WASHINGTON (KAMR/KCIT) – The US Food and Drug Administration (FDA) granted emergency use authorization for Pfizer’s Paxlovid, a packaged mixture of pills intended to treat mild-to-moderate COVID-19 in adults, and children over 12 years old, who have been diagnosed with COVID-19 and are at high risk of severe impacts from the virus. According to the FDA, Paxlovid is available by prescription only and should be initiated as soon as possible after a diagnosis of COVID-19 and within five days of symptom onset.
“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic,” said FDA Center for Drug Evaluation and Research Director Patrizia Cavazzoni, M.D., “This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19.”
The FDA announcement detailed that Paxlovid is not authorized for the pre-exposure or post-exposure prevention of COVID-19, or for those who have already been hospitalized with severe illness from the virus. The treatment is also not a substitute for vaccination from COVID-19.
The FDA has approved one vaccine and authorized others to prevent COVID-19 and serious clinical outcomes associated with a COVID-19 infection, including hospitalization and death. The FDA has continued to urge the public to get vaccinated and receive a booster if eligible.
The FDA also released a fact sheet for healthcare providers regarding drugs that should not be combined with the use of Paxlovid, and also noted a few groups who should consult with their healthcare providers and be more cautious with the treatment, including:
- People with uncontrolled or undiagnosed HIV-1 infection
- People with severe kidney or severe liver impairment