Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Department of Pediatrics, Nara Prefecture General Medical Center, Nara, Japan.
J Pediatric Infect Dis Soc. 2024 Feb 26;13(2):129-135. doi: 10.1093/jpids/piae002.
There is no risk and benefit assessment of COVID-19 vaccination for children younger than 5 years using a single health outcomes scale. The objective of this study is to compare the expected risk and benefits of the mRNA primary series of COVID-19 vaccines for children aged 6 months to 4 years in the United States using a single health outcome scale in the Omicron era.
The expected benefits and risks of the primary two-dose series of mRNA COVID-19 vaccines for children aged 6 months to 4 years were stratified by sex, the presence of underlying medical conditions, the presence of infection-induced immunity, and the type of mRNA vaccine (BNT162b2 or mRNA-1273). A scoping literature review was conducted to identify the indicators in the decision tree model. The benefit-risk ratio was the outcome of interest.
The benefit-risk ratios ranged from 200.4 in BNT162b2 for males aged 6-11 months with underlying medical conditions and without infection-induced immunity to 3.2 in mRNA-1273 for females aged 1-4 years without underlying medical conditions and with infection-induced immunity.
The expected benefit of receiving the primary series of mRNA vaccines outweighed the risk among children ages 6 months to 4 years regardless of sex, presence of underlying medical conditions, presence of infection-induced immunity, or type of mRNA vaccines. However, the continuous monitoring of the COVID-19 epidemiology as well as vaccine effectiveness and safety is important.
目前尚无使用单一健康结果量表评估 5 岁以下儿童接种 COVID-19 疫苗的风险和获益。本研究旨在比较奥密克戎时代美国 6 个月至 4 岁儿童接种 mRNA 新冠病毒疫苗初级系列的预期风险和获益，采用单一健康结果量表。
对 6 个月至 4 岁儿童接种两剂 mRNA 新冠病毒疫苗初级系列的预期获益和风险，按照性别、基础疾病存在情况、感染诱导免疫存在情况和 mRNA 疫苗类型（BNT162b2 或 mRNA-1273）进行分层。对决策树模型中的指标进行了范围界定文献综述。获益-风险比是研究的重点。
获益-风险比的范围从基础疾病伴感染诱导免疫缺失的 6-11 月龄男性接种 BNT162b2 的 200.4 到基础疾病无感染诱导免疫的 1-4 岁女性接种 mRNA-1273 的 3.2。
无论性别、基础疾病存在情况、感染诱导免疫存在情况或 mRNA 疫苗类型如何，6 个月至 4 岁儿童接种 mRNA 疫苗初级系列的预期获益均大于风险。然而，持续监测 COVID-19 流行病学以及疫苗有效性和安全性非常重要。
