Est. 2026 · Armando Cuesta, MD, Founding Editor

The Vital Record

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Wednesday, 3 June 2026 edition — The Vital Record

Symptomatic COVID-19 by day 10 (SCORPIO-PEP, mITT)
Ensitrelvir (n=1,030)2.9 % of household contacts infectedPlacebo (n=1,011)9 % of household contacts infected
Primary endpoint, modified intention-to-treat. Risk ratio 0.33; 95% CI 0.22-0.49; P<0.001. Source: Hayden FG et al., N Engl J Med 2026;394(19):1905-1915, DOI 10.1056/NEJMoa2509306 (per PubMed).

FDA & Regulatory

FDA clears ensitrelvir to prevent COVID-19 after household exposure; NEJM trial showed 2.9% vs 9.0% infection

Shionogi's oral antiviral Xocova held symptomatic COVID-19 to 2.9% in exposed household contacts versus 9.0% on placebo in the Phase 3 SCORPIO-PEP trial, published in NEJM weeks before the June 1 clearance.

The FDA on June 1 approved Shionogi’s oral antiviral ensitrelvir (Xocova) for post-exposure prophylaxis of COVID-19 in adults and adolescents 12 and older who have had household contact with an infected person, the company said. Shionogi describes it as the first and only oral option cleared in the United States to help prevent symptomatic COVID-19 after exposure, rather than treat it.

The clearance rests on SCORPIO-PEP, a Phase 3 randomized, double-blind, placebo-controlled trial sponsored by Shionogi and registered as NCT05897541. Unlike many approvals announced ahead of publication, the full dataset was already in the public record: the results appeared in the New England Journal of Medicine on May 14, 2026, weeks before the FDA decision.

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