Journal Article


Safety, immunogenicity, and efficacy of a COVID-19 vaccine (NVX-CoV2373) co-administered with seasonal influenza vaccines: an exploratory substudy of a randomised, observer-blinded, placebo-controlled, phase 3 trial

Abstract

Background: Safety and immunogenicity of COVID-19 vaccines when co-administered with influenza vaccines have not yet been reported. Methods: A sub-study on influenza vaccine co-administration was conducted as part of the phase 3 randomised trial of NVX-CoV2373’s safety and efficacy; ~400 participants meeting main study entry criteria, with no contraindications to influenza vaccination, were enroled. After randomisation to receive NVX-CoV2373 or placebo, sub-study participants received an open-label influenza vaccine at the same time as the first dose of NVX-CoV2373. Reactogenicity was evaluated for 7 days post-vaccination plus monitoring for unsolicited adverse events (AEs), medically-attended AEs (MAAEs), and serious AEs (SAEs). Vaccine efficacy against COVID-19 was assessed. Findings: Sub-study participants were younger (median age 39; 6.7 % ≥65 years), more racially diverse, and had fewer comorbid conditions than main study participants. Reactogenicity events more common in co-administration group included tenderness (70.1% vs 57.6%) or pain (39.7% vs 29.3%) at injection site, fatigue (27.7% vs 19.4%), and muscle pain (28.3% vs 21.4%). Rates of unsolicited AEs, MAAEs, and SAEs were low and balanced between the two groups. Co-administration resulted in no change to influenza vaccine immune response, while a reduction in antibody responses to the NVX-CoV2373 vaccine was noted. Vaccine efficacy against COVID-19 was 87.5% (95% CI: -0.2, 98.4) in those 18-<65 years in the sub-study while efficacy in the main study was 89.8% (95% CI: 79.7, 95.5).  Interpretation: This is the first study to demonstrate safety, immunogenicity, and efficacy of a COVID-19 vaccine when co-administered with influenza vaccines.

Attached files

Authors

Toback, Seth
Galiza, Eva
Cosgrove, Catherine
Galloway, James
Goodman, Anna L
Swift, Pauline A
Rajaram, Sankarasubramanian
Graves-Jones, Alison
Edelman, Jonathan
Burns, Fiona
Minassian, Angela M
Cho, Iksung
Kumar, Lakshmi
Plested, Joyce S
Rivers, E Joy
Robertson, Andreana
Dubovsky, Filip
Glenn, Greg
Heath, Paul T
Soiza, Roy L.
Brittain-Long, Robin
Scicluna, Chiara
Edwards, Carole
Mackay, Lynn
D'Allesandro, Mariella
Nicol, Amy
Norris, Karen
Mann, Sandra
Lawrence, Heather
Valentine, Ruth
Viljoen, Marianne Elizabeth
Pretswell, Carol H.
Nicholls, Helen
Munsoor, Imrozia
Meyrick, Agnieszka
Kyriakidou, Christina
Iyengar, Shalini
Jamal, Arham
Richards, Nick
Price, Helen
Rowbotham, Bridie
Bird, Danielle
Smith, Karen
Littler, Olga
Fielding, Kirsty
Townsend-Rose, Anna
Miller, Karen
Davis, Jessica
Elliot-Garwood, Alison
Trottier, Lauren
Edwards, Paul
McFarland, Margaret
Osanlou, Orod
Longshaw, Laura
Stockport, Jane
Grundy, Lynne
Broad, Katharine Lucy
Regan, Karen
Storton, Kim
Ryan-Wakeling, Declan

Oxford Brookes departments

Oxford School of Nursing and Midwifery

Dates

Year of publication: 2021
Date of RADAR deposit: 2022-01-26



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Related resources

This RADAR resource is the Accepted Manuscript of Safety, immunogenicity, and efficacy of a COVID-19 vaccine (NVX-CoV2373) co-administered with seasonal influenza vaccines: an exploratory substudy of a randomised, observer-blinded, placebo-controlled, phase 3 trial

Details

  • Owner: Daniel Croft
  • Collection: Outputs
  • Version: 1 (show all)
  • Status: Live