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Open accessPosted ContentDOI: 10.1101/2021.02.23.21252328

SARS-CoV-2 antibodies detected in human breast milk post-vaccination

02 Mar 2021-medRxiv (Cold Spring Harbor Laboratory Press)-
Abstract: Importance The SARS-CoV-2 pandemic has infected over a hundred million people worldwide, with almost 2.5 million deaths at the date of this publication. In the United States, Pfizer-BioNTech and Moderna vaccines were first administered to the public starting in December 2020, and no lactating women were included in the initial trials of safety/efficacy. Research on SARS-CoV-2 vaccination in lactating women and the potential transmission of passive immunity to the infant through breast milk is needed to guide patients, clinicians and policy makers during the worldwide effort to curb the spread of this virus. Objective To determine whether SARS-CoV-2 specific immunoglobins are found in breast milk post-vaccination, and to characterize the time course and types of immunoglobulins present. Design Prospective cohort study Setting Providence Portland Medical Center, Oregon, USA Participants Six lactating women who planned to receive both doses of the Pfizer-BioNTech or Moderna vaccine between December 2020 and January 2021. Breast milk samples were collected pre-vaccination and at 11 additional timepoints, with last sample at 14 days post 2nd dose of vaccine. Exposure Two doses of Pfizer-BioNTech or Moderna SARS-CoV-2 vaccine. Main Outcome(s) and Measure(s) Levels of SARS-CoV-2 specific IgA and IgG immunoglobulins in breast milk. Results In this cohort of 6 lactating women who received 2 doses of SARS-CoV-2 vaccine, we observed significantly elevated levels of SARS-CoV-2 specific IgG and IgA antibodies in breast milk beginning at Day 7 after the initial vaccine dose, with an IgG-dominant response. Conclusions and Relevance We are the first to show that maternal vaccination results in SARS-CoV-2 specific immunoglobulins in breast milk that may be protective for infants.

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Topics: Vaccination (56%), Breast milk (55%)

16 results found

Open accessJournal ArticleDOI: 10.1001/JAMA.2021.7563
15 Jun 2021-JAMA
Abstract: Importance Pregnant women are at increased risk of morbidity and mortality from COVID-19 but have been excluded from the phase 3 COVID-19 vaccine trials. Data on vaccine safety and immunogenicity in these populations are therefore limited. Objective To evaluate the immunogenicity of COVID-19 messenger RNA (mRNA) vaccines in pregnant and lactating women, including against emerging SARS-CoV-2 variants of concern. Design, setting, and participants An exploratory, descriptive, prospective cohort study enrolled 103 women who received a COVID-19 vaccine from December 2020 through March 2021 and 28 women who had confirmed SARS-CoV-2 infection from April 2020 through March 2021 (the last follow-up date was March 26, 2021). This study enrolled 30 pregnant, 16 lactating, and 57 neither pregnant nor lactating women who received either the mRNA-1273 (Moderna) or BNT162b2 (Pfizer-BioNTech) COVID-19 vaccines and 22 pregnant and 6 nonpregnant unvaccinated women with SARS-CoV-2 infection. Main outcomes and measures SARS-CoV-2 receptor binding domain binding, neutralizing, and functional nonneutralizing antibody responses from pregnant, lactating, and nonpregnant women were assessed following vaccination. Spike-specific T-cell responses were evaluated using IFN-γ enzyme-linked immunospot and multiparameter intracellular cytokine-staining assays. Humoral and cellular immune responses were determined against the original SARS-CoV-2 USA-WA1/2020 strain as well as against the B.1.1.7 and B.1.351 variants. Results This study enrolled 103 women aged 18 to 45 years (66% non-Hispanic White) who received a COVID-19 mRNA vaccine. After the second vaccine dose, fever was reported in 4 pregnant women (14%; SD, 6%), 7 lactating women (44%; SD, 12%), and 27 nonpregnant women (52%; SD, 7%). Binding, neutralizing, and functional nonneutralizing antibody responses as well as CD4 and CD8 T-cell responses were present in pregnant, lactating, and nonpregnant women following vaccination. Binding and neutralizing antibodies were also observed in infant cord blood and breast milk. Binding and neutralizing antibody titers against the SARS-CoV-2 B.1.1.7 and B.1.351 variants of concern were reduced, but T-cell responses were preserved against viral variants. Conclusion and relevance In this exploratory analysis of a convenience sample, receipt of a COVID-19 mRNA vaccine was immunogenic in pregnant women, and vaccine-elicited antibodies were transported to infant cord blood and breast milk. Pregnant and nonpregnant women who were vaccinated developed cross-reactive antibody responses and T-cell responses against SARS-CoV-2 variants of concern.

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Topics: Vaccination (53%)

69 Citations

Open accessJournal ArticleDOI: 10.1016/J.REPROTOX.2021.05.007
Abstract: BNT162b2 is a vaccine developed to prevent coronavirus disease 2019 (COVID-19) BNT162b2 is a lipid nanoparticle formulated nucleoside-modified messenger RNA (mRNA) encoding the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein locked in its prefusion conformation A developmental and reproductive toxicity study was conducted in rats according to international regulatory guidelines The full human BNT162b2 dose of 30 μg mRNA/dose (>300 times the human dose on a mg/kg basis) was administered intramuscularly to 44 female rats 21 and 14 days prior to mating and on gestation days 9 and 20 Half of the rats were subject to cesarean section and full fetal examination at the end of gestation, and the other half were allowed to deliver and were monitored to the end of lactation A robust neutralizing antibody response was confirmed prior to mating and at the end of gestation and lactation The presence of neutralizing antibodies was also confirmed in fetuses and offspring Nonadverse effects, related to the local injection site reaction, were noted in dams as expected from other animal studies and consistent with observations in humans There were no effects of BNT162b2 on female mating performance, fertility, or any ovarian or uterine parameters nor on embryo-fetal or postnatal survival, growth, physical development or neurofunctional development in the offspring through the end of lactation Together with the safety profile in nonpregnant people, this ICH-compliant nonclinical safety data supports study of BNT162b2 in women of childbearing potential and pregnant and lactating women

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Topics: Offspring (56%), Developmental toxicity (54%), Lactation (52%) ... show more

7 Citations

Open accessPosted ContentDOI: 10.1101/2021.04.02.21254642
13 Apr 2021-medRxiv
Abstract: ImportanceIn 2019, a deadly virus known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), responsible for COVID-19, emerged. In December 2020, two mRNA-based COVID-19 vaccines were approved for use in the United States (US) which provide immunity to those receiving the vaccine. Maternally derived antibodies are a key element of infants immunity. Certain vaccines given to pregnant and lactating mothers provide immunity to infants through transmission across the placenta, umbilical cord (IgG) and human milk (IgA). Human milk produced by mothers with a history of COVID-19 infection contains SARS-CoV-2 IgA and IgG. ObjectiveTo determine whether SARS-CoV-2 specific immunoglobulins are found in human milk after the COVID-19 vaccination, and to characterize the types of immunoglobulins present. Design, setting, and participantsThis is a prospective observational study conducted at Shands Hospital, University of Florida from December 2020 to March 2021. Twenty-two lactating healthcare workers who received the SARS-CoV-2 mRNA vaccine (Pfizer/BioNtech or Moderna) made up the sample group. Plasma and human milk were collected at three-time points (pre-vaccination, post-first vaccine dose, and post-second vaccine dose). SARS-CoV-2 specific IgA and IgG in human milk and in plasma were measured by ELISA. Maternal demographics was compiled. ExposuresPfizer/BioNtech or Moderna vaccination. Main outcome and measureLevels of SARS-CoV-2 IgA and IgG in human milk and plasma. ResultsWe found significant secretion of SARS-CoV-2 specific IgA and IgG in human milk and plasma after SARS-CoV-2 vaccination. Conclusions and relevanceOur results show that the mRNA-based COVID-19 vaccines induce SARS-CoV-2 specific IgA and IgG secretion in human milk. Further studies are needed to determine the duration of this immune response, its capacity to neutralize the COVID-19 virus, the transfer of passive immunity to breastfeeding infants, and the potential therapeutic use of human milk IgA to combat SARS-CoV-2 infections and COVID-19. KEY POINTSO_ST_ABSQuestionC_ST_ABSIs there SARS-CoV-2 specific IgA in the human milk of lactating women after COVID-19 vaccination? FindingsIn this prospective observational study that included 22 lactating women, we found SARS-CoV-2 specific IgA in the human milk in response to the COVID-19 vaccination series. There is statistically significant secretion of SARS-CoV-2 IgA in human milk after mRNA COVID-19 vaccination series completion (p < 0.0001). MeaningNewborn immunologic defense is present but immature. SARS-CoV-2 IgA secreted in the human milk could potentially provide COVID-19 protection to nursing infants. These results could guide a strategy for SARS-CoV-2 vaccination among lactating women.

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Topics: Vaccination (56%), Passive immunity (54%), Immunity (51%)

6 Citations

Open accessPosted ContentDOI: 10.1101/2021.04.05.21254819
07 Apr 2021-medRxiv
Abstract: The recent approval of vaccines against COVID-19 has generated great concern among breastfeeding women, since these patients were excluded from vaccination clinical trials. The present study aimed to analyze the levels of specific SARS-CoV-2 antibodies in breast milk of mRNA-vaccinated women across time and their correlation with serum antibody levels. Methodsprospective study including lactating women aged over 18 who were vaccinated against SARS-CoV-2 with the Pfizer-BioNTech(R) COVID-19 vaccine (BNT162b2). Paired serum and breast milk samples were simultaneously taken from each participant at three timepoints after receiving the vaccine: 2 weeks after 1st dose, 2 weeks after 2nd dose and 4 weeks after 2nd dose (Timepoints 1, 2 and 3, respectively). Levels of IgG antibodies against the spike protein (S1 subunit) were determined for each sample (Architect, Abbott(R)). Resultswe collected and analyzed 52 serum and 52 milk samples from the first 18 study participants. Median (interquartile range) IgG(S1) levels for serum - milk pairs at each timepoint were 410 (208-606) - 1.7 (0-2.9) AU/ml at Timepoint 1, 11505 (8933 - 21184) - 52.2 (34.1-113) at Timepoint 2 and 8311 (5578-17419) - 41.7 (24.8-75.3) at Timepoint 3. Pearsons correlation coefficient between breast milk and serum IgG(S1) levels was 0.71. No major adverse reactions were observed in mothers or infants. ConclusionsBreast milk from women vaccinated with mRNA-based Pfizer-BioNTech(R) vaccine contains specific anti-SARS-CoV-2 IgG(S1) antibodies, with levels increasing considerably after second dose. IgG(S1) levels in breast milk are positively correlated with corresponding serum levels.

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Topics: Breast milk (55%)

5 Citations

Open accessJournal ArticleDOI: 10.1038/S41541-021-00370-Z
Jia Ming Low1, Jia Ming Low2, Yue Gu1, Melissa Shu Feng Ng3  +14 moreInstitutions (3)
19 Aug 2021-Elements
Abstract: Lactating women can produce protective antibodies in their milk after vaccination, which has informed antenatal vaccination programs for diseases such as influenza and pertussis. However, whether SARS-CoV-2-specific antibodies are produced in human milk as a result of COVID-19 vaccination is still unclear. In this study, we show that lactating mothers who received the BNT162b2 vaccine secreted SARS-CoV-2-specific IgA and IgG antibodies into milk, with the most significant increase at 3-7 days post-dose 2. Virus-specific IgG titers were stable out to 4-6 weeks after dose 2. In contrast, SARS-CoV-2-specific IgA levels showed substantial decay. Vaccine mRNA was detected in few milk samples (maximum of 2 ng/ml), indicative of minimal transfer. Additionally, infants who consumed post-vaccination human milk had no reported adverse effects up to 28 days post-ingestion. Our results define the safety and efficacy profiles of the vaccine in this demographic and provide initial evidence for protective immunity conferred by milk-borne SARS-CoV-2-specific antibodies. Taken together, our study supports recommendations for uninterrupted breastfeeding subsequent to mRNA vaccination against COVID-19.

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Topics: Vaccination (58%)

4 Citations


7 results found

Open accessJournal ArticleDOI: 10.1016/S1473-3099(20)30120-1
Ensheng Dong1, Hongru Du1, Lauren Gardner1Institutions (1)
Abstract: The outbreak of the 2019 novel coronavirus disease (COVID-19) has induced a considerable degree of fear, emotional stress and anxiety among individuals around t

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Topics: Dashboard (business) (62%), Web application (53%)

5,397 Citations

Open accessJournal ArticleDOI: 10.1056/NEJMOA2034577
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 world...

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4,222 Citations

Open accessJournal ArticleDOI: 10.1056/NEJMOA2035389
Abstract: Background Vaccines are needed to prevent coronavirus disease 2019 (Covid-19) and to protect persons who are at high risk for complications. The mRNA-1273 vaccine is a lipid nanoparticle-encapsulated mRNA-based vaccine that encodes the prefusion stabilized full-length spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Covid-19. Methods This phase 3 randomized, observer-blinded, placebo-controlled trial was conducted at 99 centers across the United States. Persons at high risk for SARS-CoV-2 infection or its complications were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo 28 days apart. The primary end point was prevention of Covid-19 illness with onset at least 14 days after the second injection in participants who had not previously been infected with SARS-CoV-2. Results The trial enrolled 30,420 volunteers who were randomly assigned in a 1:1 ratio to receive either vaccine or placebo (15,210 participants in each group). More than 96% of participants received both injections, and 2.2% had evidence (serologic, virologic, or both) of SARS-CoV-2 infection at baseline. Symptomatic Covid-19 illness was confirmed in 185 participants in the placebo group (56.5 per 1000 person-years; 95% confidence interval [CI], 48.7 to 65.3) and in 11 participants in the mRNA-1273 group (3.3 per 1000 person-years; 95% CI, 1.7 to 6.0); vaccine efficacy was 94.1% (95% CI, 89.3 to 96.8%; P Conclusions The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic reactions, no safety concerns were identified. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE number, NCT04470427.).

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Topics: Vaccine efficacy (62%), Breakthrough infection (53%), Placebo (50%)

2,721 Citations

Open accessJournal ArticleDOI: 10.1056/NEJMOA2022483
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 vacci...

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1,543 Citations

Open accessJournal ArticleDOI: 10.1038/S41586-020-2814-7
22 Oct 2020-Nature
Abstract: An effective vaccine is needed to halt the spread of the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic. Recently, we reported safety, tolerability and antibody response data from an ongoing placebo-controlled, observer-blinded phase I/II coronavirus disease 2019 (COVID-19) vaccine trial with BNT162b1, a lipid nanoparticle-formulated nucleoside-modified mRNA that encodes the receptor binding domain (RBD) of the SARS-CoV-2 spike protein1. Here we present antibody and T cell responses after vaccination with BNT162b1 from a second, non-randomized open-label phase I/II trial in healthy adults, 18–55 years of age. Two doses of 1–50 μg of BNT162b1 elicited robust CD4+ and CD8+ T cell responses and strong antibody responses, with RBD-binding IgG concentrations clearly above those seen in serum from a cohort of individuals who had recovered from COVID-19. Geometric mean titres of SARS-CoV-2 serum-neutralizing antibodies on day 43 were 0.7-fold (1-μg dose) to 3.5-fold (50-μg dose) those of the recovered individuals. Immune sera broadly neutralized pseudoviruses with diverse SARS-CoV-2 spike variants. Most participants had T helper type 1 (TH1)-skewed T cell immune responses with RBD-specific CD8+ and CD4+ T cell expansion. Interferon-γ was produced by a large fraction of RBD-specific CD8+ and CD4+ T cells. The robust RBD-specific antibody, T cell and favourable cytokine responses induced by the BNT162b1 mRNA vaccine suggest that it has the potential to protect against COVID-19 through multiple beneficial mechanisms. In a phase I/II dose-escalation clinical trial, the mRNA COVID-19 vaccine BNT162b1 elicits specific T cell and antibody responses that suggest it has protective potential.

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Topics: T cell (63%), CD8 (59%), Vaccine trial (57%) ... show more

636 Citations

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