RSV Prophylaxis in Neonates: Implementation and Parental Acceptance during the First RSV Season in Germany

Abstract

Background

RSV is the leading cause of lower respiratory tract infections (LRTI) in infants. Since 2024, STIKO recommends immunising all neonates with nirsevimab prior to or during their first RSV season. This study aims to assess parental acceptance and uptake of RSV immunisation during the first implementation season in Germany.

Methods

All neonates born at our hospital between 11 November 2024 and 31 January 2025 were included in this study. Parents received an antenatal information leaflet; counselling was part of the U2 medical checkup. The immunisation rate was assessed using data from electronic medical records. In addition, an online questionnaire surveyed parental satisfaction with the information provided.

Results

Of 1030 neonates, 76% received nirsevimab, 6% were protected by maternal RSVpreF vaccination (overall immunisation rate: 82%). Children of multiparous mothers were immunised less often than children of primiparous mothers (OR = 0.52; p < 0.001). Mothers aged ≥ 30 years were more likely to consent to vaccination (30–34: OR = 1.75; ≥ 35: OR = 1.72). 68% of parents had already made their decision prior to delivery. Of 153 respondents, 17% requested more detailed information on safety, duration of vaccination protection, and availability of the vaccine.

Conclusion

Maternal age and parity appear to be associated with nirsevimab uptake. Early prepartum counselling and transparent communications regarding product safety could further increase acceptance.

Keywords

respiratory syncytial virus (RSV) - nirsevimab - RSV prophylaxis - vaccine acceptance - parental vaccine acceptance

Introduction

Respiratory syncytial virus (RSV) is the most common cause of acute infections of the lower respiratory tract (LRTI) in infants and young children worldwide [1]. Neonates are particularly at risk of severe infection in their first six months of life. In 2019, 6.6 million RSV-related cases with LRTI, 1.4 million hospitalisations and 13300 deaths recorded in hospital from RSV-related LRTI were reported worldwide for this age group [2]. Risk factors for a severe course of illness include preterm birth, congenital heart defect, and chronic lung disease [3]. However, around 80% of severe cases of RSV-related LRTI occurred in previously healthy infants [4].

Given the high burden of disease and the significant use of the health care system associated with RSV, research into effective prevention strategies has been ongoing since many years. Until recently, the monoclonal antibody (mAb) palivizumab, which is only recommended for high-risk infants and requires administration once a month during the RSV season, was the only available option [5].

In 2022, the long-lasting monoclonal antibody nirsevimab was approved for use by the European Medicines Agency (EMA) [6]. Because of its long serum half-life of 68.9 ± 10.9 days, a single intramuscular administration per RSV season is enough to provide effective prophylaxis [7]. The administration of nirsevimab is also recommended for neonates with no special risk factors [8]. The effectiveness of the vaccine in preventing RSV-related hospitalisations has been confirmed in several studies. The randomised HARMONIE study reported an effectiveness of 83.2% (95% CI: 67.8–92.0) in infants ≤ 12 months [9]. The French prospective cohort study ENVIE reported similar results (83.0%; 95% CI: 73.4–89.2) as did a retrospective US cohort study from 2025 which recorded an efficacy of 98.0% compared to hospitalised patients with RSV-LRTI [10] [11]. A meta-analysis carried out in 2025 confirmed the high effectiveness of nirsevimab in clinical practice: in 27 studies from five countries, the administration of nirsevimab was associated with significantly lower rates of RSV-related hospitalisations (OR = 0.17), admissions to the intensive care unit (OR = 0.19), and infections of the lower respiratory tract (OR = 0.25) in infants during their first year of life [12].

Since June 27, 2024, the Ständige Impfkommission (Standing Vaccination Committee, STIKO) has recommended administering nirsevimab to all neonates and infants in their first RSV season until the end of their first year of life, irrespective of their individual risk factors.

All neonates should receive nirsevimab for RSV prophylaxis during the RSV season (October to March) as early as possible, ideally before they are discharged home from the maternity ward [8].

This recommendation largely corresponds to the guidelines of the Center for Disease Control and Prevention (CDC) in the USA, with the exception of maternal vaccination with the bivalent vaccine RSVpreF which has not currently been recommended in Germany by the STIKO [13]. This vaccine should be administered between the 24th and 36th week of gestation. The placental transfer of maternal RSV antibodies provides passive immunity for four to six months, depending on the time of vaccination during pregnancy [14] [15].

In the most recent RSV season, the immunisation of neonates against RSV prior to their discharge from hospital was a logistical challenge for German maternity hospitals.

There are currently no published data available for Germany on RSV immunisation uptake. As the success of vaccination is highly dependent on parental willingness to be vaccinated or have their child vaccinated and on effective logistic implementation of vaccinations, the systematic collection of data on the willingness to be vaccinated and on vaccination rates is needed to further optimise uptake in future.

The aim of this study was to capture parental acceptance of RSV immunisation during the first RSV season in 2024/25 after the STIKO recommendation had been issued for Germany. Primary endpoint was the percentage of neonates who received RSV prophylaxis with nirsevimab before being discharged from hospital. Secondary endpoints included parental satisfaction with the provision of information, factors influencing RSV immunisation uptake, and the percentage of mothers who were vaccinated against RSV during pregnancy.

Methods

Ethics and data protection

The study was presented to the Ethics Committee of Ludwig Maximilian University of Munich, which approved the study (reference number: 24–0925). The study was also recorded in the German Registry of Clinical Studies (DRKS-ID: DRKS00035342). Data collection and evaluation were completely anonymised in accordance with the DGPR.

Study population

From October 14, 2024, nirsevimab was offered to all infants born in the perinatal centre of our medical hospital, whose mothers had not been vaccinated with RSVpreF at the latest 14 days prior to giving birth. The vaccine was administered to infants in the context of the U2 medical checkup which is carried out between the 3rd and the 10th day of life. Parents were given written information material (German/English, see appendix, online) on RSV prophylaxis prepartum when they registered the birth or when they were admitted to the delivery room and, where necessary, this information was handed out again postpartum in the maternity ward. A physician provided information about the vaccine during the U2 medical checkup. For this study, a questionnaire was used to evaluate whether parents felt that the information provided was sufficient. In addition, the RSV immunisation rate and factors influencing the immunisation rate were analysed retrospectively.

Retrospective data analysis

All children born in our centre between 01.11.2024 and 31.01.2025 were included in the study. The aim of the study was to determine the immunisation rate and potential influencing factors. The analysis was based on electronic medical records (KAS/SAP, ViewPoint 6/GE HealthCare, Mesalvo Group/Meona). Investigated variables included vaccination status, sex, birth weight, week of gestation, parity, maternal age, and high-risk pregnancy. Variables were categorized and analysed with chi²-test and Cramér’s V. Logistic regression analysis was additionally carried out for nirsevimab. Results are presented as odds ratios (OR) with 95% confidence intervals (level of significance: p < 0.05).

Questionnaire

During the study period, parents of neonates born at ≥ 35 + 0 GW were requested to participate anonymously in an online survey using EvaSys (Electric Paper Evaluationssysteme GmbH, Lüneburg, Germany). Access to the survey was provided by a QR code on flyers and posters in the maternity ward. The questionnaire consisted of nine questions and recorded parental satisfaction with the information provided and the criteria affecting their decision on RSV immunisation. Parents were asked six questions with predetermined response options and three open questions (see appendix, online). Dichotomous questions with multiple answers were excluded. Completed data from incomplete questionnaires was included. Results are presented descriptively as frequencies and means with R (version 4.4.3); chi²-tests were used for selected analyses.

Results

Retrospective data analysis

A total of 1103 children were born in our hospital between 01.11.2024 and 31.01.2025. The data of 17 children who died perinatally (eleven late miscarriages, two terminations of pregnancy, three children receiving primary palliative care, one intrauterine foetal death) and 56 cases with incomplete data about vaccination status were excluded from the analysis. The data of 1030 neonates were included in the evaluation. 786 neonates were immunised with nirsevimab, which corresponds to an immunisation rate of 76.3%. The mothers of 62 neonates (6.0%) were vaccinated with RSVpreF during their pregnancy. This resulted in an RSV immunisation rate for the neonates of 82.3% ([Table 1]).

Table 1 Characteristics of the study population: demographic and obstetric characteristics of neonates and their mothers during the study period.

	Number of neonates (in %)
Absolute figures with percentages in brackets; GW = weeks of gestation
Characteristics	Total number of neonates n = 1030	Nirsevimab n = 786	RSVpreF n = 62	With RSVpreF or nirsevimab n = 848	Unvaccinated n = 182
Sex of the child
Female	499	383 (76.8)	33 (6.6)	416 (83.4)	83 (16.6)
Male	531	403 (75.9)	29 (5.5)	432 (81.4)	99 (18.6)
Birth weight (g)
< 2500	79	68 (86.1)	3 (3.8)	71 (89.9)	8 (10.1)
2500–3999	882	665 (75.4)	57 (6.5)	722 (81.9)	160 (18.1)
≥ 4000	69	53 (76.8)	2 (2.9)	55 (79.7)	14 (20.3)
Week of gestation
< 35 GW	47	44 (93.6)	0 (0)	44 (93.6)	3 (6.4)
≥ 35 GW	983	742 (75.5)	62 (6.3)	804 (81.8)	179 (18.2)
High-risk pregnancy
High-risk pregnancy	802	612 (76.3)	52 (6.5)	664 (82.8)	138 (17.2)
Not a high-risk pregnancy	226	172 (76.1)	10 (4.4)	182 (80.5)	44 (19.5)
Unknown	2	2 (100)	0 (0)	2 (100)	0 (0)
Maternal age at delivery (years)
< 30	202	147 (72.8)	5 (2.5)	152 (75.2)	50 (24.8)
30–34	427	338 (79.2)	22 (5.2)	360 (84.3)	67 (15.7)
≥ 35	401	301 (75.1)	35 (8.7)	336 (83.8)	65 (16.2)
Parity
1	622	497 (79.9)	37 (5.9)	534 (85.9)	88 (14.1)
≥ 2	407	288 (70.8)	25 (6.1)	313 (76.9)	94 (23.1)
Unknown	1	1 (100)	0 (0)	1 (100)	0 (0)

Recorded parental refusals were available for 143 cases (78.6%) out of the 182 non-immunised neonates (17.7%). 26 cases (14.3%) were discharged early prior to immunisation. Immunisation by a non-hospital-based paediatrician was planned for eleven infants (6.0%) and the vaccine was not available for two cases (1.1%) ([Fig. 1]). The combined immunisation rate (RSVpreF or nirsevimab) remained constant over the entire study period: it was 81.6% in November 2024, 83.8% in December 2024, and 81.5% in January 2025.

Fig. 1 Flow chart of the study design.

Bivariate analysis showed significant associations between vaccination status of the neonates (RSVpreF, Nirsevimab, unvaccinated) and parity (p < 0.001) and maternal age (p = 0.001), but with a low effect size in each case (s. Table S1, online).

An association with parity (p < 0.001) and maternal age (p = 0.027) was also identified when only the groups “unvaccinated” and “nirsevimab” were evaluated, ([Fig. 2]). The week of gestation at delivery was also significantly associated with nirsevimab vaccination uptake (p = 0.041), again with a low effect size (s. Table S1, online).

Fig. 2 Mosaic plots of chi²-tests for parity (p < 0.001) and maternal age groups (p = 0.027). a Vaccination categories according to parity. b Vaccination categories according to maternal age group.

No significant association with vaccination status was found for the other examined variables such as high-risk pregnancy, birth weight, or birth month.

Multivariate analysis showed that neonates of multiparous mothers had a significantly lower probability of receiving nirsevimab (OR = 0.52; 95% CI: 0.37–0.73; p < 0.001). In contrast, the likelihood of maternal vaccination if the mother was above the age of 30 years was significantly higher in both the group aged 30–34 years (OR = 1.75; 95% CI: 1.15–2.67; p = 0.009) and in the group aged ≥ 35 years (OR = 1.72; 95% CI: 1.10–2.67; p = 0.017) (s. Table S1, online).

Questionnaire

Parental perspectives on RSV immunisation were collected during the study period using a structured survey. 153 questionnaires were included in the analysis, which corresponds to a response rate of 15.1%. 118 of the questionnaires were completed, with the answers given in a formally correct manner.

On average, participants reported that they had felt that they were well informed about RSV immunisation (n = 141, scale: 1–10; mean = 8.3; SD = 2.07).

73.5% of surveyed parents already received the information leaflet before the birth; 67.5% stated that they had read it before giving birth ([Fig. 3]).

Fig. 3 Responses to the questionnaire. a Did you read the information leaflet before giving birth? (n = 151). b Did you feel that some information was lacking? (n = 144). c If you wanted your child to have the vaccination, did you decide to vaccinate your child before or after the birth? (n = 145).

Using a scale from 1–10, the quality of the contents of the information leaflet was generally assessed as positive, with the mean response calculated as 8.6 (n = 141, SD = 1.96). 16.7% of the respondents stated that they would have liked further information ([Fig. 3]). A need for more information was specifically highlighted regarding issues such as safety of the immunisation, duration of vaccine-induced protection, and availability of the active ingredient. Individual respondents were dissatisfied with the linguistic comprehensibility of the information leaflet and criticised that individual talks about the vaccination with a physician were not available prior to the U2 medical checkup ([Fig. 4]).

Fig. 4 Word cloud of responses to the question: which information would you have additionally wanted to have?

67.6% of respondents stated that they had already decided about RSV immunisation prior to the birth ([Fig. 3]). A more detailed analysis found that reading the parental information leaflet prior to the birth was significantly associated with prepartum decision-making (χ²(1) = 7.36; p = 0.007; OR = 2.91; 95% CI: 1.40–6.08).

The most commonly given reasons for refusing neonatal vaccination were maternal vaccination with RSVpreF during pregnancy, concerns because of the limited long-term data, the lack of experience with the preparation, the general novelty of the active ingredient, and the early time of immunisation in the postnatal period.

An open question aimed to record responses to RSV immunisation. In addition to positive feedback on tolerability and on the vaccination program, information during pregnancy by the treating gynaecological practice or during the U0 medical checkup was considered useful as the information about vaccination often got lost after the birth. A personal discussion to discuss the vaccination with parents was considered more memorable because of the many other information materials provided to parents. In individual cases, parental experience of their child’s siblings who had had severe RSV led to the conscious decision to immunise any subsequent children.

Discussion

In the first season after the introduction of vaccination with nirsevimab, 76% of eligible neonates received the prophylaxis. Including maternal vaccination with RSVpreF, the total RSV immunisation rate was 82.3%.

Recommendations to vaccinate all neonates with nirsevimab were already issued for the 2023/24 RSV season in Spain, France, Luxembourg, and the USA. Studies from the USA showed clear regional differences in immunisation rates. While one study from California reported that 78% of neonates received RSVpreF prenatally or nirsevimab postnatally [16], the vaccination coverage in Massachusetts was reported as 55% [17] and it was just 36% in Wisconsin [18]. At the time of data collection, European countries had not issued recommendations on vaccinating with RSVpreF but only for nirsevimab, and reported high immunisation rates. Regional differences were also observed in Europe: the immunisation rate varied from 92% in France [19], to 90% in Spain [20], 84% in Luxembourg [21], and 69% in the Italian region of Valle d’Aosta [22].

One possible explanation for the high vaccination uptake–despite the fact that the initial recommendation had only been recently issued–could be the low-threshold availability of the vaccine and the pragmatic approach to vaccination. At our university hospital, nirsevimab was offered to all neonates in the context of the standard U2 medical checkup and it was constantly available. In contrast to maternal vaccination with RSVpreF, where the costs are currently not covered by statutory health insurance companies, the cost of the nirsevimab vaccine is fully reimbursed. This aspect might have influenced parental decision-making [23]. The antibody was already in use in several countries during the previous RSV season, and this could have boosted parental confidence in the safety and effectiveness of nirsevimab.

In contrast, maternal RSV vaccination uptake of RSVpreF was significantly lower at just 6%. Possible reasons include the limited data, the lack of a STIKO recommendation, and a lack of clarity on the part of treating medical staff who may not have actively broached the topic. This may have given parents the impression that RSVpreF is an insufficiently tested and potentially unsafe vaccination. Study results which point to a possible association between RSVpreF and higher preterm birth rates could have raised additional concerns even though a causal relation has not been confirmed to date [24].

The assumption that RSV prophylaxis would enjoy greater acceptance among parents with one or more other children because of the higher risk of neonatal exposure to RSV, their own experience, or greater knowledge could not be confirmed by our data or by other studies [19] [25] [26].

A possible explanation for the lower vaccination uptake by multiparous mothers could be their more limited time resources or the fact that the RSV vaccine was not yet available when they previously gave birth. This could have led to misconceptions, especially if their older children had not suffered severe RSV. In contrast to multiparous mothers, primiparous mothers may feel a greater need to take optimal precautions.

Our analysis found that higher maternal age (≥ 30 years) was a significant predictor for nirsevimab prophylaxis uptake. Studies from France [19] and the USA [25] reported similar findings, whereby an increased willingness to vaccinate was recorded among mothers aged 35 years and above.

A key finding obtained from the evaluation of the questionnaires was that 68% of parents had already decided prepartum whether to have their child immunised. Reading the information leaflet before giving birth was significantly associated with earlier decision-making. This underlines the importance of providing targeted information and education already in pregnancy to increase vaccination uptake.

In terms of content, the information provided to parents should address central issues such as safety, duration of the protective effect of immunisation, and the availability of the vaccine. In the responses, this was often reported as relevant for decision-making. While logistical challenges can be managed better over the longer term, parental belief in the vaccine’s safety remains a decisive factor; this was also confirmed in international studies [26] [27] [28]. Other factors influencing the decision were the generally limited knowledge of RSV [26] [29], widespread misinformation [27] [29], and the wish to have more time to decide [27] [29]. The latter point was also recorded in this study: in 11 cases, the medical records showed that the parents did not want to carry out immunisation immediately postpartum but preferred to have it done later.

Vaccination acceptance depends significantly on subjective perceptions of the burden of disease and individual perceptions of risk [30]. Evidence-based awareness campaigns which will take parental risk perceptions seriously, provide solid information, and counter misinformation are necessary to support informed decision-making.

This study has several limitations. These limitations include the retrospective data collection, the single-centre design, and the above-average percentage of high-risk pregnancies in a university hospital cohort, which could limit the extent to which the findings can be generalised. At the start of the RSV season, the vaccine was not always available and additional imports from other European countries were needed. Given the focus of the study, the fact that 5% of the data on specific immunisations was missing is a relevant data gap which might have been reduced by using additional methods to collect data, for example by carrying out a follow-up survey of the parents.

Because of the study design, it was not possible to record the children who received nirsevimab on an outpatient basis after they had been discharged from hospital. The analysis of potential predictors for vaccination uptake was restricted to a limited number of variables. And finally, data collection already ended at the end of January and therefore did not cover the entire RSV season, which could potentially limit the comparability with other studies.

The response rate for the parental questionnaires was 15%, which points to a limited willingness to participate and could limit the extent to which the results can be generalised. For logistical reasons, the questionnaire could not be provided to all parents. Moreover, a selection bias is possible as parents with a favourable attitude towards immunisation might have been more willing to take part in the survey. Parents with no knowledge of German or English were potentially excluded because the materials were only available in these languages and this could have also affected the participation rate.

Despite the above limitations, the study has several strengths. It is the first investigation carried out in Germany which has collected data on the acceptance of the new RSV prophylaxis since the STIKO issued its recommendation. The large study population of more than 1000 neonates offers a solid data basis and strengthens the validity of the data.

Future studies could investigate parental acceptance of preventive measures against RSV over longer periods of time as well as the effect of sociodemographic and psychosocial factors.

Conclusion

Since the publication of the STIKO recommendation in summer 2024 to vaccinate all neonates against RSV, a relatively high uptake rate was recorded in our perinatal centre, although it could still be increased. Early information given to parents, ideally provided prepartum, could be a potential approach to increase the acceptance of the vaccine even further, especially among multiparous women and young mothers.

Supplementary Material

• Questionnaire: Parental acceptance of the new RSV prophylaxis for neonates at LMU Hospital.

• Table S1: Results of the statistical analysis: log. regression, chi²-tests, Cramér’s V.

• Patient information leaflet: Passive immunisation of infants against RSV infection (respiratory syncytial virus). Monoclonal antibody (nirsevimab, Beyfortus) for RSV prophylaxis of neonates.

Conflict of Interest

The authors declare that they have no conflict of interest.

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Publication History

Received: 28 August 2025

Accepted after revision: 14 December 2025

Article published online:
05 February 2026