Severe COVID-19 in Pregnancy Is Almost Exclusively Limited To Unvaccinated Women − Time For Policies To Change

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Pregnant women continue to be excluded from most clinical trials of COVID-19 vaccines and medication, despite very clear pre-pandemic guidance.1 There appears little incentive amongst regulators or pharmaceutical companies to change this. Compounded by their exclusion, there is considerable vaccine hesitancy amongst pregnant women.2 Such hesitancy persists, even though at present adverse outcomes of SARS-CoV- 2 infections are increasing among pregnant and postpartum women in many countries,3 while these are improving in most other groups. The impact of the omicron variant is, as yet, unknown.

Vaccine hesitancy in pregnancy is not a new phenomenon. Salmon and colleagues4 identified three factors that influence parents’ acceptance of vaccines for either them or their children: confidence in the efficacy of the vaccines, trust in their healthcare professionals, and, importantly, the certainty of the systems to assess vaccine safety. They note that addressing vaccine hesitancy is a “complex problem [which] requires a multilevel approach, including interventions at the individual and health system levels.”

Hilde Engjom,a Thomas van den Akker,b,c Anna Aabakke,d,e Outi Ayras,f Kitty Bloemenkamp,g Serena Donati,h Danilo Cereda,i Evelien Overtoom,g and Marian Knight j,*

b Department of obstetrics and gynecology, Leiden University Medical Center, Leiden, the Netherlands

c Athena Institute, VU University, Amsterdam, the Netherlands

d Dept of Obstetrics and Gynecology, Hillerød Hospital, Nordsjaellands Hospital, Denmark

e Dept Obstetrics and Gynecology, Copenhagen University Hospital, Holbæk, Denmark

f Dept of Obstetrics and Gynecology, Helsinki University Hospital, Helsinki, Finland

g Department of Obstetrics, WKZ Birth Centre, Division Woman and Baby, UMC Utrecht, Utrecht, the Netherlands

h National Centre for Disease Prevention and Health Promotion, Istituto Superiore di Sanita - Italian National Institute of Health, Rome Italy

I Regione Lombardia DG − Welfare, Milano, Italy

j National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK

Data suggest that vaccines are highly effective protection against severe COVID-19 in the non-pregnant populations in which they were initially tested.5 However, in many countries, pregnant and postpartum women and those planning a pregnancy continue to receive conflicting messages, mainly regarding the safety of the vaccines. Misleading information on social media continues to impede the uptake of vaccination in pregnant and postpartum women, even though observational data about vaccine safety, now including more than 250 000 women, are very reassuring.6 Additionally, clear potential benefits have been documented, such as the placental transmission of protective antibodies to the fetus.7 By preventing maternal disease, vaccination may prevent stillbirths, preterm births, and associated neonatal deaths.

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Simultaneously, it has become clear that pregnant and postpartum women are at higher risk of serious illness compared to their non-pregnant contemporaries. This seems especially true for the Delta variant, which increased the risk of intensive care unit admission among pregnant women 2-3 times, with a 50% increase in iatrogenic preterm births.3,8,9 Several European countries (Norway, UK) have recently recognized pregnant and postpartum women as an ‘at at risk’ priority group for COVID vaccination. This policy has been in place for even longer in other countries (Belgium, Denmark), yet it is still not universal (for example, in Italy, the Netherlands, and Finland pregnant women are not prioritized).

Multiple initiatives to promote uptake of COVID-vaccination in pregnancy have been undertaken, with widely differing uptake rates and uptake estimates varying between 22% in England and 80% in Norway. Surprisingly, data are not available on Covid-19 vaccination rates amongst pregnant women in all European countries. Within the International Network of Obstetric Survey Systems (INOSS)10 we have been able to combine surveillance data in six countries showing that amongst the most critically ill pregnant and postpartum women, almost none were vaccinated (Table 1). This is observed despite widely varying population vaccine uptake rates.

Our findings emphasize the message to unvaccinated pregnant women, their partners, health professionals caring for pregnant women, decision-makers, and politicians that vaccination protects against severe disease. As the world is entering a new phase of the COVID-pandemic, with the Delta-variant rapidly being overtaken by the Omicron-variant, booster vaccinations are increasingly important to provide protection against severe COVID- 19, especially in vulnerable groups such as pregnant and postpartum women or women who want to become pregnant. However, large numbers of pregnant and postpartum women in low, middle, and high-income settings have yet to receive even a single vaccination dose. Health systems, as well as individual actions, are now clearly needed. The World Health Organisation recommends COVID-19 vaccination in pregnant women when the benefits of vaccination to the pregnant woman outweigh the potential risks. These multi-country data clearly show those benefits in terms of the prevention of severe disease. We believe that all governments should now prioritize pregnant and postpartum women as an at-risk group and encourage their vaccination.

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Declaration of Competing Interest

Hilde Engjom reports funding from the Nordic Federation of Societies of Obstetrics and Gynecology (NFOG) research fund and cost refund for travel costs as invited keynote speaker at the Norwegian Perinatal Society annual meeting Nov 2021; Marian Knight reports funding from the National Institute or Health Research, the Medical Research Council and Wellbeing of Women; Thomas van den Akker reports funding from the Medical Research Council and the Laerdal Foundation; Anna Aabakke reports funding from The Region of Southern Denmark and Region Zealand’s shared fund for joint health research projects and is head of the educational committee of the Danish Society of Obstetrics and Gynaecology (DSOG); Outi Ayres reports funding from the Finnish Medical Foundation and the Nordic Federation of Obstetrics and Gynaecology; Kitty Bloemenkamp reports funding from the European Medicines Agency (EMA) ‘COVID-19 infectiOn aNd medicineS In pregnancy’ for the INOSS network; Serena Donati reports funding from the Istituto Superiore di Sanita (Italian National Health Institute). Danilo Cereda and Evelien Overtoom have no interests to declare.

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References

1 The PREVENT Working Group. Pregnant Women & Vaccines Against Emerging Epidemic Threats: Ethics Guidance for Preparedness, Research, and Response. Baltimore, MD: Johns Hopkins Berman Institute of Bioethics; 2018.

2 Shook LL, Kishkovich TP, Edlow AG. Countering COVID-19 Vaccine Hesitancy in Pregnancy: the "4 Cs". American journal of perinatology. 2021.

3 Vousden N, Ramakrishnan R, Bunch K, et al. Impact of SARS-CoV-2 variant on the severity of the maternal infection and perinatal outcomes: Data from the UK Obstetric Surveillance System national cohort. medRxiv 2021: 2021.07.22.21261000.

4 Salmon DA, Dudley MZ, Glanz JM, Omer SB. Vaccine hesitancy: Causes, consequences, and a call to action. Vaccine. 2015;33(Suppl 4): D66–D71.

5 Rothschild V, Hirsh-Raccah B, Miskin I, Muszkat M, Matok I. Comparing the clinical efficacy of COVID-19 vaccines: a systematic review and network meta-analysis. Sci Rep. 2021;11(1):22777.

6 Shimabukuro TT, Kim SY, Myers TR, et al. Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons. The New England journal of medicine. 2021;384(24):2273–2282.

7 Treger S, Shiloh SR, Ben-Valid T, et al. Trans-Placental Transfer of SARS-Cov-2 Antibodies in recovered and BNT162b2-vaccinated patients. American journal of obstetrics and gynecology. 2021.

8 Donati S, Corsi E, Maraschini A, Salvatore MA. It OSSC-WG. SARS-CoV-2 infection among hospitalized pregnant women and impact of different viral strains on COVID-19 severity in Italy: a national prospective population-based cohort study. BLOG. 2022;129(2):221–231.

9 Overtoom E, Rosman A, Zwart J, et al. SARS-CoV-2 en zwangerschap in Nederland: registratie tijdens een pandemie door NethOSS. Nederlands Tijdschrift voor Obstetrie & Gynaecologie. 2021;134:406–409.

10 Knight M. INOSS. The International Network of Obstetric Survey Systems (INOSS): benefits of multi-country studies of severe and uncommon maternal morbidities. Acta Obstetricia Et Gynecologica Scandinavica. 2014;93(2):127–131.

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