key: cord-0953913-8yv4j4at
authors: Lanzafame, Massimiliano; Gibbin, Enrico; Lattuada, Emanuela; Vento, Sandro
title: Is monoclonal antibody administration necessary in all vaccinated patients with breakthrough COVID‐19 infections?
date: 2022-04-28
journal: J Med Virol
DOI: 10.1002/jmv.27802
sha: 846f08c9c4b54b40b9364bd42fceaa65e624177b
doc_id: 953913
cord_uid: 8yv4j4at

Data on anti-SARS-CoV-2 monoclonal antibodies efficacy came from clinical studies that enrolled unvaccinated patients. The implementation of massive vaccination campaigns has now considerably reduced the health burden related to COVID-19 in Italy, and treatment options for early-stage disease, such as monoclonal antibodies or antivirals, are nowadays used to treat many vaccinated people with breakthrough COVID-19 infections. Few articles have reported the clinical efficacy of monoclonal antibodies in vaccinated individuals with breakthrough COVID-19. In our retrospective study, we examined patients vaccinated with Pfizer-BioNTech, Moderna, Astra-Zeneca and Janssen Johnson & Johnson vaccines and eligible for treatment with monoclonal antibodies, enrolled from 1st September 2021 to 15th January 2022. None of the patients who refused to get monoclonal antibody treatment died or were hospitalized for severe disease, suggesting that vaccinated patients do not need to be treated. This article is protected by copyright. All rights reserved.

Anti-SARS-CoV-2 monoclonal antibodies have reduced viral shedding, time to symptom resolution, and admission to hospital for COVID-19 in patients with risk factors for severe disease. 1 The degree of medical comorbidity was assessed using the Monoclonal Antibody Screening Score (MASS) for the risk of severe COVID-19 outcomes. 5, 6 The results are reported in Table 1 .

All patients were contacted by telephone at least 28 days after COVID-19 diagnosis to assess their health status; none had died or had been hospitalized for severe disease (defined as need for oxygen supplementation or intensive care unit admission). Five patients (three treated with monoclonal antibodies, two untreated) had been hospitalized for unrelated diseases.

In the REGN-COV 2 trial, pre-existence of either IgA anti-S1, IgG anti-S1, or IgG anti-nucleocapsid protein was associated with lower baseline viral loads, and exogenously provided antibodies had substantial benefit only in antibody-negative patients. 1 Even though the role of antispike receptor binding domain antibodies in preventing severe COVID-19 disease in vaccinated individuals is not well defined, the results in our small cohort (in whom no deaths or hospitalizations for the severe disease were observed in patients untreated with monoclonal antibodies) suggest that these patients are generally protected by a severe course.

Measurement of antispike protein antibodies could guide the administration of monoclonals to vaccinated patients; reserving the treatment for antibody-negative patients would also considerably reduce costs.

REGN-COV2, a neutralizing antibody cocktail, in outpatients with Covid-19

Bamlanivimab plus Etesevimab in mild or moderate Covid-19

Monoclonal antibody treatment of breakthrough COVID-19 in fully vaccinated individuals with high-risk comorbidities

Breakthrough COVID-19 after SARS-CoV-2 vaccination in solid organ transplant recipients: an analysis of symptomatic cases and monoclonal antibody therapy

Real-world clinical outcomes of Bamlanivimab and Casirivimab-Imdevimab among high-risk patients with mild to moderate Coronavirus Disease

Influence of social and cultural factors on the decision to consent for monoclonal antibody treatment among high-risk patients with mild-moderate COVID-19