key: cord-0927410-pj87v1in authors: STAFFORD, Irene A.; PARCHEM, Jacqueline G.; SIBAI, Baha M. title: The COVID-19 vaccine in pregnancy: risks benefits and recommendations date: 2021-01-30 journal: Am J Obstet Gynecol DOI: 10.1016/j.ajog.2021.01.022 sha: 7463926d537390d54debd535515c929c0821d6e0 doc_id: 927410 cord_uid: pj87v1in The 2019 Coronavirus (COVID-19) has caused over two-million deaths worldwide, with over 412,000 deaths reported in Unites States. To date, at least 57,786 pregnant women in the US have been infected and 71 have died1-4. Although pregnant women are at higher risk for severe COVID-19 related illness, clinical trials for the available vaccines excluded pregnant and lactating women. The safety and efficacy of the vaccines for pregnant women, the fetus and the newborn remain unknown. A review of maternal and neonatal COVID-19 morbidity and mortality data along with perinatal vaccine safety considerations are presented to assist providers with shared decision-making regarding vaccine administration for this group, including the health care worker who is pregnant, lactating or considering pregnancy. The COVID-19 vaccine should be offered to pregnant women after discussing lack of safety data, with preferential administration for those at highest risk for severe infection, until safety and efficacy of these novel vaccines are validated. . These surveillance data have limitations, 107 however, as over 64.5% of total cases involving women did not have pregnancy status 108 recorded 45 . Additionally, among those with known pregnancy status, race and ethnicity status 109 was missing for 25% of cases, and information on symptoms and underlying conditions was 110 missing for approximately half 45 . A recent publication of morbidity, mortality, and pregnancy In our expert opinion, we recommend a comprehensive risk-benefit discussion regarding the lack 307 of safety data occur prior to COVID-19 vaccine administration in pregnant women with 308 preferential administration for pregnant women at highest risk for more severe infection related 309 disease, until safety and efficacy of these novel COVID-19 vaccines are ensured 118 . (Table 3) 310 J o u r n a l P r e -p r o o f Astrazeneca *** t >37·8°C, cough, shortness of breath, and anosmia or ageusia. In some sites, the list of qualifying 756 symptoms for swabbing was broader, and additionally included myalgia, chills, sore throat, headache, nasal 757 congestion, diarrhoea, runny nose, fatigue, nausea, vomiting, and loss of appetite. † † †One nasopharyngeal (NP) 758 swab, nasal swab positive for SARS-CoV-2 by RT-PCR by home kits using protocol-defined acceptable tests • Heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies Immediate allergic reaction of any severity to polysorbate (due to potential cross-reactive hypersensitivity with the 821 vaccine ingredient PEG)* Seropositivity of 632 influenza A H1NI in mothers and infants following maternal vaccination with trivalent seasonal 633 influenza vaccine after the 2009 pandemic Safety of immunization during pregnancy: a review of 636 the evidence of selected inactivated and live attenuated vaccines Influenza Vaccine Efficacy and Effectiveness in 642 Pregnant Women: Systematic Review and Meta-analysis. Matern Child Influenza vaccination 645 during pregnancy and its usefulness to mothers and their young infants Influenza vaccination given at least 2 weeks before delivery 649 to pregnant women facilitates transmission of seroprotective influenza-specific antibodies to the 650 newborn Association 675 between Rotavirus Vaccine and Type 1 Diabetes in Children The use of natural language 679 processing to identify vaccine-related anaphylaxis at five health care systems in the Vaccine 680 Pharmacoepidemiolo Drug Saf Uptake and safety of hepatitis A vaccination during pregnancy: A Vaccine Safety Datalink 683 study. Vaccine Curr Treat Options Allergy Estimation of the Incidence of Syndrome During Pregnancy in the United States. Open Forum Infect Dis The state of vaccine safety science: systematic reviews of the evidence Communicating vaccine safety during the development and introduction of 693 vaccines Infections in Pregnancy and the Role of 696 Prevention and control of influenza with vaccines: 702 recommendations of the Advisory Committee on Immunization Practices (ACIP) Erratum in: MMWR Recomm Rep Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory 707 Committee on Immunization Practices -United States, 2020-21 Influenza Season Influenza Vaccination During Pregnancy. Obstet Updated recommendations for use of 714 tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant 715 women--Advisory Committee on Immunization Practices (ACIP), 2012. MMWR Morb Mortal Wkly Rep Fever in pregnancy and the risk of congenital malformations: a cohort study Fever in 723 pregnancy and risk of fetal death: a cohort study Data presented by pregnancy status, age, race, ethnicity and comorbidities. Data for Extracorporeal Membrane 770 Oxygenation, multiple or other race, non-Hispanic and unknown were not included in Table 2. Only adjusted risk 771 ratio included Characteristics of Symptomatic Women of Reproductive Age with Laboratory-Confirmed SARS-CoV-2 Infection 775 by Pregnancy Status -United States Adjusted for age, categorical race/ethnicity 780 variable, and dichotomous indicators for diabetes, cardiovascular disease, and chronic lung disease 6%) symptomatic pregnant women and 291,539 (75.5%) symptomatic nonpregnant women 782 were missing information on ICU admission status ** Cardiovascular disease also accounts for presence of hypertension 4%) pregnant women and 299,413 (77.6%) nonpregnant women were missing information 785 regarding receipt of invasive ventilation and were assumed to have not received it Adjusted for the presence of diabetes, CVD, and chronic lung disease only, and removed race/ethnicity from 787 adjustment set because of model convergence issues Adjusted for the presence of diabetes and chronic lung disease and age as a continuous covariate only and 789 removed race/ethnicity from adjustment set because of model convergence issues 0%) pregnant women and 66,346 (17.2%) nonpregnant women were missing information 791 on death and were assumed to have survived Adjusted for the presence of CVD and chronic lung disease and age as a continuous variable Adjusted for presence of diabetes and chronic lung disease and age as a continuous variable J o u r n a l P r e -p r o o f