and LMICs have an opportunity to focus on prevention, where there is promise. Rwanda is a good example of a country investing a good deal in this area, where raising awareness on RSV has become policy by way of a strong connection between the paediatric clinical researchers and the government. Diagnostics for RSV are currently not needed programmatically, but may help quantify the problem and raise awareness in countries where healthcare providers are unaware about the scale of the RSV problem in infants. Once a treatment option becomes available, diagnostics could also become an enabler for treatment rollout.
Prevention can play a crucial role in reducing the burden of RSV among infants as it has been shown to significantly decrease rates of hospitalisation and severe illness. A recent study analysed the rollout in Spain of nirsevimab, a long-acting monoclonal antibody, for preventing severe RSV disease among infants, which is administered at birth.
The report [3] demonstrated that:
Significantly, however, nirsevimab, a patented complex and expensive to produce injectable medicine, is not currently accessible in LMICs, just like another recently-approved RSV prevention monoclonal antibody: clesrovimab. Pablo points out that: “The companies working in the RSV space are a bit different from the ones that work on HIV antiretrovirals, so I think they don’t always fully understand the LMIC market and how to make products affordable at scale in those regions that they mostly consider outside of their commercial interests.” MPP is ready to help companies extend the reach of their great medicines and ensure the best legacy.
MPP has been calling for more action to expand access to RSV monoclonal antibody medicines.
Firstly, in October 2024, The Lancet Global Health published a MPP co-authored paper entitled Access to highly effective long-acting RSV-monoclonal antibodies for children in LMICs—reducing global inequity. This emphasised the need for strategies to prevent severe RSV in infants, as well as calling for access to these preventative medicines to be prioritised for LMICs.
Availability and enablers of access to long-acting preventive RSV mAbs for infants in high- and low- and middle-income countries
Global RSV burden estimates in infants 0-6 months are mismatched with the current mAb availability (i.e. country registration updated until [date]) in HICs and LMICs. Out-of-hospital deaths for infants 0-6 months were estimated based on the in:out-hospital death ratio of 1:3:86 calculated for children aged 0-60 months. Figure created with Biorender.com [5]
Furthermore, MPP’s model has been shown to be applicable to the biologics and monoclonal antibody space, as evidenced by two major pieces of work that have also been published: Expanding access to biotherapeutics in low-income and middle-income countries through public health non-exclusive voluntary intellectual property licensing: Considerations, requirements, and opportunities in the Lancet Global Health; and in PLOS Global Public Health with Novel approaches to enable equitable access to monoclonal antibodies in low- and middle-income countries.
The cost of producing a single 50 mg dose of mAbs could range from US$ 5 to US$ 10, with higher volume production potentially lowering costs further through economies of scale [6]. This suggests that affordable pricing could be feasible in many LMICs. An MPP intervention combining voluntary licensing and technology transfer would have the potential to accelerate the broad adoption of these life-saving prevention tools.
A recent Paediatric Drug Optimization (PADO) exercise, undertaken by GAP-f and WHO, and following consensus by international RSV experts, saw the addition of nirsevimab and clesrovimab to the PADO priority list [7]; with one mAb still in development, TNM001, added to the PADO Watch List.
The PADO for RSV group emphasised the need for innovators of antiviral agents that are being investigated for the prevention or treatment of RSV infection, especially innovators investigating new molecular entities, to engage with public health organisations to define solid, broad and transparent access plans for LMICs, which have most of the RSV-related morbidity and mortality burden. Previously, the WHO Strategic Advisory Group of Experts on Immunization (SAGE) had recommended that countries introduce health products (including monoclonal antibodies) to prevent RSV in infants.[8]
While cost-effectiveness currently largely favours RSV maternal vaccines that pass through the mother to protect the unborn infants, biosimilar competition could lower the cost of RSV mAbs – which offer interesting at-birth delivery advantages and possibly higher efficacy – and make these more attractive in terms of cost-effectiveness. The RSV maternal vaccine has now been approved for supply through Gavi.[9][10]
Pablo points out: “One important challenge related to a maternal vaccine in Africa is the problem with maternal follow-up of the pregnancy. I think healthcare providers should give infants and mothers whatever is available and most cost-effective. We should focus on the joint immunisation of the mother and the child, depending on the strategy that works best in a given setting.”
A move to voluntary licensing – that is, an agreement with originator pharmaceutical companies for MPP to recruit and support the development and rollout of competing, quality-assured and more affordable generic versions – will likely help with greater access, but this move alone will not shift the dial enough.
Local epidemiological data should be generated and disseminated to first inform interventions and subsequently convince policymakers and funders to invest in RSV prevention and care – and healthcare workers to implement corresponding RSV prevention policies. Access to diagnostics, which will be required for creating the data, should be improved, with support for developing and distributing simple, low-cost, point-of-care RSV diagnostic tests, especially for rural clinics.
Health systems’ and health care professionals will need to be trained and education increased. This can be developed by distributing easy-to-follow, context-appropriate RSV management guidelines for healthcare workers and increasing public awareness of RSV prevention.The RSV Roadshow Web Series[11], hosted by WHO in collaboration with PATH and the ReSViNET Foundation, led dynamic and educational discussions, raising awareness about the opportunity and urgency of preventing RSV. Seven educational web events have covered RSV disease and burden, new immunisation products and delivery considerations, and much else besides.
“This is a big challenge,” says Pablo, “But one day soon we shall see the deployment of nirsevimab , clesrovimab, and similar medicines as a way of preventing RSV in infants worldwide, including where the burden is greatest: in LMICs. I am convinced that MPP-facilitated voluntary licensing can be a crucial mechanism for getting us there, and I expect MPP to be at the forefront of this crucial effort – together with the companies having developed these wonder medicines.”
Innovator pharmaceutical companies have a golden opportunity to be at the forefront, having developed medicines that can make a profound and lasting difference in reducing the prevalence of RSV in LMICs.
MPP’s work on reducing RSV is one of several priorities for tackling the health burden for children in LMICs. Other MPP therapeutic priorities for children in LMICs include treatments for malaria, low grade gliomas, and cystic fibrosis, as well as HIV post-natal prophylaxis. Various products for these conditions are high on MPP’s Prioritisation Framework, and we remain fully committed to the cause of better paediatric health across LMICs.
——————————————
[1] Antibiotics are not effective against viral infections, such as RSV.
[2] The Need for RSV Prophylaxis in LMICs, Pediatrics journal, October 2024.
[3] European Journal of Pediatrics, Respiratory Syncytial Virus – related lower respiratory tract infection hospitalizations in infants receiving nirsevimab in Galicia (Spain): the NIRSE-GAL study, 02 May 2025.
[4] Eurosurveillance, Early estimates of nirsevimab immunoprophylaxis effectiveness against hospital admission for respiratory syncytial virus lower respiratory tract infections in infants, Spain, October 2023 to January 2024.
[5] Diagram adapted from original source: Lancet Global Health Access to highly effective long-acting RSV-monoclonal antibodies for children in LMICs—reducing global inequity, October 2024.
[6] Wellcome, IAVI. Expanding access to monoclonal antibody-based products. A global call to action. 2020.
[7] Paediatric drug optimization for respiratory syncytial virus: meeting report, April 2025
[8] WHO, Highlights from the Meeting of the Strategic Advisory Group of Experts (SAGE) on Immunization, 23-26 September 2024
[9] Gavi Board Focuses Health Impact Priority Guiding Principle Resource Constrained, Gavi press release, 25 July 2025.
[10] How Gavi support for RSV will advance health equity, The Lancet, July 2025
[11] WHO RSV Roadshow Web Series and PATH, On the verge of RSV disease prevention: A communications toolkit
Press and Media
The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to and facilitate the development of life-saving medicines for low- and middle-income countries. Through its innovative business model, MPP partners with civil society, governments, international organisations, industry, patient groups, and other stakeholders to prioritise and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations.
To date, MPP has signed agreements with 22 patent holders for 13 HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals, a tuberculosis treatment, a cancer treatment, four long-acting technologies, a post-partum haemorrhage medicine, three oral antiviral treatments for COVID-19 and 16 COVID-19 technologies.
MPP was founded by Unitaid, which continues to be MPP’s main funder. MPP’s work on access to essential medicines is also funded by the Swiss Agency for Development and Cooperation (SDC), Government of Canada, the World Intellectual Property Organization (WIPO) and the Government of Flanders. MPP’s activities in COVID-19 are undertaken with the financial support of the Japanese Government, the French Ministry for Europe and Foreign Affairs, the German Agency for International Cooperation, and SDC.