- The FDA has asked Pfizer Inc PFE to test an additional course of its antiviral Paxlovid among people who experience a rebound in COVID-19 after treatment.
- According to the Reuters report, the company must produce the initial results of a randomized controlled trial of a second course of the antiviral by September 30 next year.
- The National Institutes of Health studied 13,644 COVID-19 patients treated with Paxlovid or Merck & Co Inc's MRK molnupiravir within five days of their COVID-19 infection.
- Related: Pfizer Seeks Complete Approval For Paxlovid For High-Risk COVID-19 Patients.
- The 7-day and 30-day rebound rates after Paxlovid treatment were 3.53% and 5.40% for COVID-19 infection, 2.31% and 5.87% for COVID-19 symptoms, and 0.44% and 0.77% for hospitalizations.
- The rates after molnupiravir treatment - 5.86% and 8.59%, 3.75% and 8.21%, and 0.84% and 1.39%.
- The study concluded that COVID-19 rebound occurred 2 to 8 days after Paxlovid and molnupiravir, especially in patients with underlying medical conditions.
- The investigators suggest studies are necessary to determine the mechanisms underlying COVID-19 rebounds and to test dosing and duration regimes that might prevent such rebounds in vulnerable patients.
- In May, the FDA did not support the idea of taking more Paxlovid in case the infection rebounded.
- The FDA said a protocol for the study is expected to be finalized this month.
- Pfizer is "working with the FDA to finalize a protocol to study patients who may require retreatment" and will provide details when available, a company spokesperson said.
- Price Action: PFE shares are down 0.51% at $48.90 during the premarket session on the last check Monday.
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