The NIH’s Data Safety Monitoring Board says AstraZeneca may have used ‘outdated information’ in data released from its north American coronavirus vaccine trial.
AstraZeneca (AZN) – Get Report slumped lower Tuesday after U.S. health officials said the drugmaker may have used ‘outdated information’ in the data release of its recent coronavirus vaccine trial.
The Data Safety Monitoring Board (DSMB), a division of the National Institutes of Health that oversees new drug trials — but is not involved in their approval — said late Monday that it was concerned that AstraZeneca had provided and ‘incomplete view” of the trial’s efficacy data.
AstraZeneca had said on Monday that its newly-developed coronavirus vaccine scored a 79% efficacy rate in a large, late-stage north American trial, adding it would seek Emergency Use Authorization from the U.S. Food & Drug Administration over the coming weeks.
“We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible,” the DSMB said in a statement published on the NIH website.
“Authorization and guidelines for use of the vaccine in the United States will be determined by the Food and Drug Administration and Centers for Disease Control and Prevention after thorough review of the data by independent advisory committees,” the Committee added.
AstraZeneca’s U.S.-listed shares were marked 2.5% lower in pre-market trading Tuesday to indicate an opening bell price of $49.95 each, a move that would extend the stock’s six month decline to around 10%.
AstraZeneca said Monday that the phase 3 study of nearly 32,500 patients accrued just 141 symptomatic cases of COVID-19 in a 2:1 randomisation of vaccine to placebo set-up, with two doses administered over a four-week interval in the United States, Chile and Peru.
The headline 79% efficacy rate was supported by data showing “no increased risk of thrombosis or events characterized by thrombosis among the 21,583 participants receiving at least one dose of the vaccine”, countering one of the key concerns in Europe, where reports of blood clot risks had resulted in the temporary suspension of its use in certain countries.
No comments:
Post a Comment