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PLOS Global Public Health logoLink to PLOS Global Public Health
. 2022 Dec 6;2(12):e0001321. doi: 10.1371/journal.pgph.0001321

The supply is there. So why can’t pregnant and breastfeeding women in rural India get the COVID-19 vaccine?

Nadia G Diamond-Smith 1,*, Preetika Sharma 2, Mona Duggal 2, Navneet Gill 2, Jagriti Gupta 3, Vijay Kumar 3, Jasmeet Kaur 4, Pushpendra Singh 4, Katy Bradford Vosburg 1, Alison M El Ayadi 1
Editor: Prashanth Nuggehalli Srinivas5
PMCID: PMC10022347  PMID: 36962889

Abstract

Despite COVID-19 vaccines being available to pregnant women in India since summer 2021, little is known about vaccine uptake among this high need population. We conducted mixed methods research with pregnant and recently delivered rural women in northern India, consisting of 300 phone surveys and 15 in-depth interviews, in November 2021. Only about a third of respondents were vaccinated, however, about half of unvaccinated respondents reported that they would get vaccinated now if they could. Fears of harm to the unborn baby or young infant were common (22% of unvaccinated women). However, among unvaccinated women who wanted to get vaccinated, the most common barrier reported was that their health care provider refused to provide them the vaccine. Gender barriers and social norms also played a role, with family members restricting women’s access. Trust in the health system was high, however, women were most often getting information about COVID-19 vaccines from sources that they did not trust, and they knew they were getting potentially poor-quality information. Qualitative data shed light on the barriers women faced from their family and health care providers but described how as more people got the vaccine that norms were changing. These findings highlight how pregnant women in India have lower vaccination rates than the general population, and while vaccine hesitancy does play a role, structural barriers from the health care system also limit access to vaccines. Interventions must be developed that target household decision-makers and health providers at the community level, and that take advantage of the trust that rural women already have in their health care providers and the government. It is essential to think beyond vaccine hesitancy and think at the system level when addressing this missed opportunity to vaccinate high risk pregnant women in this setting.

Introduction

As of December 2021, the Ministry of Health India reported that 61% of the adult population is fully vaccinated, almost reaching the WHO target for vaccination coverage for all countries to reach 70% by the end of 2022 (Fig 1) [1]. Global inequities in COVID-19 vaccine distribution remain significant; however, vaccine availability is considered robust in most high and many middle-income countries, including India—a major producer of vaccines.

Fig 1. 2021 Timeline of vaccine distribution and restrictions in India.

Fig 1

Despite these overall high rates in India, there are significant disparities in vaccination rates across income, region, education, age and especially gender [1]. Several studies highlight that individuals with an advanced education and job title are more likely to be aware of the COVID-19 vaccine and accepting of the vaccine [2, 3]. In India gender has played an important role in structuring how the COVID-19 pandemic has impacted health outcomes with women bearing an unequal COVID-19 mortality compared to men, including among younger women of reproductive age [4, 5]. This is in contrast to trends globally, where men had higher mortality than women [6]. Gender inequality is especially important to consider in India, where strict, inequitable gender norms often limit women’s autonomy, decision-making power, mobility, access to care, and overall levels of empowerment.

COVID-19 infection during pregnancy is of particular concern as pregnant women are more likely to develop severe disease from COVID-19 infection. COVID-19 during pregnancy is also associated with elevated risks of fetal and neonatal complications [7, 8]. Unvaccinated pregnant women are at even more risk of having adverse birth outcomes [9]. COVID-19 contributed greatly to maternal mortality as well. Shortly before the Indian government issued guidance that the COVID-19 vaccine was approved for pregnant and breastfeeding women in India (July 2nd, 2021, Fig 1, before our study took place), Mumbai, the second most populous city in India, declared that COVID-19 was the leading cause of death among new mothers between 2020–2021 [10]. However, despite vaccine availability for Indian pregnant women in the six months between then and when this data was collected, little is known about current uptake in this population. Currently, CoWin, which tracks India’s COVID-19 vaccine statistics, does not have the ability to look at vaccination rates broken down by key characteristics such as for pregnant or postpartum women, socio-economic status, tribal communities, or other often overlooked subpopulations. A multi-country study conducted before the vaccine was approved for pregnant women and found that most pregnant Indian respondents (93%) reported they were likely to get the COVID-19 vaccine, a substantially higher proportion than other countries included in the study [11]. However, we know little about how this translated into uptake among pregnant women once the vaccine was approved.

A 2021 systematic review of studies looking at vaccine uptake in pregnant women found that the biggest predictors of vaccine uptake included trust in the effectiveness and safety of the vaccine, communication about safety of the vaccine in pregnancy, trust in public health agencies, anxiety about COVID-19 and other COVID-19 safety behaviors [12]. Age, education and socio-economic status were also associated with vaccination in pregnant women. However, this review mostly included papers with data from high income countries, with only one paper from 2020 having collected data in India. While there are a number of papers from across India looking at vaccine acceptance and hesitancy [2, 1316], only one focuses on pregnant and postpartum women. The 2022 study from northern India explored barriers to vaccination among pregnant and postpartum women, collecting data from a mostly urban, well-educated and highly vaccinated population. This study found large differences by socio-economic and rural/urban status, and found that concerns over the impacts on the baby and lack of inclusion of women in vaccine safety trials were main contributors to vaccine hesitancy (delay in acceptance or refusal of vaccination despite availability) [17]. More, mixed-methods research is needed with rural, less well off, and un-vaccinated groups of pregnant and postpartum women to understand contributors and barriers to vaccine uptake. With this in mind, we hypothesized that a variety of factors would influence vaccine uptake among pregnant and recently delivered women in India. Specifically, belief in the effectiveness and safety, communication from trusted health care providers, norms around community acceptance/uptake, and socio-economic factors.

Materials and methods

Ethics statement

This study received ethical approval from the Human Research Protection Program at the University of California, San Francisco (#21–35278) and Indraprastha Institute of Information Technology, Delhi Institutional Review Board (IIITD/IRB/07/2021/03). All participants underwent an informed consent process and confirmation was obtained verbally.

To understand vaccine uptake, barriers, hesitancy, facilitating factors and sources of trusted information among pregnant and breastfeeding women, we conducted mixed-methods research in northern India in November 2021. Broadly, the study was carried out in lower and upper middle class populations. The WhatsApp groups through which we recruited (described below) was designed to serve a population residing in rural and suburban areas in two districts in Haryana. However, since women migrate, our estimates are that about 60% of the respondents were from these two districts in north India, the rest were most likely from Punjab, UT Chandigarh, Uttar Pradesh, Uttarakhand or UT Delhi. In terms of health and socio demographic characteristics, these districts rank in the middle, compared to other Indian districts, during the past decade. In this setting, the vaccine was available free of cost in government facilities, and for a charge in private facilities. In total, we conducted 300 phone surveys and 15 in-depth interviews with women. The eligibility criteria were to include pregnant and recently delivered women who were breastfeeding (up to one year postpartum). Since this was a formative, descriptive study, we estimated that 300 respondents would be sufficient to describe trends in vaccination, barriers and hesitation.

The surveys were conducted telephonically. The participants were active members of WhatsApp groups run by a local NGO that was a collaborator on the project. All women in the WhatsApp group were connected to the government health care system, which provides free services. A list of 552 eligible women, from a sample of about 5,000, was provided to the research assistants. Women who were either pregnant or had delivered within 1 year were eligible for the survey. The list included their name, mobile and date of delivery. These women were called one by one down the list provided by the research assistant. Women were read an informed consent and asked to provide verbal consent. A survey call was scheduled based on time convenient for the women. Most of the surveys were completed in one call and few were done in parts based on the availability of the participant. Out of about 450 women called, 300 complete surveys were taken. Some women did not pick the call, or only completed half of the survey. The team began to take the surveys in the first week of November, 2021 and 300 surveys were completed by Nov 27, 2021. The women were followed up with to get the missing information wherever possible.

The survey tool was developed and finalized by the team members and was put on web application RedCap. It included questions on vaccine acceptance, barriers, hesitancy and socio-demographics. The redcap data underwent quality assessments and then incorrect data or missed areas were addressed. Quantitative data associated with this study are publicly accessible in Dryad [18].

Quantitative survey data was analyzed using descriptive statistics (frequencies, percentages) using STATA version 15 [19]. We then explored sets of factors associated with being vaccinated (vaccinate yes/no) using logistic regression models. Our primary predictor of interest was pregnancy status, coded as currently pregnant or postpartum. First, we looked as socio-demographic factors, including age (continuous), schooling (Some secondary or more compared (to Primary or less), religion (Hindu compared to other religion), caste (General caste compared to other caste), and having a ration card or not, which is a marker of poverty status. Ration cards are provided based on the income level. Next, we looked at three measures associated with confidence in the vaccine (all coded “not at all, “somewhat”, “moderately” or “very”, but changed into a binary of “very” vs. others), including believing that the vaccine is effective, safe for the woman and safe for the baby. Next, we looked at two questions associated with trust in the medical system, (with the same four answer options as above, any made into a binary) including how much the woman trust the public health agencies that recommend the vaccine and how much they trust their perinatal care providers in recommending the vaccine. The next model looked specifically at if their perinatal care provider had recommended that they get the vaccine, told them NOT to get it while pregnant, or had not mentioned it. Next, we looked at the impact of information using a question which asked if the respondent had heard or seen any information about COVID-19 vaccines that she could not tell if was true or false (yes/no or not sure). Finally, we looked at two measures of social pressure, including whether the respondent thought that most of their community would get the vaccine (yes/no) and most of their family would get the vaccine (yes/no).

In depth interviews

At the end of the telephonic survey, women were asked if they would be willing to be contacted to participate in longer follow-up in-depth interviews. Later, the research associate reached out to those who agreed for a telephonic in-depth interviews. Of the 27 women called, 15 women agreed to give an interview. In depth interviews lasted from 35–70 minutes. In depth interviews were collected until data saturation was reached, which was determined by the study team conducting the interviews. Some surveys and interviews were taken on multiple calls due to the time constraints of the participants. The interviews were conducted in Hindi and were later transcribed and translated into English. A codebook based on the key themes covered in the interview was made to analyze the interviews, which was done by the three members from the research team (XX XX XX) using Dedoose software (Version 8). In the context of the COVID-19 vaccine, key themes covered in the interview included general impact of COVID-19 pandemic, its impact on their pregnancy, their own thoughts on COVID-19 vaccine, thoughts of their family members, views of community and perinatal care provider on COVID-19 vaccine, decision making, sources of information and understanding of technology.

Results

The mean age of respondents from the surveys was 26, ranging from 17–42 (Table 1). Just under half of respondents had secondary education or more (46%), most were Hindu (92%), a third were general caste (66.7%), and just over half had a ration card (56%). Respondents from the qualitative interviews were similar: mean age was 26, just under half had secondary education (46%), 60% were general caste, however, fewer had a ration card (33%).

Table 1. Demographics of the population.

Survey In-depth interviews
Number/mean Percent /range Number/mean Percent /range
Age (mean, range) 26 (17–42) 26 (22–31)
Education
<secondary 137 45.7% 7 46%
Secondary or more 163 54.3% 8 54%
Religion (Hindu) 275 91.7%
Caste (Other = schedule caste and other backward class, compared to general) 200 66.7% 9 60%
Has Ration Card 164 54.7% 5 33.33%

Vaccination rates were low; but desire for vaccination was high. Only one-third (36%) of pregnant and breastfeeding women had received the vaccine (Table 2). This is despite all women registering their pregnancies with either a public or private health facility, indicating that they had seen a health care provider during their pregnancy—a potential point of contact for vaccination. All of our respondents were engaged in the health system and regularly receiving care throughout their pregnancies, and all of their pregnancies occurred after vaccines were approved for pregnant women. About half (47%) of non-vaccinated women said they would get the vaccine now if they could, an additional 20% want to get it soon but would wait, and 27% reported that they would not get it at all (the remaining were unsure). As one non-vaccinated women explained:

Table 2. Vaccination practices and beliefs.

Have you received a COVID-19 vaccine?
No Yes
N = 191 % N = 103 %
Do you think the vaccine is effective?
No 13 6.8 3 2.8
Yes 178 93.2 106 97.2
Do you think the vaccine is safe for the you?
No 21 11 1 0.9
Yes 170 89 108 99.1
Do you think the vaccine is safe for the baby?
No 26 13.6 6 5.5
Yes 165 86.4 103 94.5
How much do you trust the public health agencies that recommend you get a COVID-19 vaccine?
Not at all 2 1 2 1.8
A little 1 0.5 0 0
Moderately 22 11.5 3 2.8
Very much 166 86.9 104 95.4
How much do you trust your perinatal care providers in recommending you get the COVID-19 vaccine?
Not at all 2 1.1 3 2.8
A little 2 1.1 0 0
Moderately 21 11.1 2 1.8
Very much 165 86.8 104 95.4
Have you seen or heard any information about COVID-19 vaccines?
No 83 43.5 33 30.3
Yes 108 56.5 76 69.7
Do you know where to get accurate, timely information about COVID-19 vaccine?
Yes 7 3.66 4 3.67
No 181 94.76 104 95.41
Not sure 3 1.57 1 0.92
Do you think that most of your friends and family will get a COVID-19 vaccine?
No 12 6.3 1 0.9
Yes 179 93.7 107 99.1
Do you think that most of the people in your community will get a COVID-19 vaccine?
No 12 6.3 0 0
Yes 179 93.7 109 100
Has your perinatal care provider recommended that you get the COVID-19 vaccine?
Yes—recommended vaccine 33 17.3 41 37.6
No—recommended against vaccine 89 46.6 21 19.3
No—has not addressed vaccine 69 36.1 47 43.1
Among those not vaccinated:
If a COVID-19 vaccine were available to you, would you get it?
Yes, I would get it as soon as possible 89 47.1%
Yes, but would wait to get it 38 20.1%
No 50 26.5%
Not sure 12 6.3%
How easy do you think it will be to get a COVID-19 vaccine for yourself?
Very easy 92 84.4%
Somewhat easy 10 9.2%
Somewhat difficult 2 1.8%
Very difficult 5 4.6%

“I have not got vaccinated so I can’t say but if you will ask me then I think it will have a good effect on the baby. Like there will be some immunity power that will be generated due to the Covid-19 vaccine. Just like we eat everything, that gives the baby the nutrition and the same way as my baby had the growth even though I took the injections.” (age 30, breastfeeding)

Below we describe the main themes of facilitators and barriers women faced to getting the vaccine that they wanted:

Vaccine safety

Most (95%) thought that the vaccine was effective and safe for the mother (93%) and baby (89%), these percentages were high among those who were vaccinated and those who were not (Table 2). Concerns related to health of the mother and baby were common in the survey data; for example, 22% were worried about safety for their baby in one way or another. Most (65%) had no concerns and 13% some other concerns (family members concern, general lack of trust, confusion, general “safety”); of note, none reported concerns regarding the mother’s health. Only 6% of women who were vaccinated reported concerns over safety, while 26% of women who were not vaccinated did. In our qualitative research, women described their own, or their family member’s worry about the vaccine spoiling breast-milk quality and quantity, and the potential for impact on the physical and mental development of child.

Refusal on the part of health care providers

One of the next common reasons reported that women who wanted the vaccine had not gotten it was that community health workers and doctors were refusing to administer the vaccine to pregnant women; 13% of women who were not vaccinated reported this as the reason why. We did not specifically provide this response option in our questionnaire since we were not anticipating this situation; thus, we hypothesize this could have been the case for more women, however, we only have data on the women who selected “other” as a response option and told the interviewer that this was their reason. For example, women responded to the “other” option with statements like “I wanted to get it but dispensary staff and Nurse denied to vaccinate me. What should I do?” and “This vaccine is very effective & safe. Everyone should take this, but my doctor forbade me to take the vaccine due to my pregnancy.” This theme also came up repeatedly in the qualitative interviews, again suggesting that this sentiment was even more common than survey data suggest. As women seeking COVID-19 vaccination described, they went to seek the vaccine, but were denied by health care providers—who they rely on for information:

I went to hospital a number of times but they refused to vaccinate me by saying that you are pregnant so you can’t have it. Come after delivery." (age 30, breastfeeding)

When I was pregnant, I went to ask they said that it is not allowed to get the vaccination during pregnancy and after delivery is permitted. I don’t have much knowledge, who should take it and who shall not. (age 25, breastfeeding)

Even women in the postpartum period described being denied the vaccine “When my child was 7 months old, I asked the ASHA, she said that it is not allowed to you and then I did not ask” (age 23, breastfeeding)

This finding is especially concerning given our study population reported high levels of trust in the health care system, with 90% of participants saying they trusted the government/public health agencies “very much” and 90% saying they trusted their perinatal care provider “very much”. Again, more women who were vaccinated reported high levels of trust compared to unvaccinated women (Table 2). Yet, only 25% of respondents were recommended to receive the vaccine by their providers. One respondent noted: "If Government has introduced a vaccination then it should be tried.” (age 28, breastfeeding). Where public or private healthcare providers recommended the vaccine, patients readily accepted it:

My mother had a word with the [community health worker] regarding COVID-19 vaccine. She suggested us to have it. Actually, we had discussed it with our doctor and they gave us approval only that’s why we had vaccination otherwise we would not have taken it" (age 25, pregnant).

Furthermore, even providers not discussing or mentioning the vaccine led women not to take it up, as one woman from the survey described “No one has suggested me to take my vaccination. If it’s necessary then I would have it.”

Gender and subjective norms

Aside from reluctance among health care providers to vaccinate pregnant women, the role of gender also contributed to low vaccine uptake among pregnant and breastfeeding women in our sample. As mentioned above, in the Indian setting, decisions are often made at the household level, by men or in-laws. Restrictions on mobility and norms around how women can interact with others in society were a barrier to information, as one respondent described:

I don’t know much because I stay home and rarely go out. I don’t talk to people in the community. My in-laws go out and they share what is happening in society.” (age 24, breastfeeding).

Low empowerment made it difficult for some women to advocate for vaccination or to seek information they needed about the vaccine. In the qualitative interviews, one woman who did get vaccinated when her baby was an infant described how her mother-in-law would not let her hold her baby for many hours after her vaccination.

In addition to gender norms and barriers, we observed broader subjective norms influencing behavior. As one woman explained:

They [family members] were not agreeing for it [the COVID-19 vaccine] because others were not going to get it and now they are lining up in vaccination camps because they are seeing others’ vaccination results [no side effects, helping people]” (age 24, pregnant)

However, survey data suggested that most women believed that most of their family and friends (96%) and community (96%) will get the vaccine, again with high proportions of vaccinated, compared to unvaccinated, women reporting this (Table 2).

Information

While changing social norms were shifting COVID-19 vaccine uptake and reducing hesitancy, 96% of respondents said they did not know where to get accurate information on COVID-19 and COVID-19 vaccines, and this proportion was similar among vaccinated and unvaccinated women (Table 2). Women were keenly aware that they were seeing false and misleading information (61% said they saw information that they could not tell was true or false). And yet, there was a misalignment between who women said they trusted most for information, and where they got most of their information about COVID-19 vaccines (Fig 2). The most trusted sources were public health agencies/government, followed by family/friends, and then hospital websites (Fig 2). Social media was trusted by <10%. However, the main sources of information were TV (96%), followed by family (72%), social media (56%), and then friends (48%). This highlights that some people are getting their information from sources that they may not fully trust, potentially leading to more confusion or hesitancy.

Fig 2. Most trusted and actual sources of information about COVID-19 vaccine.

Fig 2

There is a complex interplay between household decision-making, social norms, availability of reliable sources of information, and the deep trust in the government health care system that all must interact in the perfect balance to allow pregnant women in this setting to get vaccinated. One woman summed this up perfectly:

"All my family members have been vaccinated. Earlier somebody told us that pregnant ladies are not eligible for vaccination. But when I found the Prime Minister’s statement regarding vaccination on google, then I told my husband about it. We discussed it with our gynecologist, and she told us that vaccination is good to take and then I had my vaccination. Earlier, my husband was worried about if the vaccination would harm the baby, but everything went well after vaccination. My husband says that everyone should take this vaccination if they are being asked to do so” (age 25,pregnant)

Factors associated with being vaccinated

In multi-variable logistics regression models including socio-demographics, the only factor associated with being vaccinated was whether the woman had a ration card, where women with a ration card (an indicator of poverty status) had increased odds of being vaccinated (OR = 1.85, 95% CI = 1.12–3.04) (Table 3). In the next set of models on belief in the vaccine, believing that the vaccine was safe for the baby was associated with increased odds of being vaccinated with marginal significance (p = 0.058) (OR = 2.67, 95% CI = 0.97–7.39). Neither of the variables related to trust in providers was significantly associated, however, a woman having her perinatal provider tell her not to get the vaccine (OR = 0.19, 95% CI = 0.09–0.37) and not discuss it (0.56, 95% CI = 0.31–1.02, p = 0.058) were both associated with lower odds of being vaccinated. A woman saying that she heard or saw information about the vaccine that she could not tell if was true or false was associated with increased odds of vaccination (OR = 1.91, 95% CI = 1.14–3.18). Belief that her family would all get vaccinated was not significantly associated.

Table 3. Factors associated with being vaccinated among pregnant and postpartum women.

Variables Model 1 Model 2 Model 3 Model 4 Model 5 Model 6
Currently Pregnant (compared to postpartum) 1.08 (0.67–1.75) 1.20 (0.73–1.97) 1.20 (0.73–1.97) 1.21 (0.73–2.03) 1.06 (0.65–1.73) 1.14 (0.69–1.86)
Age in years 0.98 (0.92–1.05) 0.98 (0.91–1.05) 0.98 (0.92–1.05) 0.98 (0.91–1.06) 0.98 (0.91–1.05) 0.98 (0.91–1.05)
Secondary education (compared to <secondary) 1.11 (0.67–1.85) 1.09 (0.65–1.82) 1.21 (0.72–2.03) 1.03 (0.60–1.77) 1.13 (0.67–1.89) 1.09 (0.65–1.83)
Hindu (compared to all others) 0.65 (0.26–1.64) 0.66 (0.26–1.68) 0.67 (0.26–1.72) 0.60 (0.23–1.59) 0.58 (0.22–1.47) 0.74 (0.29–1.90)
General caste (compared to all others) 0.79 (0.46–1.35) 0.74 (0.43–1.28) 0.75 (0.43–1.29) 0.76 (0.43–1.32) 0.77 (0.45–1.33) 0.76 (0.44–1.32)
Has ration card 1.85** (1.12–3.04) 1.89** (1.14–3.14) 1.92** (1.15–3.20) 1.86** (1.10–3.16) 1.92** (1.16–3.18) 1.86** (1.11–3.09)
Vaccine is effective 1.46 (0.36–6.02)
Vaccine is safe for baby 2.67* (0.97–7.39)
High trust in public health agencies 1.53 (0.42–5.60)
High trust in perinatal care provider 2.93 (0.79–10.81)
Perinatal provider recommended to get vaccine
Perinatal provider recommended NOT to get vaccine 0.19*** (0.09–0.37)
Perinatal provider did not mention vaccine 0.56* (0.31–1.02)
Heard information that couldn’t tell if was true or false 1.91** (1.14–3.18)
Do you think your family and friends will/have gotten the vaccine? 1.51 (0.13–17.46)
Constant 0.74 (0.11–4.79) 0.22 (0.02–2.20) 0.16 (0.02–1.49) 1.64 (0.22–12.36) 0.54 (0.08–3.70) 0.52 (0.02–11.50)
Observations 300 300 300 300 300 287

ciEform in parentheses

*** p<0.01

** p<0.05

* p<0.1

Discussion

Our research with pregnant and breastfeeding women indicated that some women and their communities were hesitant to receive a COVID-19 vaccine, especially initially. Vaccine hesitancy is complex [20] and misinformation and disinformation are often highlighted as the key influencers driving mistrust in the COVID-19 vaccine [21]. However, our finding highlighted that as more of the population has been safely vaccinated, unvaccinated individuals have become more willing to do so themselves. Believing that the vaccine is safe, especially for the infant, is essential, as came out in the qualitative and quantitative results of this study. Addressing misinformation about side effects or impacts of the vaccine is clearly key—as these myths were pervasive among respondents and potentially driving some of the barriers enforced and lack of action of health care providers.

However, aside from this, healthcare provider refusal to vaccinate was a primary contributor to women in our sample being unable to receive a COVID-19 vaccine. This finding came out strongly in the qualitative and quantitative data—women wanted the vaccine while pregnant but were being advised not to get it, or were outright refused the vaccine. It is clear that education to providers about the safety of the vaccine in pregnancy was a missed opportunity and led to many women remaining unvaccinated in pregnancy, despite a desire for the contrary. Education would need to target all levels of health care providers, from specialized perinatal care providers to community health workers, and likely be ongoing and multi-pronged. Additionally, on a broader level, helping providers think through balancing the reality that pregnancy is a time of higher risk in some ways with the fact that COVID-19 in pregnancy posed many risks could have helped shift the paradigm.

One of the strongest predictors of not being vaccinated was a woman’s perinatal provider either recommending against it, but also the provider simply not bringing it up. Trust in health care providers, including community health workers, was very high, as has been found in past studies in India [22]. A study from India among pregnant women and their health care providers regarding influenza vaccinations also found that health care providers were the most trusted sources for advice on the vaccination, and also that despite high interest among women, there was more uncertainty among their health care providers—although it did not seem as extreme as in this case [23]. Perhaps the novelty of the COVID-19 vaccine made providers additionally hesitant; the same could be true for hesitancy among community members as well, who are used to and accepting of other vaccines in pregnancy, such as tetanus. While we might expect that women would trust their providers and not get vaccinated if their provided recommended against it, its notable that even a provider not mentioning the vaccine contributed to women not getting vaccinated. This highlights the important role that silence can play, and the need to encourage providers to play an active role in promoting the vaccine in this population.

Much focus in current research on vaccine hesitancy has highlighted the role of misinformation (false information) and it was interesting to note that a majority of women in our sample reported that they saw information that they could not tell if was true or false. While it is heartening that so many women were aware and questioning the information they saw, it is also interesting that women reporting seeing questionable information was actually associated with vaccination status. This suggests that perhaps interventions that help people think about the veracity of the information that they see or even promoting questioning could be important to study further for addressing vaccine hesitancy.

Interestingly, we find that women with a ration card, which indicates that a household is eligible for subsidized foods (a marker of poverty), were more likely to be vaccinated. Caste, religion, and education, which are also often associated with health inequalities, were not associated with vaccination status in this analysis. A study among the general population (not focused on pregnant women) in India found that religion and education were not associated with vaccine acceptance, however, though they collected data on ration cards, they did not include this in their models [24]. It is possible that people with ration cards were more likely to be connected to the health system, perhaps even targeted by providers for vaccinations, or more likely to be accepting of government programs (such as vaccination).

In order to ensure that pregnant and breastfeeding women who want the COVID-19 vaccine can receive it, we need a multi-pronged gender and health-behavior informed strategy. First, we suggest that government and civil society should invest resources in educating female, front-line healthcare workers (who provide the majority of care to pregnant and breastfeeding women), to ensure they are well informed about the benefits of vaccinating pregnant and breastfeeding women against COVID-19. Ensuring that female providers are strong advocates for vaccinating pregnant women against COVID-19 is likely to have significant benefits, given high levels of trust in the government health care system by the general public. Second, we recommend the development of widespread public health education campaigns about the COVID-19 vaccine that specifically target women to ensure they are educated about COVID-19 vaccine safety, with a focus on safety in pregnancy and for the infant. Women in this setting often face restrictions on their mobility or empowerment, and thus educating women alone is insufficient—messaging must also target and engage family members both to be supportive of COVID-19 vaccination in pregnancy, but also more broadly to address gender equality. Third, as the pandemic continues, it is critical that we continue to conduct high quality research into underlying causes of vaccine refusal or postponement in this high-risk population in India.

While this study adds to the literature by studying vaccine hesitancy and uptake among an often-neglected population who is of high risk (pregnant and postpartum women in rural India), this study does have limitations. Data is cross sectional, and thus while we look at associations we are unable to make claims about directionality of associations. Participants were recruited from one part of India, and thus findings might not be generalizable to other parts of India or outside of India. Respondents were also recruited through a community organization that provides services to pregnant and postpartum women, and thus, these respondents might be more connected to the health care system and have had more access to information about and actual uptake of COVID-19 vaccines. Additionally, all women had phones, and thus, while a large proportion noted having ration cards (a marker of poverty), this sample did not represent the least well-off populations in this setting (those without access to phones). Collecting data over the phone also posed limitations including (a) challenges in finding a suitable time for interviews and potential lack of privacy for the respondents (b) clarity of communication due to echo and voice cracking and (c) having to break up interviews over multiple phone calls for some participants.

Conclusions

The results of this study surprised us and made us reconsider some of our own assumptions about vaccine uptake and barriers. The findings also made us question the course that we, as a public health community, have been taking to address low vaccine uptake. Many pregnant women in northern India who want the COVID-19 vaccine are not receiving their COVID-19 vaccines, despite it being approved in this population for over 6 months and pregnant women being high risk for adverse maternal and fetal impacts from COVID-19. To reach the underserved and high risk population of pregnant and breastfeeding women, it is imperative that India’s COVID-19 vaccine outreach simultaneously target households [25], health care workers who are frontline along with other health care providers, and address social norms to increase vaccine uptake. Considering the complex interplay between trust in the government and health care providers, gender and social dynamics and norms, and other factors aside from supply are key to understanding and address vaccine hesitancy and vaccination—for COVID-10 and likely other vaccinations now and in the future, in India and globally.

Supporting information

S1 Text. Inclusivity in global research.

(DOCX)

Data Availability

DOI: Diamond-Smith, Nadia et al. (2022), The supply is there. So why can't pregnant and breastfeeding women in rural India get the COVID-19 vaccine? , Dryad, Dataset, https://doi.org/10.7272/Q6XD0ZX8.

Funding Statement

This project was funded by the Vaccine Confidence Fund, Grant ID VCF – 028 (Co-PI AEA and ND-S). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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PLOS Glob Public Health. doi: 10.1371/journal.pgph.0001321.r001

Decision Letter 0

Prashanth Nuggehalli Srinivas

21 Jun 2022

PGPH-D-22-00468

The supply is there. So why can’t pregnant and breastfeeding women in rural India get the COVID-19 vaccine?

PLOS Global Public Health

Dear Dr. Diamond-Smith,

Thank you for submitting your manuscript to PLOS Global Public Health. After careful consideration, we feel that it has merit but does not fully meet PLOS Global Public Health’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

This study is an important one, but currently the manuscript has has too little information to engage a reader ( for instance gaps in description of the context/setting, no socio-demographic tables or sample descriptions, no descriptive tables from the survey and no segregated themes from the qualitative data to name a few). One of the reviewers has pointed out important gaps which need to be addressed before due consideration on its merit for publication.  

Please submit your revised manuscript by . If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at globalpubhealth@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pgph/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

  • A rebuttal letter that responds to each point raised by the editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.

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Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

We look forward to receiving your revised manuscript.

Kind regards,

Prashanth Nuggehalli Srinivas, MBBS, MPH, PhD

Academic Editor

PLOS Global Public Health

Journal Requirements:

1. Please include a complete copy of PLOS’ questionnaire on inclusivity in global research in your revised manuscript. Our policy for research in this area aims to improve transparency in the reporting of research performed outside of researchers’ own country or community. The policy applies to researchers who have travelled to a different country to conduct research, research with Indigenous populations or their lands, and research on cultural artefacts. The questionnaire can also be requested at the journal’s discretion for any other submissions, even if these conditions are not met.  Please find more information on the policy and a link to download a blank copy of the questionnaire here: https://journals.plos.org/globalpublichealth/s/best-practices-in-research-reporting. Please upload a completed version of your questionnaire as Supporting Information when you resubmit your manuscript.

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Reviewer #2: Yes

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: No

Reviewer #2: I don't know

**********

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Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Thank you for an opportunity to review this article, which attempts to address a very important topic of low uptake of the COVID-19 Vaccine among pregnant and lactating women in one rural setting in India. The authors seem to have made a rigorous attempt to capture data through mixed methods, but much of the details needed to interpret the paper are missing from the paper at present. I would suggest a revised paper with more contextual details, methodological nuances such as details of the sampling size and strategy, detailed reporting of quantitative tables (there are no tables) and qualitative findings (few scattered themes reported), and a deeper discussion section in relation to current literature.

More details are below

Introduction

Important dates, COVID- context in India particularly of vaccination, type of vaccines available, the CoWin App and digitalization -perhaps a timeline here? when did vaccination begin, when did it begin for pregnant women (highlighting the fact that it was not approved for pregnant women initially)

-a strong argument for why this study was done. What does it add to what we already know in literature?

- description of the context is important, currently there is no description of the study setting. If the state name/district was masked, perhaps how does this limit interpretations of the data. For instance, study (10) has shown that 93% of women reported intentions to get vaccinated. Was something different in this context?

Methods

Detailed description of survey methods- where was it done, sample size calculations, non response rates, survey tool and its dimensions ( might help to attach), data cleaning, analysis, etc

Details of qualitative methods- purposive sample, saturation, non-response, key themes that were asked, interview guide used for facilitation. Transcription, analyses

Details of the qualitative and quantitative demographics of participants needed.

Findings

It might make sense to separate the qualitative and quantitative findings and present them separately.

In the survey section of the findings, please report main data tables-example- intention to get vaccine,sources of information, trust, etc. also if the responses differed by age, family type, parity, the trimester they are in, other socio demographics. We don’t have much details of the 500 people surveyed in the findings. Discuss the key tables in details.

In the qualitative section, one can pull from the data table and try to explain some of the ‘whys’ of the findings. But this needs to be done in 3-5 well-defined themes, for right now there is a long write-up that is a bit difficult to read. For instance, lines 140 -152 have several themes jumbled up- reasons for not getting vaccinated, some idea of trust and on uptake, etc. Quotes need to be reported in lines with how qualitative data is usually reported (in double quotes, with some description of the participant demographics)- so that quotes can be interpreted by the reader with ease. More direct quotes can be included to give readers a better flavour of the field. One can also use tables to present summarized qualitative data or data from a few cases that highlight important issues. The richness of the interviews need to come out in this section

Discussion

-the limitations of the study need to be discussed. What were some of the limitations of doing phone interviews? How was non response dealt with? Do we leave out specific sections of the population ( the most vulnerable in fact) if we do phone interviews?

-lines 209-211 seem particularly important to me, based on what I know of the Indian context. But this point hasn’t been detailed in the findings section anywhere.

-what has been found from other contexts on pregnancy and vaccination. There is a lot of literature in the non-covid areas as well on this.

- What is particularly different about India. In fact in india, pregnant women are offered vaccines ( TT) regularly, what is it that made them hesitate with regard to this vaccine? Vaccination was also happening in the private sector- in this context, did the women have access to this option.

-line 220- if the main reason for being unable to get a covid vaccine was due to the provider hesitancy, then should we not be educating providers rather than women as being suggested here. perhaps one needs to look at the main 3-5 reasons for low uptake, and see what specific measures (long-term and short-term) can be taken to address these. A table here would help to summarize these measures.

Apologies again for the long list of suggestions. I feel that such topics are important to work with. It is just that the manuscript at present needs more work in order for it to convey the rigor of the methods used as well as the depths of the findings. My very best wishes for the revisions.

Reviewer #2: Dear authors,

This is an important, timely paper, and I commend you for conducting this research. I would like to make some suggestions that will tighten the arguments.

Introduction: 

- Lines 73-76: Be sure to specify that in a reversal of what was witnessed worldwide, where men had higher Covid-19 fatality rates than women, in India women had a higher fatality rate

- Lines 83-87: The first and second part of the sentence have little in common except temporality - perhaps flip the two parts

Methods:

- Please provide an overview of topics covered in the phone survey and in-depth interview questionnaire 

- What % of women from the phone survey agreed to a follow-up interview? What % of these women were eventually interviewed? Did those who agreed to be interviewed differ in any way from those who did not? (just on some basic demographic measures)

Findings:

- To what extent did the 27% who did not want the vaccination overlap with the 30% who worried about the safety of the mother/baby?

- What were the main concerns of the remaining 70% of mothers?

- One of the 'main reasons' for lack of vaccination was the unwillingness of healthcare providers - what % of women reported this? (I assume 75%, based on line 156, but am uncertain)

- With regard to trust, in line 144 it states that 90% of women trusted govt/public health agencies, and in line 155 it states that 90% trusted perinatal care providers - do these refer to the same statistic?

- Is there any data to back up the assertions about women's lack of mobility and empowerment?- Lines 173-176 seem out of place, perhaps move to the end of the findings?

- Please be a bit clear about which findings are from the survey and which from the interviews. 

- If possible, accompany quotes with some basic information about the woman (age, pregnancy/post-partum/nursing status)

- Fascinating finding - that trusted sources are at odds with sources women actually receive information from

Discussion: 

- Line 209: please clarify 'larger proportion'

- Although women's lack of mobility and empowerment is highlighted in the findings, it finds no place in the discussion (harder to address in an intervention, of course, but should be nevertheless be noted) 

- Similarly, while suggestions focus on targeting women, the findings suggest working with family members as well 

Overall, some of the statements and assertions made in the paper require some evidence to back them up.

**********

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Reviewer #2: No

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PLOS Glob Public Health. doi: 10.1371/journal.pgph.0001321.r003

Decision Letter 1

Prashanth Nuggehalli Srinivas

17 Oct 2022

PGPH-D-22-00468R1

The supply is there. So why can’t pregnant and breastfeeding women in rural India get the COVID-19 vaccine?

PLOS Global Public Health

Dear Dr. Diamond-Smith,

Thank you for submitting your manuscript to PLOS Global Public Health. After careful consideration, we feel that it has merit but does not fully meet PLOS Global Public Health’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

Please submit your revised manuscript by Nov 16 2022 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at globalpubhealth@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pgph/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

  • A rebuttal letter that responds to each point raised by the editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.

  • A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.

  • An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

We look forward to receiving your revised manuscript.

Kind regards,

Prashanth Nuggehalli Srinivas, MBBS, MPH, PhD

Academic Editor

PLOS Global Public Health

Journal Requirements:

1. Please include a complete copy of PLOS’ questionnaire on inclusivity in global research in your revised manuscript. Our policy for research in this area aims to improve transparency in the reporting of research performed outside of researchers’ own country or community. The policy applies to researchers who have travelled to a different country to conduct research, research with Indigenous populations or their lands, and research on cultural artefacts. The questionnaire can also be requested at the journal’s discretion for any other submissions, even if these conditions are not met.  Please find more information on the policy and a link to download a blank copy of the questionnaire here: https://journals.plos.org/globalpublichealth/s/best-practices-in-research-reporting. Please upload a completed version of your questionnaire as Supporting Information when you resubmit your manuscript.

Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

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1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #2: All comments have been addressed

**********

2. Does this manuscript meet PLOS Global Public Health’s publication criteria? Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe methodologically and ethically rigorous research with conclusions that are appropriately drawn based on the data presented.

Reviewer #2: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #2: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available (please refer to the Data Availability Statement at the start of the manuscript PDF file)?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception. The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #2: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS Global Public Health does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #2: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #2: Dear authors,

Your effort in addressing comments that were raised with respect to the original submission is noted and appreciated. There is more clarity in the methodology, detail in the findings, and analysis in the discussion - and these revisions significantly strengthen the paper. But more remains to be done, described below in order of importance.

- In Table 2, is it possible to breakdown further between vaccinated and unvaccinated women? When not separated out, it is hard to identify specific drivers of vaccination/non-vaccination, and this is really the meat of the paper. Please distinguish between the two categories when describing your findings, and further reflect on them in the discussion.

- I understand the desire to protect participants, but by providing such little detail about the study site, a lot of context is lost. Would strongly suggest including some additional information.

There are many other points require additional clarification:

- Lines 129-130: are phrased ambiguously - were all participants from 2 districts, or 60% of them?

- Line 131: rank in the middle of what?

- Lines 129-134: were participants rural, or rural and suburban?

- Lines 135-142: were participants up to 6 months post-partum, or up to 1 year post-partum?

- Clarify how having or not having a ration card was a marker of poverty

- Note the version of Dedoose used

- Line 188: XX XX - I assume details will be filled in?

- Line 192: what is bot technology, and what is its relevance to this study?

- Lines 209-211: This an important point and needs to be moved up further

- Lines 211-213 - doesn't add up to 100% - what other categories included?

- Line 214+: Does this excerpt refer to one of the women in the 47%?

- Lines 224-225 show high trust in vaccines, but line 226 onwards shows some concerns - are these not at odds?

- Lines 244-245 - where is this stated in the hypothesis?

- Lines 274-275: "the health care system not wanting to vaccinate pregnant women" is awkward phrasing

- Line 320: In Factors associated with being vaccinated, p values are not provided consistently, so it is hard to know whether the finding is significant or not

- Lines 329-331 - is the association positive or negative?

- It is still not always clear what findings are from the phone surveys and/or the in-depth interviews

- Table 1: the religion/Hindu row is not filled

- The abstract is a little disorganized and I don't think it represents the content of paper effectively.

- Finally, the manuscript is filled with typos and grammatical errors: line 81 ("this is contrast"); line 105 ("vaccine uptake trust"); line 108 ("pregnancy women"); line 117 ("more, mixed methods"); line 141 ('oof' instead of 'of'); line 150 ("were called to again to..."); etc. I stopped noting these after one point, but please proof-read the paper carefully.

I do believe these are minor revisions and can be addressed easily. This is an important paper and it deserves to be published, and I look forward to seeing it in print.

Regards.

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Reviewer #2: No

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PLOS Glob Public Health. doi: 10.1371/journal.pgph.0001321.r005

Decision Letter 2

Prashanth Nuggehalli Srinivas

4 Nov 2022

The supply is there. So why can’t pregnant and breastfeeding women in rural India get the COVID-19 vaccine?

PGPH-D-22-00468R2

Dear Dr. Diamond-Smith,

We are pleased to inform you that your manuscript 'The supply is there. So why can’t pregnant and breastfeeding women in rural India get the COVID-19 vaccine?' has been provisionally accepted for publication in PLOS Global Public Health.

Before your manuscript can be formally accepted you will need to complete some formatting changes, which you will receive in a follow up email. A member of our team will be in touch with a set of requests.

Please note that your manuscript will not be scheduled for publication until you have made the required changes, so a swift response is appreciated.

IMPORTANT: The editorial review process is now complete. PLOS will only permit corrections to spelling, formatting or significant scientific errors from this point onwards. Requests for major changes, or any which affect the scientific understanding of your work, will cause delays to the publication date of your manuscript.

If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they'll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact globalpubhealth@plos.org.

Thank you again for supporting Open Access publishing; we are looking forward to publishing your work in PLOS Global Public Health.

Best regards,

Prashanth Nuggehalli Srinivas, MBBS, MPH, PhD

Academic Editor

PLOS Global Public Health

***********************************************************

Reviewer Comments (if any, and for reference):

Associated Data

    This section collects any data citations, data availability statements, or supplementary materials included in this article.

    Supplementary Materials

    S1 Text. Inclusivity in global research.

    (DOCX)

    Attachment

    Submitted filename: PlosGlobalHealth response to reviewers.docx

    Attachment

    Submitted filename: RandR2_ReviewerResponse_24Oct2022.docx

    Data Availability Statement

    DOI: Diamond-Smith, Nadia et al. (2022), The supply is there. So why can't pregnant and breastfeeding women in rural India get the COVID-19 vaccine? , Dryad, Dataset, https://doi.org/10.7272/Q6XD0ZX8.


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