Toussia-Cohen Shlomi, Yinon Yoav, Peretz-Machluf Ravit, Segal Omri, Regev Noam, Asraf Keren, Doolman Ram, Kubani Yonatan, Gonen Tal, Regev-Yochay Gili, Bookstein Peretz Shiran
The Department of Obstetrics and Gynecology, Chaim Sheba Medical Center, Tel-Hashomer, Ramat-Gan 52621, Israel.
The Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 69978, Israel.
J Clin Med. 2022 Aug 12;11(16):4720. doi: 10.3390/jcm11164720.
(1) Background: The adverse-effect profile and short-term obstetric and neonatal outcomes among pregnant women who were vaccinated with the BNT162b2 vaccine at any stage of pregnancy do not indicate any safety concerns. The vaccine is effective in generating a humoral immune response in pregnant women. (2) Objective: To determine the vaccine-induced immunity and adverse events associated with the third (booster) dose of the BNT162b2 vaccine compared to the first and second dose of the vaccine among pregnant women. (3) Study design: A prospective cohort study in a tertiary referral center comparing pregnant women who were vaccinated by the first and second dose of the BNT162b2 (Pfizer/BioNTech) vaccine to pregnant women vaccinated by a third (booster) dose, between January and November 2021. A digital questionnaire regarding adverse events was filled by both groups 2−4 weeks after vaccination. Blood samples were collected and tested for SARS-COV-2 IgG antibodies 28−32 days after the administration of the second or third BNT162b2 dose. (4) Results: Seventy-eight pregnant women who received the first and second doses of the vaccine were compared to eighty-four pregnant women who received the third dose of the vaccine. In terms of adverse events following vaccination, local rash/pain/swelling (93.6% vs. 72.6%, p < 0.001) was significantly less common after the third vaccination compared to after the second vaccination. Other adverse events, including early obstetric complications, did not differ between the two groups. SARS-CoV-2 IgG serum levels 28−32 days after the vaccination were significantly higher after the third vaccination compared to the second vaccination (1333.75 vs. 2177.93, respectively, p < 0.001). (5) Conclusion: This study confirms the safety regarding early adverse events and immunogenicity, and the lack of early obstetric complications of the BNT162b2 second- and third-dose vaccine in pregnant women. The third (booster) dose is effective in generating a stronger humoral immune response in pregnant women compared with the second dose.
(1) 背景：在孕期任何阶段接种BNT162b2疫苗的孕妇中，其不良反应情况以及短期产科和新生儿结局均未显示出任何安全问题。该疫苗能有效在孕妇体内产生体液免疫反应。(2) 目的：确定与孕妇接种BNT162b2疫苗第一剂和第二剂相比，第三剂（加强剂）疫苗所诱导的免疫及相关不良事件。(3) 研究设计：2021年1月至11月在一家三级转诊中心进行的一项前瞻性队列研究，将接种BNT162b2（辉瑞/生物科技）疫苗第一剂和第二剂的孕妇与接种第三剂（加强剂）的孕妇进行比较。两组在接种疫苗后2至4周填写一份关于不良事件的数字问卷。在接种第二剂或第三剂BNT162b2疫苗后28至32天采集血样并检测SARS-CoV-2 IgG抗体。(4) 结果：78名接种疫苗第一剂和第二剂的孕妇与84名接种第三剂疫苗的孕妇进行了比较。在接种疫苗后的不良事件方面，与第二次接种后相比，第三次接种后局部皮疹/疼痛/肿胀（93.6%对72.6%，p<0.001）明显不常见。包括早期产科并发症在内的其他不良事件在两组之间没有差异。接种疫苗后28至32天，第三次接种后的SARS-CoV-2 IgG血清水平明显高于第二次接种后（分别为1333.75和2177.93，p<0.001）。(5) 结论：本研究证实了BNT162b2疫苗第二剂和第三剂在孕妇中早期不良事件的安全性和免疫原性，以及缺乏早期产科并发症。与第二剂相比，第三剂（加强剂）能有效在孕妇中产生更强的体液免疫反应。
