The United States Federal authorities are raising concerns that AstraZeneca may have included “outdated information” on its COVID-19 vaccine trial in reporting its efficacy.
The National Institute of Allergy and Infectious Diseases (NIAID), which is led by Anthony Fauci, said in a statement on Tuesday that the Data and Safety Monitoring Board (DSMB) notified federal officials and the company 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“The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” the NIAID said.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.”
AstraZeneca said on Monday that it planned to file for an emergency use authorization with the Food and Drug Administration to get approval for vaccinations in the U.S.
In a statement on Tuesday, AstraZeneca noted that the data released the day prior was based on “pre-specified interim analysis with a data cut-off” of Feb. 17.
“We have reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis,” the company said. “We are now completing the validation of the statistical analysis.”
“We will immediately engage with the independent data safety monitoring board (DSMB) to share our primary analysis with the most up to date efficacy data,” AstraZeneca said. “We intend to issue results of the primary analysis within 48 hours.”
Fauci told ABC News’s “Good Morning America” on Tuesday morning that the statement was in response to AstraZeneca’s Monday press release on its vaccine’s efficacy.
“The Data and Safety Monitoring Board when they saw that press release they got concerned and wrote a rather harsh note to them and with a copy to me, saying that they in fact they felt that the data that was in the press release were somewhat outdated and might in fact be misleading a bit and wanted them to straighten it out,” he said.
The NIAID’s statement “essentially” told AstraZeneca that “they better get back with the DSMB and make sure the correct data get put into a press release,” he continued.
Dr. Fauci addresses concerns that Astrazeneca "may have included outdated information" in its U.S. clinical trial results that could impact the reported efficiency of its COVID-19 vaccine. https://t.co/4Gp7pjXj6l pic.twitter.com/Y57BIXz8VM
— Good Morning America (@GMA) March 23, 2021
The company’s vaccine has already been administered worldwide, including to more than 17 million people in Britain and the European Union, with nearly all cases without serious side effects, The New York Times reported.
But more than a dozen countries, most of which are in Europe, have temporarily stopped giving the vaccine after worries it was connected to a rare blood clotting disorder. Fauci had said the U.S. trial had not found a link between the vaccine and the blood clots, Reuters noted.