The National Institute of Allergy and Infectious Diseases said in a statement on Tuesday that the Data Safety Monitoring Board, an independent body overseeing the COVID-19 vaccine trials, had informed it that the U.K.-based pharmaceuticals group had provided outdated information to U.S. regulators.
The news throws into doubt the ability of drug company AstraZeneca
to obtain swift approval for emergency use authorization by the U.S. regulator.
- AstraZeneca had published on Monday the results of its U.S. trial, showing 79% efficacy against COVID-19 symptoms and 100% efficacy in preventing its most serious developments.
- The NIAID, which is headed by top infectious-diseases expert Dr. Anthony Fauci, said the monitoring board had “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.”
- The AstraZeneca vaccine, developed with the University of Oxford, was approved three months ago in the U.K. and Europe and has been the most widely used shot in the world since then.
- It has been marred by safety concerns raised by several European governments, and European Union officials’ anger over the company’s inability to fulfill its supply contract with the European Commission.
- Both the U.K. and EU medicines regulators insisted last week after new reviews that the vaccine was safe and should continue to be used.
The outlook: The latest news could have a bigger impact in the rest of the world than in the U.S. With many other shots available, the U.S. vaccination campaign can go ahead at the current pace without the AstraZeneca vaccine. But new doubts raised about the company’s trials could slow down rollouts in Europe and elsewhere.
For AstraZeneca, the continuous flow of mixed news about its shot has so far proved more of a public relations disaster than a medical one — all regulators it had submitted its vaccine to have approved it and recommended it so far.
If Europeans look at the bright side, further delays of the U.S. regulator’s approval could mean that the millions of doses already made and stored in the U.S. could be send abroad and help deal with shortages.