Related Experiment Video
Updated: Oct 24, 2025
Detection of SARS-CoV-2 Neutralizing Antibodies using High-Throughput Fluorescent Imaging of Pseudovirus Infection
Published on: June 5, 2021
Editorial: Post-Exposure Prophylactic Neutralizing Monoclonal Antibodies to SARS-CoV-2 for Individuals at High Risk
1Science Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.
Abstract:
Regulatory authorities, including the US Food and Drug Administration (FDA), have accelerated diagnostic and therapeutic approvals during the coronavirus disease 2019 (COVID-19) pandemic. Accelerated clinical development and approvals have resulted in vaccine programs for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, some individuals remain at high risk for the progression of COVID-19. In the US, the FDA has given Emergency Use Authorization (EUA) for two neutralizing therapeutic monoclonal antibody 'cocktails,' casirivimab and imdevimab (REGEN-COV), bamlanivimab and etesevimab, and one monotherapy, bamlanivimab, for prophylactic post-exposure therapy in individuals at high risk of progressing to severe COVID-19. Preclinical and clinical studies showed consistent effectiveness of REGEN-COV against current variants of SARS-CoV-2. On 21st November 2020, the FDA approved an initial EUA for REGEN-COV to treat mild to moderate COVID-19 in adults and in children 12 years or older with exposure to SARS-CoV-2 at high risk for progression to severe COVID-19. On 30th July 2021, the FDA updated its EUA for REGEN-COV for emergency use as post-exposure prophylactic to prevent COVID-19 progression in adults and children aged 12 years or older. This Editorial aims to provide an update on accelerated regulatory authorization for post-exposure prophylactic neutralizing monoclonal antibodies to SARS-CoV-2 for individuals at high risk for COVID-19.
Insights
Regulatory authorities expedited approvals for COVID-19 therapies, including monoclonal antibodies like REGEN-COV. These treatments offer post-exposure prophylaxis for high-risk individuals to prevent severe coronavirus disease 2019.
Area of Science:
- Immunology
- Virology
- Regulatory Science
Background:
- The COVID-19 pandemic prompted accelerated regulatory pathways for diagnostics and therapeutics by authorities like the US FDA.
- Emergency Use Authorization (EUA) was granted for monoclonal antibody therapies, including REGEN-COV (casirivimab and imdevimab), for high-risk individuals.
- These antibodies target severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), aiming to prevent progression to severe COVID-19.
Discussion:
- REGEN-COV has demonstrated consistent effectiveness against circulating SARS-CoV-2 variants in preclinical and clinical studies.
- The FDA's EUA for REGEN-COV was initially for treatment and later updated for post-exposure prophylaxis in eligible populations.
- This editorial focuses on the accelerated authorization of neutralizing monoclonal antibodies for SARS-CoV-2 post-exposure prophylaxis.
Key Insights:
- Neutralizing monoclonal antibodies, such as REGEN-COV, are crucial for preventing severe COVID-19 in high-risk populations.
- Accelerated regulatory processes enabled rapid deployment of these vital medical countermeasures.
- Consistent efficacy against SARS-CoV-2 variants underscores the therapeutic value of REGEN-COV.
Outlook:
- Continued monitoring of antibody effectiveness against emerging SARS-CoV-2 variants is essential.
- Further research may explore expanded indications or novel antibody-based strategies for COVID-19 prevention and treatment.
- The regulatory frameworks established during the pandemic may inform future responses to public health emergencies.
