Treatments: Safety & Effectiveness

Treatments for infectious respiratory diseases undergo rigorous research, multi-stage clinical trials, robust regulatory review and approvals, and ongoing safety monitoring once a treatment is approved for use.

Learn more about the review and approval process below.

How do antivirals get approved for use?

Approval

The Food and Drug Administration (FDA) plays a crucial role in reviewing the safety and efficacy of antiviral treatments before they become widely available. The approval process begins with extensive research and clinical trials to assess the drug’s safety, effectiveness, and optimal dosing. This careful evaluation involves multiple phases, where the antiviral is tested on increasingly larger groups of participants to gather specific data on its benefits and potential side effects.

Emergency Use Authorization

In certain situations, such as public health emergencies, the FDA may expedite this approval process through mechanisms like Emergency Use Authorization (EUA). This allows for the use of antiviral treatments that have shown promise in initial studies, providing timely access to potentially life-saving medications when no other options are available.

How effective are COVID-19 and influenza (flu) antivirals?

Oral antivirals are most effective when they are started as soon as possible after being infected — within 5 days after symptoms begin for COVID-19 and within the first 2 days for flu. Clinical trials have shown oral antivirals reduce the risk of hospitalization 60% for flu, and the risk of hospitalization or death by as much as 89% for COVID-19.