FDA wants Pfizer to study COVID rebound cases with a longer course of Paxlovid

President Joe Biden’s recent bout with COVID-19 and his subsequent rebound case has brought attention to the treatment he used—Pfizer’s Paxlovid.

Now the FDA is questioning the company about the highly touted oral antiviral for those who are infected and considered at high risk to progress to a severe form of the virus.

The United States regulator wants to know if a second five-day course of the drug would help prevent COVID from returning and has ordered Pfizer to conduct a trial by Sept. 30 of next year, Reuters said.

The FDA sent its letter on Aug. 5 as Biden was recovering from his comeback case. He originally tested positive on July 21, then again 10 days later. Another high-profile Paxlovid user, National Institute of Infectious Diseases director Anthony Fauci, experienced the same rebound effect of his case of COVID.

“We are working with the FDA to finalize a protocol to study patients who may be in need of retreatment, will share updates in due course,” Pfizer said in an emailed statement.

Three months ago, after the rebound issue first surfaced, the FDA chided Pfizer CEO Albert Bourla for saying to Bloomberg that patients should take another course of the treatment, “like you do with antibiotics.”

In a post, John Farley, M.D., the director of the FDA’s Office of Infectious Diseases, responded quickly to Bourla’s suggestion.

“There is no evidence of benefit at this time for a longer course of treatment or repeating a treatment course of Paxlovid in patients with recurrent COVID-19 symptoms,” he wrote.

Two recent studies show that COVID rebound happens to 27% of those who are infected but suggest that is more prevalent and pronounced among users of Paxlovid.

Paxlovid won FDA authorization last December after trials showed it was 90% effective in keeping at-risk patients out of the hospital and alive. Pfizer reported Paxlovid sales of $8.1 billion for the second quarter and expects revenue from the drug to reach $22 billion this year.