AstraZeneca becomes the third drugmaker to release vaccine trial protocol

Sept. 21, 2020

Last week, amid growing vaccine skepticism and calls for transparency, Moderna, followed by Pfizer, released their COVID-19 vaccine trial blueprints — and now AstraZeneca/University of Oxford has joined them.

For AstraZeneca, there has been concern that the drugmaker has not been forthcoming about the two clinical holds placed on its AZD1222 trial. The first pause was determined to be an undiagnosed case of multiple sclerosis, unrelated to the vaccine. The second serious adverse event, still unconfirmed by AstraZeneca, is believed to be transverse myelitis, and it is unclear whether or not the issue is related to the vaccine. AstraZeneca's trials have resumed in Britain, Brazil, India and South Africa, but are still on pause in the U.S.

AstraZeneca’s 111-page trial blueprint states a 50 percent efficacy goal — the same threshold set by the FDA in its  coronavirus vaccine guidance. The protocol also anticipates a safety board interim analysis after 75 infections. This differs from Moderna's plan, which anticipates two analyses (one at 53 infections and one at 106), and Pfizer's, which anticipates four (32,62, 92 and 120).  Reaching 50 percent efficacy at any of these interims could allow the drugmaker to apply for Emergency Use Authorization from the FDA.

Read the NY Times coverage