Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Nedlands, WA 6009, Australia; School of Public Health, University of Sydney, NSW 2006, Australia.
School of Public Health, University of Sydney, NSW 2006, Australia.
Vaccine. 2023 Nov 22;41(48):7250-7258. doi: 10.1016/j.vaccine.2023.10.050. Epub 2023 Oct 29.
We evaluated the frequency of moderate and severe adverse events following coadministration of seasonal influenza vaccine (SIV) versus placebo with COVID-19 vaccines among adults to support practice guidelines.
FluVID is a participant-blinded, phase IV, randomised control trial. On the same day as the participant's scheduled COVID-19 vaccine, participants were randomised to receive SIV or saline placebo; those assigned placebo at visit one then received SIV a week later, and vice versa. Self-reported adverse events were collected daily for seven days following each visit. The primary endpoint was any solicited adverse event of at least moderate severity occurring up to seven days following receipt of SIV or placebo. This was modelled using a Bayesian logistic regression model. Analyses were performed by COVID-19 vaccine type and dose number.
Overall, 248 participants were enrolled; of these, 195 had received BNT162b2 and 53 had received mRNA1273 COVID-19 vaccines according to national guidelines. After randomisation, 119 were assigned to receive SIV and 129 were assigned to receive placebo at visit one. Adverse events were most frequently reported as mild (grade 1) in nature. Among 142 BNT162b2 booster dose one and 43 BNT162b2 booster dose two recipients, the posterior median risk difference for moderate/severe adverse events following SIV versus placebo was 13% (95% credible interval [CrI] -0.03 to 0.27) and 13% (95%CrI -0.37 to 0.12), respectively. Among 18 mRNA1273 booster dose one and 35 mRNA1273 booster dose two recipients, the posterior median risk difference of moderate/severe adverse events following influenza vaccine versus placebo was 6% (95%CrI -0.29 to 0.41) and -4% (95%CrI -0.30 to 0.23), respectively.
Adverse events following SIV and COVID-19 co-administration were generally mild and occurred with similar frequency to events following COVID-19 vaccine alone. We found no evidence to justify routine separation of SIV and COVID-19 vaccine doses.
ACTRN12621001063808.
评估在成人中同时接种季节性流感疫苗（SIV）与 COVID-19 疫苗与单独接种 COVID-19 疫苗相比，出现中度和重度不良事件的频率，以支持实践指南。
FluVID 是一项参与者设盲的、四期、随机对照试验。在参与者计划接种 COVID-19 疫苗的同一天，参与者被随机分配接受 SIV 或生理盐水安慰剂；在第一次就诊时被分配安慰剂的参与者一周后接受 SIV，反之亦然。每次就诊后 7 天内每天收集自报告的不良事件。主要终点是在接受 SIV 或安慰剂后 7 天内发生的任何至少中度严重程度的不良事件。使用贝叶斯逻辑回归模型对其进行建模。根据 COVID-19 疫苗类型和剂量数进行分析。
总体而言，共纳入 248 名参与者；其中，根据国家指南，195 名接受了 BNT162b2 疫苗，53 名接受了 mRNA1273 COVID-19 疫苗。随机分组后，119 名被分配接受 SIV，129 名被分配接受第一次就诊时的安慰剂。不良事件最常被报告为轻度（1 级）。在 142 名接受 BNT162b2 加强针一剂和 43 名接受 BNT162b2 加强针两剂的患者中，SIV 与安慰剂相比，中度/重度不良事件的后验中位数风险差异分别为 13%（95%可信区间[CrI]：-0.03 至 0.27）和 13%（95%CrI：-0.37 至 0.12）。在 18 名接受 mRNA1273 加强针一剂和 35 名接受 mRNA1273 加强针两剂的患者中，流感疫苗与安慰剂相比，中度/重度不良事件的后验中位数风险差异分别为 6%（95%CrI：-0.29 至 0.41）和-4%（95%CrI：-0.30 至 0.23）。
SIV 与 COVID-19 联合接种后的不良事件通常为轻度，且与单独接种 COVID-19 疫苗后的不良事件发生频率相似。我们没有发现证据支持常规将 SIV 与 COVID-19 疫苗分开接种。
ACTRN12621001063808。
