Lack of clear national policy guidance on COVID-19 vaccines influences behaviors in pregnant and lactating women in Kenya

  • Human Vaccines and Immunotherapeutics, Volume 18, No. 6, Year 2022

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Study Justification:
The study aimed to investigate the impact of the lack of clear national policy guidance on COVID-19 vaccines on the behaviors of pregnant and lactating women (PLW) in Kenya. This is important because SARS-CoV-2 infection during pregnancy poses significant risks to both the mother and newborn. Understanding how shifts in policy influence vaccine behaviors can help inform the development of effective vaccine communication guidelines and improve vaccine access for PLW.
Highlights:
1. Lack of Communication and Uncertainty: Policymakers and health workers described a pervasive lack of communication and uncertainty regarding the national policy on COVID-19 vaccination in pregnancy. This lack of clarity contributed to confusion and hesitancy among PLW and health workers.
2. Vaccine Safety Concerns: Health workers and policymakers expressed concerns about the safety of COVID-19 vaccines for PLW. This was identified as the primary reason for their hesitation in administering vaccines to this population.
3. Inadequate Prioritization: Policymakers and health workers felt that PLW were not adequately prioritized in the COVID-19 vaccine program. This perception further contributed to vaccine hesitancy among PLW.
4. Vaccine Hesitancy and Inequities: PLW perceived the restrictive policy as an indication of safety risks, leading to vaccine hesitancy. This hesitancy potentially exacerbated inequities in vaccine access among PLW.
Recommendations:
1. Development of Effective Vaccine Communication Guidelines: The study highlights the need for the development and dissemination of clear and effective vaccine communication guidelines. These guidelines should address the concerns of health workers and provide accurate information to PLW, promoting vaccine acceptance and uptake.
2. Prioritization of PLW in Vaccination Policies and Campaigns: Policymakers should prioritize PLW in COVID-19 vaccination policies and campaigns. This includes ensuring that PLW are included in future vaccine trials and that their specific needs and concerns are addressed.
3. Systematic Data Collection: To address inequities in future epidemics, it is recommended to collect systematic data on infectious disease burdens and vaccine uptake among pregnant women. This data will help inform future policies and interventions to protect the health of PLW.
Key Role Players:
1. Policymakers: Policymakers play a crucial role in developing and implementing clear national policy guidance on COVID-19 vaccines for PLW. They need to prioritize PLW in vaccination policies and campaigns.
2. Health Workers: Health workers, including midwives, OB/GYNs, and family medicine providers, play a key role in administering vaccines and providing accurate information to PLW. Their training and support are essential in addressing vaccine hesitancy.
3. Researchers and Data Collectors: Researchers and data collectors are needed to systematically collect data on infectious disease burdens and vaccine uptake among pregnant women. They play a vital role in generating evidence to inform policies and interventions.
Cost Items for Planning Recommendations:
1. Development of Vaccine Communication Guidelines: Budget items may include research and consultation costs, development of educational materials, translation and dissemination costs, and training programs for health workers.
2. Prioritization of PLW in Vaccination Policies and Campaigns: Budget items may include advocacy and awareness campaigns, targeted outreach programs, training programs for health workers, and monitoring and evaluation activities.
3. Systematic Data Collection: Budget items may include research and data collection costs, training and capacity building for data collectors, data management and analysis, and reporting and dissemination of findings.
Please note that the provided cost items are general suggestions and may vary based on the specific context and resources available.

The strength of evidence for this abstract is 7 out of 10.
The evidence in the abstract is based on qualitative interviews conducted with pregnant and lactating women, health workers, and policymakers in Kenya. The study provides insights into how different stakeholders’ perceptions of national policy regarding COVID-19 vaccination in pregnancy shaped vaccine behaviors and decision-making. The sample size of 59 in-depth interviews is relatively small, and the study was conducted in specific regions of Kenya, which may limit the generalizability of the findings. To improve the strength of the evidence, future studies could consider expanding the sample size and including a more diverse range of participants from different regions of the country. Additionally, quantitative data on vaccine uptake and infectious disease burdens among pregnant women could be collected to complement the qualitative findings.

SARS-CoV-2 infection in pregnancy is associated with a greater risk of maternal and newborn morbidity and maternal death. In Kenya, pregnant and lactating women (PLW) were ineligible to receive COVID-19 vaccines until August 2021. How shifts in policy influence vaccine behaviors, such as health worker recommendations and vaccine uptake, is not well documented. We conducted qualitative interviews with PLW, health workers, and policymakers in Kenya to understand how different stakeholders’ perceptions of national policy regarding COVID-19 vaccination in pregnancy shaped vaccine behaviors and decision-making. Policymakers and health workers described pervasive uncertainty and lack of communication about the national policy, cited vaccine safety as their primary concern for administering COVID-19 vaccines to PLW, and expressed that PLW were inadequately prioritized in the COVID-19 vaccine program. PLW perceived the restrictive policy as indicative of a safety risk, resulting in vaccine hesitancy and potentially exacerbated inequities in vaccine access. These findings support the need for the development and dissemination of effective vaccine communication guidelines and the prioritization of PLW in COVID-19 vaccination policies and campaigns. To ensure PLW do not face the same inequities in future epidemics, data on infectious disease burdens and vaccine uptake should be collected systematically among pregnant women, and PLW should be included in future vaccine trials.

In-depth interviews (IDIs) were conducted with 29 PLW, 20 health workers, and 10 policymakers for a total of 59 IDIs. Participants were recruited from Garissa, Kakamega, and Nairobi counties, across three urban communities and three rural communities to try and obtain a representative sample across the country (Figure 1). PLW and health workers were identified through health centers in each community, and health workers were selected based on whether they provided care to PLW, such as midwives, OB/GYNs, and family medicine providers. Policymakers were selected based on their professional involvement in immunization policy and programming and/or maternal health. Study population and setting. Study area for sampling included two rural communities in Garissa county, two urban communities in Nairobi county, and one rural and one urban community in Kakamega county. PLW = pregnant and lactating women; HCW = health care workers; PM = policymakers. Data were collected from August 8th to September 3rd, 2021. Semi-structured interview guides included questions related to the COVID-19 vaccine decision-making process for PLW and the current policy recommendations (see Supplementary Material). A three-day data collection training was held, consisting of field ethics, interview techniques, and pre-testing. Participants were recruited from health clinics for PLW and health workers, and via email/phone for policymakers. After determining eligibility and interest, oral informed consent was obtained. IDIs were conducted in either English, Swahili, or a local language in semi-private settings or via Zoom. Interviews were audio recorded, transcribed, and translated into English. All data were stored on encrypted servers. Prior to the start of data collection, PLW were considered ineligible for vaccination, per the national vaccination plan.3 On August 13th 2021, the Kenya Obstetrical and Gynecological Society issued a statement recommending COVID-19 vaccines for PLW, citing the increased risks associated with COVID-19 during pregnancy and the post-authorization evidence on vaccine safety in pregnancy.27 The following week, the Ministry of Health released a press statement clarifying that PLW could choose to be vaccinated after receiving counseling on the benefits and risks.10 On December 24th, 2021, the Ministry of Health issued updated guidance stating that pregnant women should be offered mRNA vaccines.23 Seven team members analyzed the data using a grounded theory approach, which uses an inductive approach to identify emerging themes and sub-themes. Following three rounds of open coding, a code list was developed (see Supplementary Material). Inter-rater reliability was conducted by two team members using 10% of the transcripts with reliability of >90%. Themes and sub-themes were agreed upon with all members. Data management was conducted with Atlas.ti software. This study received ethical approval from the Kenya Medical Research Institute and the Institutional Review Board of the Johns Hopkins Bloomberg School of Public Health (IRB00014893).

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The lack of clear national policy guidance on COVID-19 vaccines for pregnant and lactating women in Kenya has influenced behaviors and decision-making. To address this issue and improve access to maternal health, the following recommendations can be implemented:

1. Develop and disseminate effective vaccine communication guidelines: Create guidelines that provide clear and accurate information about the safety and benefits of COVID-19 vaccines for pregnant and lactating women. Address concerns and misconceptions that health workers, policymakers, and pregnant women may have regarding vaccine safety. These guidelines can help increase vaccine uptake and reduce vaccine hesitancy.

2. Prioritize pregnant and lactating women in COVID-19 vaccination policies and campaigns: Ensure that pregnant and lactating women are included in the target population for vaccination. Provide dedicated vaccination clinics, flexible appointment scheduling, and tailored education and information for this population to improve access to vaccines.

3. Collect data on infectious disease burdens and vaccine uptake among pregnant women: Gather data on infectious disease burdens and vaccine uptake specifically among pregnant women. This data can inform future vaccination policies and programs, ensuring that pregnant women are adequately protected during outbreaks.

4. Include pregnant and lactating women in future vaccine trials: Include pregnant and lactating women in clinical trials to gather safety and efficacy data specific to this population. This data can inform vaccine recommendations and ensure that pregnant and lactating women can safely receive vaccines to protect themselves and their infants.

Implementing these recommendations can help ensure that pregnant and lactating women receive the necessary protection and support for their health and the health of their infants.
AI Innovations Description
Based on the information provided, here is a recommendation that can be developed into an innovation to improve access to maternal health:

Develop and disseminate effective vaccine communication guidelines: The lack of clear national policy guidance on COVID-19 vaccines for pregnant and lactating women in Kenya has influenced behaviors and decision-making. To address this issue, it is recommended to develop and disseminate effective vaccine communication guidelines. These guidelines should provide clear and accurate information about the safety and benefits of COVID-19 vaccines for pregnant and lactating women. They should also address any concerns or misconceptions that health workers, policymakers, and pregnant women may have regarding vaccine safety. By providing accurate information and addressing concerns, these guidelines can help increase vaccine uptake and reduce vaccine hesitancy among pregnant and lactating women.

Prioritize pregnant and lactating women in COVID-19 vaccination policies and campaigns: Policymakers and health workers expressed that pregnant and lactating women were inadequately prioritized in the COVID-19 vaccine program. To improve access to maternal health, it is important to prioritize pregnant and lactating women in COVID-19 vaccination policies and campaigns. This can be done by ensuring that pregnant and lactating women are included in the target population for vaccination and that specific efforts are made to reach out to this group. This may include providing dedicated vaccination clinics for pregnant and lactating women, offering flexible appointment scheduling, and providing education and information specifically tailored to this population.

Collect data on infectious disease burdens and vaccine uptake among pregnant women: To ensure that pregnant women do not face the same inequities in future epidemics, it is important to collect data on infectious disease burdens and vaccine uptake among pregnant women. This data can help inform future vaccination policies and programs, ensuring that pregnant women are adequately protected during outbreaks. By systematically collecting and analyzing data on infectious disease burdens and vaccine uptake among pregnant women, policymakers and health workers can make more informed decisions and develop targeted interventions to improve access to maternal health.

Include pregnant and lactating women in future vaccine trials: To further improve access to maternal health, it is recommended to include pregnant and lactating women in future vaccine trials. By including this population in clinical trials, researchers can gather important safety and efficacy data specific to pregnant and lactating women. This data can help inform vaccine recommendations and ensure that pregnant and lactating women can safely receive vaccines to protect themselves and their infants. Including pregnant and lactating women in vaccine trials also promotes equity and ensures that this population is not excluded from the benefits of medical advancements.

Overall, these recommendations aim to improve access to maternal health by addressing the lack of clear national policy guidance, prioritizing pregnant and lactating women in vaccination programs, collecting data on infectious disease burdens and vaccine uptake, and including pregnant and lactating women in vaccine trials. Implementing these recommendations can help ensure that pregnant and lactating women receive the necessary protection and support for their health and the health of their infants.
AI Innovations Methodology
The methodology used to simulate the impact of the main recommendations on improving access to maternal health could involve the following steps:

1. Develop a simulation model: Create a simulation model that represents the current state of access to maternal health in Kenya, taking into account factors such as vaccine hesitancy, vaccine uptake rates, and the impact of unclear national policy guidance on COVID-19 vaccines for pregnant and lactating women.

2. Define key variables and parameters: Identify the key variables and parameters that will be used in the simulation model, such as vaccine communication guidelines, prioritization of pregnant and lactating women in vaccination policies and campaigns, data on infectious disease burdens and vaccine uptake among pregnant women, and inclusion of pregnant and lactating women in vaccine trials.

3. Collect baseline data: Gather baseline data on the current state of access to maternal health in Kenya, including vaccine uptake rates among pregnant and lactating women, vaccine hesitancy levels, and any existing guidelines or policies related to COVID-19 vaccination for this population.

4. Implement the recommendations in the simulation model: Incorporate the main recommendations into the simulation model by adjusting the relevant variables and parameters. For example, update the model to reflect the dissemination of effective vaccine communication guidelines, the prioritization of pregnant and lactating women in vaccination policies and campaigns, the collection of data on infectious disease burdens and vaccine uptake, and the inclusion of pregnant and lactating women in vaccine trials.

5. Run the simulation: Run the simulation model to simulate the impact of the recommendations on improving access to maternal health. This can be done by comparing the outcomes of the simulation before and after implementing the recommendations. The simulation can provide insights into the potential changes in vaccine uptake rates, reduction in vaccine hesitancy, and improvements in overall access to maternal health.

6. Analyze the results: Analyze the results of the simulation to understand the potential impact of the recommendations on improving access to maternal health. This can involve comparing key metrics such as vaccine uptake rates, vaccine hesitancy levels, and equity in access to maternal health between the pre- and post-recommendation scenarios.

7. Interpret the findings: Interpret the findings of the simulation to understand the implications for policy and practice. Identify any significant changes or improvements in access to maternal health that can be attributed to the implementation of the recommendations. This information can be used to inform decision-making and guide future interventions aimed at improving access to maternal health.

8. Communicate the results: Present the findings of the simulation in a clear and concise manner, highlighting the potential impact of the recommendations on improving access to maternal health. This can be done through reports, presentations, or other communication channels to relevant stakeholders, such as policymakers, health workers, and researchers.

By following this methodology, it is possible to simulate the impact of the main recommendations on improving access to maternal health in Kenya. The simulation can provide valuable insights into the potential benefits of implementing these recommendations and guide efforts to address the challenges faced by pregnant and lactating women in accessing maternal health services.


Identifiers:
DOI: 10.1080/21645515.2022.2127561
ISSN: 21645515
Research Areas:
Community Interventions, COVID, Health System and Policy, Maternal and Child Health, Quality of Care, Sexual and Reproductive Health, Social Determinants, Workforce
Study Countries:
Kenya
Study Design:
Cross Sectional Study, Exploratory Study, Grounded Theory
Study Approach:
Qualitative
Participants Gender:
Female
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