COVID-19 mRNA Vaccination in Lactation: Assessment of Adverse Events and Vaccine Related Antibodies in Mother-Infant Dyads

  1. Yarden Golan
  2. Mary Prahl
  3. Arianna G. Cassidy
  4. Caryl Gay
  5. Alan H. B. Wu
  6. Unurzul Jigmeddagva
  7. Christine Y. Lin
  8. Veronica J. Gonzalez
  9. Emilia Basilio
  10. Megan A. Chidboy
  11. Lakshmi Warrier
  12. Sirirak Buarpung
  13. Lin Li
  14. Amy P. Murtha
  15. Ifeyinwa V. Asiodu
  16. Nadav Ahituv
  17. Valerie J. Flaherman
  18. Stephanie L. Gaw

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Abstract

Data regarding symptoms in the lactating mother-infant dyad and their immune response to COVID-19 mRNA vaccination during lactation are needed to inform vaccination guidelines.

Methods

From a prospective cohort of 50 lactating individuals who received mRNA-based vaccines for COVID-19 (mRNA-1273 and BNT162b2), blood and milk samples were collected prior to first vaccination dose, immediately prior to 2nd dose, and 4-10 weeks after 2nd dose. Symptoms in mother and infant were assessed by detailed questionnaires. Anti-SARS-CoV-2 antibody levels in blood and milk were measured by Pylon 3D automated immunoassay and ELISA. In addition, vaccine-related PEGylated proteins in milk were measured by ELISA. Blood samples were collected from a subset of infants whose mothers received the vaccine during lactation (4-15 weeks after mothers’ 2nd dose).

Results

No severe maternal or infant adverse events were reported in this cohort. Two mothers and two infants were diagnosed with COVID-19 during the study period before achieving full immune response. PEGylated proteins were not found at significant levels in milk after vaccination. After vaccination, levels of anti-SARS-CoV-2 IgG and IgM significantly increased in maternal plasma and there was significant transfer of anti-SARS-CoV-2-Receptor Binding Domain (anti-RBD) IgA and IgG antibodies to milk. Milk IgA levels after the 2nd dose were negatively associated with infant age. Anti-SARS-CoV-2 IgG antibodies were not detected in the plasma of infants whose mothers were vaccinated during lactation.

Conclusions

COVID-19 mRNA vaccines generate robust immune responses in plasma and milk of lactating individuals without severe adverse events reported.

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  1. Version published to 10.3389/fimmu.2021.777103
  2. Version published to 10.1101/2021.03.09.21253241v4 on medRxiv
  3. Version published to 10.1101/2021.03.09.21253241v3 on medRxiv
  4. Version published to 10.1101/2021.03.09.21253241v2 on medRxiv
  5. ScreenIT

    SciScore for 10.1101/2021.03.09.21253241: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementIRB: The University of California San Francisco (UCSF) institutional review board approved the study (20-32077, 20-30410).
    Consent: Informed consent was obtained from all participants.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Briefly, maternal plasma was analyzed for anti-SARS-CoV-2 IgM and IgG antibodies, which were quantified through Pylon 3D automated immunoassay (considered positive if ≥ 50 relative fluorescence units (RFU)).
    anti-SARS-CoV-2 IgM and IgG
    suggested: None
    Human milk samples were assayed by ELISA for IgA antibodies specific to SARS-CoV-2 RBD protein.
    IgA
    suggested: None
    SARS-CoV-2 RBD protein.
    suggested: None

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  6. Version published to 10.1101/2021.03.09.21253241v1 on medRxiv