Safety of mRNA COVID-19 vaccines during pregnancy

Ellington, Sascha; Olson, Christine K.

doi:10.1016/s1473-3099(22)00443-1

Cited by 28 publications

(19 citation statements)

References 10 publications

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“…Similarly, 51.9% of Saudi pregnant women refused to take the vaccine because of the possibility of harm to their baby [ 15 ]. Scientifically speaking, vaccines are reported to be quite safe among pregnant and lactating women [ 35 , 36 ]. Furthermore, anti-COVID-19 virus antibodies have been noted to be developed by infants following maternal vaccine uptake [ 37 ].…”

Section: Discussion Of the Key Findingsmentioning

confidence: 99%

COVID-19 Vaccine Uptake and Hesitancy among Pregnant and Lactating Women in Saudi Arabia

et al. 2023

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Introduction: Pregnant and breastfeeding women comprise a high-risk group for the development of severe COVID-19. Therefore, vaccination is highly recommended for perinatal women; however, vaccination levels for this group remain inadequate. This study explores the percentage of COVID-19 vaccination among Saudi pregnant and lactating women, as well as their attitudes toward it. Methods: We conducted a cross-sectional questionnaire-based survey on a sample of Saudi pregnant and breastfeeding women. The study included pregnant and lactating women. Results: The percentage of COVID-19 vaccine uptake was 78.2%. A total of 45 (21.8%) out of 206 women did not receive the vaccine. The overall vaccine hesitancy was 21.8%. Breastfeeding women were 2.86 more likely not to receive the vaccine as compared to pregnant women. Being a mother of over five children increased the vaccine uptake among our participating women (n = 20, 90%; p < 0.01). The majority of the subjects had taken the Pfizer vaccine (81.98%, 132/161). The availability of the COVID-19 vaccine was the most common factor for choosing a particular vaccine. Protection from infection (60.2%, 97/161) was reported as the main driver for vaccine uptake. The most common reason perceived for delaying COVID-19 vaccination was being worried about the side effects (176, 85.44%) on one’s own body and the effects on the unborn child (130, 63.1%). Conclusion: We uncovered high levels of hesitancy, primarily induced by concerns about adverse effects and social media-related misinformation. These high levels of vaccine uptake are likely due to the large-scale obligatory vaccination program provided in Saudi Arabia, which was well-structured and far reaching. Our results provide further support for the so-called “protection motivation theory” in boosting vaccine acceptance. Counseling and educating pregnant and breastfeeding women about COVID-19 vaccination is the need of the hour.

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Section: Discussion Of the Key Findingsmentioning

confidence: 99%

COVID-19 Vaccine Uptake and Hesitancy among Pregnant and Lactating Women in Saudi Arabia

et al. 2023

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“…In the UK, m‐RNA vaccines were recommended for pregnant women from April 2021, 10 whereas in the USA they were granted an emergency licence in December 2020 but were only recommended in June 2021 13 . This led to vaccine hesitancy among the pregnant population globally 11,12,14 . However, poor perinatal outcomes are reduced with vaccination, including a 15% reduction in stillbirth 12 …”

Section: Sars‐cov‐2 and Pregnancymentioning

confidence: 99%

“…13 This led to vaccine hesitancy among the pregnant population globally. 11,12,14 However, poor perinatal outcomes are reduced with vaccination, including a 15% reduction in stillbirth. 12…”

mentioning

confidence: 99%

SARS‐CoV‐2—Placental effects and association with stillbirth

Merriel,

Fitzgerald,

O’Donoghue

2023

BJOG

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SARS‐CoV‐2 has had a significant impact on pregnancy outcomes due to the effects of the virus and the altered healthcare environment. Stillbirth has been relatively hidden during the COVID‐19 pandemic, but a clear link between SARS‐CoV‐2 and poor fetal outcome emerged in the Alpha and Delta waves. A small minority of women/birthing people who contracted COVID‐19 developed SARS‐CoV‐2 placentitis. In many reported cases this was linked to intrauterine fetal death, although there are cases of delivery just before imminent fetal demise and we shall discuss how some cases are sub‐clinical. What is surprising, is that SARS‐CoV‐2 placentitis is often not associated with severe maternal COVID‐19 infection and this makes it difficult to predict. The worst outcomes seem to be with diffuse placental disease which occurs within 21 days of COVID‐19 diagnosis. Poor outcomes are often pre‐dated by reduced fetal movements but are not associated with ultrasound changes. In some cases, there has also been maternal thrombocytopenia, or coagulation abnormalities, which may provide a clue as to which pregnancies are at risk of fetal demise if a further variant of concern is to emerge. In future, multidisciplinary collaboration and cross‐boundary working must be prioritised, to identify quickly such a phenomenon and provide clinicians with clear guidance for reducing fetal death and associated poor outcomes. While we wait to see if COVID‐19 brings a future variant of concern, we must focus on appropriate future management of women who have had SARS‐CoV‐2 placentitis. As a placental condition with an infectious aetiology, SARS‐CoV‐placentitis is unlikely to recur in a subsequent pregnancy and thus a measured approach to subsequent pregnancy management is needed.

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“…Additionally, the encapsulated RNA therapeutics are advantageous over small molecules because they target dysregulated proteins at the genetic level with higher specificity (10). Indeed, clinical trial data suggest that the mRNA-LNP-based SARS-CoV-2 from Moderna and Pfizer–BioNTech have excellent safety profiles in pregnant people (11). Compared to unvaccinated individuals, mRNA vaccines reduced the risk of severe COVID-19 illness in pregnant individuals (12), and the risk of COVID-19 hospital admission among their infants younger than six months of age (13).…”

Section: Introductionmentioning

confidence: 99%

Lipid nanoparticle structure and delivery route during pregnancy dictates mRNA potency, immunogenicity, and health in the mother and offspring

Chaudhary

Newby

Arral

et al. 2023

Preprint

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Treating pregnancy-related disorders is exceptionally challenging because many small molecule drugs on the market may cause maternal and fetal toxicity. This potential danger has hindered the development and clinical evaluation of new drugs for several decades. Lipid nanoparticle (LNP)-based RNA therapies with high delivery efficacy, favorable immune response, and minimal transplacental transport can quell maternal-fetal toxicity concerns and propel the development of pregnancy-safe drugs. To this extent, we report potent LNP structures that robustly deliver mRNA to maternal organs and placenta. Using structure-function analysis, we show that LNP efficacy is influenced by the polyamine headgroup, and toxicity is governed by the acrylate tail. Our lead nanoparticle shows robust protein expression via multiple clinically relevant administration routes in pregnant mice. In the placenta, it transfects trophoblasts, endothelial cells, and immune cells. Further, by varying ionizable lipid structure, we demonstrate that LNP immunogenicity affects organ expression and pup health during pregnancy. Immunogenic LNPs show lower efficacy in lymphoid organs in an IL-1β dependent manner in pregnant mice. Further, pro-inflammatory immune responses provoke the infiltration of adaptive immune cells in the placenta and restrict pup growth after birth. Together, our results provide a mechanistic basis for designing safe and potent LNPs that can be administered during pregnancy.

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Safety of mRNA COVID-19 vaccines during pregnancy

Cited by 28 publications

References 10 publications

COVID-19 Vaccine Uptake and Hesitancy among Pregnant and Lactating Women in Saudi Arabia

COVID-19 Vaccine Uptake and Hesitancy among Pregnant and Lactating Women in Saudi Arabia

SARS‐CoV‐2—Placental effects and association with stillbirth

Lipid nanoparticle structure and delivery route during pregnancy dictates mRNA potency, immunogenicity, and health in the mother and offspring

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