AstraZeneca on Thursday published an updated analysis confirming that a Phase 3 trial involving its COVID-19 vaccine was safe and effective, and showed to be 76% effective against symptomatic COVID-19. The update came after the National Institute of Allergy and Infectious Diseases (NIAID) said the company may have provided an incomplete view of the efficacy data after the Data and Safety Monitoring Board (DSMB) said it was concerned about the information included in the release.
“The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” the NIAID said in a statement earlier this week. “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.”
The earlier data reflected 79% efficacy in preventing symptomatic infections and 100% efficacy at preventing severe disease and hospitalization. The new analysis also reported 100% efficacy “against severe or critical disease and hospitalization.”
“Positive high-level results from the primary analysis of the Phase III trial of AZD1222 in the U.S. have confirmed vaccine efficacy consistent with the pre-specified interim analysis announced on Monday 22 March 2021,” a press release posted by AstraZeneca early Thursday stated. “These results have been presented to the independent Data Safety Monitoring Board. The primary analysis is pre-specificed in the protocol and will be the basis for a regulatory submission for Emergency Use Authorization to the U.S. Food and Drug Administration in the coming weeks.”
The company said it plans to file for EUA with the FDA in the coming weeks.
(Kay Nietfeld/Pool via AP)
On Wednesday, when asked if the back-and-forth regarding data reporting may add to vaccine hesitancy in the U.S., Dr. Anthony Fauci lauded the FDA’s transparent approval process in helping to build the public’s confidence should the jab see approval.
“We’re always concerned when there is an apparent ‘miscommunication’ – if you want to use that word – that it would add to already existing levels of vaccine hesitancy, which is the reason why we want to make sure we’re always completely transparent in everything that goes with regard to messaging and vaccine,” Fauci said during Wednesday’s White House COVID-19 briefing.
He said that the process will “hopefully dispel any hesitancy associated with this little bump in the road we happened to have most recently with AstraZeneca.” Questions over how the public would perceive AstraZeneca’s vaccine were already swirling after reports of blood clots in Europe saw several countries temporarily pause the rollout. European regulators have since found the vaccine to be safe and effective and the rollout has continued.
“At the end of the day, when you look at the data, this is going to turn out to be a good vaccine,” Fauci said.