CFIR Domain and Construct: Intervention Source (Intervention Characteristics)
Barriers Facilitators
Region-wide contention on external vaccine inspections and regulations (1)
"[...] trying to get [trials] done for the first time was a challenge, it wasn't easy at all. Getting countries to agree that they could do something together, both ethics committees and national regulatory authorities. So there, again, because it was the first time that was quite a challenge" (Int #13)
CFIR Domain and Construct: Adaptability (Intervention Characteristics)
Barriers Facilitators
FDA-approved technology transfer for the vaccine to Serum Institute of India (1)
"So, the technology was actually made available from the FDA. A group working extensively with the FDA had developed a technology for conjugation of the protein to the polysaccharide, which is the foundation for the vaccine, and that technology was made available to Marc and his crew, put together for the
creation of this vaccine, at no cost" (Int #10)
CFIR Domain and Construct: Trialability (Intervention Characteristics)
Barriers Facilitators
Acceptance of clinical trials in a few African countries (2)
"I would say colleagues at WHO, the partnership with WHO, was a great facilitator for the clinical trials, for the acceptance of the clinical trials in Africa. [...] we have to say that facilitators were also many African doctors who really helped trusted us and really made us a lot of credit, they had credit" (Int #18)
CFIR Domain and Construct: Complexity (Intervention Characteristics)
Barriers Facilitators
Complexities and delays in production of vaccines (2)
"So only one manufacturer, one manufacturer is producing the vaccine. We had the challenge, at the beginning was that we don't have enough vaccine to cover all the 26 countries." (Int #17)
Complexities and delays in vaccine development (2)
"[...] Some of the challenges were with the actual vaccine development.
[...] the challenge with, you know, starting off with one kind of technology and they left the project and we had to find another one." (Int #11)
CFIR Domain and Construct: Design Quality and Packaging (Intervention Characteristics)
Barriers Facilitators
Narrow-scope vaccine immunity (Single serogroup) (2)
"Yes, the other challenge also is that the vaccine protects against one serogroup, the meningococcal Meningitis A. So doesn't protect against B, C, X, Y and Z [...] Even now that we have eliminated MenA, we still have Meningitis cases" (Int #7)
Cold-chain independent vaccine (1)
"It was a vaccine that was able to be provided outside of the cold-chain, which was critical in terms of getting it out to people who needed it in remote areas" (Int #16)
CFIR Domain and Construct: Cost (Intervention Characteristics)
Barriers Facilitators
Delay in EPI uptake due to lack of funding from the Gates Foundation and GAVI (1)
"Some of the issues is that near the end we ran out of additional grants from the Gates Foundation and therefore became much more defeated to find money and by that time the Gates Foundation had grown and were not willing to give us money without strings attached. So we had a hard time, we struggled to get the money for the completion pediatric program. We had difficulties also with Gavi" (Int #14)
CFIR Domain and Construct: External Policy and Incentives (Outer Setting)
Barriers Facilitators
Increasing control of funds from Gates Foundation (1)
"[…] adapting to the changing environment and approach of the Gates Foundation as the project grew and also became more complex, was a challenge, definitely, was a challenge" (Int #16)
Funding flexibility and autonomy early in project (1)
"The Gates Foundation, which was its beginning at that time because they didn't have human capacity at the foundation, decided to give us money in one go. So from the beginning the money was available. There was no chance from the donor to micromanage, to try to influence, to whatever. The money was out" (Int #14)
De-recognition of Indian regulators (2)
"Unfortunately, I think there was a situation in India at that time in 2007 or 2008, when the national control authority was de-recognised by the WHO, and that was one of the major setbacks" (Int #1)
Delay in individual country licensing/vaccine registration (1)
"We brought the countries together to do their reviews of these assessment reports with the support of WHO prequalification, and it came to going back now to the countries for each individual country to license the vaccine or register its use to be in their campaigns which were used to introduce the vaccine. Of course, some of the countries took a while to do this" (Int #13)
CFIR Domain and Construct: Structural Characteristics (Inner Setting)
Barriers Facilitators
WHO's respected reputation (1)
"The African Regional Offices and Country Offices for WHO are highly respected and have a lot of authority in those areas. So working closely with them and being based in Geneva and having them as a partner was critical" (Int #16)
CFIR Domain and Construct: Tension for Change (Inner Setting)
Barriers Facilitators
Unwillingness of neighbouring governments (low-risk countries) to adopt the vaccine (1)
l was to eliminate, so to also vaccinate all the surrounding countries of all the risk countries. For example, Uganda is a high-risk country for meningitis, so Tanzania was supposed to also be vaccinated.
[...] They say that the risk is low" (Int #3)
Commitment and advocacy of African leaders (8)
"The partnership with the leaders of the African countries who made a commitment, a verbal commitment to see this forward because of the magnitude and threat this had for their nations and their peoples" (Int #2)
Delays in routine vaccine introduction (1)
"[...] So we really there was a lot of momentum to get that vaccine out there in the form of a mass preventive campaign but the problem was that now that we see that decoupling, we have countries that even though the WHO recommendation is to introduce in their routine the maximum five years after they've done the mass preventive campaign, we're seeing countries that are delaying the introduction for much longer than that" (Int #9)
CFIR Domain and Construct: Compatibility (Inner Setting)
Barriers Facilitators
Competing ideas between MVP stakeholders (2)
"We were very different partners – PATH and WHO – so we had our agreement and disagreement" (Int #14)
Willingness of manufacturer (Serum Institute of India) to develop cost-effective vaccine (1)
"I would also say that Serum Institute is a very good partners because they accepted to develop at this low cost. So this vaccine is a cost effectiveness vaccine" (Int #16)
CFIR Domain and Construct: Leadership Engagement (Inner Setting)
Barriers Facilitators
Regular involvement of recipient countries and stakeholders in planning/development process (1)
"[...] the discussion was open, and everybody knew the discussion was going on and knew the final decision and the rational for that final decision. So, it's a bit of mix of management, clear, detailed project" (Int #5)
CFIR Domain and Construct: Available Resources (Inner Setting)
Barriers Facilitators
Inadequate funding by country governments (3)
"Of course there were also challenges in terms of funding, in terms of, even though most of the operational costs were provided by partners, Gavi, when it came to getting the government at all levels to participate or contribute to the funding it was also challenging in some countries" (Int #17)
Country-level (Burkina Faso) training of health workers (1)
"I must say that I think my full compliments to Burkina, because they were the first ones to introduce country wide, [...] they had activated the machinery and the health workers, given them training sufficiently, to ensure that this target is completed, and which they did complete" (Int #1)
Insufficient staff and training (3)
"[...] So we could have invested a little bit more in human resources. I think that would have been a plus. It would have made it easier to implement because you can't be everywhere" (Int #8)
Infrastructure support (1)
"Lastly, I would say that the development of infrastructure to support vaccine introduction, which was part of the program, was critical" (Int #16)
Logistical gaps in health systems (3)
"The health systems, most of the time, are not very strong enough to sustain large-scale interventions. So, we have logistical issues.
[...] So it's an issue of logistics and reliance on external support" (Int #12)
CFIR Domain and Construct: Access to Knowledge and Information (Inner Setting)
Barriers Facilitators
Insufficient sensitisation at local and national level (1)
"The other thing is insufficient sensitisation. Sometimes the government does rush, they skip some of the key steps toward the proper implementation, proper acceptance of the vaccine from the communities" (Int #12)
Strong communication strategy including crisis communication (5)
"But we had developed a crisis communication strategy to deal with this situation where we said scenario 1. If someone dies during the campaign. Scenario 2 if, for example, we are working with meningococcal A vaccine and during our campaign there are people who have an outbreak or in a country with meningococcal C or another, serogroup" (Int #8)
CFIR Domain and Construct: Knowledge and Beliefs about the Intervention (Characteristics of Individuals)
Barriers Facilitators
Complacency of MenA eradication (1)
"[...] there was not a single case of meningitis A in the vaccinated population. So that gave some sort of a false complacency to the people, health authorities and the public in general, that now the Meningitis A is gone" (Int #1)
Vaccine misinformation (3)
"And we often had difficult situations, the most difficult situations. It was in Mauritania, in Chad, in 2011 or at one point, we had newspapers in the media that wrote that there were people who were paralysed after being vaccinated with MenAfriVac vaccine" (Int #8)
CFIR Domain and Construct: Planning (Process)
Barriers Facilitators
Adequate time for planning project (2)
"We had started working on the introduction framework for the vaccine three years before the vaccine was ready to be introduced, so, the lesson being the secret is always planning, planning, planning, planning, and then planning" (Int #4)
Well-defined scope of project (2)
"Perhaps one of the reasons for success was this was a very focused project, we are creating a vaccine against one group of meningococcus A, which is the main cause of these epidemics" (Int #15)
CFIR Domain and Construct: Formally Appointed Internal Implementation Leaders (Process)
Barriers Facilitators
Leadership of Project Director (10)
"I would say, is very strong and consistent leadership.
[...]He is, and certainly was, and is, a remarkable leader.
[...] he really led that project with a strong focus and a sort of relentless drive to get it done, and I think that was very, very helpful to the project" (Int #16)
CFIR Domain and Construct: External Change Agents (Process)
Barriers Facilitators
Early product cancellation by contracted lab (1)
"I think I can tell you another process which made the job very difficult, that the lab who was contracted initially by PATH who developed the conjugate technology in Sienna.
[…] they get a message from this lab that the project is cancelled. And they whatever technology they had developed, they will not transfer to MVP." (Int #1)
Strong technical expertise (3)
"So, I think I would say for the development of the vaccine, the help of consultants that were highly expert in the field. These helped enormously" (Int #18)
Disinterest of Big Pharmaceuticals to partner for MenA vaccine (3)
"The barriers I think has been relatively difficult to identify among a manufacturer that would accept to manufacture for that price." (Int #5)
Involvement of variety of partners/stakeholders (9)
"I think the fact that the project, the MVP, was a very large consultation of partners, made it to be an opportunity for partners and governments to come together in a collaborative way to work together and look at the same voice, same object. So, this happened and contributed to the success of the project" (Int #17)
CFIR Domain and Construct: Executing (Process)
Barriers Facilitators
Security threats from epidemics and civil war (1)
"You have this one in South Sudan, we were obliged to postpone because of insecurities, civil war" (Int #3)
Capacity building integration in national systems (1)
"Developing, testing and introducing the vaccine by giving a lot of capacity building in the country and we make sure that it was not a vertical program even when they show when the time of introducing the vaccine came, he put to develop the project into the internal structure of WHO as well as the country organisation. I think all these together make a lot of awareness and engagement" (Int #10)