In this study, we analyzed stakeholders’ perspectives on strategies for introducing a potential TB vaccine. To our knowledge, stakeholder engagement on this topic has not previously been conducted in most high TB burden countries, including Mozambique, despite the fact that vaccine introduction strategies are likely to be country-specific. The few studies conducted so far (16–18) focused on broader implementation strategies and were conducted more than five years ago, during which time funding landscapes and program priorities may have changed.

Overall, participants identified immunocompromised individuals, particularly those living with HIV or diabetes, as well as children and older adults, as being at highest risk of developing TB disease. They also highlighted individuals with increased exposure due to occupation or living conditions, including healthcare workers, miners, TB contacts and incarcerated populations. Finally, people from low-income households were considered at elevated risk of both TB infection and progression to disease, including drug-sensitive and multidrug-resistant TB. While current surveillance systems collect data on the age and diabetes status of people diagnosed with TB, employment, socioeconomic, and carceral status is not routinely recorded. Therefore, engaging stakeholders to identify these high-risk groups is valuable, as this information is not routinely collected in TB surveillance systems in LMICs, including Mozambique, limiting the usefulness of existing data for planning vaccine introduction.

While a new TB vaccine would ideally be offered to all those eligible, financial, logistical, and possible supply constraints may require a prioritization strategy. Our findings suggest that individuals with comorbidities, particularly those living with HIV or diabetes, as well as close contacts of TB patients, should be prioritized for a new TB vaccine in Mozambique. This should be followed by other high-risk groups, including healthcare workers, miners, and, finally, incarcerated populations. A study in South Africa which explored possible introduction strategies for adult and adolescent TB vaccines suggested that a broad introduction in the general population of adults and adolescents would be ideal, but that if necessary, adolescents, due to their perceived high TB burden and transmission potential, followed by people living with HIV and healthcare workers, who face an elevated risk of TB disease, should be prioritized (16). Our findings are similar, highlighting the importance of prioritizing both individuals with comorbidities known to increase risk for TB and those whose occupation places them at high risk. Notably, participants in our study also listed close contacts of TB patients, particularly those under 15 years, as a key priority group in Mozambique. Although participants tended to prioritize younger children, while current TB Vaccine trials target older children. Evidence from studies in Ethiopia and Malawi, a neighbor of Mozambique, indicates that responses to TB care, such as uptake and adherence to TB preventive treatment (TPT), can vary by age, female gender, low education and income, poor patient acceptance, limited drug access, stigma, undernutrition, caregivers’ awareness, adverse drug reactions, and regimen type(19,20) For instance, children aged 2–15 years receiving the shorter 3HP TPT regimen were less likely to interrupt treatment, likely due to its brief duration. In contrast, older children on the 3HR regimen showed higher non-adherence, especially girls, those from low-income families, and urban residents. Healthcare workers also noted difficulties in encouraging asymptomatic household contacts to complete longer TPT courses. While some barriers are particularly pronounced in rural Mozambique - where long distances, high transport costs, limited options, and inadequate health services impede access (21) - these findings highlight the importance of implementing WHO recommendations to decentralize TB preventive services(20)

Furthermore, the prominence of people living with HIV as a key priority group highlights a major challenge for vaccine introduction. Although pivotal trials for M72-AS01_e and MTBVAC may have included people with HIV and the sample sizes were insufficient to establish efficacy in this population (22), vaccine’s efficacy in these populations, as well as among individuals with other comorbidities such as diabetes, remains unknown. Post-licensure studies to assess vaccine effectiveness in these groups will be essential to build the evidence base for their use in these groups.

Respondents reported that vaccine uptake is likely to vary by population group. People living with HIV, close contacts of people with TB, and older adults were expected to achieve relatively high coverage, partly due to their regular contact with health services for follow-up care. Likewise, healthcare workers, incarcerated individuals, formal miners, and in-school adolescents may achieve high coverage because they can be readily identified within structured settings. The South African study similarly noted that adolescents, people living with HIV, and health workers are groups that are highly accessible and likely to accept vaccination. Adolescents could be reached through existing school-based programs, similar to strategies used for human papillomavirus (HPV) vaccination, people living with HIV through their regular engagement with the health system, and via employer-facilitated vaccine programs, particularly those in high-risk occupations such as healthcare and mining (16). Although ease of access and institutional structures were emphasized in our study as facilitating acceptance among high-risk groups, vaccine programs which prioritize incarcerated populations or which involve employment-based vaccination require additional safeguards to ensure individual decision-making autonomy through transparency, clear communication, and the explicit right to refuse vaccination (23). These findings highlight the importance of collaborating with relevant institutions, such as the Ministry of Energy and Natural Resources, mining companies, and other sectoral bodies, to develop policies that promote vaccination without coercion.

In addition to institutional access and control, gender dynamics may further shape expected vaccine uptake. Our findings indicate that women may be more likely than men to accept a TB vaccine, given their greater familiarity with healthcare services. However, gender norms and household power relations may constrain their ability to act on this willingness. Evidence from a gender analysis on vaccine uptake similarly shows that inequalities, often reinforced by male religious leaders and household decision-making structures, strongly influence vaccination decisions. In contexts such as Mozambique, women frequently lack autonomy over their own health or that of their families due to systemic and sociocultural constraints (24,25). Even when women can make decisions, local norms often require male approval (25). Supporting this, USAID’s Gender Analysis for Vaccine Response toolkit reports that only 5% of married or in-union women make their own health decisions, while 78% indicate that their husband primarily decides, and 10% require permission to seek care (26). Although that analysis also identified safety concerns among some women, contrasting with our finding of generally high female acceptance, it underscores that willingness alone may not translate into uptake without addressing underlying gender power dynamics (26).

Our findings suggest that starting with campaign-based strategies combined with mobile brigades, such as door-to-door delivery for adults and school-based delivery for adolescents using a one or a closely spaced two-dose schedule, followed by integration into routine delivery, may be a cost-effective approach, as it can reach large populations within a short period. Supporting this approach, a narrative review of behavioral and social drivers and strategies to optimize vaccine acceptability in Kenya and South Africa recommended that, prior to the introduction of a TB vaccine, government and public health organizations should provide timely digital campaigns for the vaccine using diverse platforms (Facebook, Instagram, X, Reddit, YouTube, TikTok) and various media formats (film, text, etc.) (5). Such campaigns could help to address concerns related to safety, efficacy, or side effects, distrust in government or health authorities, misinformation or lack of information about the vaccine, low perceived risk of disease, religious or cultural incompatibility with vaccines, and social media use for vaccine information (5). This may be particularly important given that mass vaccination campaigns targeting adults and older adults can be challenging, as limited prior experience and potential perceptions of stigmatization may result in lower coverage (17). Furthermore, two similar studies reported that single-dose vaccines were consistently preferred by stakeholders due to ease of delivery, reduced logistical burden, and better adherence, particularly when reflecting on the poor uptake of second doses during COVID-19 (16,17). These results underscore the need to consider the dosing regimen, interval between doses, past experience with adults, sociocultural beliefs and, lastly, available funding when introducing the vaccine.

Future studies should consider perspectives beyond TB and immunization program officials such as budget and financing stakeholders, to ensure broader representation of all relevant decision-makers at the national level.