The COVID-19 oral antiviral medication Pfizer’s Paxlovid has been given full approval by the Food and Drug Administration (FDA) for use in individuals who are at high risk of developing severe disease.
The drug’s emergency use license was approved by the agency about 15 months ago, and the approval comes as hospitalization and viral-related fatalities are on the decline.
Five-Day Treatment Course
The FDA advised starting Pfizer’s Paxlovid as soon as feasible following a COVID-19 diagnosis, but no later than five days after the onset of symptoms. Paxlovid is administered as a five-day treatment course.
People over the age of 50 and those with particular medical problems that place them at a high risk of consequences, such as hospitalization and severe COVID-19 disease, are specifically encouraged to use the medication.
Based on three Pfizer clinical trials, an FDA independent advisory committee recommended the agency completely approve Paxlovid in March. The committee found the drug to be secure and efficient for treating COVID-19 in high-risk adults. Pfizer’s Paxlovid does not “rebound” COVID-19 infection, the agency added. Patients who have not gotten the COVID-19 vaccine or who have never had the disease respond to Pfizer’s Paxlovid the best, according to studies.
Decreased Proportion of COVID-19 Patients
In a Pfizer clinical trial, Paxlovid significantly decreased the proportion of patients with COVID-19-related hospitalization or mortality by 89 percent in patients treated within three days of symptom onset and by 86 percent in patients treated within five days of symptom onset as compared to placebo.
“Today’s approval demonstrates that Pfizer’s Paxlovid has met the agency’s rigorous standards for safety and effectiveness and that it remains an important treatment option for people at high risk of progression to severe COVID-19, including those with prior immunity,” said Patrizia Cavazzoni, director of the FDA’s Centre for Drug Evaluation and Research.
She stated, “The FDA remains committed to collaborating with sponsors to support the development of innovative COVID-19 preventive and treatment options.
