AstraZeneca may have ‘included outdated information’ in COVID-19 vaccine trial report, US says

AstraZeneca may have used “outdated information” when it released data from a late-stage trial of its COVID-19 vaccine early Monday, federal officials say. The Data and Safety Monitoring Board (DSMB) said late in the day it “was concerned” about the information the British drug maker made public about the trial of the vaccine it developed along with Oxford University.

The National Institute of Allergy and Infectious Diseases (NIAID) said “The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. 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.”

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AstraZeneca reported Monday that its COVID-19 vaccine provided strong protection among adults of all ages in a long-anticipated U.S. study, a finding that could have helped rebuild public confidence in the shot around the world and move it a step closer to clearance in the U.S.

But the latest statement from federal officials may prove to be a setback in those efforts.

The statement from the NIAID appeared to take both AstraZeneca and its partners, the scientists who developed the vaccine at Oxford University, by surprise. Neither provided any immediate reaction to the assertion that outdated data had been included in their report on the large U.S. trial.

Dr. Anthony Facui is the director of the NIAID. “It was not necessary. If you look at it, the data really are quite good but when you put it in the press released it wasn’t completely accurate,” Dr. Fauci said.

Fauci believes a review of data wills how AstraZeneca’s vaccine is still not effective in combatting the coronavirus.

“This is really what you call an unforced error because the fact is, this is very likely a very good vaccine and this kind of thing does, as you say, do nothing but really cast some doubt about the vaccines and maybe contribute to the hesitancy,” he said.

In the study of 30,000 people, the vaccine was 79% effective at preventing symptomatic cases of COVID-19 – including in older adults. There were no severe illnesses or hospitalizations among vaccinated volunteers, compared with five such cases in participants who received placebo shots – a small number, but consistent with findings from Britain and other countries that the vaccine protects against the worst of the disease.

AstraZeneca also said the study’s independent safety monitors found no serious side effects, including no increased risk of rare blood clots like those identified in Europe, a scare that led numerous countries to briefly suspend vaccinations last week.

AstraZeneca is working to provide the most up-to-date data to regulators.

The company intended to file an application with the Food and Drug Administration in coming weeks. There was no word on whether that application would be delayed due to the DSMB’s concerns.

The government’s outside advisers will publicly debate the evidence before the agency makes a decision. 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 a thorough review of the data by independent advisory committees.

AstraZeneca said in a statement the results posted yesterday were based on a February 17 cutoff.