Tamim Hessa, Hashim Rosnani, Jamil Nurdiana, Chong Li Yin, Johari Zainol
Faculty of Pharmacy, University of Cyberjaya, Persiaran Bestari, Cyber 11, 63000, Cyberjaya, Selangor, Malaysia.
Sultan Idris Shah Serdang Hospital, Jalan Puchong, 43000, Kajang, Selangor, Malaysia.
Heliyon. 2024 Apr 20;10(8):e29574. doi: 10.1016/j.heliyon.2024.e29574. eCollection 2024 Apr 30.
The SARS-CoV-2 pandemic drove global vaccination. However, breakthrough infections raised concerns about vaccine performance, leading the World Health Organization (WHO) to recommend investigations thereof. This study aimed to evaluate the clinical outcomes (time to breakthrough infection, intensive care unit [ICU] admission, and in-hospital mortality) of hospitalised patients with SARS-CoV-2 breakthrough infection. This was the primary outcome and the risk factors associated with its severity were the secondary outcomes.
This retrospective cohort study at a multispecialty tertiary hospital in Selangor, Malaysia included 200 fully adult vaccinated patients, with confirmed SARS-CoV-2 infection, admitted from September 2021 to February 2022. Participants were selected by simple random sampling. Infection severity was categorised as CAT 2-3 (mild-moderate) and 4-5 (severe-critical).
The time to breakthrough infection was significantly longer for BNT162B2 recipients (128.47 ± 46.21 days) compared to CoronaVac (94.09 ± 48.71 days; P = 0.001) and ChAdOx1-S recipients (90.80 ± 37.59 days; P = 0.019). No significant associations were found between SARS-CoV-2-related ICU admission, mortality, and the vaccines. Multivariable analysis identified vaccine type, variant of concern, ethnicity, and hypertension as significant predictors of severity. BNT162b2 and ChAdOx1-S recipients had significantly (81 % and 74 %, respectively) lower odds of CAT 4-5 infection compared to CoronaVac recipients. Indian patients had a significantly (83 %) lower chance of CAT 4-5 infection compared to Malay patients. Patients with breakthrough infections during the Omicron period had a significantly (58 %) lower risk of CAT 4-5 compared to those in the Delta period. The CAT 4-5 risk was significantly (nearly threefold) higher in hypertensive patients.
The results support the Malaysian Ministry of Health's recommended booster three months after primary vaccination and the WHO's recommended heterologous booster following CoronaVac. Certain ethnic groups, hypertensive patients, and viral variants may require attention in future pandemics.
严重急性呼吸综合征冠状病毒2（SARS-CoV-2）大流行推动了全球疫苗接种。然而，突破性感染引发了对疫苗效果的担忧，导致世界卫生组织（WHO）建议对此进行调查。本研究旨在评估SARS-CoV-2突破性感染住院患者的临床结局（突破性感染时间、重症监护病房[ICU]入院情况和院内死亡率）。这是主要结局，与其严重程度相关的风险因素为次要结局。
这项在马来西亚雪兰莪一家多专科三级医院开展的回顾性队列研究纳入了202名确诊感染SARS-CoV-2的成年完全接种疫苗患者，这些患者于2021年9月至2022年2月入院。参与者通过简单随机抽样选取。感染严重程度分为2 - 3级（轻 - 中度）和4 - 5级（重度 - 危重度）。
与接种科兴疫苗（94.09 ± 48.71天；P = 0.001）和接种ChAdOx1 - S疫苗（90.80 ± 37.59天；P = 0.019）的患者相比，接种BNT16Bb2疫苗的患者出现突破性感染的时间显著更长（128.47 ± 46.21天）。在SARS-CoV-2相关的ICU入院、死亡率与疫苗之间未发现显著关联。多变量分析确定疫苗类型、关注的变异株、种族和高血压是严重程度的显著预测因素。与接种科兴疫苗的患者相比，接种BNT162b2和ChAdOx1 - S疫苗的患者发生4 - 5级感染的几率显著更低（分别为81%和74%）。与马来患者相比，印度患者发生4 - 5级感染的几率显著更低（83%）。与德尔塔时期相比，奥密克戎时期出现突破性感染的患者发生4 - 5级感染的风险显著更低（58%）。高血压患者发生4 - 5级感染的风险显著更高（近三倍）。
研究结果支持马来西亚卫生部关于在初次接种疫苗三个月后接种加强针的建议以及WHO关于在接种科兴疫苗后接种异源加强针的建议。在未来大流行中，某些种族群体、高血压患者和病毒变异株可能需要关注。
