Safety, Immunogenicity, and Effectiveness of Chinese-Made COVID-19 Vaccines in the Real World: An Interim Report of a Living Systematic Review.

Publication date: Jul 16, 2024

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.

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Concepts Keywords
Algorithms China
China COVID-19
Inactivated effectiveness
Month inactivated vaccines
Vaccines meta-analysis
safety

Semantics

Type Source Name
disease VO effectiveness
disease MESH COVID-19
disease VO report
disease VO CoronaVac
disease VO vaccine
drug DRUGBANK Methionine
disease IDO quality
disease VO dose
disease VO immunization
disease MESH syndrome
disease MESH anaphylaxis
disease MESH acute stroke
disease VO titer
disease MESH death
disease VO vaccine effectiveness
disease VO time
drug DRUGBANK Guanosine
drug DRUGBANK Coenzyme M
drug DRUGBANK Medical air
disease VO organization
disease MESH emergency
disease IDO facility
disease VO storage
disease VO population

Original Article

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