Capitine Igor Ubisse, Aziz Asma Binte, Manhiça Alvaro, Tivane Inês, Zumba Absalão, Nhumba Milton, Rebocho Zamith, Miquicene Elias, Nguenha Neusa, Langa José, Shrivastava Harshvardhan, Yang Yunkai, Wang Shiyu, Park Ju Yeon, Kyung Seung Eun, You Young Ae, Lee Hyoryoung, Park Eun Lyeong, Rakotozandrindrainy Raphaël, Kyoung Jo Sue, Sherliker Chloe, Sugimoto Jonathan D, Jeon Hyon Jin, Binger Tabea, Siribie Mohamadou, Kim Deok Ryun, Jani Ilesh V, Marks Florian, Tadesse Birkneh Tilahun
Instituto Nacional de Saúde, Maputo, Mozambique.
International Vaccine Institute, Seoul, Republic of Korea.
Clin Infect Dis. 2025 Jul 22;80(Supplement_1):S47-S56. doi: 10.1093/cid/ciaf093.
BACKGROUND: We evaluated the effectiveness of the Sinopharm coronavirus disease 2019 (COVID-19) vaccine, introduced in Mozambique, against the Omicron variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), prevalent from March 2022 to December 2023. METHODS: A test-negative case-control study was nested in a community-based enhanced COVID-19 surveillance in seven healthcare facilities including mobile testing stations in the Dondo District, Mozambique, between March 2022 and December 2023. Participants were individuals aged ≥2 years with COVID-19-like symptoms for <10 days. Cases were those with polymerase chain reaction (PCR)-confirmed COVID-19. For each case, three PCR test-negative controls were matched, according to age (±5 years), sex, and date of PCR test (±7 days). Follow-up for all cases was conducted until disease resolution. Vaccine protection was assessed according to the association between complete vaccination and SARS-CoV-2 disease onset ≥14 days after vaccination. RESULTS: The study did not reach the targeted sample size, and only a third were analyzed. A total of 253 cases were matched to 759 test-negative controls by age, sex, and testing date, a process known as matching. Among cases, 41% had one dose of Sinopharm, 53% had two doses, and 6% were unvaccinated. Among the test-negative controls, 37% had 1 dose, 57% had two doses, and 7% were unvaccinated. The adjusted vaccine effectiveness, calculated using matching and adjusted for age and PCR test date, was 18.0% (95% confidence interval, -85.3 to 63.7; P = .63). No COVID-19-positive participants required hospitalization. CONCLUSIONS: In an Omicron-dominant setting, two doses of the Sinopharm vaccine did not show significant protection against symptomatic COVID-19. However, as our analysis was based on data from only a third of enrolled individuals with confirmed vaccination status, these findings should be interpreted with caution. Our results underscore the importance of real-time vaccine effectiveness evaluations to inform optimal rollout strategies in low- and middle-income countries.
背景：我们评估了莫桑比克引入的国药集团新型冠状病毒肺炎（COVID-19）疫苗对2022年3月至2023年12月期间流行的严重急性呼吸综合征冠状病毒2（SARS-CoV-2）奥密克戎变种的有效性。 方法：在2022年3月至2023年12月期间，在莫桑比克栋多区的七个医疗机构（包括移动检测站）开展的基于社区的强化COVID-19监测中进行了一项检测阴性病例对照研究。参与者为年龄≥2岁、出现COVID-19样症状少于10天的个体。病例为聚合酶链反应（PCR）确诊的COVID-19患者。对于每例病例，根据年龄（±5岁）、性别和PCR检测日期（±7天）匹配三名PCR检测阴性对照。对所有病例进行随访直至疾病缓解。根据全程接种疫苗与接种疫苗后≥14天出现SARS-CoV-2疾病之间的关联评估疫苗保护效果。 结果：该研究未达到目标样本量，仅分析了三分之一的样本。共有253例病例按年龄（±5岁）、性别和检测日期与759名检测阴性对照进行匹配，这一过程称为匹配。在病例中，41%接种了一剂国药疫苗，53%接种了两剂，6%未接种。在检测阴性对照中，37%接种了1剂，57%接种了两剂，7%未接种。使用匹配方法并根据年龄和PCR检测日期进行调整后计算的调整后疫苗效力为18.0%（95%置信区间，-85.3至63.7；P = 0.63）。没有COVID-19阳性参与者需要住院治疗。 结论：在以奥密克戎为主的环境中，两剂国药疫苗对有症状的COVID-19未显示出显著保护作用。然而，由于我们的分析仅基于三分之一已确认疫苗接种状态的入组个体的数据，这些发现应谨慎解读。我们的结果强调了实时评估疫苗效力对于为低收入和中等收入国家制定最佳推广策略提供信息的重要性。
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