Real-world Evaluation of the Effectiveness of Sinopharm COVID-19 Vaccine Against Symptomatic COVID-19 in an Omicron-Dominant Setting in Mozambique: A Test-Negative, Case-Control Study
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-...
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| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
15 June 2025
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| In: |
Clinical infectious diseases
Year: 2025, Volume: 80, Pages: S47-S56 |
| ISSN: | 1537-6591 |
| DOI: | 10.1093/cid/ciaf093 |
| Online Access: | Resolving-System, kostenfrei, Volltext: https://doi.org/10.1093/cid/ciaf093 Verlag, kostenfrei, Volltext: https://academic.oup.com/cid/article/80/Supplement_1/S47/8210481 
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| Author Notes: | Igor Ubisse Capitine, Asma Binte Aziz, Alvaro Manhiça, Inês Tivane, Absalão Zumba, Milton Nhumba, Zamith Rebocho, Elias Miquicene, Neusa Nguenha, José Langa, Harshvardhan Shrivastava, Yunkai Yang, Shiyu Wang, Ju Yeon Park, Seung Eun Kyung, Young Ae You, Hyoryoung Lee, Eun Lyeong Park, Raphaël Rakotozandrindrainy, Sue Kyoung Jo, Chloe Sherliker, Jonathan D. Sugimoto, Hyon Jin Jeon, Tabea Binger, Mohamadou Siribie, Deok Ryun Kim, Ilesh V. Jani, Florian Marks, and Birkneh Tilahun Tadesse |
| Summary: | 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. |
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| Item Description: | Online verfügbar: 22. Juli 2025 Gesehen am 09.12.2025 |
| Physical Description: | Online Resource |
| ISSN: | 1537-6591 |
| DOI: | 10.1093/cid/ciaf093 |