AstraZeneca on Tuesday said it will share up-to-date vaccine data with federal advisers “within 48 hours” after federal officials — in a highly unusual move — said promising results from the company’s COVID-19 trial might have been based on outdated information.
The drugmaker said the new information should be consistent with the analysis it used to report promising results of its vaccine on Monday. That analysis had a data cutoff of Feb. 17.
The infectious-diseases arm of the National Institutes of Health released a post-midnight statement Tuesday that said an outside panel of experts, known as the Data and Safety Monitoring Board, had problems with the data used to tout the results.
“The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.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,” read the statement from the National Institute of Allergy and Infectious Diseases.
NIAID Director Anthony Fauci said the monitoring board felt a news release on the results was misleading and wanted the company to “straight it out.” He said the dustup amounted to an unforced error.
“This is likely a very good vaccine,” Dr. Fauci told ABC News’ “Good Morning America.” “If you look at it, the data really are quite good, but when they put it into the press release it wasn’t completely accurate.”
AstraZeneca on Monday said its vaccine completely staved off hospitalizations and severe disease and was 79% effective at preventing all forms of disease from the coronavirus in a large U.S. trial that also included participants in Chile and Peru.
It was a promising sign after the vaccine faced hiccups in Europe. Shipments were delayed earlier, and European regulators had to assure nations the vaccine was safe amid concerns about blood clotting in some recipients.
Biden coronavirus adviser Andy Slavitt, speaking to CNN, characterized the clash with U.S. advisers as a sign that regulatory mechanisms are working.
“Nothing will get approved unless the FDA does a thorough analysis of this data,” Mr. Slavitt said. “Until that time, this is all stuff that will happen in the background.”
AstraZeneca expects to seek emergency approval from the Food and Drug Administration in the coming weeks. If approved, it would become the fourth vaccine approved in the U.S.
A Maryland company, Novavax, reported positive results from its trials and is targeting FDA authorization by May.
The nation is administering an average of 2.5 million shots per day of the two-dose versions from Pfizer-BioNTech and Moderna and one-shot version from Johnson & Johnson.
About a quarter of the U.S. population has received at least one shot and nearly 14% is fully vaccinated, according to the Centers for Disease Control and Prevention.
More than 540,000 Americans have died from COVID-19, while almost 30 million have contracted the virus.
States are gradually opening up eligibility as supply ramps up.
Texas said it plans to make all adults eligible on Monday, making it the fourth state to fling open the gates after Alaska, Mississippi and West Virginia.