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FDA and Pfizer differ in interpreting Paxlovid treatment recommendations

By Brian Buntz | May 5, 2022

FDA logoPfizer CEO Dr. Albert Bourla recently said that patients who relapse after completing a course of the COVID-19 antiviral Paxlovid (nirmatrelvir and ritonavir) could continue taking the drug.  

“Paxlovid does what it has to do: it reduces the viral load,” Bourla told Bloomberg. “Then your body is supposed to do the job.”  

“While the FDA label states Paxlovid is not authorized for use for longer than 5 consecutive days, there are no limitations within the authorized label around use for subsequent COVID-19 infections if the patient is at high risk of progression to severe illness,” said a Pfizer spokesperson. 

Paxlovid

[Paxlovid image courtesy of Wikimedia Commons]

In a clinical trial, between 1% and 2% of COVID-19-infected participants taking Paxlovid experienced a relapse, which was a similar rate to placebo recipients. 

In a recent article, Dr. John Farley, director of the FDA’s Center for Drug Evaluation and Research, said the agency was aware of reports of some patients developing COVID-19 symptoms after completing a five-day course of Paxlovid. 

Farley concluded that “there is no evidence of benefit at this time for a longer course of treatment (e.g., 10 days rather than the 5 days recommended in the Provider Fact Sheet for Paxlovid) or repeating a treatment course of Paxlovid in patients with recurrent COVID-19 symptoms following completion of a treatment course.”

Farley also stressed that there is robust data indicating Paxlovid cuts the risk of hospitalization and death in patients with an elevated risk of developing severe COVID-19. 

The drug appears to be less effective when used as a post-exposure prophylactic based on data from a recent Phase 2/3 study.


Filed Under: Infectious Disease
Tagged With: antiviral, covid-19, COVID-19 antiviral, Paxlovid, Pfizer
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at [email protected].

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