FDA Fires Back At Pfizer: ‘No Evidence’ A Second Round Of Paxlovid Helps

At issue is how to help patients who suffer a relapse in symptoms. Also, new research suggests that wearing two face coverings doesn’t offer more respiratory protection.

Bloomberg: Pfizer’s Advice On Retaking Covid Drug Contradicted By FDAThere is “no evidence” that a second course of Pfizer Inc.’s Paxlovid will help Covid-19 patients whose symptoms return after an initial course of the antiviral, a U.S. Food and Drug Administration official said a day after Pfizer executives advocated the idea. Doctors and virologists have been struggling to understand a number of patient reports of viral rebounds after completion of a five-day course of the Covid treatment. In an interview Tuesday, Pfizer Chief Executive Officer Albert Bourla said doctors could prescribe a second course of treatment to patients who suffer a rebound. (Langreth, 5/4)

Axios: FDA: “No Evidence” Second Pfizer COVID Pill Stops Repeat Symptoms, Contradicting CEOA Food and Drug Administration (FDA) official said Wednesday that there is “no evidence” that a second round of the Pfizer COVID pill Paxlovid will help patients who suffer a relapse in symptoms. The FDA’s comments contradict Pfizer chief executive officer Albert Bourla, who said patients experiencing COVID-19 symptoms after their first treatment can take more of the pill. “There is no evidence of benefit at this time for a longer course of treatment or repeating a treatment course of Paxlovid,” John Farley, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, said in a statement. (Scribner, 5/4)

In other news about covid sufferers —

CIDRAP: Remdesivir Slightly Lowers Death, Ventilation In COVID Hospital Patients COVID-19 patients already on ventilators don’t benefit from remdesivir, but the antiviral drug offers a slight reduction in death or progression to ventilation among other hospitalized patients, according to final results from the adaptive World Health Organization’s (WHO’s) Solidarity randomized trial and an updated meta-analysis. The findings, published this week in The Lancet, were from an ongoing study of four repurposed antiviral drugs as treatments for COVID-19 in hospitalized patients. (Van Beusekom, 5/4)

CIDRAP: Neurologic Illness May Affect 1 In 8 Hospitalized COVID-19 PatientsNearly 13% of hospitalized COVID-19 patients had serious neurologic illnesses in the first year of the pandemic, suggests an international study published last week in Critical Care Explorations. … Among the 16,225 patients enrolled in the registry whose hospital release status was available, 12.9% had serious neurologic illnesses, of whom 10.2% had encephalopathy (disease affecting brain structure or function) at admission, 2.0% had a stroke, 1.5% had seizures, and 0.5% had encephalopathy or meningitis (inflammation of the membranes surrounding the brain and spinal cord) at admission or during their hospital stay. (5/4)

In updates on masks —

CIDRAP: Study Suggests Double-Masking For COVID-19 Hurts More Than HelpsA study yesterday in Physics of Fluid shows that wearing two face coverings to protect against COVID-19 does not offer more respiratory protection, and may offer a false sense of protection for the wearer. Researchers from Florida State University and Johns Hopkins University used fluid dynamics simulation models to show how improperly fitted masks—even when layered—force flow from a simulated cough out of the perimeter gaps (sides, top, and bottom) of masks. (5/4)

Atlanta Journal-Constitution: Decatur Schools Urges Mask Wearing Again Due To Uptick In COVID CasesCity Schools of Decatur is asking staff and students to wear masks due to rising COVID-19 cases over the past two weeks. But the district is stopping short of a mandate due to a new Georgia law. “As we can see, COVID is a disease we will continue to live with and as we see spikes in our community, we must continue to adjust our mitigation strategies accordingly,” Superintendent Maggie Fehrman said in a letter sent to the school community on Wednesday. (Reyes, 5/5)

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