Carlo Giaquinto, Professor of Paediatrics, President of the Penta Foundation and coordinator of the Penta ID Network

RSV causes severe illness and pneumonia in young children, particularly in low- and middle-income countries. MPP is exploring how voluntary licensing could support earlier, more affordable access to new RSV medicines. We speak to Carlo Giaquinto, Professor of Paediatrics, President of the Penta Foundation and coordinator of the Penta ID Network, an international research collaboration connecting more than 1,000 healthcare professionals and researchers worldwide, about how to increase access to RSV treatment solutions in LMICs.

Respiratory syncytial virus (RSV) disproportionately affects infants and children under five. The symptoms may seem common enough – a runny nose, cough, fever or reduced appetite – but the damage is much more profound. RSV can cause pneumonia and bronchiolitis which in turn causes breathing difficulties, and in some cases, death or long-term health consequences.

Babies under six months are particularly vulnerable because not only are their airways small but their immune systems are far from fully developed. Very young babies may struggle to maintain oxygen levels. RSV spreads rapidly too, through close contact and contaminated surfaces. And unlike many other conditions, because infection does not lead to lasting immunity, re-infection is a persistent problem.

Vaccines already approved

A vaccine to prevent RSV in infants was first approved in 2023. Maternal vaccination transfers protective antibodies to the baby before birth. RSV monoclonal antibodies (mAbs), of which there are two already quality-approved by Stringent Regulatory Approvals, and a further two recently approved in China, provide direct protection to infants who receive the vaccination at birth. It is hoped that these two interventions will be able to prevent much of the most severe forms of the disease. For children who may not have had access to the preventative vaccine, there are also antivirals in the pipeline for RSV treatment.

Nonetheless, as at the end of 2025, it was estimated by WHO that annually there are approximately 3.6 million RSV-associated hospital admissions of children under five each year, with 100,000 annual deaths. This is startling enough, but low- and middle-income countries (LMICs) are disproportionately affected by RSV, with an astonishing 97 per cent of paediatric deaths occurring in these countries.

High cost of preventative medicines in LMICs

There are several reasons for this. There is limited access to preventative medicines in LMICs, largely because of the high cost. With poor national health infrastructure, many children do not reach a hospital in time, and even if they do, many hospitals in LMICs lack the necessary care facilities, such as a ready availability of oxygen. As the symptoms are very similar to those of other respiratory conditions, limited testing and surveillance make it much more unlikely that RSV will be diagnosed.

Collaboration crucial to RSV response

It is to this end that in June 2026, MPP signed a Memorandum of Understanding with Penta, an international independent scientific network dedicated to maternal and child health. The collaboration will lean on the individual expertise of the two organisations, both of which are crucial to the RSV response in LMICs.

Penta will focus on paediatric clinical research, the design of clinical trials, and evidence-generation. MPP’s work will cover voluntary licensing, intellectual property management and access strategies. Working together, the result will be a vital and necessary connection between prevention, diagnosis and treatment.

‘We have a solution’

As Professor Giaquinto makes clear, now is exactly the right time to work towards greater access to RSV medicines in LMICs. As he explains: “RSV is extremely important because now we have a solution. There are two very, very effective interventions [the maternal vaccine and the mAbs] which can dramatically reduce the risk of infection and mortality in the first year of life. Since their introduction in high-income countries, there’s been a really dramatic decrease in the number of cases, and also in terms of mortality.”

“A very large clinical trial for RSV was completed three years ago in South Africa. It was shown to be extremely effective in reducing infant mortality and morbidity. Unfortunately it is still unaffordable to have a global mass vaccination strategy in South Africa, and Africa in general.”

Lessons learnt from early clinical experience in HIV

Professor Giaquinto emphasises that access strategies must be embedded at the beginning of the intervention process, and not tacked on as an ‘afterthought’ – an approach that is also central to MPP’s model.

He cites his early clinical experience in the HIV field, where he says he learnt that, “In the 1980s and 1990s, a classical medical approach was completely insufficient to meet the needs of paediatric and family disease. A multidisciplinary approach and a global reach are absolutely essential. We have to work together with the communities to tackle not just sexually transmitted diseases, but also infectious diseases in general, as well as chronic diseases.”

Practical value of involving affected populations early in research

Penta is now undertaking studies to evaluate different strategies to address the disease burden of  RSV, with access considerations built in from the outset. More broadly, Penta’s experience shows the practical value of involving affected populations early in the research process. Through Penta Youth Trial Boards, young people have contributed to the design of paediatric studies, including recruitment approaches and participant-facing materials.

This has helped make trials more inclusive, accessible and responsive to participants’ needs. While patient and community involvement does not replace the regulatory, licensing or affordability components of an access strategy, it can help identify barriers to participation, acceptability and potential uptake before these become embedded in the study design and subsequent implementation.

Penta will contribute evidence on paediatric needs, trial feasibility and the populations that could benefit most, while MPP will assess the implications for voluntary licensing, regulatory pathways and broader access.

Rationale for choosing one drug over another

“This is all really essential in helping MPP to prioritise which type of drug to work on for voluntary licensing, and which type of population should be targeted,” Professor Giaquinto continues. “We are going to provide MPP with the rationale for prioritising one drug over another.”

MPP and Penta have already approached several companies regarding access in many LMICs, to ascertain if these companies might be interested in undertaking a large drug trial in Africa. These trials would support broader registration, policy changes and programmatic uptake.

Working with companies to set up registration pathways

“MPP’s role is also to work with us to identify and enter into discussions with innovators, who might have an excellent drug, but one that is not yet accessible in LMICs. MPP would then work with the companies to ensure access through voluntary licensing and provide the guidance on registration pathways, such as WHO pre-qualification,” Professor Gianquinto concludes.

Drug trials need first to be undertaken to generate evidence in LMICs, and eventually roll-out – where it matters most. But both Penta and MPP can only do so much. Governments, funders and product developers need to play their part in creating affordable access to life-saving products in LMICs. That can only mean engaging from the start of the process and establishing access plans in good time.