MONTGOMERY-The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization to Pfizer for its oral antiviral drug Paxlovid to treat COVID-19. Data indicates that it is 88 percent effective in reducing the proportion of people with COVID-19-related hospitalization or death. Paxlovid is in tablet form and the initial limited supply of 780 patient courses will be available by prescription only by the first week of January. Alabama will initially use pharmacies to dispense the oral antiviral drug, and will add other providers as allocation allows.
State Health Officer Dr. Scott Harris said, “As new variants continue to emerge, we are excited that the oral tablet Paxlovid will soon be available to help combat COVID-19 in non-hospitalized patients. While we are very pleased Paxlovid will be a treatment option, it is not a substitute for vaccinations which remain the best way for most people to protect themselves against severe illness and death due to COVID-19. I continue to urge all Alabamians to be vaccinated and receive a booster dose when eligible.”
Paxlovid is authorized for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Paxlovid should be initiated as soon as possible after diagnosis of COVID-19 and within five days of the onset of symptoms. Patients who are prescribed this treatment must have a positive SARS-CoV-2 test, be at high risk for progressing to severe COVID-19, and be age 12 years or older and weigh at least about 88 pounds. It is administered as three tablets taken together twice daily for five days. Paxlovid is not authorized for use for longer than five consecutive days.
The supply of Paxlovid will be limited initially. According to the FDA, the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, will oversee its fair and equitable allocation to state and territorial health departments and select Health Resources & Services Administration (HRSA) – funded health clinics. The federal government has purchased 10 million courses of Paxlovid, the FDA stated. Production will ramp up significantly in the coming months, and an initial 65,000 courses of Paxlovid will be made available for shipment. The first allocations of Paxlovid were determined on a pro rata basis and will be provided to state and territorial health departments at no charge.
Previously authorized monoclonal antibodies require administration with an IV or injections. Paxlovid’s safety and effectiveness continue to be evaluated, and some side effects and contraindications have been documented.
Media Release/Wes Stubblefield, M.D./ALABAMA DEPARTMENT OF PUBLIC HEALTH
