AstraZeneca may have included “outdated information” in U.S. trial results for its COVID-19 vaccine, providing an “incomplete view of the efficacy data,” a U.S. federal health agency said early on Tuesday.
On Monday, drug company AstraZeneca said that interim data from a major late-stage trial found the vaccine was 79% effective in preventing symptomatic COVID-19 and 100% effective at preventing people from falling seriously ill.
In a rare statement, the National Institute of Allergy and Infectious Diseases (NIAID), said it had been notified by the Data and Safety Monitoring Board (DSMB), an independent committee overseeing the U.S. trial, that it was “concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial.”
“The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” the NIAID said. “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.”
NIAID is headed by U.S. infectious diseases expert Dr. Anthony Fauci and is part of the National Institutes of Health.
AstraZeneca didn’t immediately respond to request for comment.
Shares in AstraZeneca
fell more than 1% in early morning trading in London on Tuesday.
The concerns will cast doubt on whether AstraZeneca will be able to seek U.S. emergency use authorization for the shot, which was developed in collaboration with the University of Oxford, in the coming weeks as planned.
The trial also showed there were no safety issues regarding blood clots.
AstraZeneca said on Monday that it will prepare for the primary analysis from its U.S. trial to be submitted to the U.S. Food and Drug Administration for emergency use authorization in the coming weeks. The analysis will also be submitted for publication in a peer-reviewed journal.
Data from the Phase 3 trial involved more than 32,000 volunteers, mostly in the U.S., but also in Chile and Peru.
The NIAID statement said authorization and guidelines for use of the vaccine in the U.S. will be determined after thorough review of the data by independent advisory committees.
If AstraZeneca’s vaccine is approved, it will be the fourth to be authorized by the U.S. following green lights for the vaccines developed by Germany’s BioNTech
with its U.S. partner, drug company Pfizer
and by biotech
and by medical device company Johnson & Johnson
The rollout of the AstraZeneca vaccine has been temporarily paused in some countries, including Finland, Norway, Denmark and Sweden, over concerns about blood clots in a number of recipients.
Countries including Germany, Italy and Spain have restarted inoculations since the European Medicines Agency declared the vaccine “safe and effective” after its own investigation found no link to blood clots. France is still limiting use of the shot to those aged over 55.
The U.S. trial also showed there were no safety issues regarding blood clots.
AstraZeneca has said its own review of safety data of more than 17 million people vaccinated in the U.K. and European Union had shown no evidence of an increased risk of blood clots.
The World Health Organization last week urged countries to keep their inoculation campaigns going, as it said the benefits of AstraZeneca’s vaccine still outweigh the risks.