Institute of General Practice, Friedrich-Alexander-Universität Erlangen-Nürnberg, Uniklinikum Erlangen, Universitätsstraße 29, Erlangen, Germany.
Institute of Clinical and Molecular Virology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Uniklinikum Erlangen, Schloßgarten 4, Erlangen, Germany.
BMC Med. 2023 Jun 20;21(1):218. doi: 10.1186/s12916-023-02924-5.
Since the beginning of the COVID-19 vaccination campaigns, recommendations regarding the vaccination have been very dynamic. Although the safety and efficacy of different vaccines have been analysed, data were scarce for vaccine regimens combining different vaccines. We therefore aimed to evaluate and compare the perceived reactogenicity and need for medical consultation after the most frequently applied homologous and heterologous COVID-19 vaccination regimens.
In an observational cohort study, reactogenicity and safety were assessed within a maximum follow-up time of 124 days using web-based surveys. Reactogenicity was assessed for different vaccination regimens 2 weeks after a vaccination (short-term survey). The following surveys, long-term and follow-up surveys, focused on the utilisation of medical services, including those that were not suspected to be vaccine-related.
Data of 17,269 participants were analysed. The least local reactions were seen after a ChAdOx1 - ChAdOx1 regimen (32.6%, 95% CI [28.2, 37.2]) and the most after the first dose with mRNA-1273 (73.9%, 95% CI [70.5, 77.2]). Systemic reactions were least frequent in participants with a BNT162b2 booster after a homologous primary immunisation with ChAdOx1 (42.9%, 95% CI [32.1, 54.1]) and most frequent after a ChAdOx1 - mRNA-1273 (85.5%, 95% CI [82.9, 87.8]) and mRNA-1273/mRNA-1273 regimen (85.1%, 95% CI [83.2, 87.0]). In the short-term survey, the most common consequences were medication intake and sick leave (after local reactions 0% to 9.9%; after systemic reactions 4.5% to 37.9%). In the long-term and follow-up surveys, between 8.2 and 30.9% of participants reported consulting a doctor and between 0% and 5.4% seeking hospital care. The regression analyses 124 days after the first and after the third dose showed that the odds for reporting medical consultation were comparable between the vaccination regimens.
Our analysis revealed differences in reactogenicity between the COVID-19 vaccines and vaccination regimens in Germany. The lowest reactogenicity as reported by participants was seen with BNT162b2, especially in homologous vaccination regimens. However, in all vaccination regimens reactogenicity rarely led to medical consultations. Small differences in seeking any medical consultation after 6 weeks diminished during the follow-up period. In the end, none of the vaccination regimens was associated with a higher risk for medical consultation.
DRKS DRKS00025881 ( https://drks.de/search/de/trial/DRKS00025373 ). Registered on 14 October 2021. DRKS DRKS00025373 ( https://drks.de/search/de/trial/DRKS00025881 ). Registered on 21 May 2021. Registered retrospectively.
自 COVID-19 疫苗接种运动开始以来，有关疫苗接种的建议一直非常活跃。虽然不同疫苗的安全性和有效性已得到分析，但关于结合使用不同疫苗的疫苗接种方案的数据却很少。因此，我们旨在评估和比较最常应用的同源和异源 COVID-19 疫苗接种方案后，接种者感知的不良反应发生率和对医疗咨询的需求。
在一项观察性队列研究中，通过基于网络的调查，在最长 124 天的随访时间内评估不良反应和安全性。在接种后 2 周（短期调查）评估不同疫苗接种方案的不良反应发生率。以下调查（长期和随访调查）重点关注医疗服务的使用情况，包括那些疑似与疫苗无关的服务。
共分析了 17269 名参与者的数据。ChAdOx1-ChAdOx1 方案的局部反应最少（32.6%，95%CI[28.2,37.2]），mRNA-1273 的首次剂量引起的全身反应最多（73.9%，95%CI[70.5,77.2]）。同源初次免疫后接种 BNT162b2 加强针的参与者全身反应最少（42.9%，95%CI[32.1,54.1]），ChAdOx1-mRNA-1273 和 mRNA-1273/mRNA-1273 方案的全身反应最多（85.5%，95%CI[82.9,87.8]和 85.1%，95%CI[83.2,87.0]）。在短期调查中，最常见的后果是药物摄入和病假（局部反应为 0%至 9.9%；全身反应为 4.5%至 37.9%）。在长期和随访调查中，8.2%至 30.9%的参与者报告了就诊医生，0%至 5.4%的参与者寻求了住院治疗。首次接种后 124 天和第三次接种后 124 天的回归分析显示，不同疫苗接种方案报告医疗咨询的几率相当。
我们的分析揭示了德国 COVID-19 疫苗和疫苗接种方案之间在不良反应发生率方面的差异。参与者报告的最低不良反应发生率与 BNT162b2 有关，尤其是在同源疫苗接种方案中。然而，在所有疫苗接种方案中，不良反应很少导致医疗咨询。接种后 6 周内寻求任何医疗咨询的小差异在随访期间逐渐减少。最终，没有任何一种疫苗接种方案与更高的医疗咨询风险相关。
DRKS DRKS00025881（https://drks.de/search/de/trial/DRKS00025373）。2021 年 10 月 14 日注册。DRKS DRKS00025373（https://drks.de/search/de/trial/DRKS00025881）。2021 年 5 月 21 日注册。已注册。
