- AstraZeneca may have included "outdated information" in announcing preliminary results from a large U.S. trial of its coronavirus vaccine this week, U.S. officials said early Tuesday in a perplexing statement that raises further questions about the British drugmaker's communication around the shot.
- "If you look at it, the data really are quite good," said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, which helped AstraZeneca conduct the trial. "But when they put it into the press release it wasn't completely accurate," he said on Good Morning America, calling the back-and-forth an "unforced error."
- In its response, AstraZeneca said numbers from the trial that it published Monday were based on an interim analysis of results through Feb. 17. Updated data from the full primary analysis of the study will be disclosed within 48 hours, according to the company.
On Monday, both AstraZeneca and NIAID released initial findings from the U.S. trial, indicating the vaccine was 79% effective in preventing COVID-19 and even more protective against the disease's worst symptoms. The result was better than previous clinical data and a win for AstraZeneca, which has hit numerous delays and setbacks in developing its shot alongside partner the University of Oxford.
Less than 24 hours later, however, AstraZeneca is grappling with another misstep that could seed further doubt about its vaccine.
Following the Monday morning data release, a U.S.-organized committee that oversees the study grew concerned about the company's representation of the data, Fauci said, and wrote AstraZeneca and NIH a "rather harsh note."
"They felt the data that was in the press release were somewhat outdated and might in fact be misleading a bit," the NIAID director said.
AstraZeneca and NIAID included similar information in their statements on the vaccine's results, noting a 78.9% efficacy rate against symptomatic COVID-19, complete protection against severe disease and an equivalent 79.9% efficacy rate among adults older than 65 years.
But AstraZeneca included further information, such as the number of COVID-19 cases on which those efficacy numbers were based.
In emailed statements, neither NIAID nor AstraZeneca offered further details on which specific data the trial's monitoring board considered to be out of date.
It's unusual for a data safety and monitoring board to comment publicly about an ongoing trial.
More data from AstraZeneca could clear up the confusion later this week, but the episode may further damage trust in the company's communication about the vaccine.
Last year, U.S. regulators placed the company's U.S. trial on hold over concerns about a neurological illness observed in one patient. The pause dragged out for nearly two months, reportedly as AstraZeneca was slow to provide the Food and Drug Administration with needed information.
Later, when trials in the U.K. and South Africa showed the vaccine could protect against COVID-19, the good news was tarnished by a mix-up that resulted in some participants receiving the wrong dose. AstraZeneca later changed its explanation describing which regimen it believed to be most effective.
More recently, AstraZeneca has sparred with EU officials, which have argued the company is short-changing the economic bloc on vaccine supplies.
And earlier this month, many European countries paused rollout of the shot after reports of rare and potentially dangerous blood clotting in a handful of people among the more than 20 million vaccinated to date. Both the European Medicines Agency and the World Health Organization have supported the vaccine's safety, after reviewing data on the side effect.
Results from the U.S. trial are expected to support an application for emergency use in the U.S., although by the time the vaccine review is completed, much of the county's population will likely have already been vaccinated with one of the three other shots now available.