Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons

Abstract

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.

Targeting COVID-19 Vaccine Hesitancy in Minority Populations in the US: Implications for Herd Immunity

“…In a study performed by Shimabukuro et al, who examined 35,691 women v-safe participants 16 to 54 years of age that identified as pregnant, injection site pain was the most frequently reported by pregnant women compared to non-pregnant women. Among 3958 pregnant women enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) experienced pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester) [ 31 ]. Although no neonatal deaths were reported, adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%) [ 31 ].…”

“…Among 3958 pregnant women enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) experienced pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester) [ 31 ]. Although no neonatal deaths were reported, adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%) [ 31 ]. Even more, although not directly comparable, there appeared no significant difference in adverse events and neonatal outcomes compared to other studies with similar cohorts before the COVID-19 pandemic.…”

Schwangere Mitarbeiterinnen im Gesundheitswesen: Schutz durch Impfen gegen SARS-CoV-2 und Tragen von FFP2-Masken

“…Somit sind künftig Daten zum Outcome dieser Schwangerschaften zu erwarten [3]. Eine jüngst publizierte Registerstudie (V-Safe) zu vorläufigen Ergebnissen bei über 30.000 trotz Schwangerschaft geimpften Frauen zeigte, dass impfbedingte Nebenwirkungen sich bis auf vermehrte lokale Schmerzen im Bereich der Impfung nicht von denen der Nichtschwangeren unterschieden [4]. Häufigkeit und Art von unerwünschten Schwangerschafts-und Neugeborenenereignissen waren vergleichbar mit den vorbekannten Inzidenzen vor der COVID-19-Pandemie [4] [6].…”

Safety and efficacy of COVID-19 vaccines in pregnant women with rheumatic diseases: an immunologic perspective

“…A large study by Shimabukuro et al recently described no glaring concerns except spontaneous abortions in pregnant women who got the mRNA vaccine [ 7 ]. It was proposed that antibodies against SARS-Cov2 spike protein might cross-react with human placental protein syncytin 1, causing damage to placenta, but no similarity was noticed in amino acid sequence of both proteins.…”