Study design

A phenomenological research design was applied to explore Malaysian pregnant women’s barriers and facilitators to COVID-19 vaccination during pregnancy. In-depth semi-structured interviews were conducted in Malay language, face-to-face on the field, with open-ended and exploratory questions to gather non-numerical data. The researcher’s team consists of three family medicine specialists (FMS) and one FMS in training. Two of the FMS are known experts in conducting qualitative research for more than 10 years. The interviews were conducted by single interviewer (principal researcher) which was the FMS in training. The FMS in training had undergone training in qualitative research and the initial two interviews were conducted under supervision of the FMS to ensure good and structured interviews. The principal researcher maintained self-reflexivity throughout the research process to avoid personal assumptions about participants’ descriptions. A topic guide was created based on the theoretical frameworks of HBM and the TPB. HBM suggests that individuals’ decisions to engage in health-related behaviors (getting vaccinated) and TPB posits that an individual’s intention to be vaccinated [17–19]. Using both HBM and TPB provides a comprehensive framework for exploring complex reasons behind vaccine hesitation among pregnant women regarding COVID-19 vaccines in Malaysia. This approach helps identify specific psychological and social factors driving vaccine hesitancy among this demographic group. The interviews were also conducted in comfy meeting rooms at local health clinics, antenatal clinics, and wards to ensure privacy. Each participant received RM50 (approximately USD12) as a token of appreciation for their voluntary enrolment. The honorarium may appear modest in some contexts; however, it is considered appropriate and adequate within the Malaysian setting. The compensation was determined in line with local ethical guidelines and norms to appreciate participants’ time without exerting undue influence on their decision to participate.

Participants and setting

Participants were pregnant women attending three antenatal clinics in Kelantan, including Universiti Sains Malaysia Specialist Hospital, Bachok Health Clinic, and Rantau Panjang Health Clinic. To focus on those who experience COVID-19 vaccination activity either receiving, refusing or hesitating, a purposeful sample was selected from clinics. Key informants (chief staff nurses) were used to identify suitable participants. The inclusion criteria included Malaysian citizens and pregnant women aged 18 and above who could comprehend and read in Malay language. The exclusion criteria were pregnant women who had acute symptoms of labor or any unstable conditions (uncontrolled hypertension, preeclampsia, etc.), pregnancy with intrauterine death, or any psychiatric conditions. We provided research information together with written consent for those agreeable in participating in the study.

Interviews were conducted over a 16-week from February 29th to June 29th, 2024, and each interview lasted between 30 and 60 minutes. Data collection was discontinued when data saturation was reached.

Analysis

All interviews were audio-recorded and transcribed verbatim. The data collections were initially managed using the computer software NVivo; subsequently, by-hand table work was employed using Microsoft Word software. The transcriptions were checked by participants and read thoroughly and repeatedly by all researchers to ensure rigor and trustworthiness. The interviews were conducted until the data was saturated, which is described as no more new information, themes or any insights relevant to the research questions were obtained. The principal researcher conducted the first five interviews, which were later transcribed verbatim. Then, a meeting was arranged with other researchers to identify and organize the themes and subthemes. Subsequent interviews were carried out until no new insights were gathered by the 16th interview. However, three more interviews were conducted to ensure that data saturation had been reached, after which data collection was discontinued. Discussions were held frequently to refine and triangulate the findings. The researchers also look into the previous findings in other studies to ensure no new study insights need to be explored. Thematic analysis with inductive and deductive approaches was employed to ensure thoroughness and minimize bias.

Rigor and trustworthiness

Prolonged engagement was applied during the in-depth interviews by the main researcher to build rapport with the participants to obtain authentic results. The research process, which included the data collection and analysis details, was fully described (audit trail) and evaluated by all researchers (peer review), including a researcher whose expertise in qualitative research. The transcriptions and interpretations were checked by the participants (member checking) to ensure rigor and trustworthiness.

Ethical approvals

This project was approved by the Human Research Ethics Committee (JEPEM), Universiti Sains Malaysia (protocol number: USM/JEPeM/22050297) and Medical Research & Ethic Committee (MREC), Ministry of Health Malaysia (protocol number: 22–01456-AQA).

Barriers to COVID-19 vaccination during pregnancy

Facilitators of COVID-19 vaccination during pregnancy

Barriers & implications for practice and policy

From our study, we found barriers to COVID-19 vaccination during pregnancy stem from several key concerns including fear of the side effects, negative social influences, perception returning to normalcy, and vaccine skepticism or prejudice. Being afraid to side effects, perception returning to normalcy and vaccine prejudice are aligned with constructs from the HBM, particularly perceived barriers and low perceived susceptibility [11,13–17]. Conversely, having negative social influences was described under the subjective norm in TPB [12–15,18,19]. Policymakers should implement educational initiatives to address misinformation and fear surrounding COVID-19 vaccination during pregnancy. Fear of side effects, including potential harm to both mother and baby, as well as previous unpleasant vaccine experiences, contribute to hesitancy [6,20–26]. Surprisingly, a qualitative study in Bristol, UK, during the first wave of the pandemic found that participants showed a variety of responses on vaccine trials on pregnant women, ranging from feeling it was important but were unwilling to volunteer to mention vaccine trials should not be conducted, and some were uncertain about it, mainly due to fear of the unknown vaccine side effects [27]. Several studies had shown that pregnant women demonstrated similar adverse effects of the COVID-19 vaccine as nonpregnant women [28,29]. Pregnant women expressed significant concerns about the potential risks of COVID-19 vaccination, particularly regarding fetal health and their own well-being. This indicates a gap between perceived risks and actual vaccine safety data, emphasizing the need for better communication and reassurance regarding COVID-19 vaccination during pregnancy.

Negative social influences, such as perceptions shaped by social media and discouragement from family and peers, further reinforce reluctance. Social media plays a role in shaping perceptions, while opinions from family and peers can further discourage vaccination. In the Southeastern Asian region, Malaysian citizens are the largest internet users, with a reported internet penetration rate of 97.4% in 2024 [30]. As regards social media influence, it contributed to pregnant women’s hesitancy and refusal of the vaccine during pregnancy, as a lot of misinformation, such as the COVID-19 vaccine, caused harm being spread virtually [26]. Negative social influences from spouses, family members, and peers had a substantial impact on pregnant women’s willingness to accept the COVID-19 vaccine. Spouses and family members are the individuals closest to the pregnant women, and the most reachable advisors and trusted individuals which involve in their decision making [23,24,31]. Living in the rapidly developing technological era has given pregnant women better access to digital information sources regarding the COVID-19 vaccine. Nevertheless, they were at risk of exposure to misinformation and misconceptions about the COVID-19 vaccine for pregnancy.

Additionally, some pregnant women believe that life has returned to normal, reducing the urgency for vaccination. Malaysia has reported a marked reduction in the number of new cases of COVID-19 infection since the initiation of nationwide COVID-19 vaccine rollouts in February 2021 [32]. In addition, the COVID-19 tracker has stopped reporting the cases since 6 October 2022 [33]. In contrast to the pandemic era, news of COVID-19 hospitalizations or deaths was no longer broadcast in mass communications. MOH has also lifted the rules of wearing masks and social distancing in public areas since 19 December 2023 [34]. Consequently, pregnant women felt that the current situation had returned to normal, and the COVID-19 virus was not a threat anymore. The new norm phenomenon had affected pregnant women’s willingness toward COVID-19 vaccine as they perceived a low risk of contracting the infection [20,22,25]. The perception that life has returned to normal has contributed to reduced urgency for COVID-19 vaccination among pregnant women. The decline in reported cases, the cessation of COVID-19 tracking, and the lifting of public health restrictions have reinforced the belief that the virus is no longer a significant threat.

Vaccine skepticism and prejudice, driven by conspiracy theories and doubts about its effectiveness, also play a significant role in their decision-making. Conspiracy theory and the belief human beings were used as experimental subjects were the significant factors impeding pregnant women’s willingness to the COVID-19 vaccine during pregnancy [22,27]. The theme that emerged was “I am not going to be a guinea pig”, indicating pregnant women were unwilling to participate in COVID-19 vaccine trials [27]. Furthermore, pregnant women were easily exposed to conspiracy theories while actively navigating the internet and looking for vaccine-related information [31]. A mixed-method study revealed 91% rumors and 9% conspiracy theories from 637 COVID-19 vaccine-related online sources from 52 countries including rumored to be used as guinea pigs for vaccine trials [35]. In addition, being a novel vaccine that was produced in a short period without sufficient research has made pregnant women more hesitant [22,25] or reluctant [6]. In line with other studies, pregnant women were uncertain about the vaccine’s effectiveness for pregnancy [24,25] and believed vaccines were ineffective [26]. Vaccine skepticism and prejudice, fueled by conspiracy theories and doubts about effectiveness, significantly influence pregnant women’s hesitancy toward COVID-19 vaccination. The fear of being used as experimental subjects and exposure to misinformation online further reinforces their reluctance.

Facilitators & implications for practice and policy

The facilitators for pregnant women’s acceptance of the COVID-19 vaccine are multifactorial. In our study, three main themes were identified including concerns about the effects of COVID-19 infection, trust in the vaccine and personal and shared vaccination experiences. When individuals are concerned about the risk of contracting COVID-19 or believe the disease can cause serious health consequences, they are more likely to perceive the threat as high as described in HBM (perceived susceptibility and perceived benefit) [11,13–17]. Having personal and shared experiences is reflecting a cue to action in HBM [11,13–17]. Having trust in the vaccine is a form acceptance attitude toward vaccine which illustrated in TPB as well as personal and shared experiences can shape subjective norms [12–15,18,19]. Emphasizing the risks of COVID-19 infection during pregnancy by health authorities, including potential complications for both mother and baby as well as integrating the discussion by healthcare providers during antenatal visit are crucial.

A key factor facilitates pregnant women’s acceptance of vaccine was their increased concern about the potential impact of illness on both their own health and that of their unborn babies [6,25,27]. Additionally, participants believed the COVID-19 vaccine could vertically provide their unborn babies with the antibodies for protection during infancy [36]. They therefore supported the effectiveness of the COVID-19 vaccine for both pregnant women and their unborn babies. Pregnant women who accepted the vaccine also believed the vaccine was safe for themselves and their unborn babies [6]. In our study, this belief emerged as a result of an uneventful previous COVID-19 vaccination experienced by the participants, either before or during pregnancy. Participants’ experiences of observing the effects of the COVID-19 vaccine in curbing the viral transmission effectively in their family members had also facilitate their acceptance. Family experiences served as impactful cues to action whenever participants observed that their relatives were less likely to contract COVID-19. It acted as a compelling prompt for them to consider vaccination significantly. Pregnant women felt more motivated to receive the COVID-19 vaccine after observing others especially family members, friends, other women, young adult, neighbours, and prominent people in the country getting vaccinated and recommending it [26,37,38]. Seeing positive experiences from people they trusted or others with similar backgrounds helped to reduce their fears and reinforced their confidence in the safety and benefits of the vaccine. This highlights the importance of social influence in shaping one’s attitude and action as regards vaccination acceptance.

Pregnant women viewed the COVID-19 vaccine through the maternal lens – they outweighed the COVID-19 vaccine benefits and risks on their unborn babies first before writing down their signatures on the consent form. They can also be at the stage of ambivalence, whereby they neither accept nor refuse the vaccine for many reasons. Vaccine hesitancy is a complex issue, particularly in a multiracial country like Malaysia, whereby the attitudes of pregnant women are influenced by personal, sociocultural, and institutional factors. HCPs play important roles in recognizing these pregnant women at what stage they are so that targeted counselling and vaccine education can be provided in a timely manner [22,23,39].