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Article: Minimal mRNA uptake and inflammatory response to COVID-19 mRNA vaccine exposure in human placental explants.

Gonzalez, Veronica / Li, Lin / Buarpung, Sirirak / Prahl, Mary / Robinson, Joshua F / Gaw, Stephanie L

medRxiv : the preprint server for health sciences

2023

Abstract: Despite universal recommendations for COVID-19 mRNA vaccination in pregnancy, uptake has been lower than desired. There have been limited studies of the direct impact of COVID-19 mRNA vaccine exposure in human placental tissue. Using a primary human ... ...

Abstract	Despite universal recommendations for COVID-19 mRNA vaccination in pregnancy, uptake has been lower than desired. There have been limited studies of the direct impact of COVID-19 mRNA vaccine exposure in human placental tissue. Using a primary human villous explant model, we investigated the uptake of two common mRNA vaccines (BNT162b2 Pfizer-BioNTech or mRNA-1273 Moderna), and whether exposure altered villous cytokine responses. Explants derived from second or third trimester chorionic villi were incubated with vaccines at supraphysiologic concentrations and analyzed at two time points. We observed minimal uptake of mRNA vaccines in placental explants by in situ hybridization and quantitative RT-PCR. No specific or global cytokine response was elicited by either of the mRNA vaccines in multiplexed immunoassays. Our results suggest that the human placenta does not readily absorb the COVID-19 mRNA vaccines nor generate a significant inflammatory response after exposure.
Language	English
Publishing date	2023-02-02
Publishing country	United States
Document type	Preprint
DOI	10.1101/2023.02.01.23285349
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Nirmatrelvir-Ritonavir (Paxlovid) for Mild Coronavirus Disease 2019 (COVID-19) in Pregnancy and Lactation.

Lin, Christine Y / Cassidy, Arianna G / Li, Lin / Prahl, Mary K / Golan, Yarden / Gaw, Stephanie L

Obstetrics and gynecology

2023 Volume 141, Issue 5, Page(s) 957–960

Abstract: Nirmatrelvir-ritonavir (Paxlovid) is recommended to reduce the risk of hospitalization from coronavirus disease 2019 (COVID-19) in pregnancy. Data on use in pregnancy, including prescribing patterns and patient experience (adverse effects, incidence of ... ...

Abstract	Nirmatrelvir-ritonavir (Paxlovid) is recommended to reduce the risk of hospitalization from coronavirus disease 2019 (COVID-19) in pregnancy. Data on use in pregnancy, including prescribing patterns and patient experience (adverse effects, incidence of rebound), are limited. We performed a cross-sectional study in which we surveyed a cohort of vaccinated pregnant or lactating individuals with breakthrough COVID-19. Of 35 pregnant respondents, 51.4% were prescribed and 34.3% took nirmatrelvir-ritonavir; of these, 91.7% experienced dysgeusia and 50.0% had rebound (50.0% positive test result, 33.3% return of symptoms). Three of five lactating respondents were prescribed and two took nirmatrelvir-ritonavir. There were no significant adverse outcomes. Unknown risk was the most common reason for declining nirmatrelvir-ritonavir. More research is needed to establish the safety of nirmatrelvir-ritonavir in pregnancy and lactation, to improve public health messaging, and to increase uptake of this treatment.
MeSH term(s)	Female ; Pregnancy ; Humans ; Lactation ; Ritonavir/therapeutic use ; Cross-Sectional Studies ; COVID-19 ; COVID-19 Drug Treatment ; Antiviral Agents
Chemical Substances	nirmatrelvir (7R9A5P7H32) ; nirmatrelvir and ritonavir drug combination ; Ritonavir (O3J8G9O825) ; Antiviral Agents
Language	English
Publishing date	2023-03-15
Publishing country	United States
Document type	Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Letter
ZDB-ID	207330-4
ISSN	1873-233X ; 0029-7844
ISSN (online)	1873-233X
ISSN	0029-7844
DOI	10.1097/AOG.0000000000005152
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Article ; Online: Minimal mRNA uptake and inflammatory response to COVID-19 mRNA vaccine exposure in human placental explants.

Gonzalez, Veronica J / Li, Lin / Buarpung, Sirirak / Prahl, Mary / Robinson, Joshua F / Gaw, Stephanie L

iScience

2023 Volume 26, Issue 9, Page(s) 107549

Abstract	Despite universal recommendations for COVID-19 mRNA vaccination in pregnancy, uptake has been lower than desired. There have been limited studies of the direct impact of COVID-19 mRNA vaccine exposure in human placental tissue. Using a primary human placental explants model, we investigated the uptake of two common mRNA vaccines (BNT162b2 Pfizer-BioNTech or mRNA-1273 Moderna), and whether exposure altered villous cytokine responses. Explants derived from second or third trimester chorionic villi were incubated with vaccines at supraphysiologic concentrations and analyzed at two time points. We observed minimal uptake of mRNA vaccines in placental explants by
Language	English
Publishing date	2023-08-07
Publishing country	United States
Document type	Journal Article
ISSN	2589-0042
ISSN (online)	2589-0042
DOI	10.1016/j.isci.2023.107549
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Effects of Vaccination Against Influenza, Pertussis, and COVID-19 on Human Milk Antibodies: Current Evidence and Implications for Health Equity.

Hunagund, Soumya / Golan, Yarden / Asiodu, Ifeyinwa V / Prahl, Mary / Gaw, Stephanie L

Frontiers in immunology

2022 Volume 13, Page(s) 910383

Abstract: Human milk contains three antibody classes that confer mucosal immunity to the breastfed infant: secretory IgA (SIgA), secretory IgM (SIgM), and IgG. Influenza and pertussis vaccines administered during pregnancy induce pathogen specific SIgA and IgG ... ...

Abstract	Human milk contains three antibody classes that confer mucosal immunity to the breastfed infant: secretory IgA (SIgA), secretory IgM (SIgM), and IgG. Influenza and pertussis vaccines administered during pregnancy induce pathogen specific SIgA and IgG responses in human milk that have been shown to protect the breastfed infant from these respiratory illnesses. In addition, mRNA vaccines against the SARS-CoV-2 virus administered during pregnancy and lactation induce anti-SARS-CoV-2 IgG and IgA responses in human milk. This review summarizes the immunologic benefits of influenza, pertussis, and COVID-19 vaccines conferred by human milk. Additionally, future research direction in human milk immunity and public health needs to improve lactational support are discussed.
MeSH term(s)	COVID-19/prevention & control ; COVID-19 Vaccines ; Female ; Health Equity ; Humans ; Immunoglobulin A, Secretory ; Immunoglobulin G ; Infant ; Influenza Vaccines ; Influenza, Human/prevention & control ; Milk, Human ; Pregnancy ; SARS-CoV-2 ; Vaccination ; Whooping Cough/prevention & control
Chemical Substances	COVID-19 Vaccines ; Immunoglobulin A, Secretory ; Immunoglobulin G ; Influenza Vaccines
Language	English
Publishing date	2022-07-12
Publishing country	Switzerland
Document type	Journal Article ; Review ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2606827-8
ISSN	1664-3224 ; 1664-3224
ISSN (online)	1664-3224
ISSN	1664-3224
DOI	10.3389/fimmu.2022.910383
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: In Utero Exposure to Maternal COVID-19 Vaccination and Offspring Neurodevelopment at 12 and 18 Months.

Jaswa, Eleni G / Cedars, Marcelle I / Lindquist, Karla J / Bishop, Somer L / Kim, Young-Shin / Kaing, Amy / Prahl, Mary / Gaw, Stephanie L / Corley, Jamie / Hoskin, Elena / Cho, Yoon Jae / Rogers, Elizabeth / Huddleston, Heather G

JAMA pediatrics

2024 Volume 178, Issue 3, Page(s) 258–265

Abstract: Importance: Uptake of COVID-19 vaccines among pregnant individuals was hampered by safety concerns around potential risks to unborn children. Data clarifying early neurodevelopmental outcomes of offspring exposed to COVID-19 vaccination in utero are ... ...

Abstract	Importance: Uptake of COVID-19 vaccines among pregnant individuals was hampered by safety concerns around potential risks to unborn children. Data clarifying early neurodevelopmental outcomes of offspring exposed to COVID-19 vaccination in utero are lacking. Objective: To determine whether in utero exposure to maternal COVID-19 vaccination was associated with differences in scores on the Ages and Stages Questionnaire, third edition (ASQ-3), at 12 and 18 months of age. Design, setting, and participants: This prospective cohort study, Assessing the Safety of Pregnancy During the Coronavirus Pandemic (ASPIRE), enrolled pregnant participants from May 2020 to August 2021; follow-up of children from these pregnancies is ongoing. Participants, which included pregnant individuals and their offspring from all 50 states, self-enrolled online. Study activities were performed remotely. Exposure: In utero exposure of the fetus to maternal COVID-19 vaccination during pregnancy was compared with those unexposed. Main outcomes and measures: Neurodevelopmental scores on validated ASQ-3, completed by birth mothers at 12 and 18 months. A score below the established cutoff in any of 5 subdomains (communication, gross motor, fine motor, problem solving, social skills) constituted an abnormal screen for developmental delay. Results: A total of 2487 pregnant individuals (mean [SD] age, 33.3 [4.2] years) enrolled at less than 10 weeks' gestation and completed research activities, yielding a total of 2261 and 1940 infants aged 12 and 18 months, respectively, with neurodevelopmental assessments. In crude analyses, 471 of 1541 exposed infants (30.6%) screened abnormally for developmental delay at 12 months vs 203 of 720 unexposed infants (28.2%; χ2 = 1.32; P = .25); the corresponding prevalences at 18 months were 262 of 1301 (20.1%) vs 148 of 639 (23.2%), respectively (χ2 = 2.35; P = .13). In multivariable mixed-effects logistic regression models adjusting for maternal age, race, ethnicity, education, income, maternal depression, and anxiety, no difference in risk for abnormal ASQ-3 screens was observed at either time point (12 months: adjusted risk ratio [aRR], 1.14; 95% CI, 0.97-1.33; 18 months: aRR, 0.88; 95% CI, 0.72-1.07). Further adjustment for preterm birth and infant sex did not affect results (12 months: aRR, 1.16; 95% CI, 0.98-1.36; 18 months: aRR, 0.87; 95% CI, 0.71-1.07). Conclusions and relevance: Results of this cohort study suggest that COVID-19 vaccination was safe during pregnancy from the perspective of infant neurodevelopment to 18 months of age. Additional longer-term research should be conducted to corroborate these findings and buttress clinical guidance with a strong evidence base.
MeSH term(s)	Adult ; Female ; Humans ; Infant ; Infant, Newborn ; Pregnancy ; Cohort Studies ; COVID-19/epidemiology ; COVID-19/prevention & control ; COVID-19 Vaccines/adverse effects ; Premature Birth ; Prospective Studies
Chemical Substances	COVID-19 Vaccines
Language	English
Publishing date	2024-01-22
Publishing country	United States
Document type	Journal Article
ZDB-ID	2701223-2
ISSN	2168-6211 ; 2168-6203
ISSN (online)	2168-6211
ISSN	2168-6203
DOI	10.1001/jamapediatrics.2023.5743
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Article ; Online: Minimal mRNA uptake and inflammatory response to COVID-19 mRNA vaccine exposure in human placental explants

Gonzalez, Veronica / Li, Lin / Buarpung, Sirirak / Prahl, Mary / Robinson, Joshua F. / Gaw, Stephanie L.

medRxiv

Abstract	Despite universal recommendations for COVID-19 mRNA vaccination in pregnancy, uptake has been lower than desired. There have been limited studies of the direct impact of COVID-19 mRNA vaccine exposure in human placental tissue. Using a primary human villous explant model, we investigated the uptake of two common mRNA vaccines (BNT162b2 Pfizer-BioNTech or mRNA-1273 Moderna), and whether exposure altered villous cytokine responses. Explants derived from second or third trimester chorionic villi were incubated with vaccines at supraphysiologic concentrations and analyzed at two time points. We observed minimal uptake of mRNA vaccines in placental explants by in situ hybridization and quantitative RT-PCR. No specific or global cytokine response was elicited by either of the mRNA vaccines in multiplexed immunoassays. Our results suggest that the human placenta does not readily absorb the COVID-19 mRNA vaccines nor generate a significant inflammatory response after exposure.
Keywords	covid19
Language	English
Publishing date	2023-02-02
Publisher	Cold Spring Harbor Laboratory Press
Document type	Article ; Online
DOI	10.1101/2023.02.01.23285349
Database	COVID19

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Article ; Online: Evaluation of Messenger RNA From COVID-19 BTN162b2 and mRNA-1273 Vaccines in Human Milk.

Golan, Yarden / Prahl, Mary / Cassidy, Arianna / Lin, Christine Y / Ahituv, Nadav / Flaherman, Valerie J / Gaw, Stephanie L

JAMA pediatrics

2021 Volume 175, Issue 10, Page(s) 1069–1071

MeSH term(s)	2019-nCoV Vaccine mRNA-1273 ; Adult ; BNT162 Vaccine ; COVID-19/prevention & control ; COVID-19 Vaccines/pharmacology ; Female ; Humans ; Milk, Human/metabolism ; Milk, Human/virology ; RNA, Messenger/metabolism ; RNA, Viral/metabolism ; SARS-CoV-2/genetics ; SARS-CoV-2/isolation & purification ; Time Factors ; Young Adult
Chemical Substances	COVID-19 Vaccines ; RNA, Messenger ; RNA, Viral ; 2019-nCoV Vaccine mRNA-1273 (EPK39PL4R4) ; BNT162 Vaccine (N38TVC63NU)
Language	English
Publishing date	2021-07-06
Publishing country	United States
Document type	Journal Article
ZDB-ID	2701223-2
ISSN	2168-6211 ; 2168-6203
ISSN (online)	2168-6211
ISSN	2168-6203
DOI	10.1001/jamapediatrics.2021.1929
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Milk antibody response after 3

Golan, Yarden / Ilala, Mikias / Li, Lin / Gay, Caryl / Hunagund, Soumya / Lin, Christine Y / Cassidy, Arianna G / Jigmeddagva, Unurzul / Matsui, Yusuke / Ozarslan, Nida / Asiodu, Ifeyinwa V / Ahituv, Nadav / Flaherman, Valerie J / Gaw, Stephanie L / Prahl, Mary

iScience

2023 Volume 26, Issue 10, Page(s) 107767

Abstract: Little is known about the persistence of human milk anti-SARS-CoV-2 antibodies after ... ...

Abstract	Little is known about the persistence of human milk anti-SARS-CoV-2 antibodies after 2
Language	English
Publishing date	2023-08-29
Publishing country	United States
Document type	Journal Article
ISSN	2589-0042
ISSN (online)	2589-0042
DOI	10.1016/j.isci.2023.107767
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Assessment of Adverse Reactions, Antibody Patterns, and 12-month Outcomes in the Mother-Infant Dyad After COVID-19 mRNA Vaccination in Pregnancy.

Cassidy, Arianna G / Li, Lin / Golan, Yarden / Gay, Caryl / Lin, Christine Y / Jigmeddagva, Unurzul / Chidboy, Megan A / Ilala, Mikias / Buarpung, Sirirak / Gonzalez, Veronica J / Basilio, Emilia / Duck, Meghan / Murtha, Amy P / Wu, Alan H B / Lynch, Kara L / Asiodu, Ifeyinwa V / Prahl, Mary K / Gaw, Stephanie L

JAMA network open

2023 Volume 6, Issue 7, Page(s) e2323405

Abstract: Importance: Longitudinal data on COVID-19 messenger RNA (mRNA) vaccine reactogenicity and immunogenicity in pregnancy and for the mother-infant dyad are needed.: Objective: To examine COVID-19 mRNA vaccine reactogenicity and immunogenicity in ... ...

Abstract	Importance: Longitudinal data on COVID-19 messenger RNA (mRNA) vaccine reactogenicity and immunogenicity in pregnancy and for the mother-infant dyad are needed. Objective: To examine COVID-19 mRNA vaccine reactogenicity and immunogenicity in pregnancy and observe longitudinal maternal and infant outcomes. Design, setting, and participants: This prospective cohort study of pregnant individuals enrolled in the COVID-19 Vaccination in Pregnancy and Lactation study from December 1, 2020, through December 31, 2021, with follow-up through March 31, 2022, was conducted at a large academic medical center in an urban metropolitan area in California. Pregnant individuals receiving COVID-19 mRNA vaccines (mRNA-1273 [Moderna] and BNT162b2 [Pfizer-BioNTech]) were eligible. Of 81 participants enrolled, 5 were excluded after enrollment: 1 terminated pregnancy, 1 received the third vaccine dose prior to delivery, and 3 delivered prior to completing the initial vaccine series. Exposure: COVID-19 mRNA vaccination at any time during pregnancy. Main outcomes and measures: The primary outcomes were vaccine response as measured by blood Immunoglobulin G (IgG) titers after each vaccine dose and self-reported postvaccination symptoms. Patients' IgG titers were measured in cord blood and in infant blood at intervals up to 1 year of life; IgG and IgA titers were measured in maternal milk. Clinical outcomes were collected from medical records. Results: Of 76 pregnant individuals included in final analyses (median [IQR] maternal age, 35 [29-41] years; 51 [67.1%] White; 28 [36.8%] primigravid; 37 [48.7%] nulliparous), 42 (55.3%) received BNT162b2 and 34 (44.7%) received mRNA-1237. There were no significant differences in maternal characteristics between the 2 vaccine groups. Systemic symptoms were more common after receipt of the second vaccine dose than after the first dose (42 of 59 [71.2%] vs 26 of 59 [44.1%]; P = .007) and after mRNA-1237 than after BNT162b2 (25 of 27 [92.6%] vs 17 of 32 53.1%; P = .001). Systemic symptoms were associated with 65.6% higher median IgG titers than no symptoms after the second vaccine dose (median [IQR], 2596 [1840-4455] vs 1568 [1114-4518] RFU; P = .007); mean cord titers in individuals with local or systemic symptoms were 6.3-fold higher than in individuals without symptoms. Vaccination in all trimesters elicited a robust maternal IgG response. The IgG transfer ratio was highest among individuals vaccinated in the second trimester. Anti-SARS-CoV-2 IgG was detectable in cord blood regardless of vaccination trimester. In milk, IgG and IgA titers remained above the positive cutoff for at least 5-6 months after birth, and infants of mothers vaccinated in the second and third trimesters had positive IgG titers for at least 5 to 6 months of life. There were no vaccine-attributable adverse perinatal outcomes. Conclusions and relevance: The findings of this cohort study suggest that mRNA COVID-19 vaccination in pregnancy provokes a robust IgG response for the mother-infant dyad for approximately 6 months after birth. Postvaccination symptoms may indicate a more robust immune response, without adverse maternal, fetal, or neonatal outcomes.
MeSH term(s)	Female ; Infant, Newborn ; Pregnancy ; Infant ; Humans ; Adult ; COVID-19 Vaccines/adverse effects ; BNT162 Vaccine ; Mothers ; Cohort Studies ; Prospective Studies ; COVID-19/prevention & control ; Vaccination/adverse effects ; Immunoglobulin A ; Immunoglobulin G
Chemical Substances	COVID-19 Vaccines ; BNT162 Vaccine ; Immunoglobulin A ; Immunoglobulin G
Language	English
Publishing date	2023-07-03
Publishing country	United States
Document type	Journal Article
ISSN	2574-3805
ISSN (online)	2574-3805
DOI	10.1001/jamanetworkopen.2023.23405
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Milk antibody response after 3rd dose of COVID-19 mRNA vaccine and SARS-CoV-2 breakthrough infection and implications for infant protection.

Golan, Yarden / Ilala, Mikias / Gay, Caryl / Hunagund, Soumya / Lin, Christine Y / Cassidy, Arianna G / Jigmeddagva, Unurzul / Li, Lin / Ozarslan, Nida / Asiodu, Ifeyinwa V / Ahituv, Nadav / Flaherman, Valerie J / Gaw, Stephanie L / Prahl, Mary

medRxiv : the preprint server for health sciences

2022

Abstract: Anti-SARS-CoV-2 antibodies have been found in human-milk after COVID-19 infection and vaccination. However, little is known about their persistence in milk after booster vaccination and breakthrough infection. In this study, human-milk, saliva and blood ... ...

Abstract	Anti-SARS-CoV-2 antibodies have been found in human-milk after COVID-19 infection and vaccination. However, little is known about their persistence in milk after booster vaccination and breakthrough infection. In this study, human-milk, saliva and blood samples were collected from 33 lactating individuals before and after mRNA-based vaccination and COVID-19 breakthrough infections. Antibody levels were measured using ELISA and symptoms were assessed using questionnaires. Evaluation of maternal and infant symptomatology revealed that infected mothers reported more symptoms than vaccinated mothers. We found that after vaccination, human-milk anti-SARS-CoV-2 antibodies persisted for up to 8 months. In addition, distinct patterns of human milk IgA and IgG production we observed after breakthrough infection compared to 3-dose vaccination series alone, indicating a differential central and mucosal immune profiles in hybrid compared with vaccine-induced immunity. To investigate passively-derived milk antibody protection in infants, we examined the persistence of these antibodies in infant saliva after breastfeeding. We found that IgA was more abundant in infant saliva compared to IgG and persist in infant saliva longer after feeding. Our results delineate the differences in milk antibody response to vaccination as compared to breakthrough infection and emphasize the importance of improving the secretion of IgA antibodies to human milk after vaccination to improve the protection of breastfeeding infants.
Language	English
Publishing date	2022-12-14
Publishing country	United States
Document type	Preprint
DOI	10.1101/2022.12.12.22283367
Database	MEDical Literature Analysis and Retrieval System OnLINE

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