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Wednesday, 3 June 2026 edition — The Vital Record
Vol. 1 · No. 2Wednesday, 3 June 2026“Primary sources, measured claims, no hype.”
Symptomatic COVID-19 by day 10 (SCORPIO-PEP, mITT)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).
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.
WHO declared a public health emergency on 17 May; by ECDC's 1 June data cut, confirmed cases had passed 350, and the agency issued hospital infection-control advice on 2 June.
In TROPiCS-04, the antibody-drug conjugate did not significantly extend life over chemotherapy in pretreated urothelial cancer, and an excess of treatment-related deaths outweighed gains on some secondary endpoints.
Digital Health & AIPhilips puts AI auto-measurement and on-cart Koios on its general-imaging ultrasoundA 510(k) clearance brings automated abdominal measurements and breast/thyroid decision support to EPIQ Elite and Affiniti carts — but the headline accuracy figure rests on a vendor's retrospective n=150 analysis, not a peer-reviewed trial.