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By Domenico Umberto De Rose Domenico Umberto De Rose Scilit Google Scholar, Guglielmo Salvatori Guglielmo Salvatori Scilit Google Scholar, Andrea Dotta Andrea Dotta Scilit Google Scholar and Cinzia Auriti Cinzia Auriti Scilit Google Scholar *

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Neonatal Intensive Care Unit, Fetal-Neonatal-Infant Medicine and Surgery, “Bambino Gesù” Children’s Hospital IRCCS, 00165 Rome, Italy

Receipt date: January 13, 2022 / Review date: February 19, 2022 / Acceptance date: March 3, 2022 / Publication date: March 5, 2022

(1) Objective: This systematic review summarizes the latest knowledge on maternal and neonatal outcomes after vaccination against COVID-19 during pregnancy and lactation. (2) Study design: PubMed, Cochrane Library, and Educational Resource Information Center (ERIC) were searched through 27 October 2021. Key outcomes were estimates of how many pregnant and lactating women were vaccinated and the number of pregnant women and infants who have been vaccinated when available. Neonatal outcomes. (3) Results: 45 studies collected data from 74,908 pregnant women and 5,098 breastfeeding women vaccinated against COVID-19. No major side effects have been reported, especially during the second and third trimesters and while breastfeeding. Instead, existing research suggests that babies acquire specific SARS-CoV-2 antibodies after their mothers have been vaccinated. (4) Conclusion: After fully explaining its advantages and disadvantages, pregnant women should be advised to be vaccinated against the SARS-CoV-2 virus. In particular, given the still limited evidence and the fact that fever during the first few months of pregnancy increases the risk of birth defects, caution should be advised. The same considerations apply to breastfeeding women, taking into account that mRNA vaccines can generate an immune response in breast milk.

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Physiological, mechanical, and immunologic changes in pregnant women may affect their likelihood of being challenged by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) [1]. The main symptoms of the disease (COVID-19) are associated with impaired microcirculation; infected pregnant women are indeed at increased risk of developing preeclampsia (PE)-like symptoms [2] and require hospitalization and admission to the intensive care unit [3] . As the incidence of obstetric complications, such as prematurity, appears to be directly proportional to the severity of the infection, babies born to infected mothers with a more severe clinical course may have worse outcomes, mainly due to the neonatal morbidity and mortality associated with preterm delivery. Therefore, immunization of pregnant women against SARS-CoV-2 seems reasonable [4].

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While there is no conclusive evidence for the efficacy and safety of the COVID-19 vaccine during pregnancy, studies conducted to date have been able to detect a significant reduction in the risk of contractions because these women were not enrolled in clinical trials evaluating the vaccine. Vaccinated pregnant women were more likely to be infected with SARS-CoV-2 than those who were not vaccinated. To date, more than hundreds of thousands of pregnant women have been vaccinated against COVID-19 worldwide, with no more adverse events reported than in the non-pregnant population [5]. The same applies to the effect of vaccination during breastfeeding, which is considered to be comparable to vaccination in non-pregnant women. There is currently consensus that there is no biological evidence to support possible harm to infants cared for by vaccinated mothers [6]. With regard to fertility in women vaccinated against COVID-19, international public health authorities and scientific societies have ruled out a possible link between the vaccine and fertility problems [7].

Our aim was to summarize the evidence in the literature on the outcomes of vaccination against SARS-CoV-2 in pregnant and postpartum women and the possible impact of currently used vaccines (Figure 1) on their neonates.

This systematic review was conducted according to the PRISMA guidelines [8]. Search terms included “SARS-CoV-2” or “COVID-19” and “vaccine” or “vaccine” and “pregnancy” or “pregnancy” or “breastfeeding”. We considered studies published after January 1, 2021 that provided information on outcomes for mothers and/or children after vaccination with mRNA-based vaccines. We did not place any restrictions on the study design to include all existing literature, but preprint studies were not considered. Study selection was via PubMed (, accessed 27 October 2021), The Cochrane Library ( search), accessed October 27, 2021) and the Educational Resource Information Center (ERIC,, accessed October 27, 2021) (Box 1).

The search process worked like this: Dr. De Rose (D.U.D.R.) identified relevant studies by reading abstracts and looking for other studies through the reference lists of selected articles. Subsequently, Dr. Dross (D.U.D.R.) and Dr. Auriti (C.A.) independently reviewed these studies, reviewing article titles and abstracts and deciding whether to include each article.

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The Pfizer-BioNTech BNT162b2 vaccine and the Moderna mRNA-1273 vaccine contain mRNA encoding the spike membrane protein encapsulated in lipid nanoparticles. Oxford-AstraZeneca ChAdOx1 contains a cDNA fragment from the SARS-CoV-2 virus encapsulated in a viral vector. Both are non-replicating and self-destructing. When administered, macrophages and dendritic cells capture the particles and convert them into proteins, which are broken down into peptides and exposed as antigens. Antigenic viral peptides are presented to major histocompatibility complex (MHC) I and II and recognized by helper T lymphocytes, leading to the synthesis of neutralizing antibodies by B cells and cytotoxic T lymphocytes, which kill infected cells.

Neutralizing antibodies against viral membrane glycoproteins, such as the spike and nucleocapsid proteins, induce humoral immune responses against the SARS-CoV-2 virus. These antibodies prevent the virus from entering cells, thus preventing their ability to infect. However, not all antibodies have neutralizing activity and some antibodies can increase virus activity. Therefore, to solve this problem, mRNA fragments were isolated and encapsulated in lipid nanoparticles to create mRNA vaccines. The COVID-19 infection was the first to be prevented by an mRNA vaccine, which was quickly tested multiple times before being used in humans. Both viral vectors and mRNA vaccines induce cell-mediated Th1 and CD8 cytotoxic responses

Lymphocytes that recognize and digest viral antigens exposed by class I MCH molecules. To date, the induction of regulatory T cells in vaccine-induced immune responses has not been reported. Other types of COVID-19 vaccines are currently being studied in Phase 1, 2 and 3 clinical trials (

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We assessed the quality and risk of bias of the included cohort studies using the Newcastle-Ottawa Scale (NOS). NOS includes ‘participant selection’, ‘study group comparability’ and ‘outcome or exposure assessment’. Scores above 6-7 indicate fair quality.

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The search revealed 1345 potentially relevant articles and studies, while 576 duplicates were removed. After title and abstract screening, 60 full-text studies were considered potentially eligible for inclusion. Figure 2 presents a flowchart of the study selection process. We considered 46 records: 30 of them are pregnant women [9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29 , 30, 31, 32, 33, 34, 35, 36, 37, 38], two studies included pregnant and lactating mothers [39, 40] and 14 studies included breastfeeding mothers [41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54]. Most studies were carried out in the United States (41.3%) and Israel (26.1%), three in Italy (6.5%), two in Spain (4.3%) and Poland (4. 3%) and the remainder (17.2%) in the United Kingdom, Qatar, Belgium, Germany, Norway, Portugal, the Netherlands and Singapore.

Most cohort studies in pregnant women were of reasonable quality, as shown in Figure 3 (excluding case series and case reports without an unexposed group).

Most studies of breastfeeding mothers reported data only on exposed women, without a control group; the remaining six studies were of moderate quality, as shown in Figure 4.

Table 1 presents the most relevant characteristics and results of the included pregnancy vaccination studies. The most relevant issues involve security

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