Family Medicine, Aga Khan University, Karachi, Pakistan
Department of Family Medicine, Dean's Clinical Research Fellowship Program, Aga Khan University, Karachi, Pakistan.
BMJ Open. 2023 Jun 27;13(6):e071789. doi: 10.1136/bmjopen-2023-071789.
During the COVID-19 pandemic, several vaccines that were efficacious in randomised controlled trials were authorised for mass vaccination. In developing countries, inactivated vaccines were widely administered. While inactivated vaccines have been deemed effective in reducing disease severity, for healthcare personnel (HCP), effectiveness against SARS-CoV-2 infections is essential to reduce the risk to vulnerable patients and ensure a stable healthcare workforce. There are limited studies examining inactivated vaccines' effectiveness against SARS-CoV-2 variants of concern (VOCs) in real-world settings. We estimated the effectiveness of inactivated vaccines (BBIBP-CorV and CoronaVac) against reverse transcription PCR (RT-PCR)-confirmed SARS-CoV-2 infections among HCP in the setting of emerging SARS-CoV-2 VOCs in Pakistan.
A retrospective matched, test-negative case-control analysis using existing data from an Employee Health database on HCP at a large, private healthcare system in Pakistan.
4599 HCP were tested between 1 April and 30 September 2021. Each case (PCR positive) was matched to two to six controls (PCR negative) by the date of the RT-PCR test (±7 days) to reduce bias.
The primary outcome was vaccine effectiveness (VE) against SARS-CoV-2 infection. The secondary outcome was VE against symptomatic SARS-CoV-2 infection. Per cent VE was calculated using (1-OR)*100, with the OR of getting a PCR-confirmed SARS-COV-2 infection estimated using conditional logistic regression, after adjusting for age, gender, work area and history of SARS-CoV-2 infection.
Inactivated vaccines were ineffective against SARS-CoV-2 infections after receiving the first dose (VE 17%, 95% CI -10, 39; p=0.261). They showed modest effectiveness ≥14 days after the second dose against SARS-CoV-2 infections (VE 30%, 95% CI 7, 48; p=0.015) and symptomatic SARS-CoV-2 infections (VE 33%, 95% CI 6, 52; p=0.002).
Inactivated vaccines show modest effectiveness against SARS-CoV-2 infections in the setting of emerging VOCs. This builds a strong case for boosters and/or additional vaccination.
在 COVID-19 大流行期间,几种在随机对照试验中有效的疫苗被授权用于大规模接种。在发展中国家,广泛使用了灭活疫苗。虽然灭活疫苗已被证明可有效降低疾病严重程度,但对于医护人员(HCP)而言,对抗 SARS-CoV-2 感染的有效性对于降低易感患者的风险和确保稳定的医疗保健劳动力至关重要。在现实环境中,针对 SARS-CoV-2 变异株(VOCs),关于灭活疫苗有效性的研究有限。我们估计了在巴基斯坦 SARS-CoV-2 新兴 VOC 环境中,灭活疫苗(BBIBP-CorV 和 CoronaVac)对 HCP 中逆转录 PCR(RT-PCR)确诊的 SARS-CoV-2 感染的有效性。
使用巴基斯坦一家大型私立医疗保健系统的员工健康数据库中现有的数据,进行回顾性匹配的、阴性对照病例对照分析。
4599 名 HCP 在 2021 年 4 月 1 日至 9 月 30 日期间接受了检测。每个病例(PCR 阳性)通过 RT-PCR 检测日期(±7 天)与 2 至 6 名对照(PCR 阴性)相匹配,以减少偏倚。
主要结局是疫苗对 SARS-CoV-2 感染的有效性(VE)。次要结局是针对有症状的 SARS-CoV-2 感染的 VE。通过使用条件逻辑回归估计获得 PCR 确诊的 SARS-COV-2 感染的 OR,计算疫苗预防感染的百分比(VE),(1-OR)*100,在调整年龄、性别、工作区域和 SARS-CoV-2 感染史后。
在接种第一剂疫苗后,灭活疫苗对 SARS-CoV-2 感染无效(VE 17%,95%CI-10,39;p=0.261)。在接种第二剂疫苗后 14 天以上,它们对 SARS-CoV-2 感染显示出适度的有效性(VE 30%,95%CI 7,48;p=0.015)和有症状的 SARS-CoV-2 感染(VE 33%,95%CI 6,52;p=0.002)。
在新兴 VOC 环境中,灭活疫苗对 SARS-CoV-2 感染显示出适度的有效性。这有力地支持了加强针和/或额外接种疫苗的必要性。