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. 2023 Jun 13;41(26):3930-3936.
doi: 10.1016/j.vaccine.2023.05.016. Epub 2023 May 10.

Safety of the NVX-CoV2373 COVID-19 vaccine in randomized placebo-controlled clinical trials

Katherine Smith  1 , Karim Hegazy  2 , Miranda R Cai  2 , Irene McKnight  2 , Matthew D Rousculp  2 , Katia Alves  2
Affiliations

Safety of the NVX-CoV2373 COVID-19 vaccine in randomized placebo-controlled clinical trials

Katherine Smith et al. Vaccine. .

Abstract

Background: NVX-CoV2373 (Nuvaxovid™ or the Novavax COVID-19 Vaccine, Adjuvanted), the first protein-based COVID-19 vaccine, received emergency use authorization (EUA) as a primary series/booster and is available globally. NVX-CoV2373 primary series demonstrated efficacy rates of 89.7-90.4 % and an acceptable safety profile. This article summarizes safety in adult recipients (aged ≥ 18 years) of primary series NVX-CoV2373 in four randomized placebo-controlled trials.

Methods: All participants who received NVX-CoV2373 primary series or placebo (pre-crossover) were included according to actual received treatment. The safety period was from Day 0 (first vaccination) to unblinding/receipt of EUA-approved/crossover vaccine, end of each study (EOS), or last visit date/cutoff date minus 14 days. The analysis reviewed local and systemic solicited adverse events (AEs) within 7 days after NVX-CoV2373 or placebo; unsolicited AEs from after Dose 1 to 28 days after Dose 2; serious AEs (SAEs), deaths, AEs of special interest, and vaccine-related medically attended AEs from Day 0 through end of follow-up (incidence rate per 100 person-years).

Findings: Pooled data from 49,950 participants (NVX-CoV2373, n = 30,058; placebo, n = 19,892) were included. Solicited reactions after any dose were more frequent in NVX-CoV2373 recipients (local, 76 %/systemic, 70 %) than placebo recipients (local, 29 %/systemic, 47 %), and were mostly of mild-to-moderate severity. Grade 3+ reactions were infrequent, with greater frequency in NVX-CoV2373 recipients (local, 6.28 %/systemic, 11.36 %) than placebo recipients (local, 0.48 %/systemic, 3.58 %). SAEs and deaths occurred with similarly low frequency in NVX-CoV2373 (SAEs: 0.91 %, deaths: 0.07 %) and placebo recipients (SAEs: 1.0 %, deaths: 0.06 %).

Interpretation: To date, NVX-CoV2373 has displayed an acceptable safety profile in healthy adults.

Funding: Supported by Novavax, Inc.

Keywords: COVID-19; Immunogenicity; NVX-CoV2373; SARS-CoV-2; Safety summary.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: All authors are employees and shareholders of Novavax, Inc.

Figures

Fig. 1
Fig. 1
Study inclusion diagram Four trials were completed at the time of this analysis and were selected for inclusion. Safety data on participants from each trial (Study 101 had two phases) were pooled. Only participants who received the approved 5 ug dose of NVX-CoV2373 or placebo were included. Abbreviations: M, Matrix-MTM adjuvant; P, placebo; V, active NVX-CoV2373 vaccine.
Fig. 2
Fig. 2
Local and systemic reactogenicity Solicited local (A) and systemic (B) reactions are shown for Dose 1 and Dose 2, for all participants in each treatment group or split by age group (18–64 years and ≥65 years). Frequency of reactions of any dose is plotted, as well as frequency of Grade 3+ reactions.
Fig. 2
Fig. 2
Local and systemic reactogenicity Solicited local (A) and systemic (B) reactions are shown for Dose 1 and Dose 2, for all participants in each treatment group or split by age group (18–64 years and ≥65 years). Frequency of reactions of any dose is plotted, as well as frequency of Grade 3+ reactions.
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References

    1. Liu Y.C., Kuo R.L., Shih S.R. COVID-19: The first documented coronavirus pandemic in history. Biomed J. 2020;43(4):328–333. - PMC - PubMed
    1. World Health Organization, WHO coronavirus disease (COVID-19) dashboard. 2021. https://covid19.who.int (accessed September 21 2022).
    1. Centers for Disease Control and Prevention. COVID-19: Possibility of COVID-19 illness after vaccinations. 2022. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/effectiveness/why-mea... (accessed October 12 2022).
    1. Centers for Disease Control and Prevention. COVID-19: Benefits of getting vaccinated. 2022. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits.html (accessed October 12 2022).
    1. US Food and Drug Administration. Regulatory information - Letter of authorization (reissued): Novavax letter of authorization 10192022. 2022. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-dise... (accessed October 24 2022).

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