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U.S. FDA orders Pfizer to test 2nd Paxlovid course for rebound COVID patients

Click to play video: 'People should look ‘at own set of circumstances’ when deciding to wait for possible bivalent COVID-19 vaccine: Tam' People should look ‘at own set of circumstances’ when deciding to wait for possible bivalent COVID-19 vaccine: Tam
Canada's chief public health officer Dr. Theresa Tam was asked Friday whether people should wait to get a COVID-19 booster for when potential bivalent vaccines are available and said people should "look at their own set of circumstances." She said while the bivalent vaccine would target both the original strain but also the BA.1 Omicron strain, people should consider their risk factors for exposure and potential for severe outcomes and not miss the chance to get a booster dose if it's been six months since last infection or booster – Aug 19, 2022

The U.S. Food and Drug Administration (FDA) has ordered Pfizer Inc PFE.N to test the effects of an additional course of its antiviral Paxlovid among people who experience a rebound in COVID-19 after treatment, the regulator said on Friday.

The drugmaker must produce initial results of a randomized controlled trial of a second course of the antiviral by Sept. 30 next year, the FDA told Pfizer in a letter dated Aug. 5.

Read more: Health Canada approves 1st COVID-19 booster for kids 5-11

The regulator said a formal plan for the clinical trial is expected to be finalized this month.

Pfizer is “working with the FDA to finalize a protocol to study patients who may be in need of retreatment,” and will provide details when available, a company spokesperson said.

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(Reporting by Leroy Leo in Bengaluru; Editing by Aditya Soni)

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