# Responding to emerging COVID-19 variants of concern

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/e2f17950-dc73-4435-910a-2e52c73cc904
Type: Guidance
Published: February 2, 2023

> This document details a collaborative initiative led by the UK Medicines and Healthcare products Regulatory Agency (MHRA), the Antivirals and Therapeutics Taskforce of the Department of Health and Social Care (DHSC), the UKHSA, and academic experts. On September 12, 2022, these organizations held a workshop to address critical challenges in the management of the SARS-CoV-2 pandemic. The primary issue identified was the rapid evolution of viral variants, which has led to viral escape mechanisms and a significant loss of activity in existing antiviral drugs and monoclonal antibodies (mAbs). These mutations create a major regulatory and clinical hurdle: the inability to generate traditional efficacy data at a speed that matches the emergence of new strains. To overcome this, the regulatory framework established through these discussions focuses on leveraging in vitro data and Pharmacokinetic-Pharmacodynamic (PK-PD) analysis. This framework is designed to assist industry stakeholders and product developers in evaluating the ongoing effectiveness of therapeutic agents. Required actions for developers include utilizing these advanced analytical models to bridge knowledge gaps and support the rapid deployment of treatments. By shifting toward these predictive evaluations, the MHRA and its partners aim to provide a more responsive pathway for maintaining the efficacy of treatments against a constantly changing viral landscape.

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## Content

The evolution and spread of the original SARS-CoV-2 virus - and subsequent variants of the virus creating cyclical waves of infection - has demanded the rapid development and deployment of many antiviral therapeutic agents which presents a unique opportunity to assist in the management of the pandemic. The viral escape mechanisms due to new variants have also presented unique challenges arising from the apparent loss of activity of therapeutic agents, such as the challenge of generating efficacy data in a timely fashion. To address these challenges, the Antivirals and Therapeutics Taskforce established by the Department of Health and Social Care, together with academic expert pharmacologists, the UKHSA and the MHRA, held a workshop on 12 September 2022, involving several stakeholders, to identify knowledge gaps and encourage better utilisation of in vitro and Pharmacokinetic-Pharmacodynamic (PK-PD) analysis that could support the ongoing evaluation of the efficacy of several products. This document describes the discussions and outputs from the workshop and subsequent interactions. It is intended to assist industry and the developers of products by providing a framework for the development of antiviral drugs and monoclonal antibodies (mAbs).

## Attachments

- [Responding to emerging COVID-19 variants of concern](https://assets.publishing.service.gov.uk/media/63dbbb0ad3bf7f070ce863e5/Responding_to_emerging_Covid-19_variants_of_concern_pdf.pdf)
- [Responding to emerging COVID-19 variants of concern](/government/publications/responding-to-emerging-covid-19-variants-of-concern/responding-to-emerging-covid-19-variants-of-concern)