Clinical Immunology, Angioedema and Allergy Unit, Center for Autoimmune Diseases, Sheba Medical Center, Tel Hashomer, Israel.
Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
JAMA Netw Open. 2021 Aug 2;4(8):e2122255. doi: 10.1001/jamanetworkopen.2021.22255.
Allergic reactions among some individuals who received the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine discourage patients with allergic conditions from receiving this vaccine and physicians from recommending the vaccine.
To describe the assessment and immunization of highly allergic individuals with the BNT162b2 vaccine.
DESIGN, SETTING, AND PARTICIPANTS: In a prospective cohort study from December 27, 2020, to February 22, 2021, 8102 patients with allergies who applied to the COVID 19 vaccine referral center at the Sheba Medical Center underwent risk assessment using an algorithm that included a detailed questionnaire. High-risk patients (n = 429) were considered "highly allergic" and were immunized under medical supervision.
Pfizer-BioNTech (BNT162b2) COVID-19 vaccine.
Allergic and anaphylactic reactions after the first and second doses of BNT162b2 vaccine among highly allergic patients.
Of the 429 individuals who applied to the COVID-19 referral center and were defined as highly allergic, 304 (70.9%) were women and the mean (SD) age was 52 (16) years. This highly allergic group was referred to receive immunization under medical supervision. After the first dose of the BNT162b2 vaccine, 420 patients (97.9%) had no immediate allergic event, 6 (1.4%) developed minor allergic responses, and 3 (0.7%) had anaphylactic reactions. During the study period, 218 highly allergic patients (50.8%) received the second BNT162b2 vaccine dose, of which 214 (98.2%) had no allergic reactions and 4 patients (1.8%) had minor allergic reactions. Other immediate and late reactions were comparable with those seen in the general population, except for delayed itch and skin eruption, which were more common among allergic patients.
The rate of allergic reactions to BNT162b2 vaccine, is higher among patients with allergies, particularly among a subgroup with a history of high-risk allergies. This study suggests that most patients with a history of allergic diseases and, particularly, highly allergic patients can be safely immunized by using an algorithm that can be implemented in different medical facilities and includes a referral center, a risk assessment questionnaire, and a setting for immunization under medical supervision of highly allergic patients. Further studies are required to define more specific risk factors for allergic reactions to the BNT162b2 vaccine.
在一些接种辉瑞-生物科技（BNT162b2）COVID-19 疫苗的人群中出现过敏反应，这使患有过敏症的患者不愿接种该疫苗，也使医生不愿推荐该疫苗。
描述对具有高过敏风险的个体使用 BNT162b2 疫苗进行评估和免疫接种。
设计、地点和参与者：在 2020 年 12 月 27 日至 2021 年 2 月 22 日期间，来自谢巴医疗中心 COVID-19 疫苗转介中心的 8102 名患有过敏症的患者应用了一种包括详细问卷的算法进行风险评估。高危患者（n=429）被认为是“高度过敏”，并在医疗监督下进行免疫接种。
辉瑞-生物科技（BNT162b2）COVID-19 疫苗。
高度过敏患者接种 BNT162b2 疫苗第一针和第二针后的过敏和过敏反应。
在申请 COVID-19 转介中心并被定义为高度过敏的 429 名患者中，有 304 名（70.9%）为女性，平均（SD）年龄为 52（16）岁。该高度过敏组被转介至医疗监督下进行免疫接种。在接受 BNT162b2 疫苗第一剂后，420 名患者（97.9%）无即刻过敏事件，6 名（1.4%）出现轻微过敏反应，3 名（0.7%）出现过敏反应。在研究期间，218 名高度过敏患者（50.8%）接受了第二剂 BNT162b2 疫苗，其中 214 名（98.2%）无过敏反应，4 名（1.8%）出现轻微过敏反应。其他即刻和迟发反应与一般人群相似，但过敏患者更常见迟发性瘙痒和皮疹。
在过敏患者中，BNT162b2 疫苗的过敏反应率较高，尤其是在具有高风险过敏史的亚组中。本研究表明，大多数有过敏病史的患者，特别是高度过敏的患者，可以通过使用一种算法安全接种疫苗，该算法可在不同的医疗设施中实施，包括转介中心、风险评估问卷以及在医疗监督下为高度过敏患者接种疫苗的环境。需要进一步研究以确定对 BNT162b2 疫苗过敏反应的更具体的危险因素。
