The U.S. Food and Drug Administration (FDA) has granted approval for Paxlovid, an oral antiviral medication, for the treatment of mild-to-moderate COVID-19 in adults at high risk for severe illness. This marks a significant milestone as Paxlovid becomes the first oral antiviral pill to receive FDA approval for COVID-19 treatment in adults.
Paxlovid, developed as a collaboration between various organizations, including the U.S. Department of Health and Human Services, has been available under emergency use authorization (EUA). This approval ensures continued access for adults and expands treatment eligibility to include children aged 12-18 who were not covered by the previous authorization. However, it should be noted that Paxlovid is not approved or authorized for use as a preventive measure against COVID-19.
Dr. Patrizia Cavazzoni, the director for the FDA's Center for Drug Evaluation and Research, acknowledged the progress made in mitigating the impact of COVID-19 and emphasized the importance of Paxlovid as a treatment option for individuals at high risk of severe illness.
“The FDA remains committed to working with sponsors to facilitate the development of new prevention and treatment options for COVID-19,” she said.
The FDA's approval of Paxlovid is based on rigorous scientific standards, requiring substantial evidence of effectiveness and safety. Clinical trials demonstrated the efficacy of Paxlovid in reducing hospitalization or death from COVID-19 by 86 percent compared to a placebo.
The trials also addressed concerns about COVID-19 rebound, showing that both Paxlovid and the placebo could lead to a subset of patients experiencing the resurgence of symptoms or shedding of the virus. However, the FDA's current data does not indicate a clear association between Paxlovid treatment and COVID-19 rebound.
The FDA is providing detailed prescribing information, including dosing instructions and potential side effects, to ensure the proper and safe use of Paxlovid. Common side effects include impaired sense of taste and diarrhea. Individuals should consult their health care providers to determine if Paxlovid is suitable for their treatment plan.