Evaluation of transplacental transfer of mRNA vaccine products and functional antibodies during pregnancy and infancy

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Abstract

Studies are needed to evaluate the safety and effectiveness of mRNA SARS-CoV-2 vaccination during pregnancy, and the levels of protection provided to their newborns through placental transfer of antibodies. Here, we evaluate the transplacental transfer of mRNA vaccine products and functional anti-SARS-CoV-2 antibodies during pregnancy and early infancy in a cohort of 20 individuals vaccinated during late pregnancy. We find no evidence of mRNA vaccine products in maternal blood, placenta tissue, or cord blood at delivery. However, we find time-dependent efficient transfer of IgG and neutralizing antibodies to the neonate that persists during early infancy. Additionally, using phage immunoprecipitation sequencing, we find a vaccine-specific signature of SARS-CoV-2 Spike protein epitope binding that is transplacentally transferred during pregnancy. Timing of vaccination during pregnancy is critical to ensure transplacental transfer of protective antibodies during early infancy.

Abstract

Pregnant individuals are at higher risk of SARS-CoV-2-related morbidity and mortality, yet more studies are needed to evaluate safety and efficacy of vaccination during pregnancy, and also the level of protection provided to the newborn. Here, the authors evaluate transplacental transfer of mRNA vaccine products and functional SARS-CoV-2 antibodies during pregnancy and early infancy.

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Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

Fernando P Polack, Stephen J. Thomas, Nicholas R.E. Kitchin … (2023)

Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently. Methods In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. Results A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. Conclusions A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)

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An mRNA Vaccine against SARS-CoV-2 — Preliminary Report

Lisa A Jackson, Evan J Anderson, Nadine G Rouphael … (2020)

Abstract Background The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in late 2019 and spread globally, prompting an international effort to accelerate development of a vaccine. The candidate vaccine mRNA-1273 encodes the stabilized prefusion SARS-CoV-2 spike protein. Methods We conducted a phase 1, dose-escalation, open-label trial including 45 healthy adults, 18 to 55 years of age, who received two vaccinations, 28 days apart, with mRNA-1273 in a dose of 25 μg, 100 μg, or 250 μg. There were 15 participants in each dose group. Results After the first vaccination, antibody responses were higher with higher dose (day 29 enzyme-linked immunosorbent assay anti–S-2P antibody geometric mean titer [GMT], 40,227 in the 25-μg group, 109,209 in the 100-μg group, and 213,526 in the 250-μg group). After the second vaccination, the titers increased (day 57 GMT, 299,751, 782,719, and 1,192,154, respectively). After the second vaccination, serum-neutralizing activity was detected by two methods in all participants evaluated, with values generally similar to those in the upper half of the distribution of a panel of control convalescent serum specimens. Solicited adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site. Systemic adverse events were more common after the second vaccination, particularly with the highest dose, and three participants (21%) in the 250-μg dose group reported one or more severe adverse events. Conclusions The mRNA-1273 vaccine induced anti–SARS-CoV-2 immune responses in all participants, and no trial-limiting safety concerns were identified. These findings support further development of this vaccine. (Funded by the National Institute of Allergy and Infectious Diseases and others; mRNA-1273 ClinicalTrials.gov number, NCT04283461).

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A neutralizing human antibody binds to the N-terminal domain of the Spike protein of SARS-CoV-2

Xiangyang Chi, Renhong Yan, Jun Zhang … (2020)

Developing therapeutics against SARS-CoV-2 could be guided by the distribution of epitopes, not only on the receptor binding domain (RBD) of the Spike (S) protein, but also across the full Spike (S) protein. We isolated and characterized monoclonal antibodies (mAbs) from ten convalescent COVID-19 patients. Three mAbs showed neutralizing activities against authentic SARS-CoV-2. An mAb, named 4A8, exhibits high neutralization potency against both authentic and pseudotyped SARS-CoV-2, but does not bind the RBD. We defined the epitope of 4A8 as the N terminal domain (NTD) of the S protein by determining its cryo-EM structure in complex with the S protein to an overall resolution of 3.1 Angstrom and local resolution of 3.3 Angstrom for the 4A8-NTD interface. This points to the NTD as a promising target for therapeutic mAbs against COVID-19.

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Author and article information

Contributors

Mary Prahl:

ORCID: http://orcid.org/0000-0003-0091-2731

mary.prahl@ucsf.edu

Stephanie L. Gaw:

ORCID: http://orcid.org/0000-0003-0891-6964

Stephanie.Gaw@ucsf.edu

Journal

Journal ID (nlm-ta): Nat Commun

Journal ID (iso-abbrev): Nat Commun

Title: Nature Communications

Publisher: Nature Publishing Group UK (London )

ISSN (Electronic): 2041-1723

Publication date (Electronic): 30 July 2022

Publication date PMC-release: 30 July 2022

Publication date Collection: 2022

Volume: 13

Electronic Location Identifier: 4422

Affiliations

[1 ]GRID grid.266102.1, ISNI 0000 0001 2297 6811, Department of Pediatrics, , University of California, ; San Francisco, CA USA

[2 ]GRID grid.266102.1, ISNI 0000 0001 2297 6811, Division of Pediatric Infectious Diseases and Global Health, , University of California, ; San Francisco, CA USA

[3 ]GRID grid.266102.1, ISNI 0000 0001 2297 6811, Department of Bioengineering and Therapeutic Sciences, , University of California, ; San Francisco, CA USA

[4 ]GRID grid.266102.1, ISNI 0000 0001 2297 6811, Division of Maternal Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, , University of California San Francisco, ; San Francisco, CA USA

[5 ]GRID grid.249878.8, ISNI 0000 0004 0572 7110, Gladstone Center for HIV Cure Research, Gladstone Institute, ; San Francisco, CA USA

[6 ]GRID grid.266102.1, ISNI 0000 0001 2297 6811, Center for Reproductive Sciences, Department of Obstetrics, Gynecology, and Reproductive Sciences, , University of California San Francisco, ; San Francisco, CA USA

[7 ]GRID grid.266102.1, ISNI 0000 0001 2297 6811, Department of Neurology, , University of California, ; San Francisco, CA USA

[8 ]GRID grid.266102.1, ISNI 0000 0001 2297 6811, Department of Medicine, , University of California, ; San Francisco, CA USA

[9 ]GRID grid.266102.1, ISNI 0000 0001 2297 6811, Departments of Microbiology and Immunology, , University of California, ; San Francisco, CA USA

[10 ]GRID grid.266102.1, ISNI 0000 0001 2297 6811, Department of Laboratory Medicine, , University of California, ; San Francisco, CA USA

Author information

Mary Prahl http://orcid.org/0000-0003-0091-2731

Bonny Alvarenga http://orcid.org/0000-0001-7922-9454

Kara L. Lynch http://orcid.org/0000-0003-1367-0401

Stephanie L. Gaw http://orcid.org/0000-0003-0891-6964

Article

Publisher ID: 32188

DOI: 10.1038/s41467-022-32188-1

PMC ID: 9338928

PubMed ID: 35908075

SO-VID: b9033b0e-dde1-4059-a0f3-da49759dea7f

License:

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.

History

Date received : 7 December 2021

Date accepted : 20 July 2022

Funding

Funded by: FundRef https://doi.org/10.13039/100006492, Division of Intramural Research, National Institute of Allergy and Infectious Diseases (Division of Intramural Research of the NIAID);

Award ID: K23AI127886

Award ID: K08AI141728

Award Recipient : Mary Prahl

Funded by: FundRef https://doi.org/10.13039/501100001735, Weizmann Institute of Science;

Funded by: FundRef https://doi.org/10.13039/100009724, Roddenberry Foundation;

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Keywords: vaccines,translational research,infectious diseases,sars-cov-2,paediatric research

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ScienceOpen disciplines: Uncategorized

Keywords: vaccines, translational research, infectious diseases, sars-cov-2, paediatric research

Evaluation of transplacental transfer of mRNA vaccine products and functional antibodies during pregnancy and infancy

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Novel Coronavirus Disease COVID-19

Most cited references 59

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

An mRNA Vaccine against SARS-CoV-2 — Preliminary Report

A neutralizing human antibody binds to the N-terminal domain of the Spike protein of SARS-CoV-2

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