Trial reportFrontiers in immunology2021
COVID-19 mRNA Vaccination in Lactation: Assessment of Adverse Events and Vaccine Related Antibodies in Mother-Infant Dyads.
Trial report in Frontiers in immunology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 52 papers, 6 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
52 citing papers in PubMed, 6 syntheses or guidelines pooled it, 77 citations in OpenAlex.
- Pooled it
- The dose- and time-dependent effectiveness and safety associated with COVID-19 vaccination during pregnancy: a systematic review and meta-analysis.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2023Pooled it
- Detection of SARS-CoV-2-Specific Antibodies in Human Breast Milk and Their Neutralizing Capacity after COVID-19 Vaccination: A Systematic Review.International journal of molecular sciences · 2023Pooled it
- Cutaneous adverse reactions following COVID-19 vaccinations: A systematic review and meta-analysis.Journal of cosmetic dermatology · 2022Pooled it
- SARS-CoV-2 Vaccines during Pregnancy and Breastfeeding: A Systematic Review of Maternal and Neonatal Outcomes.Viruses · 2022Pooled it
- Pooled it
- Article
- Serum SARS-CoV-2-Specific Antibodies and Neutralization Capacity Following Vaccination.Maternal-fetal medicine (Wolters Kluwer Health, Inc.) · 2025Article
- Genomic characterization of normal and aberrant human milk production.Science advances · 2025Article
- Review
- Neonatal Feeding Practices and SARS-CoV-2 Transmission in Neonates with Perinatal SARS-CoV-2 Exposure: A Systematic Review and Meta-Analysis.Journal of clinical medicine · 2025Review
- Immune response in breastmilk of Black women to SARS-CoV-2 infection and vaccination against COVID-19.Frontiers in nutrition · 2025Article
- Neutralizing and binding antibody responses to SARS-CoV-2 with hybrid immunity in pregnancy.NPJ vaccines · 2024Article
- Immune responses in COVID-19 patients: Insights into cytokine storms and adaptive immunity kinetics.Heliyon · 2024Review
- Review
- Neonatal SARS-CoV-2 immunoglobulin G antibodies at delivery and their impact on COVID-19.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2024Observational
- Milk antibody response after 3iScience · 2023Article
- Side Effects of COVID-19 Vaccines in Pregnant and Lactating Mexican Women and Breastfed Infants: A Survey-Based Study.Vaccines · 2023Article
- Assessment of Adverse Reactions, Antibody Patterns, and 12-month Outcomes in the Mother-Infant Dyad After COVID-19 mRNA Vaccination in Pregnancy.JAMA network open · 2023Article
- mRNA: Vaccine or Gene Therapy? The Safety Regulatory Issues.International journal of molecular sciences · 2023Review
Corrections and comments
- Update of
Authors and funding
18 authors at 2 institutions in 1 country.
Funding
Abstract
Background: 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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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.