Interviews among key stakeholders in South Africa to understand the priorities and implementation strategies of a potential new TB vaccine – Data Codebook

Persistent identifier

10.17037/DATA.00004885

Description

Data collected through semi-structured interviews with key stakeholders possessing different expertise and backgrounds to understand their approach to the implementation of a potential new TB vaccine. A total of 26 stakeholders were interviewed during April and May 2025. Interviews were conducted individually or as groups, both online and in-person.

Data collection methods

Semi-structured interviews were conducted with 26 stakeholders during April and May 2025. Stakeholders were interviewed individually or in groups, using online and in-person capture as appropriate. Participant responses were recorded using Slido – a platform to capture real-time responses – by a member of the research team.

Codebook

The dataset contains 122 variables, outlined below.

Variable Name	Variable Label	Answer Label	Answer Code	Variable Type
PID	Participant ID			Numeric
Expertise	Area of Expertise			String
Q1	1. If an efficacious and safe TB vaccine were available, do you think there would be interest in introducing it in your country?			String
		Yes
		No
		Unsure
Q1-comment	Please provide reasons/comments if any			String
Q2	2.a What are the main data points and factors that would influence your country’s decision and timeline to introduce TB vaccines? (Select all that apply and state the rationale)			String
		Vaccination schedule, i.e., one or two doses per fully immunized person
		Route of action of TB vaccines, i.e., intramuscular or intradermal
		Efficacy
		Effectiveness of TB vaccines compared to other TB interventions, e.g., TB preventive treatment
		Local manufacturing
		Local clinical trials
		Price
		Access to external funding
		Projected impact of TB vaccination on the TB epidemic
		Operational requirements e.g., storage temperature
		Others
Q2-other	Q2.a. Other factors			String
Q2-reason	Please provide reasons/comments if any			String
Q2a1	2.a.i. How would the vaccination schedule affect your country’s decision to introduce TB vaccine? Select one option and state why.			String
		Only introduce vaccine with one dose per fully immunized person
		Only introduce vaccine with two doses per fully immunized person
		Introduce whether one or two doses per fully immunized person
		Unsure
Q2a1-comment	Please provide reasons/comments if any			String
Q2a2	2.a.ii. Would the route of action of the vaccines impact your country’s decision on TB vaccine introduction?			String
		Only introduce intramuscular TB vaccines
		Only introduce Intradermal TB vaccines
		Introduce whether intramuscular or intradermal
Q2a2-comment	Please provide reasons/comments if any			String
Q2a3	2.a. iii. Based on WHO’s guidance, efficacy of 50% or greater is preferred for TB vaccines. If efficacy was lower than 50%, would your country introduce the TB vaccine?			String
		Yes
		No
		Unsure
Q2a3-comment	Please provide reasons/comments if any			String
Q2a4	2.a.iv What is the minimum efficacy required for TB vaccines to be considered for introduction in South Africa?			String
		40%
		30%
		20%
		Less than 20%
		Unsure
Q2a4-comment	Please provide reasons/comments if any			String
Q2a6	2.a.vi) Would your country consider prioritizing TB vaccines over TB preventive therapy (TPT)/ other preventative measures?			String
		Yes, TB vaccines would be prioritized over TPT
		Yes, TB vaccines would be prioritised over TPT, but only if the vaccine had certain characteristics (specify which characteristics in the rationale)
		No, TPT would be prioritised over TB vaccines
		No, TPT and vaccines would both be offered (specify how in the rationale)
		Unsure
Q2a6-comment	Please provide reasons/comments if any			String
Q2a7	2.a.vii.What would be the main drivers of preferences between TPT and TB vaccines? (Select all that apply, and prioritise)			String
		Price
		TB vaccine cost effectiveness compared to TPT
		Vaccine efficacy compared to TPT effectiveness
		Vaccine efficacy/safety in target populations compared to TPT
		Anticipated population acceptability (the population may prefer TB vaccines over TPT or vice versa)
		Unsure
Q2a7-comment	More details/ other drivers?			String
Q2a8	2.a.viii. Does your country’s local manufacturing requirement imply that all components of the vaccines (i.e. the antigen and adjuvant) must be locally manufactured?			String
		Yes, all components must be manufactured locally
		No, only some of the vaccine components must be manufactured locally
		Unsure
Q2a8-comment	Please provide reasons/comments if any			String
Q2a9	2.a.ix Will the country delay TB vaccine introduction until there are local clinical trials?			String
		Yes, wait until there are local clinical trial results before introducing TB vaccines
		No, introduce TB vaccines, but wait with widespread scale-up until data from local trials is available
		No, introduce and scale up TB vaccines without local clinical trials
		Unsure
Q2a9-comment	Please provide reasons/comments if any			String
Q2a10a	2.a.x If the efficacy of a TB vaccine is 50% and persists for 10 years, would the option of a vaccine cost of USD 20 equivalent to 364 ZAR/person delay the introduction of the TB vaccine?			String
		Yes, would delay
		No, would not delay
		Unsure
Q2a10a-comment	Please provide reasons/comments if any			String
Q2a10b	2.a.x If the efficacy of a TB vaccine is 50% and persists for 10 years, would the option of a vaccine cost of USD 10 equivalent to ZAR 182/person delay the introduction of the TB vaccine?			String
		Yes, would delay
		No, would not delay
		Unsure
Q2a10b-comment	Please provide reasons/comments if any			String
Q2a10c	2.a.x If the efficacy of a TB vaccine is 50% and persists for 10 years, would the option of a vaccine cost of USD 5 equivalent to ZAR 91/person delay the introduction of the TB vaccine?			String
		Yes, would delay
		No, would not delay
		Unsure
Barrier-politics	Is politics a barrier? If yes, please state why and the potential implications and recommended solutions			String
Barrier-finance	Is financing one of the barriers? If yes, state why and what the the potential implications and recommended solutions are			String
Barrier-regulation	Is regulation a barrier? If yes, please state why and what the potential implications and recommended solutions are			String
Barrier-demand	Is demand a barrier? If yes, please state why and what the potential implications and recommended solutions are			String
Barrier-other	If 'other', please state what the barrier is, why it is a p=barrier and what the potential implications and recommendations are			String
Q3	3. Assuming TB vaccines are licensed, prequalified by WHO and available for purchase by 2030, when do you expect to introduce the vaccines?			String
		Within 0–2 years
		Within 3–5 years
		Within 6–10 years
		Within 11–20 years
		After more than 20 years
Q3-comment	Please provide reasons/comments if any	Unsure		String
Q4	4. What would be South Africa's preferred approach to determine the target population for TB vaccination?			String
		Broad population-based approach e.g., adolescents, adults
		Risk group-based approach i.e., target specific high-risk groups e.g., PLHIV etc.
Q4-comment	Please provide reasons/comments if any			String
Q5	5. Would your country want to introduce TB vaccine to the following populations? (Please select the priority population groups and rank them in order of importance for TB vaccine introduction; also take a moment to note down your priority populations)			String
		Adolescents (12-17 years)
		Adults (18-64 years)
		People over 65 years
		Healthcare workers
		Homeless people
		Household contacts of TB patients
		Immunocompromised/ immunosuppressed people
		Lactating women
		Migrants
		People living in high density areas
		People living in high risk congregate settings
		People living with diabetes
		People living with HIV/AIDS
		People who are malnourished
		People who have previously had TB
		People who have previously had TB; Migrants
		People with unhealthy alcohol use or substance use
		Pregnant women
		Pregnant women; Lactating women
		Refugees
		Other
Q5-other	If other, please state below:			String
Q6a1	6a(i) Where in your country would you roll out the TB vaccine to this population group?			String
		Nationwide
		Specific subnational areas/districts/ settlements
		Other
Q6a1-other	If other, please specify			String
Q6a1-reason	Please provide reasons/comments if any			String
Q6a2	6a(ii) What would be your country’s strategy for delivery of TB vaccines to adolescents (12-17)?			String
		Routine immunization (RI) for age group 12-17 years
		Campaign/Catch-up Immunization for age group 12-17 years
Q6a2-other	Other strategies:			String
Q6a3	6a(iii) What is the reason for targeting this population with this delivery strategy?			String
Q6a4	6a(iv). For RI, what coverage rate would your country aim to achieve? (percentage)			String
Q6a5	6a(v). How long after starting RI would you expect to reach this target RI coverage rate?			String
		1-2 years
		3-5 years
		6-10 years
Q6a6	6a(vi). For campaigns / catch-up, what coverage rate would your country aim to achieve? (percent)			String
Q6a7	6a(vii). How long after starting the campaigns / catch up would you expect to reach this target coverage?			String
		1-2 years
		3-5 years
		6-10 years
		Unsure
Q6a8	6a(viii). In what order will your country implement RI and campaigns/ catch-up?			String
		Implement RI first
		Implement catch up campaigns first
		Implement RI and catch up campaigns in parallel
Q6a9	6a(ix). Feasibility: Eg has the government been able to reach this population with other programs in the past?			String
		Yes
		No
		Unsure
Q6b1	6b(i). Where in your country would you roll-out the TB vaccines to these population groups?			String
		Nationwide
		Specific subnational areas/ districts/ settlements (in which locations?)
Q6b1-other	If other please state:			String
Q6b1-comment	Please provide reasons/comments if any			String
Q6b2	6b(ii). What would be your country’s strategy for delivery of TB vaccines to adults (18-64)?			String
		Campaign/Catch-up Immunization for age group 18-64 years
		Routine immunization (RI) for age group 18-64 years
Q6b2-other	Other strategies
Q6b3	6b(iii). What is the reason for targeting adults (18-64) with this delivery strategy?			String
Q6b4	6b(iv). For RI, what coverage rate would your country aim to achieve? (percentage)			String
Q6b5	6b(v). How long after starting RI would you expect to reach this target RI coverage rate?			String
		1–2 years
		3–5 years
		6–10 years
		>10 years
		Other
Q6b6	6b(vi). For campaigns / catch-up, what coverage rate would your country aim to achieve? (percent)			String
Q6b7	6b(vii). How long after starting the campaigns / catch up would you expect to reach this target coverage?			String
		1–2 years
		3–5 years
		6–10 years
		>10 years
		Other
Q6b8	6b(viii). In what order will your country implement RI and campaigns/ catch-up?			String
		Implement RI first
		Implement catch up campaigns first
		Implement RI and catch up campaigns in parallel
Q6b9	6b(ix). Feasibility: Eg has the government been able to reach this population with other programs in the past?			String
		Yes
		No
		Unsure
Q6C1	6c(i). Where in your country would you roll-out the TB vaccines to these population groups?			String
		Nationwide
		Specific subnational areas/ districts/ settlements (in which locations?)
Q6c1-other	If other please state:			String
Q6c1-reason	Please provide reasons/comments if any			String
Q6c2	6c(ii). What would be your country’s strategy for delivery of TB vaccines to people living with HIV?			String
		Routine immunization (RI) for age group: x-x years (specify)
		Catch up campaigns/ immunization for age group: x-x years (specify)
		Other
Q6c2-other	Other strategies			String
Q6c3	6c(iii). What is the reason for targeting people living with HIV with this delivery strategy?			String
Q6c4	6c(iv). For RI, what coverage rate would your country aim to achieve? (percent)			String
Q6c5	6c(v). How long after starting RI would you expect to reach this target RI coverage rate?			String
		1–2 years
		3–5 years
		6–10 years
		>10 years
		Other
Q6c6	6c(vi). For campaigns / catch-up, what coverage rate would your country aim to achieve? (percent)			String
Q6c7	6c(vii). How long after starting the campaigns / catch up would you expect to reach this target coverage?			String
		1–2 years
		3–5 years
		6–10 years
		>10 years
		Other
Q6c8	6c(viii). In what order will your country implement RI and campaigns/ catch-up?			String
		Implement RI first
		Implement catch up campaigns first
		Implement RI and catch up campaigns in parallel
Q6c9	6c(ix). Feasibility: Eg has the government been able to reach people living with HIV for other programs in the past?			String
		Yes
		No
		Unsure
Q6d1	6d(i). Where in your country would you roll-out the TB vaccines to these population groups?			String
		Nationwide
		Specific subnational areas/ districts/ settlements (in which locations?)
Q6d1-comment	Please provide reasons/comments if any			String
Q6d2	6d (ii). What would be your country’s strategy for delivery of TB vaccines to household contacts of TB patients			String
		Routine immunization (RI) for age group: x-x years (specify)
		Catch up campaigns/ immunization for age group: x-x years (specify)
		Other
Q6d2-other	Other strategies			String
Q6d3	6d (iii) What is the reason for targeting household contacts of TB patients with this delivery strategy?			String
Q6d4	6d (iv). For RI, what coverage rate would your country aim to achieve? (percent)			String
Q6d5	6d(v). How long after starting RI would you expect to reach this target RI coverage rate?			String
		1–2 years
		3–5 years
		6–10 years
		>10 years
		Other
Q6d6	6d(vi). For campaigns / catch-up, what coverage rate would your country aim to achieve?			String
Q6d7	6d (vii). How long after starting the campaigns / catch up would you expect to reach this target coverage?			String
		1–2 years
		3–5 years
		6–10 years
		>10 years
		Other
Q6d8	6d (viii). In what order will your country implement RI and campaigns/ catch-up?			String
		Implement RI first
		Implement catch up campaigns first
		Implement RI and catch up campaigns in parallel
Q6d9	6d(ix). Feasibility: Eg has the government been able to reach household contacts of TB patients for other programs in the past?			String
		Yes
		No
		Unsure
Q6e1	6e (i). Where in your country would you roll-out the TB vaccines to this population groups?			String
		Nationwide
		Specific subnational areas/ districts/ settlements (in which locations?)
Q6e1-other	If other, please specify:			String
Q6e1-comment	Please provide reasons/comments if any			String
Q6e2	6e (ii). What would be your country’s strategy for delivery of TB vaccines to healthcare workers			String
		Routine immunization (RI) for age group: x-x years (specify)
		Catch up campaigns/ immunization for age group: x-x years (specify)
		Other
Q6e4	6e (iv). For RI, what coverage rate would your country aim to achieve? (percent)			String
Q6e5	6e (v). How long after starting RI would you expect to reach this target RI coverage rate?			String
		1–2 years
		3–5 years
		6–10 years
		>10 years
		Other
Q6e6	6e (vi). For campaigns / catch-up, what coverage rate would your country aim to achieve? (percent)			String
Q6e7	6e (vii). How long after starting the campaigns / catch up would you expect to reach this target coverage?			String
		1–2 years
		3–5 years
		6–10 years
		>10 years
		Other
Q6e8	6e (viii). In what order will your country implement RI and campaigns/ catch-up?			String
		Implement RI first
		Implement catch up campaigns first
		Implement RI and catch up campaigns in parallel
Q6e9	6e (ix). Feasibility: Eg has the government been able to reach healthcare workers for other programs in the past?			String
		Yes
		No
		Unsure
Q6f1	6f(i). Where in your country would you roll-out the TB vaccines to this population groups?			String
		Nationwide
		Specific subnational areas/ districts/ settlements (in which locations?)
Q6f2	6f(ii). What would be your country’s strategy for delivery of TB vaccines to people living with diabetes			String
Q6f3	6f(iii) What is the reason for targeting people living with diabetes with this delivery strategy?			String
Q6f4	6f(iv). For RI, what coverage rate would your country aim to achieve? (percent)			String
Q6f8	6f(viii). In what order will your country implement RI and campaigns/ catch-up?			String
		Implement RI first
		Implement catch up campaigns first
		Implement RI and catch up campaigns in parallel
Q6f9	6f(ix). Feasibility: Eg has the government been able to reach people living with diabetes for other programs in the past?			String
		Yes
		No
		Unsure
Q8	8. Under what conditions does your country consider approvals for the off-label use of vaccines? I.e. administering vaccines for an indication, dosage, schedule, or population not specified in its approved labelling			String
Q7a1	7.a.i. In the absence of efficacy data for IGRA negative people by 2030, do you anticipate the TB vaccines will be approved for use in IGRA negative populations in your country?			String
		Yes
		No
		Unsure
Q7a1-comment	Please provide reasons/comments if any			String
Q7a2	7.a.ii. Will IGRA pre-screening be a prerequisite for TB vaccination or would you skip IGRA screening?			String
		IGRA pre-screening will be a pre-requisite for TB vaccination
		IGRA pre-screening will not be a pre-requisite for TB vaccination
		Unsure
Q7a2-comment	Please provide reasons/comments if any			String
Q7a4	7.a.iv. In the absence of efficacy data for PLHIV by 2030, do you anticipate the TB vaccines will be approved for use among people living with HIV in your country?			String
		Yes
		No
		Unsure
Q7a4-reason	Please provide reasons/comments if any			String
Q7ab	7.b. Would concerns of vaccinating individuals with compromised immunity with a live attenuated vaccine prevent your country from vaccinating these populations with a live-attenuated TB vaccine? Recall that safety data for PLHIV will be available			String
		Yes
		No
		Unsure
Q7ab-comment	Please provide reasons/comments if any			String
Q9a	9. What is the average timeline for vaccine registration and do you see the option to fast track the timeline for registration of TB vaccines in South Africa?			String
Q9a-comment	Please provide reasons/comments if any			String
Q9b	9.b. What is the timeline for fast-tracked approvals compared to the normal process for regulatory approval (in business days)?			String
Q10a	10.a. Could you share key lessons from other vaccination or health programs that have targeted similar age groups? What went well?			String
Q10b	10.b. What were some of the challenges?			String
Q10d	10.d. What was done to build demand for these vaccines/health programs (e.g., advertisements, campaigning etc.)?			String
Q17	17) Is there, or will there be, an anticipated financing mechanism available to support the introduction of a new TB vaccine in your country?			String
		Yes
		No
		Unsure
Q17-comment	Please provide reasons/comments if any			String
Q18	18) Are you able to share the approximate governmental budget for the TB programme, the immunisation programme, and/or the HIV programme? If you do not know the budget, do you know where this data could be found?			String
Q19	19.a. Who would need to give approval for reallocation of existing funding or allocation of new funding to cover the resource requirements of this program? What do you think they would consider in making this decision?			String
Q20	20. When thinking about a potential budget for a TB vaccine, do you consider impacts on other areas beyond the direct costs and benefits of this program when thinking about how much to spend?			String