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February 26, 2021

Coronavirus company news summary – J&J single-shot jab deemed safe and effective after FDA review – Chimerix and Atossa announce trial results for Covid-19 therapies

By Chris Lo

The US Food and Drug Administration (FDA) announced that healthcare company Johnson & Johnson’s single-shot Covid-19 vaccine is safe and effective for use according to trial data submitted to the agency for emergency use authorisation (EUA). Known as Ad26.COV2.S, the vaccine candidate will help prevent hospitalisations and deaths from severe Covid-19 and death from it.

Biopharmaceutical company Chimerix has announced topline results from its first cohort in a randomised, double-blind, placebo-controlled Phase II/III study among hospitalised patients suffering with acute lung injury (ALI) and Covid-19. Survival without the need for mechanical ventilation was the primary endpoint of the study through the 28th day. The first cohort enrolled 12 patients randomised 1:1. One patient on DSTAT was ventilated and recovered, two on placebo were ventilated and died, while no deaths occurred in patients on the DSTAT arm.

Atossa Therapeutics, a Seattle-based clinical-stage biopharmaceutical company, announced final results from its Phase I double-blinded, randomised, placebo-controlled clinical study that used AT-301, Atossa’s patented drug candidate administered via a nasal spray. AT-301 was found to be safe and tolerable among healthy participants at two different dose levels over 14 days. AT-301 is being developed for at-home use for recently diagnosed Covid-19 patients. The FDA has not yet approved any at-home therapy for Covid-19.

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