Department of Paediatrics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
Department of Neonatology, Khoo Teck Puat-National University Children's Medical Institute, National University Health System, Singapore.
J Hum Lact. 2022 Feb;38(1):37-42. doi: 10.1177/08903344211056522. Epub 2021 Oct 29.
Pre-approval clinical trials of the Pfizer/BioNTech messenger RNA COVID-19 vaccine, BNT162b2 did not include participants who were breastfeeding. Therefore, there is limited evidence about outcomes of breastfeeding mother-child dyads and effects on breastfeeding after vaccination.
To determine: (1) solicited adverse effects (e.g., axillary lymphadenopathy, mastitis, and breast engorgement), which are unique to lactating individuals; and (2) systemic and local adverse effects of COVID-19 mRNA vaccine on mothers and potential effects on their breastfed infants.
This was a prospective cohort study of lactating healthcare workers ( = 88) in Singapore who received two doses of BNT162b2 vaccination (Pfizer/BioNTech). The outcomes of mother-child dyads within 28 days after the second vaccine dose were determined through a participant-completed questionnaire.
Minimal effects related to breastfeeding were reported by this cohort; three of 88 (3.4%) participants had mastitis, one (1.1%) participant experienced breast engorgement, five of 88 (5.7%) participants reported cervical or axillary lymphadenopathy. There was no change in human milk supply after vaccination. The most common side effect was pain/redness/swelling at the injection site, which was experienced by 57 (64.8%) participants. There were no serious adverse events of anaphylaxis or hospital admissions. There were no short-term adverse effects reported in the infants of 67 lactating participants who breastfed within 72 hr after BNT162b2 vaccination.
BNT162b2 vaccination was well tolerated in lactating participants and was not associated with short-term adverse effects in their breastfed infants.
The study protocol was registered at clinicaltrials.gov (NCT04802278).
辉瑞/生物技术公司的信使 RNA COVID-19 疫苗 BNT162b2 的预批准临床试验不包括哺乳期参与者。因此，关于母乳喂养母婴对疫苗接种后母乳喂养的影响和结局，证据有限。
确定（1）哺乳期个体特有的不良事件（例如腋窝淋巴结病、乳腺炎和乳房肿胀）；以及（2）COVID-19 mRNA 疫苗对母亲的全身和局部不良事件及其对母乳喂养婴儿的潜在影响。
这是一项在新加坡接受两剂 BNT162b2 疫苗（辉瑞/生物技术公司）的哺乳期医护人员（=88 人）的前瞻性队列研究。通过参与者完成的问卷调查确定第二剂疫苗接种后 28 天内母婴对的结局。
该队列报告了与母乳喂养相关的最小影响；88 名参与者中有 3 名（3.4%）患有乳腺炎，1 名（1.1%）经历了乳房肿胀，88 名参与者中有 5 名（5.7%）报告了颈部或腋窝淋巴结病。接种疫苗后，人乳供应没有变化。最常见的副作用是注射部位疼痛/发红/肿胀，57 名（64.8%）参与者有此症状。没有过敏反应或住院的严重不良事件。在 67 名母乳喂养的哺乳期参与者中，他们在 BNT162b2 疫苗接种后 72 小时内母乳喂养，他们的婴儿没有报告短期不良反应。
BNT162b2 疫苗在哺乳期参与者中耐受性良好，与其母乳喂养婴儿的短期不良事件无关。
该研究方案在 clinicaltrials.gov 上注册（NCT04802278）。
