Publication status of 95 clinical trials of 3 COVID-19 vaccines developed by Chinese companies: An observational cohort study

Abstract

Transparency shortcomings can undermine confidence in the safety and efficacy of vaccines. This study assesses the publication status of 95 clinical trials of 3 COVID-19 vaccines developed by Chinese companies that received a World Health Organization Emergency Use Listing (EUL) and have been marketed globally. We searched trial registries and the scientific literature to assess current trial status and the public availability of results. After excluding 2 withdrawn trials, we found that at least 62/93 trials (67%) involving 307,933 patients had verifiably been completed or terminated. Only 44 of those 62 trials (71%) had published results in a peer-reviewed journal; none had tabular summary results available on a trial registry. The results of 18/62 (29%) verifiably completed or terminated trials remained unpublished. The trial status information stated in trial registries was often incorrect. Our findings reveal a substantial gap between the disclosure practices of the 3 Chinese companies and global best practice benchmarks. Transparency and global public trust in Chinese biopharmaceutical products could be improved by aligning Chinese legal disclosure requirements with those prevalent in more mature markets, or by the voluntary adoption of stronger transparency practices by Chinese companies.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Protocols

https://osf.io/4f9k7

Funding Statement

This study did not receive any funding

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors

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