FDA finds ‘no evidence’ that second Pfizer pill stops repeat COVID-19 symptoms

While Pfizer’s COVID-19 antiviral Paxlovid does offer a reduction in hospitalization and deaths, there is currently “no evidence” to suggest that prolonging and repeating a course of the drug has any more benefit, according to an FDA official.

John Farley, director of the Food and Drug Administration’s (FDA) Office of Infectious Diseases, said on Wednesday that there is currently “no evidence of benefit at this time for a longer course of treatment” of Paxlovid.

Farley was responding to reports of patients testing positive for COVID-19 following a round of Paxlovid after initially testing negative at the end of treatment.

The FDA official noted that 1 to 2 percent of patients in Pfizer’s clinical trial tested positive for COVID-19 after having initially testing negative at the end of their round of the antiviral. This was observed in both patients who received Paxlovid and those who received a placebo.

A round of Paxlovid is administered as three tablets — two tablets of nirmatrelvir and one tablet of ritonavir — taken twice a day over five days. Farley said extending this to 10 days or beginning a second round for patients with “recurrent COVID-19 symptoms” has not been shown to have added benefit.

Farley’s remarks go directly against what Pfizer CEO Albert Bourla said in an interview this week. Bourla told Bloomberg in an interview that patients who experience a relapse in COVID-19 symptoms should start “a second course, like you do with antibiotics, and that’s it.”

Paxlovid is not fully approved by the FDA, and the agency’s emergency use authorization states that the drug is “not authorized for use for longer than five consecutive days.”