Several approved or authorized treatments are expected to remain active to fight against the currently circulating variants and are widely available.
The FDA has worked around the clock throughout the pandemic and used the best available data to ensure options are available to prevent and treat COVID-19. This work is particularly important for people who are unable to get vaccinated and for immunocompromised people who may not mount an adequate immune response to vaccination.
Disease experts at HHS continually watch for new variants of any viruses and continue to monitor the potential impact that new variants might have on existing therapies. By taking this approach, we can identify the need for new medical products and ways to expedite development of new medical products to address emerging variants. For example, nearly two years ago, the FDA provided guidance to industry on how to efficiently generate non-clinical and chemistry, manufacturing and controls data that could potentially support an Emergency Use Authorization for monoclonal antibody products that had potential to be effective against emerging variants.
In December 2022, FDA and European Medicines Agency (EMA) convened a workshop to bring together the expertise of academics, clinicians, industry, and regulatory bodies to address the acceptability and challenges of alternative strategies to support the development of novel monoclonal antibody therapies including those based on prototype products that have demonstrated safety and efficacy in clinical trials. FDA is committed to working with industry sponsors to expedite the development of new drug products to meet unmet needs, such as the need for new preventive therapies for immune suppressed patients who are unlikely to respond to vaccination.