23rd Mar 2021 12:25
(Alliance News) - AstraZeneca PLC on Tuesday said it will release more data on US trials of its Covid-19 jab within the next two days following regulatory concerns that the pharmaceutical firm used "outdated information".
The Data & Safety Monitoring Board said it was concerned that AstraZeneca may have provided an incomplete view of the efficacy data.
The company on Monday said the US phase III trial of its AZD1222 vaccine - co-developed with the University of Oxford - demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic Covid-19 and 100% efficacy at preventing severe disease and hospitalisation.
But just hours after those encouraging results were reported, the US National Institute of Allergy and Infectious Diseases said the DSMB "expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data".
AstraZeneca on Tuesday said the numbers on Monday was from data with a cut-off of February 17.
"We will immediately engage with the independent data safety monitoring board to share our primary analysis with the most up to date efficacy data. We intend to issue results of the primary analysis within 48 hours," Astra said.
Shares in the company were 1.1% lower at 7,263.29 pence each in London on Tuesday afternoon.
By Eric Cunha; [email protected]
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