Results from a U.S. clinical trial testing the efficacy and safety of AstraZeneca’s COVID-19 vaccine may have included “outdated information,” American officials said early Tuesday.
The Data Safety Monitoring Board notified the company and two health agencies late Monday that it was worried by the information AstraZeneca released on its trial.
The board, which monitors trials and reviews data collected at regular intervals, “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” according to the National Institute of Allergy and Infectious Diseases (NIAID), one of the agencies.
The institute urged AstraZeneca to work with the board to review the data and ensure the release of the most accurate, up-to-date information as quickly as possible.
AstraZeneca, based in England, said earlier Monday that an interim analysis of phase three trial data showed its vaccine is safe and effective.
The company said the vaccine “was well tolerated” and the Data Safety Monitoring Board “identified no safety concerns related to the vaccine.”
But the board didn’t necessarily agree.
“This likely a very good vaccine,” Dr. Anthony Fauci, NIAID’s chief, said during an appearance on ABC’s “Good Morning America.”
But the monitoring board “got concerned and wrote a rather harsh note” to AstraZeneca after seeing the press release, he added, “saying that in fact they felt the data that were in the press release were somewhat outdated and might, in fact, be misleading a bit, and wanted them to straighten them out.”
Over a dozen countries this month suspended use of AstraZeneca’s COVID-19 vaccine after patients died after being injected. Others experienced blood clots.
The European Union’s drug regulator said last week the vaccine is “safe and effective,” finding the shot wasn’t linked with an increase in overall risk in developing blood clots, and that the benefits of using it outweigh potential risks.
The United States hasn’t yet cleared AstraZeneca’s vaccine for use. The company said in announcing the trial results that it was preparing to apply for emergency authorization in the coming weeks.
American drug regulators have authorized three shots so far. Regulators authorized shots from Moderna and Pfizer late last year. Johnson & Johnson’s vaccine was granted emergency authorization on Feb. 27.
The Food and Drug Administration, which reviews requests for emergency authorization, last year suspended a U.S. trial for AstraZeneca’s shot for six weeks. The trial resumed in October after regulators reviewed all safety data from trials globally and concluded it was safe to resume the trial, the company said.
Officials said then that results were expected by the end of the year.
AstraZeneca’s vaccine was co-developed by the University of Oxford.
The United States has vaccinated nearly 45 million people fully against the CCP (Chinese Communist Party) virus, which causes COVID-19, as of early Monday. Another roughly 38 million have received one shot, but are waiting for another. Both Moderna and Pfizer recommend people get two shots, spaced several weeks apart. Johnson & Johnson’s is a single shot.