Safety, Immunogenicity, and Effectiveness of Chinese-Made COVID-19 Vaccines in the Real World: An Interim Report of a Living Systematic Review
Author:
Qi Yangyang12ORCID, Zheng Hui3, Wang Jinxia4, Chen Yani3, Guo Xu3, Li Zheng12, Zhang Wei5, Zhou Jiajia3, Wang Songmei6, Lin Boyi3, Zhang Lin3, Yan Tingting3, Clemens John7, Xia Jielai8, An Zhijie3, Yin Zundong3, Wang Xuanyi129, Feng Zijian10
Affiliation:
1. Shanghai Institute of Infectious Disease and Biosecurity, Shanghai 200032, China 2. Key Laboratory of Medical Molecular Virology of MoE & MoH and Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University, Shanghai 200032, China 3. National Immunization Program, Chinese Center for Disease Control and Prevention, Beijing 102206, China 4. Clinical Research Unit, Shanghai Children’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200240, China 5. Medical Library, Fudan University Library, Fudan University, Shanghai 200032, China 6. Laboratory of Molecular Biology, Training Center of Medical Experiments, School of Basic Medical Sciences, Fudan University, Shanghai 200032, China 7. International Vaccine Institute, Seoul 08826, Republic of Korea 8. Xijing Hospital, Air Force Medical University, Xi’an 710032, China 9. Children’s Hospital, Fudan University, Shanghai 200032, China 10. Chinese Preventive Medicine Association, Beijing 100009, China
Abstract
Background: Several COVID-19 vaccines were developed and approved in China. Of these, the BIBB-CorV and CoronaVac inactivated whole-virion vaccines were widely distributed in China and developing countries. However, the performance of the two vaccines in the real world has not been summarized. Methods: A living systematic review based on findings from ongoing post-licensure studies was conducted, applying standardized algorithms. Articles published between 1 May 2020 and 31 May 2022 in English and Chinese were searched for in Medline, Embase, WanFang Data, medRxiv, bioRxiv, arXiv, SSRN, and Research Square, using SARS-CoV-2, COVID-19, and vaccine as the MeSH terms. Studies with estimates of safety, immunogenicity, and effectiveness from receiving the BIBB-CorV or CoronaVac vaccine that met the predefined screening criteria underwent a full-text review. The Joanna Briggs Institute’s Critical Appraisal Checklist and the Cochrane risk of bias were used for assessment of the quality. A random-effects meta-regression model was applied to identify the potential impact factors on the vaccines’ effectiveness. Results: In total, 32578 articles were identified, of these, 770 studies underwent a full-text review. Eventually, 213 studies were included. The pooled occurrence of solicited and unsolicited adverse events after any dose of either vaccine varied between 10% and 40%. The top five commonly reported rare adverse events were immunization stress-related responses (211 cases, 50.0%), cutaneous responses (43 cases, 10.2%), acute neurological syndrome (39 cases, 9.2%), anaphylaxis (17 cases, 4.0%), and acute stroke (16 cases, 3.8%). The majority (83.3%) recovered or were relieved within several days. The peak neutralization titers against the ancestral strain was found within 1 month after the completion of the primary series of either vaccine, with a GMT (geometric mean titer) of 43.7 (95% CI: 23.2–82.4), followed by a dramatic decrease within 3 months. At Month 12, the GMT was 4.1 (95% CI: 3.8–4.4). Homologous boosting could restore humoral immunity, while heterologous boosting elicited around sixfold higher neutralization titers in comparison with homologous boosting. The effectiveness of receiving either vaccine against death and severe disease was around 85% for both shortly after the primary series. At Month 12, the protection against death did not decline, while the protection against severe disease decreased to ~75%. Conclusions: Both the BIBP-CorV and CoronaVac inactivated vaccines are safe. Sustained vaccine effectiveness against death was determined 12 months after the primary series, although protection against severe disease decreased slightly over time. A booster dose could strengthen the waning effectiveness; however, the duration of the incremental effectiveness and the additional benefit provided by a heterologous booster need to be studied.
Funder
Chinese Centre for Disease Control and Prevention under the COVID-19 Vaccines Evaluation Program
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