Abstract
BackgroundPregnant and lactating women were excluded from initial coronavirus disease 2019 vaccine trials; thus, data to guide vaccine decision making are lacking.ObjectiveThis study aimed to evaluate the immunogenicity and reactogenicity of coronavirus disease 2019 messenger RNA vaccination in pregnant and lactating women compared with: (1) nonpregnant controls and (2) natural coronavirus disease 2019 infection in pregnancy.Study DesignA total of 131 reproductive-age vaccine recipients (84 pregnant, 31 lactating, and 16 nonpregnant women) were enrolled in a prospective cohort study at 2 academic medical centers. Titers of severe acute respiratory syndrome coronavirus 2 spike and receptor-binding domain immunoglobulin G, immunoglobulin A, and immunoglobulin M were quantified in participant sera (n=131) and breastmilk (n=31) at baseline, at the second vaccine dose, at 2 to 6 weeks after the second vaccine, and at delivery by Luminex. Umbilical cord sera (n=10) titers were assessed at delivery. Titers were compared with those of pregnant women 4 to 12 weeks from the natural infection (n=37) by enzyme-linked immunosorbent assay. A pseudovirus neutralization assay was used to quantify neutralizing antibody titers for the subset of women who delivered during the study period. Postvaccination symptoms were assessed via questionnaire. Kruskal-Wallis tests and a mixed-effects model, with correction for multiple comparisons, were used to assess differences among groups.ResultsVaccine-induced antibody titers were equivalent in pregnant and lactating compared with nonpregnant women (pregnant, median, 5.59; interquartile range, 4.68–5.89; lactating, median, 5.74; interquartile range, 5.06–6.22; nonpregnant, median, 5.62; interquartile range, 4.77–5.98, P=.24). All titers were significantly higher than those induced by severe acute respiratory syndrome coronavirus 2 infection during pregnancy (P<.0001). Vaccine-generated antibodies were present in all umbilical cord blood and breastmilk samples. Neutralizing antibody titers were lower in umbilical cord than maternal sera, although this finding did not achieve statistical significance (maternal sera, median, 104.7; interquartile range, 61.2–188.2; cord sera, median, 52.3; interquartile range, 11.7–69.6; P=.05). The second vaccine dose (boost dose) increased severe acute respiratory syndrome coronavirus 2–specific immunoglobulin G, but not immunoglobulin A, in maternal blood and breastmilk. No differences were noted in reactogenicity across the groups.ConclusionCoronavirus disease 2019 messenger RNA vaccines generated robust humoral immunity in pregnant and lactating women, with immunogenicity and reactogenicity similar to that observed in nonpregnant women. Vaccine-induced immune responses were statistically significantly greater than the response to natural infection. Immune transfer to neonates occurred via placenta and breastmilk.
Highlights
IntroductionMore than 73,600 infections and 80 maternal deaths have occurred in pregnant women in the United States alone as of March 1, 2021.1 Severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) infection is more severe in
More than 73,600 infections and 80 maternal deaths have occurred in pregnant women in the United States alone as of March 1, 2021.1 Severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) infection is more severe inCite this article as: Gray KJ, Bordt EA, Atyeo C, et al Coronavirus disease 2019 vaccine response in pregnant and lactating women: a cohort study
Pregnant and lactating women were not included in any initial coronavirus disease 2019 (COVID-19) vaccine trials, the first vaccine trial began in pregnant women in February 2021 (Pfizer/BioNTech, ClinicalTrials.gov identifier: NCT04754594)
Summary
More than 73,600 infections and 80 maternal deaths have occurred in pregnant women in the United States alone as of March 1, 2021.1 Severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) infection is more severe in. OBJECTIVE: This study aimed to evaluate the immunogenicity and reactogenicity of coronavirus disease 2019 messenger RNA vaccination in pregnant and lactating women compared with: (1) nonpregnant controls and (2) natural coronavirus disease 2019 infection in pregnancy. Titers of severe acute respiratory syndrome coronavirus 2 spike and receptor-binding domain immunoglobulin G, immunoglobulin A, and immunoglobulin M were quantified in participant sera (n1⁄4131) and breastmilk (n1⁄431) at baseline, at the second vaccine dose, at 2 to 6 weeks after the second vaccine, and at delivery by Luminex. Kruskal-Wallis tests and a mixed-effects model, with correction for multiple comparisons, were used to assess differences among groups
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