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Review
. 2021 Jul-Sep;12(3):215-221.
doi: 10.4103/japtr.JAPTR_229_20. Epub 2021 Jul 16.

Efficacy and safety of potential vaccine candidates against coronavirus disease 2019: A systematic review

Affiliations
Review

Efficacy and safety of potential vaccine candidates against coronavirus disease 2019: A systematic review

Subodh Kumar et al. J Adv Pharm Technol Res. 2021 Jul-Sep.

Abstract

Search for an effective and safe vaccine to prevent transmission of current pandemic is an unmet need. This study reviews and compares the available early phase clinical data of vaccine candidates which have reached phase 3 of clinical development. The latest update of "DRAFT landscape of coronavirus (CoV) disease 2019 candidate vaccines (October 2, 2020)" released by the World Health Organization was accessed to identify the potential vaccine candidates. The full text articles (published and/or preprint) of data of early clinical trials of the selected vaccines were accessed from the links provided in the same document, PubMed and/or medRxiv.com. After extraction and synthesis, the data were critically evaluated for the study efficacy and safety outcomes. Of the total 193 candidate vaccines 10 were found to reach phase 3 of the clinical development. Nine of these were included in the evaluation process. In all of the included studies, immunogenicity and serious adverse events/local or systemic adverse events/laboratory parameters abnormality was considered as efficacy and safety outcomes respectively. Immunogenicity response with most of the vaccines was either higher than or similar to the respective controls except one (recombinant adenovirus type 26 COV2 [Ad26.COV2.S]) for which it was less than that in control. Overall adverse events (related and/or unrelated) were more with vaccines than those with respective control(s) in three studies, in other two, these were similar whereas in one study, the events were less in the vaccine group than in control group and in the rest, data described were descriptive only without any mention for the same for the control. In conclusion all studies showed immunogenic response to target protein of severe acute respiratory syndrome CoV-2 and which was higher than the respective control except for Ad26.CoV2.S. Many of the vaccines caused more adverse events than the controls, however most were mild and transient and/or manageable.

Keywords: Coronavirus disease 2019; immunogenicity; severe acute respiratory syndrome-coronavirus-2.

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Conflict of interest statement

There are no conflicts of interest.

Figures

Figure 1
Figure 1
Flow diagram showing the process of inclusion of the studies

References

    1. Pronker ES, Weenen TC, Commandeur H, Claassen EH, Osterhaus AD. Risk in vaccine research and development quantified. PLoS One. 2013;8:e57755. - PMC - PubMed
    1. Slaoui M, Hepburn M. Developing safe and effective Covid vaccines - Operation warp speed's strategy and approach. N Engl J Med. 2020;383:1701–3. - PubMed
    1. World Health Organization. COVAX: Working for Global Equitable Access to COVID-19 Vaccines. [[Last accessed on 2020 Oct 08]]. Available from: https://www.who.int/initiatives/act-accelerator/covax .
    1. World Health Organization. Draft Landscape of COVID-19 Candidate Vaccines. [[Last accessed on 2020 Oct 08; Last updated on 2020 Oct 02]]. Available from: https://www.who.int/publications/m/item/draft-landscape-of-covid-19-cand... .
    1. Jiang S, Hillyer C, Du L. Neutralizing antibodies against SARS-CoV-2 and other human coronaviruses. Trends Immunol. 2020;41:355–9. - PMC - PubMed