Capponi Martina, Pulvirenti Federica, Cinicola Bianca Laura, Brindisi Giulia, Conti Maria Giulia, Colaiocco Giovanni, de Castro Giovanna, Guido Cristiana Alessia, Duse Marzia, Midulla Fabio, Zicari Anna Maria, Spalice Alberto
Department of Maternal Infantile and Urological Sciences, Sapienza University of Rome, 00185 Rome, Italy.
Reference Centre for Primary Immune Deficiencies, Azienda Ospedaliera Universitaria Policlinico Umberto I, 00161 Rome, Italy.
Vaccines (Basel). 2022 Jun 30;10(7):1056. doi: 10.3390/vaccines10071056.
Vaccination against COVID-19 is the most effective tool to protect both the individual and the community from this potentially life-threatening infectious disease. Data from phase-3 trials showed that two doses of the BNT162b2 vaccine were safe, immunogenic, and effective against COVID-19 in children aged 5-11 years. However, no surveys in real-life settings have been carried out in this age range. Here, we conducted a cross-sectional study to evaluate the short-term adverse reactions (ARs) and the rate of protection against infection of the BNT162b2 vaccine in children aged 5-11 years by the compilation of two surveillance questionnaires conceived using Google Forms. Five-hundred and ninety one children were included in the analysis. ARs were reported by 68.9% of the children, being mainly local. The incidence of systemic ARs, especially fever, was higher after the second dose. The incidence of infection after completing the immunization accounted for 13.6% of the children. COVID-19 symptoms reported were mild, with the exception of one case of pneumonia. Only 40% of infected participants needed to take medication to relieve symptoms, mostly paracetamol and NSAIDs, and none reported persistent symptoms. The Pfizer-BioNTech vaccine in children aged 5-11 years is safe and well tolerated. The mild clinical course of COVID-19 in immunized children confirmed the favorable risk-benefit ratio, encouraging parents to immunize their children.
接种新冠病毒疫苗是保护个人和社区免受这种潜在危及生命的传染病侵害的最有效工具。3期试验数据表明，两剂BNT162b2疫苗对5至11岁儿童安全、具有免疫原性且对新冠病毒有效。然而，尚未在这个年龄范围内进行过现实环境中的调查。在此，我们通过编制两份使用谷歌表单设计的监测问卷，开展了一项横断面研究，以评估5至11岁儿童接种BNT162b2疫苗后的短期不良反应（AR）及感染防护率。591名儿童纳入分析。68.9%的儿童报告了AR，主要为局部反应。第二剂后全身AR的发生率，尤其是发热，更高。完成免疫后感染发生率占儿童的13.6%。报告的新冠病毒症状较轻，除1例肺炎病例外。仅40%的感染参与者需要服药缓解症状，主要是对乙酰氨基酚和非甾体抗炎药，且无人报告有持续症状。5至11岁儿童接种的辉瑞 - BioNTech疫苗安全且耐受性良好。免疫儿童中新冠病毒的临床过程较轻，证实了有利的风险效益比，鼓励家长为孩子接种疫苗。
