PMID- 37211453
OWN - NLM
STAT- MEDLINE
DCOM- 20230614
LR  - 20230620
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Print)
IS  - 0264-410X (Linking)
VI  - 41
IP  - 26
DP  - 2023 Jun 13
TI  - Safety of the NVX-CoV2373 COVID-19 vaccine in randomized placebo-controlled 
      clinical trials.
PG  - 3930-3936
LID - S0264-410X(23)00543-1 [pii]
LID - 10.1016/j.vaccine.2023.05.016 [doi]
AB  - 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.
CI  - Copyright (c) 2023. Published by Elsevier Ltd.
FAU - Smith, Katherine
AU  - Smith K
AD  - Novavax, Inc., 21 Firstfield Rd, Gaithersburg, MD 20878, USA. Electronic address: 
      kasmith@novavax.com.
FAU - Hegazy, Karim
AU  - Hegazy K
AD  - Novavax, Inc., 21 Firstfield Rd, Gaithersburg, MD 20878, USA.
FAU - Cai, Miranda R
AU  - Cai MR
AD  - Novavax, Inc., 21 Firstfield Rd, Gaithersburg, MD 20878, USA.
FAU - McKnight, Irene
AU  - McKnight I
AD  - Novavax, Inc., 21 Firstfield Rd, Gaithersburg, MD 20878, USA.
FAU - Rousculp, Matthew D
AU  - Rousculp MD
AD  - Novavax, Inc., 21 Firstfield Rd, Gaithersburg, MD 20878, USA.
FAU - Alves, Katia
AU  - Alves K
AD  - Novavax, Inc., 21 Firstfield Rd, Gaithersburg, MD 20878, USA.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20230510
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 2SCD8Q63PF (NVX-CoV2373 adjuvated lipid nanoparticle)
RN  - 0 (COVID-19 Vaccines)
RN  - 0 (Vaccines)
RN  - 0 (Antibodies, Viral)
SB  - IM
MH  - Adult
MH  - Humans
MH  - COVID-19 Vaccines
MH  - *COVID-19/prevention & control
MH  - *Vaccines
MH  - Vaccination/adverse effects
MH  - Antibodies, Viral
MH  - Immunogenicity, Vaccine
MH  - Double-Blind Method
PMC - PMC10169578
OTO - NOTNLM
OT  - COVID-19
OT  - Immunogenicity
OT  - NVX-CoV2373
OT  - SARS-CoV-2
OT  - Safety summary
COIS- 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.
EDAT- 2023/05/22 00:41
MHDA- 2023/06/14 06:42
PMCR- 2023/05/10
CRDT- 2023/05/21 21:57
PHST- 2023/03/07 00:00 [received]
PHST- 2023/05/02 00:00 [revised]
PHST- 2023/05/04 00:00 [accepted]
PHST- 2023/06/14 06:42 [medline]
PHST- 2023/05/22 00:41 [pubmed]
PHST- 2023/05/21 21:57 [entrez]
PHST- 2023/05/10 00:00 [pmc-release]
AID - S0264-410X(23)00543-1 [pii]
AID - 10.1016/j.vaccine.2023.05.016 [doi]
PST - ppublish
SO  - Vaccine. 2023 Jun 13;41(26):3930-3936. doi: 10.1016/j.vaccine.2023.05.016. Epub 
      2023 May 10.