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Kaitlyn E James - One of the best experts on this subject based on the ideXlab platform.

  • coronavirus disease 2019 vaccine response in pregnant and Lactating Women a cohort study
    American Journal of Obstetrics and Gynecology, 2021
    Co-Authors: Kathryn J Gray, Evan A Bordt, Caroline Atyeo, Elizabeth Deriso, Babatunde Akinwunmi, Nicola Young, Aranxta Medina Baez, Dana Cvrk, Lydia L Shook, Kaitlyn E James
    Abstract:

    BACKGROUND: Pregnant and Lactating Women were excluded from initial coronavirus disease 2019 vaccine trials; thus, data to guide vaccine decision making are lacking. 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. STUDY DESIGN: A 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. RESULTS: Vaccine-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. CONCLUSION: Coronavirus 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.

  • covid 19 vaccine response in pregnant and Lactating Women a cohort study
    American Journal of Obstetrics and Gynecology, 2021
    Co-Authors: Kathryn J Gray, Evan A Bordt, Caroline Atyeo, Elizabeth Deriso, Babatunde Akinwunmi, Nicola Young, Aranxta Medina Baez, Dana Cvrk, Lydia L Shook, Kaitlyn E James
    Abstract:

    Abstract Background Pregnant and Lactating Women were excluded from initial COVID-19 vaccine trials; thus, data to guide vaccine decision-making are lacking. Objectives To evaluate the immunogenicity and reactogenicity of COVID-19 mRNA vaccination in pregnant and Lactating Women compared to: (1) non-pregnant controls and (2) natural COVID-19 infection in pregnancy. Study Design 131 reproductive-age vaccine recipients (84 pregnant, 31 Lactating, and 16 non-pregnant) were enrolled in a prospective cohort study at two academic medical centers. Titers of SARS-CoV-2 Spike and RBD IgG, IgA and IgM were quantified in participant sera (N=131) and breastmilk (N=31) at baseline, second vaccine dose, 2-6 weeks post second vaccine, and at delivery by Luminex. Umbilical cord sera (N=10) titers were assessed at delivery. Titers were compared to those of pregnant Women 4-12 weeks from natural infection (N=37) by ELISA. A pseudovirus neutralization assay was used to quantify neutralizing antibody titers for the subset of Women who delivered during the study period. Post-vaccination symptoms were assessed via questionnaire. Kruskal-Wallis tests and a mixed effects model, with correction for multiple comparisons, were used to assess differences between groups. Results Vaccine-induced antibody titers were equivalent in pregnant and Lactating compared to non-pregnant Women (median [IQR] 5.59 [4.68-5.89] pregnant, 5.74 [5.06-6.22] Lactating, 5.62 [4.77-5.98] non-pregnant, p = 0.24). All titers were significantly higher than those induced by SARS-CoV-2 infection during pregnancy (p Conclusions COVID-19 mRNA vaccines generated robust humoral immunity in pregnant and Lactating Women, with immunogenicity and reactogenicity similar to that observed in non-pregnant Women. Vaccine-induced immune responses were significantly greater than the response to natural infection. Immune transfer to neonates occurred via placenta and breastmilk.

  • covid 19 vaccine response in pregnant and Lactating Women a cohort study
    American Journal of Obstetrics and Gynecology, 2021
    Co-Authors: Kathryn J Gray, Evan A Bordt, Caroline Atyeo, Elizabeth Deriso, Babatunde Akinwunmi, Nicola Young, Aranxta Medina Baez, Dana Cvrk, Lydia L Shook, Kaitlyn E James
    Abstract:

    BACKGROUND: Pregnant and Lactating Women were excluded from initial COVID-19 vaccine trials; thus, data to guide vaccine decision-making are lacking. OBJECTIVES: To evaluate the immunogenicity and reactogenicity of COVID-19 mRNA vaccination in pregnant and Lactating Women compared to: (1) non-pregnant controls and (2) natural COVID-19 infection in pregnancy. STUDY DESIGN: 131 reproductive-age vaccine recipients (84 pregnant, 31 Lactating, and 16 non-pregnant) were enrolled in a prospective cohort study at two academic medical centers. Titers of SARS-CoV-2 Spike and RBD IgG, IgA and IgM were quantified in participant sera (N=131) and breastmilk (N=31) at baseline, second vaccine dose, 2-6 weeks post second vaccine, and at delivery by Luminex. Umbilical cord sera (N=10) titers were assessed at delivery. Titers were compared to those of pregnant Women 4-12 weeks from natural infection (N=37) by ELISA. A pseudovirus neutralization assay was used to quantify neutralizing antibody titers for the subset of Women who delivered during the study period. Post-vaccination symptoms were assessed via questionnaire. Kruskal-Wallis tests and a mixed effects model, with correction for multiple comparisons, were used to assess differences between groups. RESULTS: Vaccine-induced antibody titers were equivalent in pregnant and Lactating compared to non-pregnant Women (median [IQR] 5.59 [4.68-5.89] pregnant, 5.74 [5.06-6.22] Lactating, 5.62 [4.77-5.98] non-pregnant, p = 0.24). All titers were significantly higher than those induced by SARS-CoV-2 infection during pregnancy (p < 0.0001). Vaccine-generated antibodies were present in all umbilical cord blood and breastmilk samples. Neutralizing antibody titers were lower in umbilical cord compared to maternal sera, although this finding did not achieve statistical significance (median [IQR] 104.7 [61.2-188.2] maternal sera, 52.3 [11.7-69.6] cord sera, p=0.05). The second vaccine dose (boost dose) increased SARS-CoV-2-specific IgG, but not IgA, in maternal blood and breastmilk. No differences were noted in reactogenicity across the groups. CONCLUSIONS: COVID-19 mRNA vaccines generated robust humoral immunity in pregnant and Lactating Women, with immunogenicity and reactogenicity similar to that observed in non-pregnant Women. Vaccine-induced immune responses were significantly greater than the response to natural infection. Immune transfer to neonates occurred via placenta and breastmilk.

  • covid 19 vaccine response in pregnant and Lactating Women a cohort study
    medRxiv, 2021
    Co-Authors: Kathryn J Gray, Evan A Bordt, Caroline Atyeo, Elizabeth Deriso, Babatunde Akinwunmi, Nicola Young, Aranxta Medina Baez, Lydia Shook, Dana Cvrk, Kaitlyn E James
    Abstract:

    BackgroundPregnant and Lactating Women were excluded from initial COVID-19 vaccine trials; thus, data to guide vaccine decision-making are lacking. We sought to evaluate the immunogenicity and reactogenicity of COVID-19 mRNA vaccination in pregnant and Lactating Women. Methods131 reproductive-age vaccine recipients (84 pregnant, 31 Lactating, and 16 non-pregnant) were enrolled in a prospective cohort study at two academic medical centers. Titers of SARS-CoV-2 Spike and RBD IgG, IgA and IgM were quantified in participant sera (N=131), umbilical cord sera (N=10), and breastmilk (N=31) at baseline, 2nd vaccine dose, 2-6 weeks post 2nd vaccine, and delivery by Luminex, and confirmed by ELISA. Titers were compared to pregnant Women 4-12 weeks from native infection (N=37). Post-vaccination symptoms were assessed. Kruskal-Wallis tests and a mixed effects model, with correction for multiple comparisons, were used to assess differences between groups. ResultsVaccine-induced immune responses were equivalent in pregnant and Lactating vs non-pregnant Women. All titers were higher than those induced by SARS-CoV-2 infection during pregnancy. Vaccine-generated antibodies were present in all umbilical cord blood and breastmilk samples. SARS-CoV-2 specific IgG, but not IgA, increased in maternal blood and breastmilk with vaccine boost. No differences were noted in reactogenicity across the groups. ConclusionsCOVID-19 mRNA vaccines generated robust humoral immunity in pregnant and Lactating Women, with immunogenicity and reactogenicity similar to that observed in non-pregnant Women. Vaccine-induced immune responses were significantly greater than the response to natural infection. Immune transfer to neonates occurred via placental and breastmilk.

Kathryn J Gray - One of the best experts on this subject based on the ideXlab platform.

  • coronavirus disease 2019 vaccine response in pregnant and Lactating Women a cohort study
    American Journal of Obstetrics and Gynecology, 2021
    Co-Authors: Kathryn J Gray, Evan A Bordt, Caroline Atyeo, Elizabeth Deriso, Babatunde Akinwunmi, Nicola Young, Aranxta Medina Baez, Dana Cvrk, Lydia L Shook, Kaitlyn E James
    Abstract:

    BACKGROUND: Pregnant and Lactating Women were excluded from initial coronavirus disease 2019 vaccine trials; thus, data to guide vaccine decision making are lacking. 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. STUDY DESIGN: A 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. RESULTS: Vaccine-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. CONCLUSION: Coronavirus 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.

  • covid 19 vaccine response in pregnant and Lactating Women a cohort study
    American Journal of Obstetrics and Gynecology, 2021
    Co-Authors: Kathryn J Gray, Evan A Bordt, Caroline Atyeo, Elizabeth Deriso, Babatunde Akinwunmi, Nicola Young, Aranxta Medina Baez, Dana Cvrk, Lydia L Shook, Kaitlyn E James
    Abstract:

    Abstract Background Pregnant and Lactating Women were excluded from initial COVID-19 vaccine trials; thus, data to guide vaccine decision-making are lacking. Objectives To evaluate the immunogenicity and reactogenicity of COVID-19 mRNA vaccination in pregnant and Lactating Women compared to: (1) non-pregnant controls and (2) natural COVID-19 infection in pregnancy. Study Design 131 reproductive-age vaccine recipients (84 pregnant, 31 Lactating, and 16 non-pregnant) were enrolled in a prospective cohort study at two academic medical centers. Titers of SARS-CoV-2 Spike and RBD IgG, IgA and IgM were quantified in participant sera (N=131) and breastmilk (N=31) at baseline, second vaccine dose, 2-6 weeks post second vaccine, and at delivery by Luminex. Umbilical cord sera (N=10) titers were assessed at delivery. Titers were compared to those of pregnant Women 4-12 weeks from natural infection (N=37) by ELISA. A pseudovirus neutralization assay was used to quantify neutralizing antibody titers for the subset of Women who delivered during the study period. Post-vaccination symptoms were assessed via questionnaire. Kruskal-Wallis tests and a mixed effects model, with correction for multiple comparisons, were used to assess differences between groups. Results Vaccine-induced antibody titers were equivalent in pregnant and Lactating compared to non-pregnant Women (median [IQR] 5.59 [4.68-5.89] pregnant, 5.74 [5.06-6.22] Lactating, 5.62 [4.77-5.98] non-pregnant, p = 0.24). All titers were significantly higher than those induced by SARS-CoV-2 infection during pregnancy (p Conclusions COVID-19 mRNA vaccines generated robust humoral immunity in pregnant and Lactating Women, with immunogenicity and reactogenicity similar to that observed in non-pregnant Women. Vaccine-induced immune responses were significantly greater than the response to natural infection. Immune transfer to neonates occurred via placenta and breastmilk.

  • covid 19 vaccine response in pregnant and Lactating Women a cohort study
    American Journal of Obstetrics and Gynecology, 2021
    Co-Authors: Kathryn J Gray, Evan A Bordt, Caroline Atyeo, Elizabeth Deriso, Babatunde Akinwunmi, Nicola Young, Aranxta Medina Baez, Dana Cvrk, Lydia L Shook, Kaitlyn E James
    Abstract:

    BACKGROUND: Pregnant and Lactating Women were excluded from initial COVID-19 vaccine trials; thus, data to guide vaccine decision-making are lacking. OBJECTIVES: To evaluate the immunogenicity and reactogenicity of COVID-19 mRNA vaccination in pregnant and Lactating Women compared to: (1) non-pregnant controls and (2) natural COVID-19 infection in pregnancy. STUDY DESIGN: 131 reproductive-age vaccine recipients (84 pregnant, 31 Lactating, and 16 non-pregnant) were enrolled in a prospective cohort study at two academic medical centers. Titers of SARS-CoV-2 Spike and RBD IgG, IgA and IgM were quantified in participant sera (N=131) and breastmilk (N=31) at baseline, second vaccine dose, 2-6 weeks post second vaccine, and at delivery by Luminex. Umbilical cord sera (N=10) titers were assessed at delivery. Titers were compared to those of pregnant Women 4-12 weeks from natural infection (N=37) by ELISA. A pseudovirus neutralization assay was used to quantify neutralizing antibody titers for the subset of Women who delivered during the study period. Post-vaccination symptoms were assessed via questionnaire. Kruskal-Wallis tests and a mixed effects model, with correction for multiple comparisons, were used to assess differences between groups. RESULTS: Vaccine-induced antibody titers were equivalent in pregnant and Lactating compared to non-pregnant Women (median [IQR] 5.59 [4.68-5.89] pregnant, 5.74 [5.06-6.22] Lactating, 5.62 [4.77-5.98] non-pregnant, p = 0.24). All titers were significantly higher than those induced by SARS-CoV-2 infection during pregnancy (p < 0.0001). Vaccine-generated antibodies were present in all umbilical cord blood and breastmilk samples. Neutralizing antibody titers were lower in umbilical cord compared to maternal sera, although this finding did not achieve statistical significance (median [IQR] 104.7 [61.2-188.2] maternal sera, 52.3 [11.7-69.6] cord sera, p=0.05). The second vaccine dose (boost dose) increased SARS-CoV-2-specific IgG, but not IgA, in maternal blood and breastmilk. No differences were noted in reactogenicity across the groups. CONCLUSIONS: COVID-19 mRNA vaccines generated robust humoral immunity in pregnant and Lactating Women, with immunogenicity and reactogenicity similar to that observed in non-pregnant Women. Vaccine-induced immune responses were significantly greater than the response to natural infection. Immune transfer to neonates occurred via placenta and breastmilk.

  • covid 19 vaccine response in pregnant and Lactating Women a cohort study
    medRxiv, 2021
    Co-Authors: Kathryn J Gray, Evan A Bordt, Caroline Atyeo, Elizabeth Deriso, Babatunde Akinwunmi, Nicola Young, Aranxta Medina Baez, Lydia Shook, Dana Cvrk, Kaitlyn E James
    Abstract:

    BackgroundPregnant and Lactating Women were excluded from initial COVID-19 vaccine trials; thus, data to guide vaccine decision-making are lacking. We sought to evaluate the immunogenicity and reactogenicity of COVID-19 mRNA vaccination in pregnant and Lactating Women. Methods131 reproductive-age vaccine recipients (84 pregnant, 31 Lactating, and 16 non-pregnant) were enrolled in a prospective cohort study at two academic medical centers. Titers of SARS-CoV-2 Spike and RBD IgG, IgA and IgM were quantified in participant sera (N=131), umbilical cord sera (N=10), and breastmilk (N=31) at baseline, 2nd vaccine dose, 2-6 weeks post 2nd vaccine, and delivery by Luminex, and confirmed by ELISA. Titers were compared to pregnant Women 4-12 weeks from native infection (N=37). Post-vaccination symptoms were assessed. Kruskal-Wallis tests and a mixed effects model, with correction for multiple comparisons, were used to assess differences between groups. ResultsVaccine-induced immune responses were equivalent in pregnant and Lactating vs non-pregnant Women. All titers were higher than those induced by SARS-CoV-2 infection during pregnancy. Vaccine-generated antibodies were present in all umbilical cord blood and breastmilk samples. SARS-CoV-2 specific IgG, but not IgA, increased in maternal blood and breastmilk with vaccine boost. No differences were noted in reactogenicity across the groups. ConclusionsCOVID-19 mRNA vaccines generated robust humoral immunity in pregnant and Lactating Women, with immunogenicity and reactogenicity similar to that observed in non-pregnant Women. Vaccine-induced immune responses were significantly greater than the response to natural infection. Immune transfer to neonates occurred via placental and breastmilk.

Dana Cvrk - One of the best experts on this subject based on the ideXlab platform.

  • coronavirus disease 2019 vaccine response in pregnant and Lactating Women a cohort study
    American Journal of Obstetrics and Gynecology, 2021
    Co-Authors: Kathryn J Gray, Evan A Bordt, Caroline Atyeo, Elizabeth Deriso, Babatunde Akinwunmi, Nicola Young, Aranxta Medina Baez, Dana Cvrk, Lydia L Shook, Kaitlyn E James
    Abstract:

    BACKGROUND: Pregnant and Lactating Women were excluded from initial coronavirus disease 2019 vaccine trials; thus, data to guide vaccine decision making are lacking. 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. STUDY DESIGN: A 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. RESULTS: Vaccine-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. CONCLUSION: Coronavirus 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.

  • covid 19 vaccine response in pregnant and Lactating Women a cohort study
    American Journal of Obstetrics and Gynecology, 2021
    Co-Authors: Kathryn J Gray, Evan A Bordt, Caroline Atyeo, Elizabeth Deriso, Babatunde Akinwunmi, Nicola Young, Aranxta Medina Baez, Dana Cvrk, Lydia L Shook, Kaitlyn E James
    Abstract:

    Abstract Background Pregnant and Lactating Women were excluded from initial COVID-19 vaccine trials; thus, data to guide vaccine decision-making are lacking. Objectives To evaluate the immunogenicity and reactogenicity of COVID-19 mRNA vaccination in pregnant and Lactating Women compared to: (1) non-pregnant controls and (2) natural COVID-19 infection in pregnancy. Study Design 131 reproductive-age vaccine recipients (84 pregnant, 31 Lactating, and 16 non-pregnant) were enrolled in a prospective cohort study at two academic medical centers. Titers of SARS-CoV-2 Spike and RBD IgG, IgA and IgM were quantified in participant sera (N=131) and breastmilk (N=31) at baseline, second vaccine dose, 2-6 weeks post second vaccine, and at delivery by Luminex. Umbilical cord sera (N=10) titers were assessed at delivery. Titers were compared to those of pregnant Women 4-12 weeks from natural infection (N=37) by ELISA. A pseudovirus neutralization assay was used to quantify neutralizing antibody titers for the subset of Women who delivered during the study period. Post-vaccination symptoms were assessed via questionnaire. Kruskal-Wallis tests and a mixed effects model, with correction for multiple comparisons, were used to assess differences between groups. Results Vaccine-induced antibody titers were equivalent in pregnant and Lactating compared to non-pregnant Women (median [IQR] 5.59 [4.68-5.89] pregnant, 5.74 [5.06-6.22] Lactating, 5.62 [4.77-5.98] non-pregnant, p = 0.24). All titers were significantly higher than those induced by SARS-CoV-2 infection during pregnancy (p Conclusions COVID-19 mRNA vaccines generated robust humoral immunity in pregnant and Lactating Women, with immunogenicity and reactogenicity similar to that observed in non-pregnant Women. Vaccine-induced immune responses were significantly greater than the response to natural infection. Immune transfer to neonates occurred via placenta and breastmilk.

  • covid 19 vaccine response in pregnant and Lactating Women a cohort study
    American Journal of Obstetrics and Gynecology, 2021
    Co-Authors: Kathryn J Gray, Evan A Bordt, Caroline Atyeo, Elizabeth Deriso, Babatunde Akinwunmi, Nicola Young, Aranxta Medina Baez, Dana Cvrk, Lydia L Shook, Kaitlyn E James
    Abstract:

    BACKGROUND: Pregnant and Lactating Women were excluded from initial COVID-19 vaccine trials; thus, data to guide vaccine decision-making are lacking. OBJECTIVES: To evaluate the immunogenicity and reactogenicity of COVID-19 mRNA vaccination in pregnant and Lactating Women compared to: (1) non-pregnant controls and (2) natural COVID-19 infection in pregnancy. STUDY DESIGN: 131 reproductive-age vaccine recipients (84 pregnant, 31 Lactating, and 16 non-pregnant) were enrolled in a prospective cohort study at two academic medical centers. Titers of SARS-CoV-2 Spike and RBD IgG, IgA and IgM were quantified in participant sera (N=131) and breastmilk (N=31) at baseline, second vaccine dose, 2-6 weeks post second vaccine, and at delivery by Luminex. Umbilical cord sera (N=10) titers were assessed at delivery. Titers were compared to those of pregnant Women 4-12 weeks from natural infection (N=37) by ELISA. A pseudovirus neutralization assay was used to quantify neutralizing antibody titers for the subset of Women who delivered during the study period. Post-vaccination symptoms were assessed via questionnaire. Kruskal-Wallis tests and a mixed effects model, with correction for multiple comparisons, were used to assess differences between groups. RESULTS: Vaccine-induced antibody titers were equivalent in pregnant and Lactating compared to non-pregnant Women (median [IQR] 5.59 [4.68-5.89] pregnant, 5.74 [5.06-6.22] Lactating, 5.62 [4.77-5.98] non-pregnant, p = 0.24). All titers were significantly higher than those induced by SARS-CoV-2 infection during pregnancy (p < 0.0001). Vaccine-generated antibodies were present in all umbilical cord blood and breastmilk samples. Neutralizing antibody titers were lower in umbilical cord compared to maternal sera, although this finding did not achieve statistical significance (median [IQR] 104.7 [61.2-188.2] maternal sera, 52.3 [11.7-69.6] cord sera, p=0.05). The second vaccine dose (boost dose) increased SARS-CoV-2-specific IgG, but not IgA, in maternal blood and breastmilk. No differences were noted in reactogenicity across the groups. CONCLUSIONS: COVID-19 mRNA vaccines generated robust humoral immunity in pregnant and Lactating Women, with immunogenicity and reactogenicity similar to that observed in non-pregnant Women. Vaccine-induced immune responses were significantly greater than the response to natural infection. Immune transfer to neonates occurred via placenta and breastmilk.

  • covid 19 vaccine response in pregnant and Lactating Women a cohort study
    medRxiv, 2021
    Co-Authors: Kathryn J Gray, Evan A Bordt, Caroline Atyeo, Elizabeth Deriso, Babatunde Akinwunmi, Nicola Young, Aranxta Medina Baez, Lydia Shook, Dana Cvrk, Kaitlyn E James
    Abstract:

    BackgroundPregnant and Lactating Women were excluded from initial COVID-19 vaccine trials; thus, data to guide vaccine decision-making are lacking. We sought to evaluate the immunogenicity and reactogenicity of COVID-19 mRNA vaccination in pregnant and Lactating Women. Methods131 reproductive-age vaccine recipients (84 pregnant, 31 Lactating, and 16 non-pregnant) were enrolled in a prospective cohort study at two academic medical centers. Titers of SARS-CoV-2 Spike and RBD IgG, IgA and IgM were quantified in participant sera (N=131), umbilical cord sera (N=10), and breastmilk (N=31) at baseline, 2nd vaccine dose, 2-6 weeks post 2nd vaccine, and delivery by Luminex, and confirmed by ELISA. Titers were compared to pregnant Women 4-12 weeks from native infection (N=37). Post-vaccination symptoms were assessed. Kruskal-Wallis tests and a mixed effects model, with correction for multiple comparisons, were used to assess differences between groups. ResultsVaccine-induced immune responses were equivalent in pregnant and Lactating vs non-pregnant Women. All titers were higher than those induced by SARS-CoV-2 infection during pregnancy. Vaccine-generated antibodies were present in all umbilical cord blood and breastmilk samples. SARS-CoV-2 specific IgG, but not IgA, increased in maternal blood and breastmilk with vaccine boost. No differences were noted in reactogenicity across the groups. ConclusionsCOVID-19 mRNA vaccines generated robust humoral immunity in pregnant and Lactating Women, with immunogenicity and reactogenicity similar to that observed in non-pregnant Women. Vaccine-induced immune responses were significantly greater than the response to natural infection. Immune transfer to neonates occurred via placental and breastmilk.

Babatunde Akinwunmi - One of the best experts on this subject based on the ideXlab platform.

  • coronavirus disease 2019 vaccine response in pregnant and Lactating Women a cohort study
    American Journal of Obstetrics and Gynecology, 2021
    Co-Authors: Kathryn J Gray, Evan A Bordt, Caroline Atyeo, Elizabeth Deriso, Babatunde Akinwunmi, Nicola Young, Aranxta Medina Baez, Dana Cvrk, Lydia L Shook, Kaitlyn E James
    Abstract:

    BACKGROUND: Pregnant and Lactating Women were excluded from initial coronavirus disease 2019 vaccine trials; thus, data to guide vaccine decision making are lacking. 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. STUDY DESIGN: A 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. RESULTS: Vaccine-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. CONCLUSION: Coronavirus 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.

  • covid 19 vaccine response in pregnant and Lactating Women a cohort study
    American Journal of Obstetrics and Gynecology, 2021
    Co-Authors: Kathryn J Gray, Evan A Bordt, Caroline Atyeo, Elizabeth Deriso, Babatunde Akinwunmi, Nicola Young, Aranxta Medina Baez, Dana Cvrk, Lydia L Shook, Kaitlyn E James
    Abstract:

    Abstract Background Pregnant and Lactating Women were excluded from initial COVID-19 vaccine trials; thus, data to guide vaccine decision-making are lacking. Objectives To evaluate the immunogenicity and reactogenicity of COVID-19 mRNA vaccination in pregnant and Lactating Women compared to: (1) non-pregnant controls and (2) natural COVID-19 infection in pregnancy. Study Design 131 reproductive-age vaccine recipients (84 pregnant, 31 Lactating, and 16 non-pregnant) were enrolled in a prospective cohort study at two academic medical centers. Titers of SARS-CoV-2 Spike and RBD IgG, IgA and IgM were quantified in participant sera (N=131) and breastmilk (N=31) at baseline, second vaccine dose, 2-6 weeks post second vaccine, and at delivery by Luminex. Umbilical cord sera (N=10) titers were assessed at delivery. Titers were compared to those of pregnant Women 4-12 weeks from natural infection (N=37) by ELISA. A pseudovirus neutralization assay was used to quantify neutralizing antibody titers for the subset of Women who delivered during the study period. Post-vaccination symptoms were assessed via questionnaire. Kruskal-Wallis tests and a mixed effects model, with correction for multiple comparisons, were used to assess differences between groups. Results Vaccine-induced antibody titers were equivalent in pregnant and Lactating compared to non-pregnant Women (median [IQR] 5.59 [4.68-5.89] pregnant, 5.74 [5.06-6.22] Lactating, 5.62 [4.77-5.98] non-pregnant, p = 0.24). All titers were significantly higher than those induced by SARS-CoV-2 infection during pregnancy (p Conclusions COVID-19 mRNA vaccines generated robust humoral immunity in pregnant and Lactating Women, with immunogenicity and reactogenicity similar to that observed in non-pregnant Women. Vaccine-induced immune responses were significantly greater than the response to natural infection. Immune transfer to neonates occurred via placenta and breastmilk.

  • covid 19 vaccine response in pregnant and Lactating Women a cohort study
    American Journal of Obstetrics and Gynecology, 2021
    Co-Authors: Kathryn J Gray, Evan A Bordt, Caroline Atyeo, Elizabeth Deriso, Babatunde Akinwunmi, Nicola Young, Aranxta Medina Baez, Dana Cvrk, Lydia L Shook, Kaitlyn E James
    Abstract:

    BACKGROUND: Pregnant and Lactating Women were excluded from initial COVID-19 vaccine trials; thus, data to guide vaccine decision-making are lacking. OBJECTIVES: To evaluate the immunogenicity and reactogenicity of COVID-19 mRNA vaccination in pregnant and Lactating Women compared to: (1) non-pregnant controls and (2) natural COVID-19 infection in pregnancy. STUDY DESIGN: 131 reproductive-age vaccine recipients (84 pregnant, 31 Lactating, and 16 non-pregnant) were enrolled in a prospective cohort study at two academic medical centers. Titers of SARS-CoV-2 Spike and RBD IgG, IgA and IgM were quantified in participant sera (N=131) and breastmilk (N=31) at baseline, second vaccine dose, 2-6 weeks post second vaccine, and at delivery by Luminex. Umbilical cord sera (N=10) titers were assessed at delivery. Titers were compared to those of pregnant Women 4-12 weeks from natural infection (N=37) by ELISA. A pseudovirus neutralization assay was used to quantify neutralizing antibody titers for the subset of Women who delivered during the study period. Post-vaccination symptoms were assessed via questionnaire. Kruskal-Wallis tests and a mixed effects model, with correction for multiple comparisons, were used to assess differences between groups. RESULTS: Vaccine-induced antibody titers were equivalent in pregnant and Lactating compared to non-pregnant Women (median [IQR] 5.59 [4.68-5.89] pregnant, 5.74 [5.06-6.22] Lactating, 5.62 [4.77-5.98] non-pregnant, p = 0.24). All titers were significantly higher than those induced by SARS-CoV-2 infection during pregnancy (p < 0.0001). Vaccine-generated antibodies were present in all umbilical cord blood and breastmilk samples. Neutralizing antibody titers were lower in umbilical cord compared to maternal sera, although this finding did not achieve statistical significance (median [IQR] 104.7 [61.2-188.2] maternal sera, 52.3 [11.7-69.6] cord sera, p=0.05). The second vaccine dose (boost dose) increased SARS-CoV-2-specific IgG, but not IgA, in maternal blood and breastmilk. No differences were noted in reactogenicity across the groups. CONCLUSIONS: COVID-19 mRNA vaccines generated robust humoral immunity in pregnant and Lactating Women, with immunogenicity and reactogenicity similar to that observed in non-pregnant Women. Vaccine-induced immune responses were significantly greater than the response to natural infection. Immune transfer to neonates occurred via placenta and breastmilk.

  • covid 19 vaccine response in pregnant and Lactating Women a cohort study
    medRxiv, 2021
    Co-Authors: Kathryn J Gray, Evan A Bordt, Caroline Atyeo, Elizabeth Deriso, Babatunde Akinwunmi, Nicola Young, Aranxta Medina Baez, Lydia Shook, Dana Cvrk, Kaitlyn E James
    Abstract:

    BackgroundPregnant and Lactating Women were excluded from initial COVID-19 vaccine trials; thus, data to guide vaccine decision-making are lacking. We sought to evaluate the immunogenicity and reactogenicity of COVID-19 mRNA vaccination in pregnant and Lactating Women. Methods131 reproductive-age vaccine recipients (84 pregnant, 31 Lactating, and 16 non-pregnant) were enrolled in a prospective cohort study at two academic medical centers. Titers of SARS-CoV-2 Spike and RBD IgG, IgA and IgM were quantified in participant sera (N=131), umbilical cord sera (N=10), and breastmilk (N=31) at baseline, 2nd vaccine dose, 2-6 weeks post 2nd vaccine, and delivery by Luminex, and confirmed by ELISA. Titers were compared to pregnant Women 4-12 weeks from native infection (N=37). Post-vaccination symptoms were assessed. Kruskal-Wallis tests and a mixed effects model, with correction for multiple comparisons, were used to assess differences between groups. ResultsVaccine-induced immune responses were equivalent in pregnant and Lactating vs non-pregnant Women. All titers were higher than those induced by SARS-CoV-2 infection during pregnancy. Vaccine-generated antibodies were present in all umbilical cord blood and breastmilk samples. SARS-CoV-2 specific IgG, but not IgA, increased in maternal blood and breastmilk with vaccine boost. No differences were noted in reactogenicity across the groups. ConclusionsCOVID-19 mRNA vaccines generated robust humoral immunity in pregnant and Lactating Women, with immunogenicity and reactogenicity similar to that observed in non-pregnant Women. Vaccine-induced immune responses were significantly greater than the response to natural infection. Immune transfer to neonates occurred via placental and breastmilk.

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  • coronavirus disease 2019 vaccine response in pregnant and Lactating Women a cohort study
    American Journal of Obstetrics and Gynecology, 2021
    Co-Authors: Kathryn J Gray, Evan A Bordt, Caroline Atyeo, Elizabeth Deriso, Babatunde Akinwunmi, Nicola Young, Aranxta Medina Baez, Dana Cvrk, Lydia L Shook, Kaitlyn E James
    Abstract:

    BACKGROUND: Pregnant and Lactating Women were excluded from initial coronavirus disease 2019 vaccine trials; thus, data to guide vaccine decision making are lacking. 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. STUDY DESIGN: A 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. RESULTS: Vaccine-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. CONCLUSION: Coronavirus 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.

  • covid 19 vaccine response in pregnant and Lactating Women a cohort study
    American Journal of Obstetrics and Gynecology, 2021
    Co-Authors: Kathryn J Gray, Evan A Bordt, Caroline Atyeo, Elizabeth Deriso, Babatunde Akinwunmi, Nicola Young, Aranxta Medina Baez, Dana Cvrk, Lydia L Shook, Kaitlyn E James
    Abstract:

    Abstract Background Pregnant and Lactating Women were excluded from initial COVID-19 vaccine trials; thus, data to guide vaccine decision-making are lacking. Objectives To evaluate the immunogenicity and reactogenicity of COVID-19 mRNA vaccination in pregnant and Lactating Women compared to: (1) non-pregnant controls and (2) natural COVID-19 infection in pregnancy. Study Design 131 reproductive-age vaccine recipients (84 pregnant, 31 Lactating, and 16 non-pregnant) were enrolled in a prospective cohort study at two academic medical centers. Titers of SARS-CoV-2 Spike and RBD IgG, IgA and IgM were quantified in participant sera (N=131) and breastmilk (N=31) at baseline, second vaccine dose, 2-6 weeks post second vaccine, and at delivery by Luminex. Umbilical cord sera (N=10) titers were assessed at delivery. Titers were compared to those of pregnant Women 4-12 weeks from natural infection (N=37) by ELISA. A pseudovirus neutralization assay was used to quantify neutralizing antibody titers for the subset of Women who delivered during the study period. Post-vaccination symptoms were assessed via questionnaire. Kruskal-Wallis tests and a mixed effects model, with correction for multiple comparisons, were used to assess differences between groups. Results Vaccine-induced antibody titers were equivalent in pregnant and Lactating compared to non-pregnant Women (median [IQR] 5.59 [4.68-5.89] pregnant, 5.74 [5.06-6.22] Lactating, 5.62 [4.77-5.98] non-pregnant, p = 0.24). All titers were significantly higher than those induced by SARS-CoV-2 infection during pregnancy (p Conclusions COVID-19 mRNA vaccines generated robust humoral immunity in pregnant and Lactating Women, with immunogenicity and reactogenicity similar to that observed in non-pregnant Women. Vaccine-induced immune responses were significantly greater than the response to natural infection. Immune transfer to neonates occurred via placenta and breastmilk.

  • covid 19 vaccine response in pregnant and Lactating Women a cohort study
    American Journal of Obstetrics and Gynecology, 2021
    Co-Authors: Kathryn J Gray, Evan A Bordt, Caroline Atyeo, Elizabeth Deriso, Babatunde Akinwunmi, Nicola Young, Aranxta Medina Baez, Dana Cvrk, Lydia L Shook, Kaitlyn E James
    Abstract:

    BACKGROUND: Pregnant and Lactating Women were excluded from initial COVID-19 vaccine trials; thus, data to guide vaccine decision-making are lacking. OBJECTIVES: To evaluate the immunogenicity and reactogenicity of COVID-19 mRNA vaccination in pregnant and Lactating Women compared to: (1) non-pregnant controls and (2) natural COVID-19 infection in pregnancy. STUDY DESIGN: 131 reproductive-age vaccine recipients (84 pregnant, 31 Lactating, and 16 non-pregnant) were enrolled in a prospective cohort study at two academic medical centers. Titers of SARS-CoV-2 Spike and RBD IgG, IgA and IgM were quantified in participant sera (N=131) and breastmilk (N=31) at baseline, second vaccine dose, 2-6 weeks post second vaccine, and at delivery by Luminex. Umbilical cord sera (N=10) titers were assessed at delivery. Titers were compared to those of pregnant Women 4-12 weeks from natural infection (N=37) by ELISA. A pseudovirus neutralization assay was used to quantify neutralizing antibody titers for the subset of Women who delivered during the study period. Post-vaccination symptoms were assessed via questionnaire. Kruskal-Wallis tests and a mixed effects model, with correction for multiple comparisons, were used to assess differences between groups. RESULTS: Vaccine-induced antibody titers were equivalent in pregnant and Lactating compared to non-pregnant Women (median [IQR] 5.59 [4.68-5.89] pregnant, 5.74 [5.06-6.22] Lactating, 5.62 [4.77-5.98] non-pregnant, p = 0.24). All titers were significantly higher than those induced by SARS-CoV-2 infection during pregnancy (p < 0.0001). Vaccine-generated antibodies were present in all umbilical cord blood and breastmilk samples. Neutralizing antibody titers were lower in umbilical cord compared to maternal sera, although this finding did not achieve statistical significance (median [IQR] 104.7 [61.2-188.2] maternal sera, 52.3 [11.7-69.6] cord sera, p=0.05). The second vaccine dose (boost dose) increased SARS-CoV-2-specific IgG, but not IgA, in maternal blood and breastmilk. No differences were noted in reactogenicity across the groups. CONCLUSIONS: COVID-19 mRNA vaccines generated robust humoral immunity in pregnant and Lactating Women, with immunogenicity and reactogenicity similar to that observed in non-pregnant Women. Vaccine-induced immune responses were significantly greater than the response to natural infection. Immune transfer to neonates occurred via placenta and breastmilk.

  • covid 19 vaccine response in pregnant and Lactating Women a cohort study
    medRxiv, 2021
    Co-Authors: Kathryn J Gray, Evan A Bordt, Caroline Atyeo, Elizabeth Deriso, Babatunde Akinwunmi, Nicola Young, Aranxta Medina Baez, Lydia Shook, Dana Cvrk, Kaitlyn E James
    Abstract:

    BackgroundPregnant and Lactating Women were excluded from initial COVID-19 vaccine trials; thus, data to guide vaccine decision-making are lacking. We sought to evaluate the immunogenicity and reactogenicity of COVID-19 mRNA vaccination in pregnant and Lactating Women. Methods131 reproductive-age vaccine recipients (84 pregnant, 31 Lactating, and 16 non-pregnant) were enrolled in a prospective cohort study at two academic medical centers. Titers of SARS-CoV-2 Spike and RBD IgG, IgA and IgM were quantified in participant sera (N=131), umbilical cord sera (N=10), and breastmilk (N=31) at baseline, 2nd vaccine dose, 2-6 weeks post 2nd vaccine, and delivery by Luminex, and confirmed by ELISA. Titers were compared to pregnant Women 4-12 weeks from native infection (N=37). Post-vaccination symptoms were assessed. Kruskal-Wallis tests and a mixed effects model, with correction for multiple comparisons, were used to assess differences between groups. ResultsVaccine-induced immune responses were equivalent in pregnant and Lactating vs non-pregnant Women. All titers were higher than those induced by SARS-CoV-2 infection during pregnancy. Vaccine-generated antibodies were present in all umbilical cord blood and breastmilk samples. SARS-CoV-2 specific IgG, but not IgA, increased in maternal blood and breastmilk with vaccine boost. No differences were noted in reactogenicity across the groups. ConclusionsCOVID-19 mRNA vaccines generated robust humoral immunity in pregnant and Lactating Women, with immunogenicity and reactogenicity similar to that observed in non-pregnant Women. Vaccine-induced immune responses were significantly greater than the response to natural infection. Immune transfer to neonates occurred via placental and breastmilk.