Department of Respiratory Medicine, Luton and Dunstable Hospital NHS Foundation Trust, Luton, UK.
District Health Officer, Health Medical Services, Faisalabad, Pakistan.
Postgrad Med J. 2023 Jun 8;99(1171):463-469. doi: 10.1136/postgradmedj-2022-141649.
The first case of novel SARS-COV-2 (COVID-19) in Pakistan was detected on 26 February 2020. Pharmacological and non-pharmacological strategies have been tried to lessen the mortality and morbidity burden. Various vaccines have been approved. The Drug Regulatory Authority of Pakistan gave emergency approval for Sinopharm (BBIBP-CorV) COVID-19 vaccine in December 2021. The phase 3 trial of BBIBP-CorV included only 612 participants aged 60 years and above. The primary aim of this study was to assess the safety and efficacy of BBIBPP-CorV (Sinopharm) vaccine within the Pakistani adult population aged 60 or above. The study was carried out in the Faisalabad district of Pakistan.
A test negative case-control study design was used to assess safety and efficacy of BBIBP-CorV in individuals aged 60 and above against symptomatic infection, hospitalisations and mortality due to SARS-CoV-2 among vaccinated and unvaccinated individuals. ORs were calculated using logistic regression model at 95% CI. ORs were used to calculate the vaccine efficacy (VE) by using the following formula.VE= (1-OR) ×100.
3426 individuals with symptoms of COVID-19 were PCR tested between 5 May 2021 and 31 July 2021. The results showed that Sinopharm vaccine 14 days after the second dose was efficient in reducing the risk of symptomatic COVID-19 infection, hospitalisations and mortality by 94.3%, 60.5% and 98.6%, respectively, among vaccinated individuals with a significant p value of 0.001.
Our study showed that BBIBP-CorV vaccine is highly effective in preventing infection, hospitalisations and mortality due to COVID-19.
巴基斯坦于 2020 年 2 月 26 日首次发现新型 SARS-COV-2（COVID-19）病例。已尝试采用药理学和非药理学策略来减轻死亡率和发病率负担。已批准了各种疫苗。巴基斯坦药品监管局于 2021 年 12 月紧急批准了国药（BBIBP-CorV）COVID-19 疫苗。BBIBP-CorV 的 3 期试验仅纳入了 612 名 60 岁及以上的参与者。本研究的主要目的是评估 BBIBP-CorV（国药）疫苗在 60 岁及以上的巴基斯坦成年人群中的安全性和有效性。该研究在巴基斯坦费萨拉巴德区进行。
本研究采用病例对照研究设计，以评估接种和未接种 BBIBP-CorV 的个体中，疫苗对 60 岁及以上个体因 SARS-CoV-2 引起的症状感染、住院和死亡的安全性和有效性。采用逻辑回归模型在 95%置信区间内计算比值比（OR）。通过以下公式计算疫苗效力（VE），使用 OR 计算 VE：VE=（1-OR）×100。
2021 年 5 月 5 日至 7 月 31 日期间，共有 3426 名有 COVID-19 症状的个体接受了 PCR 检测。结果表明，在接种者中，国药疫苗第二剂接种后 14 天，预防有症状的 COVID-19 感染、住院和死亡的效力分别为 94.3%、60.5%和 98.6%，具有显著的统计学意义（p 值均<0.001）。
本研究表明，BBIBP-CorV 疫苗对预防 COVID-19 感染、住院和死亡具有高度有效性。
