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Estimated Effectiveness of a Primary Cycle of Protein Recombinant Vaccine NVX-CoV2373 Against COVID-19

Importance Protein recombinant vaccine NVX-CoV2373 (Novavax) against COVID-19 was authorized for its use in adults in late 2021, but evidence on its estimated effectiveness in a general population is lacking. Objective To estimate vaccine effectiveness of a primary cycle with NVX-CoV2373 against SAR...

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Published in:JAMA network open 2023-10, Vol.6 (10), p.e2336854-e2336854
Main Authors: Mateo-Urdiales, Alberto, Sacco, Chiara, Petrone, Daniele, Bella, Antonino, Riccardo, Flavia, Del Manso, Martina, Bressi, Marco, Siddu, Andrea, Brusaferro, Silvio, Palamara, Anna Teresa, Rezza, Giovanni, Pezzotti, Patrizio, Fabiani, Massimo, Boros, Stefano, D'Ancona, Fortunato (Paolo), Di Benedetto, Corrado, Filia, Antonietta, Rota, Maria Cristina, Tallon, Marco, Vescio, Maria Fenicia, Petrucci, Antonia, La Bianca, Michele, Mignuoli, Anna Domenica, Buono, Pietro, Massimiliani, Erika, Barbone, Fabio, Vario, Francesco, Sticchi, Camilla, Cereda, Danilo, Pompili, Marco, Sforza, Francesco, Bertoli, Pierpaolo, Benetollo, Pier Paolo, Pasqualini, Chiara, Cisceglia, Lucia, Palmas, Maria Antonietta, Addario, Sebastiano Pollina, Balocchini, Emanuela, Tosti, Anna, Ruffier, Mauro, Da Re, Filippo, Battilomo, Serena, Proietti, Valeria, Odio, Camillo, Recine, Michele, Ruberto, Innocenza, Ascione, Salvatore, Bisogno, Massimo, Miserendino, Gandolfo, Navacchia, Massimiliano, Del Frate, Beatrice, Cau, Emanuela, Baiocchi, Diego, Fusco, Danilo, Gallo, Domenico, Marchetti, Maria Rosa, Conforti, Diego, Trentini, Carlo, Ruggeri, Antonino, Ladalardo, Concetta, Albano, Nehludoff, Corona, Marco, Lombardi, Paolo, Iacono, Massimo, Angori, Paolo Bruno, Belardinelli, Andrea, Solfiti, Milena, Fioraso, Stefano, Poma, Chiara, Raccanello, Nadia
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Summary:Importance Protein recombinant vaccine NVX-CoV2373 (Novavax) against COVID-19 was authorized for its use in adults in late 2021, but evidence on its estimated effectiveness in a general population is lacking. Objective To estimate vaccine effectiveness of a primary cycle with NVX-CoV2373 against SARS-CoV-2 infection and symptomatic COVID-19. Design, Setting, and Participants Retrospective cohort study linking data from the national vaccination registry and the COVID-19 surveillance system in Italy during a period of Omicron predominance. All adults starting a primary vaccination with NVX-CoV2373 between February 28 and September 4, 2022, were included, with follow-up ending on September 25, 2022. Data were analyzed in February 2023. Exposures Partial (1 dose only) vaccination and full vaccination (2 doses) with NVX-CoV-2373. Main Outcomes and Measures Notified SARS-CoV-2 infection and symptomatic COVID-19. Poisson regression models were used to estimate effectiveness against both outcomes. Adjusted estimated vaccine effectiveness was calculated as (1 − incidence rate ratio) × 100. Results The study included 20 903 individuals who started the primary cycle during the study period. Median (IQR) age of participants was 52 (39-61) years, 10 794 (51.6%) were female, and 20 592 participants (98.5%) had no factors associated with risk for severe COVID-19. Adjusted estimated vaccine effectiveness against notified SARS-CoV-2 infection in those partially vaccinated with NVX-CoV2373 was 23% (95% CI, 13%-33%) and was 31% (95% CI, 22%-39%) in those fully vaccinated. Estimated vaccine effectiveness against symptomatic COVID-19 was 31% (95% CI, 16%-44%) in those partially vaccinated and 50% (95% CI, 40%-58%) in those fully vaccinated. Estimated effectiveness during the first 4 months after completion of the primary cycle decreased against SARS-CoV-2 infection but remained stable against symptomatic COVID-19. Conclusions and Relevance This cohort study found that, in an Omicron-dominant period, protein recombinant vaccine NVX-CoV2373 was associated with protection against SARS-CoV-2 infection and symptomatic COVID-19. The use of this vaccine could remain an important element in reducing the impact of the SARS-CoV-2 pandemic.
ISSN:2574-3805
2574-3805
DOI:10.1001/jamanetworkopen.2023.36854