BNT162b2 vaccination induces SARS-CoV-2 specific antibody secretion into human milk with minimal transfer of vaccine mRNA
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Abstract
Importance
To examine the impact of SARS-CoV-2 vaccination of lactating mothers on human milk
Objective
(1) To quantify SARS-CoV-2-specific immunoglobulin A (IgA) and immunoglobulin G (IgG) in human milk of lactating mothers who received the BNT162b2 vaccine, with reference to a cohort convalescent from antenatal COVID-19, and healthy lactating mothers. (2) To detect and quantify vaccine mRNA in human milk after BNT162b2 vaccination.
Design
Gestational Immunity For Transfer 2 (GIFT-2) is a prospective cohort study of lactating mothers who were due to receive two doses of BNT162b2 vaccine, recruited between 5th February 2021 and 9th February 2021.
Setting
Lactating healthcare workers living in Singapore
Participants
Convenience sample of ten lactating healthcare workers. Human milk samples were collected at four time points: pre-vaccination, 1-3 days after dose one, 7-10 days after dose one, and 3-7 days after dose two of the BNT162b2 vaccine.
Exposure
Two doses of the BNT162b2 vaccine 21 days apart.
Main Outcome and Measure
(i) SARS-CoV-2-specific IgA and IgG in human milk of lactating mothers who received BNT162b2 vaccine, (ii) Detection and quantification of vaccine mRNA in human milk after BNT162b2 vaccination.
Results
Ten lactating healthcare workers aged 32.5 years (range 29 – 42) were recruited, with 40 human milk samples collected and analysed. SARS-CoV-2-specific IgA was predominant in human milk of lactating mothers who received BNT162b2 vaccine. The sharpest rise in antibody production was 3 −7 days after dose two of the BNT162b2 vaccine, with medians of 1110 picomolar of anti-SARS-CoV-2 spike and 374 picomolar of anti-Receptor Binding Domain IgA. Vaccine mRNA was detected only on rare occasions, at a maximum concentration of 2 ng/mL.
Conclusions and Relevance
In this cohort of ten lactating mothers following BNT162b2 vaccination, nine (90%) produced SARS-CoV-2 IgA, and ten (100%) produced IgG in human milk with minimal amounts of vaccine mRNA. Lactating individuals should continue breastfeeding in an uninterrupted manner after receiving mRNA vaccination for SARS-CoV-2.
Trial Registration
Registered at clinicaltrials.gov ( NCT04802278 ).
Key Points
Question
Does BNT162b2 (i) induce the production and secretion of SARS-CoV-2 specific antibodies into human milk, and/or (ii) get secreted into human milk?
Findings
In this cohort that included ten lactating healthcare workers following BNT162b2 vaccination, 90% produced SARS-CoV-2 immunoglobulin A, and 100% produced immunoglobulin G in human milk, with minimal amounts of vaccine mRNA transfer.
Meaning
Lactating individuals should continue breastfeeding in an uninterrupted manner after receiving SARS-CoV-2 mRNA vaccination.
Article activity feed
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SciScore for 10.1101/2021.04.27.21256151: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The study was approved by the Institutional Review Board (Gestational Immunity For Transfer GIFT-2: DSRB Reference Number: 2021/00095) and the study protocol was registered at clinicaltrials.gov (NCT04802278). Sex as a biological variable Human milk samples at 1 month postpartum from convalescent and healthy mothers were also analysed for reference. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources A human monoclonal antibody specific for SARS-CoV-2 was recombinantly engineered and expressed as human IgG1 and/or IgA1. human IgG1suggested: NoneIgA1suggested: NoneSoftware and Algorithms Sentences Resources Clinical … SciScore for 10.1101/2021.04.27.21256151: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The study was approved by the Institutional Review Board (Gestational Immunity For Transfer GIFT-2: DSRB Reference Number: 2021/00095) and the study protocol was registered at clinicaltrials.gov (NCT04802278). Sex as a biological variable Human milk samples at 1 month postpartum from convalescent and healthy mothers were also analysed for reference. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources A human monoclonal antibody specific for SARS-CoV-2 was recombinantly engineered and expressed as human IgG1 and/or IgA1. human IgG1suggested: NoneIgA1suggested: NoneSoftware and Algorithms Sentences Resources Clinical characteristics of the cohorts were summarised using GraphPad Prism 8. GraphPad Prismsuggested: (GraphPad Prism, RRID:SCR_002798)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: We detected the following sentences addressing limitations in the study:This study has limitations. Firstly, we did not perform any functional assays; however, binding affinity of spike- and RBD-specific antibodies have been correlated with neutralization.2 Secondly, the relatively short duration of follow-up period also did not allow for characterization of durability of IgA in human milk after vaccination. Sample collection is ongoing for subsequent studies on antibody durability. These results lend immunological and clinical evidence to the current recommendation of the ACOG, RCOG and WHO that lactating individuals should continue breastfeeding in an uninterrupted manner after receiving COVID-19 mRNA vaccines.7,8,22
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04802278 Recruiting Gestational Immunity for Transfer 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.
Results from scite Reference Check: We found no unreliable references.
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