AstraZeneca Updates its COVID-19 Vaccine Efficacy
Overnight, the company restated it had a 76% efficacy against symptomatic disease and is looking to file an Emergency Use Authorization (EUA) with the Food and Drug Administration (FDA).
AstraZeneca presented updated data from its phase 3 trial for its AZD1222 COVID-19 vaccine. It is now reporting it had a 76% efficacy against symptomatic disease in the trial.
This primary endpoint of vaccine efficacy at preventing symptomatic COVID-19 had a confidence interval (CI): 68% to 82%, and it occurred 15 days or more after receiving 2 doses given 4 weeks apart.
The company also reported results were comparable across age groups, with vaccine efficacy of 85% (CI: 58% to 95%) in adults 65 years and older. In a secondary endpoint, the vaccine showed 100% efficacy against preventing severe or critical disease and hospitalization.
Earlier this week, the NIAID challenged the company’s reported data when it stated it had demonstrated a 79% efficacy in symptomatic disease
President Biden advisor and NIAID Director Anthony Fauci, MD, said the NIH’s Data and Safety Monitoring Board was concerned over the efficacy reporting provided in a press release written by AstraZeneca on Monday.
"When they saw that press release, they got concerned, and wrote a rather harsh note to them, copied to me, saying that in fact, they felt the data that was in the press release were somewhat outdated and might in fact be misleading a bit, and wanted them to straighten it out," Fauci said, in an interview on "Good Morning America" on Tuesday morning.
"The fact is, this is very likely a good vaccine, and this kind of thing does nothing except cast some doubt about the vaccines and maybe contribute to the hesitancy," Fauci went on to say. "It was not necessary. When you look at the data, they really are quite good. When they put it into the press release, it wasn't completely accurate."
Despite the data reporting issues, as well as other problems along the way, the company is planning to move forward with securing an FDA EUA.
“We look forward to filing our regulatory submission for Emergency Use Authorization in the US and preparing for the rollout of millions of doses across America,” Mene Pangalos, AstraZeneca executive vice president, BioPharmaceuticals R&D, said.