WHO published three documents in one day about medicines that do not yet exist

On 6 November the World Health Organization published three separate documents. One is about tuberculosis vaccines for adults; one is about cancer medicines for children; one is about paediatric clinical trials generally. They have almost nothing in common clinically, and one thing in common structurally: each is an attempt to write a specification for a product the market has not produced on its own.

The TB vaccine problem is financing, not science

The first document, launched at the G20 Health Ministers Meeting in Limpopo, South Africa, is a first-of-its-kind analysis of the barriers, bottlenecks and market dynamics affecting access to novel TB vaccines for adults and adolescents [s1]. It was developed by the TB Vaccine Accelerator Council's Finance and Access Working Group, co-convened by WHO, the Government of South Africa and Gavi [s1].

The science is finally moving. No new TB vaccine has been licensed in over a century; BCG protects infants against the most serious consequences of TB but offers only limited and variable protection against pulmonary TB in adolescence and adulthood [s1]. As of September 2025, the report counts at least 16 new TB vaccine candidates in clinical development, including six in phase III trials [s1].

The report's projection is that demand will outpace supply in the early years. Global demand is projected to exceed 3 billion regimens between 2030 and 2040, with high-burden countries driving most of it, while supply projections indicate a gap in the initial years after registration [s1]. Procurement costs alone are estimated at US$5–8 billion over the decade 2030–2040, excluding delivery costs and health system strengthening [s1]. There is currently no earmarked funding for novel TB vaccines [s1].

The six proposed solutions are market-shaping rather than scientific: catalytic global financing instruments such as advanced market commitments and volume guarantees; country-level demand forecasts and cost-effectiveness analyses; clarified domestic and donor financing commitments; a coordination platform for supply and demand stakeholders; sharing of non-commercially-sensitive supply information; and technology transfer to at least one manufacturer in each high-burden region [s1].

The prize is stated as modelling, not fact: over 25 years, a vaccine 50% effective at preventing TB disease in adolescents and adults, if approved and rapidly scaled, could avert up to 76 million TB cases, 8.5 million deaths, 42 million courses of antibiotics and up to US$42 billion in household costs [s1].

A discrepancy worth noting

Six days later, WHO's Global Tuberculosis Report 2025 counted 18 vaccine candidates in clinical trials, including six in phase 3, as of August 2025 [s4]. The access report, published earlier, counts at least 16 as of September 2025 [s1]. The later document reports a higher number with an earlier cut-off. Both are WHO publications from the same month; the discrepancy is unexplained in either, and the phase III count of six is the one both agree on.

The children's cancer problem is formulation

The second document defines six target product profiles for child-friendly formulations of essential cancer medicines: cyclophosphamide, etoposide, mercaptopurine, methotrexate, procarbazine and temozolomide [s2].

The gap it addresses is not that these drugs are unavailable. It is that children with cancer often rely on adult formulations that are difficult or impractical to administer, leading to inaccurate dosing and unnecessary treatment risks [s2]. An estimated 400,000 children and adolescents develop cancer each year, and survival remains below 30% in most low- and middle-income countries against over 80% in high-income settings [s2].

The profiles specify what a usable product looks like: flexible dosage forms such as dispersible or orodispersible tablets, minitablets or multiparticulates; formulations stable in hot and humid climates with shelf lives over 24 months; palatable taste profiles tested through validated assessments; clear caregiver instructions including for low-literacy settings; and affordable, sustainable production [s2].

That list is an admission of where the current products fail — a refrigerated, bitter, adult-sized tablet is not a treatment a family in a hot country without reliable power can actually give a child.

The profiles were developed through WHO's Global Accelerator for Paediatric Formulations network, following an expert consultation held virtually in December 2024 and a public consultation in spring 2025 [s2]. WHO's GAP-f lead, Martina Penazzato, is quoted describing paediatric oncology drug development as a field that still trails adult oncology by nearly a decade [s2].

One oddity: the WHO item carries a dateline of "Geneva, October 2025" while being published on 6 November [s2]. Nothing turns on it, but it is the kind of inconsistency worth flagging when citing a launch date.

The trials problem is upstream of both

The third document is a technical report setting a global research agenda for children aged 0–9, following the call in WHO's 2024 best-practice guidance for clinical trials to include under-represented populations [s3]. More than 380 stakeholders contributed 653 research questions, refined to a final list of 172 clinical research priorities spanning infectious diseases, noncommunicable diseases, newborn health, early childhood development and nutrition [s3].

Children remain under-represented in clinical trials, producing gaps in evidence directly applicable to their needs [s3]. That is the same root cause as the formulation gap: a product developed and tested in adults arrives in paediatric practice as an improvisation.

What these three documents can and cannot do

None of them creates supply, funding or a trial. They are specifications and priority lists, and their theory of change is that a clearly stated requirement lowers the risk for whoever might meet it — a manufacturer deciding whether to build a dispersible formulation, a donor deciding whether to guarantee volume.

The reality check arrived six days later. WHO's Global Tuberculosis Report 2025 recorded 1.2 million deaths and an estimated 10.7 million people ill in 2024, with only US$5.9 billion available for prevention, diagnosis and treatment against a US$22 billion annual target set for 2027 [s4]. TB research funding reached US$1.2 billion in 2023, or 24% of its target [s4]. Modelling cited in that report warns long-term cuts to international donor funding could result in up to 2 million additional deaths and 10 million additional people falling ill between 2025 and 2035 [s4].

Specifications are cheap and money is not. Both documents published on 6 November are honest about which of those they are.

What to watch

Whether any manufacturer commits to one of the six paediatric oncology target product profiles, and whether an advanced market commitment for TB vaccines is actually structured before the phase III readouts arrive. Those are the two events that would convert these documents into products.

Sources

• New WHO report urges bold steps for equitable access to novel TB vaccines — World Health Organization, 2025-11-06
• WHO sets new global standard for child-friendly cancer drugs, paving way for industry innovation — World Health Organization, 2025-11-06
• WHO publishes new global research agenda to strengthen paediatric clinical trials — World Health Organization, 2025-11-06
• Global gains in tuberculosis response endangered by funding challenges — World Health Organization, 2025-11-12