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      Vaccination Against COVID-19 Disease During Pregnancy Translated title: Vakcinacija nuo COVID-19 ligos nėštumo metu

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          Abstract.

          Background.

          The effect of COVID-19 disease during pregnancy is still under investigation, however scientific studies have shown that pregnant women with COVID-19 infection are at increased risk for severe illness or complications [ 1]. Risk factors for severe disease and death in pregnancy include maternal age (especially ≥35 years), obesity, preexisting medical comorbidities (particularly hypertension and diabetes or more than one comorbidity), and being unvaccinated [ 2]. Many societies of obstetricians and gynecologists recommend that all pregnant patients undergo COVID-19 vaccination [ 1]. The aim of this study is to observe demographic characteristics, including education, place of residence and type of employment of women who chose to be vaccinated against COVID-19 in Lithuania, as well as to investigate any adverse reactions following the COVID-19 vaccine during pregnancy and compare the results to published scientific data.

          Materials and methods.

          An online questionnaire for pregnant women primarily located in Lithuania who received at least one dose of COVID-19 vaccine before giving birth has been launched in July, 2021. Data were entered via Google Forms and analyzed using Microsoft Excel and IBM SPSS Statistics. Literature review was performed on PubMed and Google Scholar search engines on inclusion criteria: publication date 2019–2021, used keywords pregnancy, COVID-19, vaccination, side effects.

          Results.

          Data were collected from 227 women vaccinated against COVID-19 during pregnancy. It was observed that the most chosen vaccine was Pfizer-BioNTech BNT162b2 (196 out of 227 individuals (86%)). More pregnant women confirmed having fever after the second dose compared to the first dose (p=0.006). In addition, injection site pain was the most common local side effect after both doses (98%) and more common after the first dose compared to the second (p=0.002). Regarding systemic reactogenicity more women experienced fatigue after the second dose comparing to the first dose (p=0.01). Furthermore, more women were unable to engage in daily activities after the second dose (p=0.03). All other symptoms did not differ after doses 1 and 2.

          Conclusions.

          Overall findings of this study did not suggest any obvious safety signals among pregnant individuals who received COVID-19 vaccine and all the side effects were comparable to the general population. Completed literature review indicates that pregnant women vaccinated against COVID-19 experience the same side effects as individuals in general population and no specific postvaccination reactions among pregnant individuals are observed.

          Santrauka.

          Įvadas.

          COVID-19 ligos poveikis nėštumui dar nėra visiškai ištirtas, tačiau iki šiol atlikti moksliniai tyrimai parodė, kad nėščiosioms COVID-19 ligos eiga dažniau būna sunki ir komplikuota nei ne nėščių reprodukcinio amžiaus moterų [ 1]. Sunkios ligos ir mirties nėštumo metu rizikos veiksniai yra vyresnis amžius (ypač ≥35 metų), nutukimas, gretutinės ligos (ypač hipertenzija ir diabetas arba daugiau nei viena gretutinė liga) ir nesiskiepijimas [ 2]. Daugelis akušerių ir ginekologų draugijų rekomenduoja visoms nėščiosioms pasiskiepyti nuo COVID-19 [ 1]. Šio tyrimo tikslas yra apžvelgti moterų, kurios pasiskiepijo nuo COVID-19 ligos Lietuvoje, demografinius rodiklius, įskaitant jų išsilavinimą, gyvenamąją vietą, darbo pobūdį, taip pat ištirti, koks šalutinis poveikis joms pasireiškė po vakcinacijos, ir palyginti gautus rezultatus su duomenimis, publikuojamais mokslinėje literatūroje.

          Medžiagos ir metodai.

          2021 metų liepos mėnesį paruošėme internetinę apklausą nėščiosioms, gyvenančioms Lietuvoje, kurios prieš gimdymą pasiskiepijo bent viena vakcinos nuo COVID-19 ligos doze. Duomenys buvo renkami per „Google Forms“ ir analizuojami naudojant „Microsoft Excel“ ir „IBM SPSS Statistics“. Literatūros paieška buvo atlikta „PubMed“ ir „Google Scholar“ duomenų bazėse pagal šiuos kriterijus: publikacijos data 2019–2021 m., vartojami raktiniai žodžiai nėštumas, COVID-19, vakcinacija, šalutinis poveikis.

          Rezultatai.

          Gauti 227 nėščiųjų, pasiskiepijusių nuo COVID-19 ligos, duomenys. Rezultatai parodė, kad dažniausiai nėščiosios rinkosi Pfizer-BioNTech BNT162b2 vakciną (196 iš 227 respondenčių (86 %)). Daugiau nėščiųjų karščiavo po antros vakcinos dozės (p = 0,006). Skausmas šalia dūrio ar dūrio vietoje buvo dažniausias šalutinis poveikis po abiejų vakcinos dozių ir dažnesnis po pirmos vakcinos dozės (p = 0,002). Lyginant sisteminius šalutinius poveikius, daugiau moterų jautė nuovargį po antros vakcinos dozės (p = 0,01). Be to, daugiau moterų negalėjo užsiimti kasdiene veikla po antros vakcinos dozės (p = 0,03). Visi kiti simptomai po pirmos ir antros vakcinos dozės reikšmingai nesiskyrė.

          Išvados.

          Mūsų tyrimo rezultatai ir atlikta literatūros apžvalga parodė, kad moterys, pasiskiepijusios nuo COVID-19 ligos nėštumo metu, patiria tokį patį šalutinį poveikį kaip ir bendrosios populiacijos pasiskiepijusios moterys ir jokio išskirtinio šalutinio poveikio nėščiosioms nebuvo nustatyta.

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          Most cited references13

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          Maternal and Neonatal Morbidity and Mortality Among Pregnant Women With and Without COVID-19 Infection : The INTERCOVID Multinational Cohort Study

          This cohort study assesses the association between COVID-19 and maternal and neonatal outcomes in pregnant women with COVID-19 diagnosis compared with concomitantly enrolled pregnant women without COVID-19 diagnosis. Question To what extent does COVID-19 in pregnancy alter the risks of adverse maternal and neonatal outcomes compared with pregnant individuals without COVID-19? Findings In this multinational cohort study of 2130 pregnant women in 18 countries, women with COVID-19 diagnosis were at increased risk of a composite maternal morbidity and mortality index. Newborns of women with COVID-19 diagnosis had significantly higher severe neonatal morbidity index and severe perinatal morbidity and mortality index compared with newborns of women without COVID-19 diagnosis. Meaning This study indicates a consistent association between pregnant individuals with COVID-19 diagnosis and higher rates of adverse outcomes, including maternal mortality, preeclampsia, and preterm birth compared with pregnant individuals without COVID-19 diagnosis. Importance Detailed information about the association of COVID-19 with outcomes in pregnant individuals compared with not-infected pregnant individuals is much needed. Objective To evaluate the risks associated with COVID-19 in pregnancy on maternal and neonatal outcomes compared with not-infected, concomitant pregnant individuals. Design, Setting, and Participants In this cohort study that took place from March to October 2020, involving 43 institutions in 18 countries, 2 unmatched, consecutive, not-infected women were concomitantly enrolled immediately after each infected woman was identified, at any stage of pregnancy or delivery, and at the same level of care to minimize bias. Women and neonates were followed up until hospital discharge. Exposures COVID-19 in pregnancy determined by laboratory confirmation of COVID-19 and/or radiological pulmonary findings or 2 or more predefined COVID-19 symptoms. Main Outcomes and Measures The primary outcome measures were indices of (maternal and severe neonatal/perinatal) morbidity and mortality; the individual components of these indices were secondary outcomes. Models for these outcomes were adjusted for country, month entering study, maternal age, and history of morbidity. Results A total of 706 pregnant women with COVID-19 diagnosis and 1424 pregnant women without COVID-19 diagnosis were enrolled, all with broadly similar demographic characteristics (mean [SD] age, 30.2 [6.1] years). Overweight early in pregnancy occurred in 323 women (48.6%) with COVID-19 diagnosis and 554 women (40.2%) without. Women with COVID-19 diagnosis were at higher risk for preeclampsia/eclampsia (relative risk [RR], 1.76; 95% CI, 1.27-2.43), severe infections (RR, 3.38; 95% CI, 1.63-7.01), intensive care unit admission (RR, 5.04; 95% CI, 3.13-8.10), maternal mortality (RR, 22.3; 95% CI, 2.88-172), preterm birth (RR, 1.59; 95% CI, 1.30-1.94), medically indicated preterm birth (RR, 1.97; 95% CI, 1.56-2.51), severe neonatal morbidity index (RR, 2.66; 95% CI, 1.69-4.18), and severe perinatal morbidity and mortality index (RR, 2.14; 95% CI, 1.66-2.75). Fever and shortness of breath for any duration was associated with increased risk of severe maternal complications (RR, 2.56; 95% CI, 1.92-3.40) and neonatal complications (RR, 4.97; 95% CI, 2.11-11.69). Asymptomatic women with COVID-19 diagnosis remained at higher risk only for maternal morbidity (RR, 1.24; 95% CI, 1.00-1.54) and preeclampsia (RR, 1.63; 95% CI, 1.01-2.63). Among women who tested positive (98.1% by real-time polymerase chain reaction), 54 (13%) of their neonates tested positive. Cesarean delivery (RR, 2.15; 95% CI, 1.18-3.91) but not breastfeeding (RR, 1.10; 95% CI, 0.66-1.85) was associated with increased risk for neonatal test positivity. Conclusions and Relevance In this multinational cohort study, COVID-19 in pregnancy was associated with consistent and substantial increases in severe maternal morbidity and mortality and neonatal complications when pregnant women with and without COVID-19 diagnosis were compared. The findings should alert pregnant individuals and clinicians to implement strictly all the recommended COVID-19 preventive measures.
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            Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons

            Background Many pregnant persons in the United States are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Methods From December 14, 2020, to February 28, 2021, we used data from the “v-safe after vaccination health checker” surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Results A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.
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              Potential Maternal and Infant Outcomes from Coronavirus 2019-nCoV (SARS-CoV-2) Infecting Pregnant Women: Lessons from SARS, MERS, and Other Human Coronavirus Infections

              In early December 2019 a cluster of cases of pneumonia of unknown cause was identified in Wuhan, a city of 11 million persons in the People’s Republic of China. Further investigation revealed these cases to result from infection with a newly identified coronavirus, initially termed 2019-nCoV and subsequently SARS-CoV-2. The infection moved rapidly through China, spread to Thailand and Japan, extended into adjacent countries through infected persons travelling by air, eventually reaching multiple countries and continents. Similar to such other coronaviruses as those causing the Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS), the new coronavirus was reported to spread via natural aerosols from human-to-human. In the early stages of this epidemic the case fatality rate is estimated to be approximately 2%, with the majority of deaths occurring in special populations. Unfortunately, there is limited experience with coronavirus infections during pregnancy, and it now appears certain that pregnant women have become infected during the present 2019-nCoV epidemic. In order to assess the potential of the Wuhan 2019-nCoV to cause maternal, fetal and neonatal morbidity and other poor obstetrical outcomes, this communication reviews the published data addressing the epidemiological and clinical effects of SARS, MERS, and other coronavirus infections on pregnant women and their infants. Recommendations are also made for the consideration of pregnant women in the design, clinical trials, and implementation of future 2019-nCoV vaccines.
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                Author and article information

                Contributors
                Journal
                Acta Med Litu
                Acta Med Litu
                amed
                Acta Medica Lituanica
                Vilnius University Press
                1392-0138
                2029-4174
                2022
                26 July 2022
                : 29
                : 1
                : 51-57
                Affiliations
                Faculty of Medicine, Vilnius University, Vilnius, Lithuania
                Center of Obstetrics and Gynaecology, Institute of Clinical Medicine, Faculty of Medicine, Vilnius, Lithuania
                Center of Obstetrics and Gynaecology, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania
                Center of Obstetrics and Gynaecology, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania
                Center of Obstetrics and Gynaecology, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania
                Author notes
                * Corresponding author: Miglė Černiauskaitė, Vilnius University, M. K. Čiurlionio St. 21, LT-03101, Lithuania. E-mail mig.cern@ 123456gmail.com
                Author information
                https://orcid.org/0000-0002-6604-9056
                https://orcid.org/0000-0003-1481-3558
                Article
                Amed.2021.29.1.11
                10.15388/Amed.2021.29.1.11
                9428649
                36061938
                86673868-71e3-41e4-8297-b8ab1f14610e
                Copyright © 2022 Austėja Voiniušytė, Miglė Černiauskaitė, Virginija Paliulytė, Rūta Einikytė, Diana Ramašauskaitė. Published by Vilnius University Press.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 10 January 2022
                : 17 February 2022
                : 22 February 2022
                Categories
                Research Articles

                pregnancy,covid-19 infection,vaccination,side effect
                pregnancy, covid-19 infection, vaccination, side effect

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