Department of Pediatrics, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
Hausärzte am Spritzenhaus, Family Practice, Baiersbronn, Germany.
JAMA Netw Open. 2022 Oct 3;5(10):e2237140. doi: 10.1001/jamanetworkopen.2022.37140.
SARS-CoV-2 vaccines are authorized for use in most age groups. The safety of SARS-CoV-2 vaccines is unknown in children younger than 5 years.
To retrospectively evaluate the safety of the BNT162b2 vaccine used off-label in children younger than 5 years compared with the safety of non-SARS-CoV-2 vaccines in the same sample.
DESIGN, SETTING, AND PARTICIPANTS: This investigator-initiated retrospective cohort study included parents or caregivers who registered children for SARS-CoV-2 vaccination in outpatient care facilities in Germany. The study was performed as an authenticated online survey. A total of 19 000 email addresses were contacted from vaccination registration databases between April 14 and May 9, 2022. Inclusion criteria were child age younger than 5 years at the first BNT162b2 vaccination and use of a correct authentication code to prove invitation.
Off-label BNT162b2 vaccination and on-label non-SARS-CoV-2 vaccinations.
Reported short-term safety data of 1 to 3 doses of 3 to 10 μg BNT162b2 in children from birth to younger than 60 months are presented. Coprimary outcomes were the frequencies of 11 categories of symptoms after vaccination with bivariate analyses and regression models adjusting for age, sex, weight, and height.
The study included 7806 children (median age, 3 years [IQR, 2-4 years]; 3824 [49.0%] female) who were followed up of for a mean (SD) of 91.4 (38.8) days since first BNT162b2 vaccination (survey response rate, 41.1%). A 10-μg dosage was more frequently associated with local injection-site symptoms compared with lower dosages. In the active-comparator analysis, the probability of any symptoms (odds ratio [OR], 1.62; 95% CI, 1.43-1.84), local symptoms (OR, 1.68; 95% CI, 1.38-2.05), musculoskeletal symptoms (OR, 2.55; 95% CI, 1.32-4.94), dermatologic symptoms (OR, 2.18; 95% CI, 10.7-4.45), or otolaryngologic symptoms (OR, 6.37; 95% CI, 1.50-27.09) were modestly elevated after BNT162b2 compared with non-SARS-CoV-2 vaccines, whereas the probabilities of general symptoms (OR, 0.77; 95% CI, 0.63-0.95) and fever (OR, 0.42; 95% CI, 0.32-0.55) were lower after BNT162b2. Symptoms requiring hospitalization (n = 10) were reported only at BNT162b2 dosages above 3 μg.
In this cohort study, the symptoms reported after BNT162b2 administration were comparable overall to those for on-label non-SARS-CoV-2 vaccines in this cohort of children younger than 5 years. The present data may be used together with prospective licensure studies of BNT162b2 efficacy and safety and could help guide expert recommendations about BNT162b2 vaccinations in this age group.
SARS-CoV-2 疫苗已获准在大多数年龄段使用。对于 5 岁以下的儿童，SARS-CoV-2 疫苗的安全性未知。
回顾性评估 BNT162b2 疫苗在 5 岁以下儿童中的使用情况，与同一样本中未用于 SARS-CoV-2 的疫苗进行比较。
设计、设置和参与者：本研究为一项由研究人员发起的回顾性队列研究，纳入了在德国门诊护理机构登记接种 SARS-CoV-2 疫苗的父母或看护人。本研究是作为一个经过身份验证的在线调查进行的。从 2022 年 4 月 14 日至 5 月 9 日，从疫苗接种登记数据库中联系了 19000 个电子邮件地址。纳入标准为：儿童在首次接种 BNT162b2 疫苗时年龄小于 5 岁，并且使用正确的认证码来证明邀请。
标签外 BNT162b2 疫苗接种和标签内非 SARS-CoV-2 疫苗接种。
本研究报告了出生至 59 个月大的儿童接种 3 至 10μg 剂量的 BNT162b2 的 1 至 3 剂的短期安全性数据。主要结果是通过双变量分析和调整年龄、性别、体重和身高的回归模型来评估接种疫苗后 11 类症状的频率。
该研究纳入了 7806 名儿童（中位年龄，3 岁[IQR，2-4 岁]；3824[49.0%]为女性），自首次接种 BNT162b2 以来平均（SD）随访 91.4（38.8）天（调查回复率为 41.1%）。与较低剂量相比，10μg 剂量更常与局部注射部位症状相关。在活性对照分析中，任何症状的概率（比值比[OR]，1.62；95%置信区间[CI]，1.43-1.84）、局部症状（OR，1.68；95%CI，1.38-2.05）、肌肉骨骼症状（OR，2.55；95%CI，1.32-4.94）、皮肤病症状（OR，2.18；95%CI，10.7-4.45）或耳鼻喉症状（OR，6.37；95%CI，1.50-27.09）的可能性在 BNT162b2 与非 SARS-CoV-2 疫苗之间略有升高，而全身症状（OR，0.77；95%CI，0.63-0.95）和发热（OR，0.42；95%CI，0.32-0.55）的可能性较低。仅在 BNT162b2 剂量高于 3μg 时报告了需要住院治疗的症状（n=10）。
在本队列研究中，与该年龄组中标签内非 SARS-CoV-2 疫苗相比，BNT162b2 给药后报告的症状总体上相似。目前的数据可与 BNT162b2 疗效和安全性的前瞻性许可研究一起使用，并有助于指导专家组对该年龄段 BNT162b2 疫苗接种的建议。
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