A socio-ecological exploration to identify factors influencing the COVID-19 vaccine decision-making process among pregnant and lactating women: Findings from Kenya.

The vaccine decision-making process of pregnant and lactating women is complex. Regarding COVID-19, pregnant women are at increased risk for severe disease and poor health outcomes. While pregnant and lactating women were excluded from COVID-19 vaccine trials, available evidence suggests that COVID-19 vaccines are safe and protective during pregnancy. In this study, we used a socio-ecological approach to explore factors influencing the decision-making process for COVID-19 vaccines in pregnant and lactating women in Kenya, for the purpose of informing demand generation strategies. As pregnant and lactating women are influenced by many factors, we conducted 84 in-depth interviews with a variety of stakeholders, including 31 pregnant or lactating women, 20 healthcare workers such as nurses, midwives, doctors, and frontline workers, 25 male family members of pregnant or lactating women, and 8 gatekeepers such as community leaders and faith-based leaders. These individuals were recruited from six communities in Kenya: three urban, and three rural. We applied a grounded theory approach to identify emerging themes and organized emerging themes using the SAGE Vaccine Hesitancy model, which includes three categories of determinants of vaccine acceptance, including contextual influences, individual and group influences, and vaccine and vaccination specific issues. Myths, interpersonal norms, and religion emerged as themes related to contextual influences. Safety, risk perception, and the role of the healthcare worker emerged as themes related to individual and group influences. For vaccine and vaccination specific issues, emerging themes included availability, accessibility, and eligibility. While maternal immunization can substantially reduce the effect of infectious diseases in mothers and infants, vaccine acceptance is critical. However, vaccines do not save lives; vaccination does. We hope the results of this study can be used to tailor communication efforts to increase vaccine demand among pregnant and lactating women.

Using maternal and neonatal data collection systems for coronavirus disease 2019 (COVID-19) vaccines active safety surveillance in low- and middle-income countries: an international modified Delphi study: [version 1;peer review: 1 approved with reservations]

Background: Given that pregnant women are now included among those for receipt coronavirus disease 2019 (COVID-19) vaccines, it is important to ensure that information systems can be used (or available) for active safety surveillance, especially in low- and middle-income countries (LMICs). The aim of this study was to build consensus about the use of existing maternal and neonatal data collection systems in LMICs for COVID-19 vaccines active safety surveillance, a basic set of variables, and the suitability and feasibility of including pregnant women and LMIC research networks in COVID-19 vaccines pre-licensure activities. Methods: A three-stage modified Delphi study was conducted over three months in 2020. An international multidisciplinary panel of 16 experts participated. Ratings distributions and consensus were assessed, and ratings’ rationale was analyzed. Results: The panel recommended using maternal and neonatal data collection systems for active safety surveillance in LMICs (median 9;disagreement index [DI] -0.92), but there was no consensus (median 6;DI 1.79) on the feasibility of adapting these systems. A basic set of 14 maternal, neonatal, and vaccination-related variables. Out of 16 experts, 11 supported a basic set of 14 maternal, neonatal, and vaccination-related variables for active safety surveillance. Seven experts agreed on a broader set of 26 variables.The inclusion of pregnant women for COVID-19 vaccines research (median 8;DI -0.61) was found appropriate, although there was uncertainty on its feasibility in terms of decision-makers’ acceptability (median 7;DI 10.00) and regulatory requirements (median 6;DI 0.51). There was no consensus (median 6;DI 2.35) on the feasibility of including research networks in LMICs for conducting clinical trials amongst pregnant women. Conclusions: Although there was some uncertainty regarding feasibility, experts recommended using maternal and neonatal data collection systems and agreed on a common set of variables for COVID-19 vaccines active safety surveillance in LMICs.