Contributions to the literature
-
This research systematically describes the policy and decision-making process for introduction of new vaccines, with particular emphasis on maternal vaccines.
-
According to our findings, public policy process is complex and multifaceted in its nature and needs to be transparent and involves all key stakeholders.
-
The research identifies policy gaps, challenges with policy processes, and opportunities for improving vaccine policy formulation and implementation process.
-
As the maternal vaccine pipeline expands, the opportunities identified for improving vaccine policy process will help in informing coordinated, more inclusive, and better understood policy-making process for smoother implementation of maternal immunization programs in low- and middle-income countries.
Introduction
Methods
Study design
Study setting
Sample
Officer interviewed | Office level | Number interviewed |
---|---|---|
Deputy director public health | County | 1 |
Deputy director preventive and promotive services | County | 1 |
Deputy director reproductive health | County | 1 |
Head of National Immunization Program, MoH | National | 1 |
Officer in charge of expanded program on immunization logistics | County | 5 |
Nursing officer, in charge of reproductive health and maternal and child health | County | 4 |
Head, Division of Family Health, MoH | National | 1 |
Health promotion officer | County | 4 |
Deputy chair, KENITAG | National | 1 |
Core member, KENITAG | National | 3 |
Officer in charge of monitoring and evaluation | County | 2 |
Officer in charge of advocacy, communication, and social mobilization | National | 1 |
Nursing officer | County | 1 |
Officer in charge of community strategy | County | 1 |
Officer in charge of vaccines locally & internationally | National | 1 |
Public health coordinator | County | 1 |
Total | County | 29 |
Participant identification
Data collection at national and county levels
Data management and analysis
Results
Themes | Sub-themes |
---|---|
Decision-making process for policy development and implementation | - Problem identification - Considerations for vaccine introduction |
- Monopolized engagement of national level entities in vaccine policy recommendation | |
- Complexity of decision-making process | |
- Policy implementation process (systematic implementation) | |
- Policy evaluation | |
Effects of devolution on health care policies | - Policy adaptation to local needs |
- Intra-governmental communication | |
- Delineation of responsibilities | |
- Resource provision within government | |
Resilience of policy to external influences | - Rumours |
- Anti-vaccine campaigners | |
- Sociocultural influences | |
Recommendations for improving vaccine policy-making process | - Stakeholder engagement at all levels - Improve intra-governmental communication |
Policy development and implementation: decision-making process
Problem identification
“First, there must be a problem for us to have a policy to work towards that problem. Maybe we have done a situation analysis and found an area that has a gap. We usually call in stakeholders to deliberate with us on the issue during policy formulation.” (R05, national level)
“… I think by and large for the government, it is almost as if we do not have that response where the local research is informing and driving the policy agenda. It is sort of like it is reversed where we are fitting in the global agenda which is related to high level discussion where you may be want to eradicate or eliminate a disease, or introduce this vaccine because it has been introduced elsewhere and there is funding that can sponsor the introduction and all that. We do not have that where our own research is driving the policy but maybe with time we will get there.” (R03, national level)
Considerations for vaccine introduction
“The first thing is it must be safe. …what it protects from should be more than what it could cause us because vaccines also have their negative impacts…It should also be able to do what we are saying it can do.…It should be cheap for us to be able to buy it because if it is too expensive it is of no use…
Let me say it should be accessible meaning if I want to buy it as an individual, the little I have should be able to buy it.…Safety, effectiveness, accessibility and other factors along that line.” (R06, national level)
Monopolized engagement of national level entities in vaccine policy recommendation
“The next level after the above considerations is the technical phase. This is the level at which we look at the considerations with an inquisitive and critical mind. … This is where Kenya National Advisory Group on immunization (KENITAG) comes in. This is a technical group to which we forward all the gathered information and let them discuss logically. We do this because they have technical knowledge of each aspect. KENITAG comes up with recommendations as advisories to each aspect of the policy dimension.” (R04, national level)
Sub-theme | Quotes |
---|---|
Problem identification | First you need, first we do an analysis, situation analysis, to identify whether there’s a need or if there’s a gap. Once we identify if there’s a gap for this policy, specific policy, we write to our permanent secretary... We make a request to start the process of developing a policy towards the either maternal or child health... Once we get that approval, we constitute a steering technical committee that understands very well on that area that will work on that mmmmmm policy document. And there will be steering meetings to inform and in those, there will be public participation, there’s partners’ participation. So for maternal policy I think, applies just like any other, any other policy, in the ministry or the division. (R05, national level) |
Considerations for vaccine introduction | We have epidemiological data which guides the ministry on the rationale behind introducing vaccines. We also have general directions globally from the World Health Organization of what is required. We also use authority bodies like the Pharmacy and Poisons Board where we get licensed vaccines into the country. We do all these in consultations with research institutes such as KEMRI polio lab and KEMRI measles lab. Collating this data helps us to tell the worth of a vaccine and its cost. (R01, national level) We must also consider our capacity to deliver the vaccines. We have to determine the side effects of the vaccine as well. You understand that vaccines are just like any other drug with side effects. We have to establish that the benefits outdo side effects. We also take into consideration the population which is at risk. What is the magnitude of the burden of diseases in question? (R02, national level) Well, of course involves both the division of disease surveillance and the division of vaccines at national level. I have not been engaged in the policy development process but the best of my knowledge at county level is we would look at disease prevalence, we would look at some of the conditions that are affecting our mothers, we would look at availability of vaccines that are effective globally, uh WHO …WHO approved and then look at possibly what is the cost of that disease …uh in terms of life, …so the Disability Adjusted Life Years (DALYs) …look at the cost of the vaccine and then do a cost effectiveness analysis. (R05, county level) The need for a vaccine is driven by certain factors about diseases. For example, the prevalence of the diseases, ability to control the disease, is the vaccine available, is the vaccine desirable, safe and all other basic sciences about the vaccine. However, bottom line is that after doing baseline issues such as the need for a vaccine, the cost is always a factor. (R07, county level) The first thing is it must be safe. Its pros must outdo its cons; what it protects from should be more than what it could cause us because vaccines also have their negative impacts… It should also be able to do what we are saying it can do. Safety alone does not guarantee that it is effective… Safety, effectiveness, accessibility and other factors along that line. (R06, national level) |
Monopolized engagement of national level entities in vaccine policy recommendation | When the government has an intention of rolling out a vaccine. … they seek justification first to decide for or against rolling out a vaccine. We (KENITAG) therefore, adduce the evidence and submit it to the ministry by collating information and discussing it with the aim of unearthing the pros and cons. These will lead us into making recommendations based on scientific facts, our own studies and experiences. We collate information from all these sources and pass it to our client, ministry of health. They do not have to take our advice. (R07, national level) KENITAG is comprised of experts in different fields. These include pediatricians, researchers and professors who look at the diseases and they are able to delve deeper. They find out more issues about the disease to create understanding that helps shape the direction of a vaccine policy. They also look at the justifications for introducing a vaccine or not. (R04, national level) The final decision is at the discretion of the government since it considers several angles. On our part, we are guided by the scientific dimension of the vaccines. (R07, national level) Since we are mostly at the county level, we pick the national policy and domesticate it at our level; we rarely come up with our own policy… We then call our stakeholders, pick the policy issues relevant to us from the national policy, and put in our own policy document. (R20, county level) |
Complexity of decision-making process | …before it (vaccine policy) reaches endorsement, there is a lot of technical deliberations and fact finding about the vaccine. As a unit, we (Unit of Vaccines and Immunizations) are mandated to take charge of that. I can therefore say that there is no policy which can be made without our involvement. We are the only program (National Immunization Program) with the authority to handle immunization issues in the country. (R08, national level) It is the cabinet secretary of health who makes the final decision. He has his technical officers at the Division of Vaccines and Immunization (DVI) who advice the cabinet secretary (CS) who then pass that on the decisions. Even as they deliberate on that, there are financial implications which the CS must consider when tabling vaccination recommendation at the cabinet. There must be a round table where you explain the money to be allocated. (R07, county level) |
Policy implementation process (systematic implementation) | Once the policy has been drafted, tried and passed, then it is the ministry to cascade it down. Remember we now have a devolved system with forty-seven governments. The bigger role of the central government is policy-making then cascade it down to the devolved units to make it in to practice. (R03, national level) The ministry makes policy documents to the people who will implement the policies. (R16, county level) What I have seen is there is a launch, normally there would be a launch, an introductory launch. At county level we normally would get sensitized, invited to the launch get a sensitization package on the new policy, get introduced to it and then the national would actually roll it out to us then it would be our responsibility at the county to ensure that we have implemented that policy. So what would happen is we would have meetings with our sub-county teams, sub-county would have meetings with facilities introduce that then would see how to now roll it out to the community with the sensitization through our community health structures and through our health promotion officers and ensure that the information goes round but the implementation really falls on us at the county, how we do procurement, what we administer then would be at the county level. (R20, county level) |
Policy evaluation | We also support the counties with policy guidelines on immunization in soft and hard copies for their reference during practice. We also organize several trainings, so that we update new issues, discuss observed challenges and possible solutions. (R02, national level) …as a country, and as a county, we have adopted the performance approach. So each person has their set targets, so if you don’t meet, your supervisor will ask you why haven’t you met your targets, you will explain. (R08, county level) |
“One of the terms of reference is that we advise the ministry of health on all matters relating to vaccines and immunizations and this involves introduction of new vaccines or even modification of existing vaccine schedules… Those are basically our roles in NITAG, mainly related to making evidence-based recommendations for vaccines and immunizations.
… we have a document called the Internal Procedures Manual that was developed by all the KENITAG members.
…The procedures manual is our day-to-day document that guides the operation of KENITAG and inside there it clearly spells out the process for making vaccine policies.” (R07, national level)
“These are then brought back to Division of Vaccines and Immunization (DVI) where we engage widely and at all levels of policy-making. We are responsible for engaging all relevant bodies and organizations to have a thorough discussion on the policy. We engage different levels of leadership and dimension; political level, technical level and potential obstacles among others.
…After engaging all relevant leadership and organizations, we then put in a request to have the vaccine introduced and to go through. Just before the request is made, we have the National Immunization Interagency Coordinating Committee which provides oversight and gives the approval for the policy change for the introduction of the vaccine.” (R08, national level)
“Like we know the policies are made at the national level … we also have our policy makers...They should also be able to participate and also, some technical persons from county level. (R01, county level)
…so most of the policies we disseminate at the county have been developed at the national office.” (R02, county level)
Complexity of the decision-making process
“The policy-making process is lengthy…Considering vaccines, if we wanted to come up with any vaccine to be included in the schedule then we must ensure that the whole broad area of vaccination information is available. That means that all vaccines now and in the future must be taken care of since vaccines are bound to increase.” (R06, county level)
Policy implementation process (Systematic implementation)
“In terms of implementation, it is the mandate of Unit of Vaccines and Immunization (UVI) or Division of Vaccines and Immunization (DVI) (now referred to as the National Immunization Program) to ensure operationalization of the policy. This is done through capacity building to cascade it to the lower levels using the governance in place in the health system. We are the central level and the next level to cascade the program would be the county. At the county, we have the County Health Management Team. We then roll it to sub-county where we have Sub-county Health Management Team who then roll it out to facilities. That is when the common mwananchi (Swahili term for citizen) as we call them in Kenya gets the vaccines.” (R02, national level)
“I; who receives instructions from the national level?R; The national level has to write to the council of governors, the council of governors will write to the governor, who will action his county executive committee member for health who will write to the chief officer and director to implement, and at the end of it then the county logistician under my department (preventive and promotive services) will actually be responsible and of course under the directive of the director to implement… we will look at what are the instructions and make sure, of course still in consultation with the national office, it meets the needs of the county.” (R16, county level)
“We pick the national policy and domesticate it at our level; we rarely come up with our own policy. We then call our stakeholders, pick the policy issues relevant to us from the national policy, and put in our own policy document. We have both political and general stakeholders, who must buy in to our policy... we take the policy to the county assembly for approval, after which we give it to the executive at the county level to approve. The policy document is launched once it has been approved at the county level.” (R20, county level)
Policy evaluation
We conduct support supervision and technical visits to the county, sub-county and the health facilities. We also go to the community so that we are able to get information from the real beneficiaries to get their view about the service which we are providing. From there we are able to cover information on new policy if there are. If there is anything we need to correct that is the place to do it.” (R02, national level)
Effects of devolution on health care policies
Policy adaptation to local needs
“The county works within committees such as health and policy committees. We use the health committee when we want to talk to the assembly. There is a committee that brings all the committees of the county assembly together, where members of the health committee are also members there. They deliberate and approve it first, and then we take it to the governor’s office where the last approval happens then we launch the document. (R12, county level)
…We find very many gaps in the national policy because they do not realize how unique Nairobi is. We fill those gaps and domesticate it for ourselves.” (R21, county level)
Intra-governmental communication
“So sometimes forums are lacking to sensitize all the leadership so that we are on common page, you know. (R02, county level)
But importantly you also need to look at the health care workers who’ll be the people administering the serum. They also need to be sensitized and be updated on that.” (R18, county level)
Delineation of responsibilities
“So that now with the devolution, I mean we are a little bit on breakdown between who is-who is to do what between the county government and the national government… personally I would say it has taken time for Nairobi as a county, the health sector and generally the county, to take up its rightful role in allocating the required resources for vaccine.” (R07, county level)
Resource provision within government
Sub-theme | Quotes |
---|---|
Policy adaptation to local needs | The county works within committees such as health and policy committees. We use the health committee when we want to talk to the assembly. There is a committee that brings all the committees of the county assembly together, where members of the health committee are also members there. They deliberate and approve it first, and then we take it to the governor’s office where the last approval happens then we launch the document. (R12, county level) |
Intra-governmental communication | …regular updates on the KEPI schedule because we’ve been introducing several vaccines in the last three years but there’s been no trainings going on the schedule, the complete schedule. So we are training on specific antigen. … before, it was very clear if they were 9 they were 9 and everyone knew they were 9 now people don’t know if they are 10 or 20 but they know there is something, yeah they brought something ‘ya’ (for) diarrhoea, there is something ‘ya’ (for) pneumonia but nobody is talking about the package… ok we have introduced fine, but what is the package? …information is scanty. (R04, county level) |
Delineation of responsibilities | “With the vaccine policy of I think 2013, the national government is supposed to procure the vaccines and the county government is supposed to implement and make sure people get the vaccines or the vaccines get to the end users. There have been many challenges with the devolved system because there was a year we did not have budget allocation for procuring vaccines, all the money went to the counties, and when it reached there, it could not go back [to national procurement]. I think there is a gentleman’s agreement where the money to procure the vaccine remains at the national level, but I am not sure the counties even have the budget to administer the vaccines and take them to the community.” (R07, county level) …initially the funding for everything would come from Nairobi, but now we are finding that the funding has to come from the county. Now at the county level, to access now the funding, now it has become a problem. (R17, county level) |
Resource provision within government | Proper planning and resource mobilization is also critical, we have had some challenges in the past. Yes, it’s important especially for resources… like when we were doing the switch for the OPV (oral polio vaccine) vaccines we didn’t have enough resources, when we were introducing rotavirus the resources came way later so it posed a challenge for us. (R03, county level) Lack of IEC (information, education and communication) materials, I don’t know the last time we had IEC materials on vaccines so it is very difficult to educate communities without that. (R06, county level) …of course we’ll always say resource limitation, as much as now we have a budget on EPI it is still very limited, it is less than 1% of the total county budget on health. (R11, county level) When it comes to vaccine distribution, we are talking about transport, in terms of net cost, we are talking about storage facilities for the cold chain of the vaccines, which this year I’m aware, Nairobi County has budgeted for procurement of cold chain equipment like fridges and other equipment, bearing in mind that vaccine program was run at the national level, and the county at the county level, it has not been fully taken over as a county function in terms of allocation of resources. (R07, county level) |
“…sometimes there is stock out of the vaccine and that’s basically because of the transportation chain and also the procurement chain. Sometimes we may miss some of the logistics. …like either syringes, ice packs.” (R13, county level)
Resilience of policy to external influences
Rumours
Sub-theme | Quotes |
---|---|
Rumours | The Roman Catholic Church has given us issues concerning vaccines. There are certain events that occurred two to three years ago and that has given us a problem with vaccination. The aspect of getting the Jesuits on board is very important. They are the scientific wing for the Catholics. (R05, national level) Yes, but then those health professionals have their beliefs as well. There is this group called Opus Dei. They are learned too. However, they do not want to hear about vaccination. Community attitudes to certain vaccines like TT and the idea that it is contraception and that is also a religious organization propagating this I think due to miscommunication. (R07, national level) |
Anti-vaccine campaigners | Yes, we are there (anti-vaccine campaign) just that the degree is different. It is not just in vaccination but also in medicine. There are issues around traditional herbs and there are people who want us to go back to that. It all starts as a small religious learned group of a sophisticated learned class. They argue that we have lived like that before and it can be done again. They can be quite influential. (R05, national level) The key point is addressing their concerns in timely and proper manner because a lot of it is misinformation and misdirected journalists who write materials with the commercial aim and not necessarily from professional point of view. Part of the effort is therefore to have scientific writers who can be critical in journalism. (R10, county level) |
Sociocultural influences | The other thing is belief that some of these diseases have solutions within the cultural setup and remedies are not found on conventional medicine. Therefore, people believe the diseases do not exist or are just results of bad omen. It is like when you talk about neonatal death for example. When a child dies at three days old, you hardly notice a funeral activity for the child… yet it can be neonatal tetanus which can be prevented through vaccination with tetanus vaccine. To them, the death can be related to other cultural issues such as ‘in my lineage first born children have to die and it is normal’. …What is important is understanding the vaccine and culture around people. (R19, county level) In-deed culture has a role to play. Everything has its base in culture because your mother is more powerful even when you go to school or not. Even if you have gone to school, there is no much difference between what you do and what she believes. If you are talking about culture in relation to pregnant mothers, we can consider Traditional Birth Attendants which we are trying to play with now. (R21, county level) We cannot rule out culture since it is part of us. Those doing anthropology and sociology study patterns of resort and how people behave; even health seeking behavior which are entrenched in culture. Therefore, you cannot ignore that. However, education can solve certain cultural beliefs. For example, someone may believe that smearing cow dung on the cut umbilical cord can fasten healing process while education tells you that is the most effective way of contracting tetanus. Some of them can be mitigated. (R14, county level) |
“Back here in Kenya we had controversies with tetanus vaccine. The church and the state had a standoff in that the former claimed the vaccine caused sterilization in children. We had misinformation about the cervical cancer vaccine given to girls and not boys…” (R08, national level)
“There are rumors spread all over that the vaccines are laced with family planning. …If the doctors themselves are outright Catholics and oppose some of the vaccines. If there are staunch Catholics who sit on a panel to discuss vaccines and they say no to a vaccine they will be believed.” (R05, national level)“Anti-vaccine” campaigners
“Anti-vaccine” campaigners
Vaccine hesitancy is not just a Kenyan case but world over. People who are against vaccines are so audible yet it is a small group in the country…With IT (information technology) and communication technology make it easy for information to flow. People who are pro vaccine talk less more loudly as opposed to those who are against it. The latter amplify their information and cause problems in the country. (R08, national level)
Sociocultural influences
“So I think you must address those type of concerns [vaccine side effects] before you're asked. … preempt those things, answer them, and then give the information to the public before you just say, take this germ...Therefore, it is timeliness, accurate information and less use of press. There must be proper use and handling information professionally so that consumers are not confused.” (R10, county level)
Recommendations for improving vaccine policy-making process
Stakeholder engagement at all levels
Sub-theme | Quotes |
---|---|
Stakeholder engagement at all levels | I have one recommendation that in policy-making process all stakeholders must be engaged. By stakeholders I mean right from those benefiting from the service and the service providers. Therefore, to me it is team work and you need everybody with an interest on board so that when decision is taken, it is implemented together. (R09, county level) The beneficiaries of a policy are important in policy making process. If you ask me, I would be more direct with health providers as well. They are the entry point and should form part of policy making particularly when the vaccine is not surrounded by controversy. These are facilitators who can also be pushback factors when there are controversies. (R03, national level) It is important to get buy in from communities and opinion leaders to avoid resistance over misinformation, that is the greatest lesson I think that has really come out, because you can have all good intentions but if the opinion leaders do not understand then there is miscommunication then you get very low uptake. (R10, county level) So actually involving the, the entry point to any introduction of any antigen also helps a lot. Because if you avoid some people somewhere down the ground, they can be a roadblock and then you find that you don’t succeed. (R15, county level) |
Improve intra-governmental communication | Engage the counties more, we are in a new system of devolution so I think moving forward we need to have more engagement. We have seen some attempts …but increasing the engagement. (R17, county level) I think one of the lessons has been being inclusive. We must be inclusive in passing of information. (R01, county level) |
“Well first, from the inception of that vaccine, all the stakeholders must be involved. Now that we are devolved, we are told that the national level prepares the policies. I’d wish, even if they have to pick one person per county to go and take part so that we feel involved… not just as a way of communicating your decision, but communicating to them the essence of introducing this and showing the need of having these vaccines… So that as this policy comes down, we are able to, take it up.” (R09, county level)
Improve intra-governmental communication
“But for the TT that time, only two persons, that was the director and nursing officer, were called to a meeting in Nairobi [on TT catch-up campaigns]... and it will run concurrently with the polio. So the larger team were fully involved in the polio, but the TT was left for the two to run. So the TT was not well pronounced… in terms of preparation, … advocacy, … social mobilization, it was never well planned, never well executed.” (R11, county level)