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

Author:

Mateo-Urdiales Alberto1,Sacco Chiara12,Petrone Daniele1,Bella Antonino1,Riccardo Flavia1,Del Manso Martina1,Bressi Marco1,Siddu Andrea3,Brusaferro Silvio4,Palamara Anna Teresa1,Rezza Giovanni3,Pezzotti Patrizio1,Fabiani Massimo1,Boros Stefano5,D'Ancona Fortunato (Paolo)5,Di Benedetto Corrado5,Filia Antonietta5,Rota Maria Cristina5,Tallon Marco5,Vescio Maria Fenicia5,Petrucci Antonia5,La Bianca Michele5,Mignuoli Anna Domenica5,Buono Pietro5,Massimiliani Erika5,Barbone Fabio5,Vario Francesco5,Sticchi Camilla5,Cereda Danilo5,Pompili Marco5,Sforza Francesco5,Bertoli Pierpaolo5,Benetollo Pier Paolo5,Pasqualini Chiara5,Cisceglia Lucia5,Palmas Maria Antonietta5,Addario Sebastiano Pollina5,Balocchini Emanuela5,Tosti Anna5,Ruffier Mauro5,Da Re Filippo5,Battilomo Serena5,Proietti Valeria5,Odio Camillo5,Recine Michele5,Ruberto Innocenza5,Ascione Salvatore5,Bisogno Massimo5,Miserendino Gandolfo5,Navacchia Massimiliano5,Del Frate Beatrice5,Cau Emanuela5,Baiocchi Diego5,Fusco Danilo5,Gallo Domenico5,Marchetti Maria Rosa5,Conforti Diego5,Trentini Carlo5,Ruggeri Antonino5,Ladalardo Concetta5,Albano Nehludoff5,Corona Marco5,Lombardi Paolo5,Iacono Massimo5,Angori Paolo Bruno5,Belardinelli Andrea5,Solfiti Milena5,Fioraso Stefano5,Poma Chiara5,Raccanello Nadia5,

Affiliation:

1. Department of Infectious Diseases, Istituto Superiore di Sanità, Rome, Italy

2. European Programme for Intervention Epidemiology Training, European Centre for Disease Prevention and Control, Stockholm, Sweden

3. General Directorate of Prevention, Ministero della Salute, Rome, Italy

4. Office of the President, Istituto Superiore di Sanità, Rome, Italy

5. for the Italian National COVID-19 Integrated Surveillance System and the Italian COVID-19 vaccines registry

Abstract

ImportanceProtein 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.ObjectiveTo estimate vaccine effectiveness of a primary cycle with NVX-CoV2373 against SARS-CoV-2 infection and symptomatic COVID-19.Design, Setting, and ParticipantsRetrospective 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.ExposuresPartial (1 dose only) vaccination and full vaccination (2 doses) with NVX-CoV-2373.Main Outcomes and MeasuresNotified 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.ResultsThe 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 RelevanceThis 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.

Publisher

American Medical Association (AMA)

Subject

General Medicine

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