Development and regulation of medical countermeasures for Covid-19 (vaccines, diagnostics, and treatments): Frequently asked questions

ABSTRACT

In recent months, the Coronavirus Disease 2019 (COVID-19) pandemic has spread globally, with the United States now reporting the highest number of cases of any country in the world. Currently, there are few treatment options available to lessen the health impact of the disease and no vaccines or other prophylactic treatments to curb the spread of the virus. The biomedical community has been working to develop new therapies or vaccines, and to repurpose already approved therapeutics, that could prevent COVID-19 infections or lessen severe outcomes in patients. In addition, efforts have been underway to develop new diagnostic tools (i.e., testing) to help better identify and isolate positive cases, thereby reducing the spread of the disease. To this end, Congress has appropriated funds for research and development into new medical countermeasures (MCMs) in several recent supplemental appropriations acts. MCMs are medical products that may be used to treat, prevent, or diagnose conditions associated with emerging infectious diseases or chemical, biological, radiological, or nuclear (CBRN) agents. MCMs include biologics (e.g., vaccines, monoclonal antibodies), drugs (e.g., antimicrobials, antivirals), and medical devices (e.g., diagnostic tests). This chapter answers frequently asked questions about current efforts related to research and development of medical countermeasures, their regulation, and related policy issues. Although several efforts are underway, medical product research, development, and approval is a difficult and high-risk endeavor that takes years in typical circumstances. In response to COVID-19, this process has been expedited, including through several federal programs and mechanisms covered in this chapter. However, expedited medical product development can carry certain risks, such as a more limited safety profile for new products upon approval. © 2021 by Nova Science Publishers, Inc.