AstraZeneca confirmed the results of late-stage trials after a federal health safety panel questioned whether outdated information was used.
The results were presented to the independent Data Safety Monitoring Board of the National Institutes of Health. The board asked AstraZeneca to review its findings and pass along guidance.
AstraZeneca stated that the analysis would be the basis for a regulatory submission for Emergency Use Authorization to the U.S. Food and Drug Administration in the coming weeks.
AstraZeneca employs 1,500 in Delaware.
This primary efficacy analysis included 190 no-symptoms cases of Covid-19 from the 32,449 trial participants, an addition of 49 cases from the previously announced interim analysis.
The primary endpoint, vaccine efficacy at preventing symptomatic COVID-19, was 76 percent after receiving two doses given four weeks apart. Also, results were comparable across age groups, with vaccine efficacy of 85 percent in adults 65 years and older.
When it came to preventing severe or critical disease and hospitalization, efficacy was 100 percent. There were eight cases of severe COVID-19 observed in the primary analysis, with all of those cases in the placebo group.
The vaccine was well-tolerated, and no safety concerns related to the vaccine were identified.
Mene Pangalos, executive vice President, BioPharmaceuticals R&D, said: “The primary analysis is consistent with our previously released interim analysis and confirms that our COVID-19 vaccine is highly effective in adults, including those aged 65 years and over. 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.”
AstraZeneca will also submit the primary analysis for peer-reviewed publication in the coming weeks.
The AstraZeneca vaccine is already being used in many nations but did see a brief pause when a few of those inoculated had side effects. The company has also been the subject of controversy over the distribution of its vaccine.
The company’s clinical trials have the subject of controversy, especially when it came to a finding over the effectiveness of a half dose used in a second vaccination three months after the first innoculation.
The finding showed the vaccine compared favorably with the 90 percent-plus effectiveness of Moderna and Pfizer vaccines. The trials in the U.S. are limited to the twin doses being administered a month or so apart.
The AZ vaccine comes with advantages that include a cost per dose that is a fraction of the figure for Moderna and Pfizer vaccines. The vaccine can also be stored in refrigerators rather than deep freeze units.
Should the finding of effectiveness for two doses being spread out over 12 weeks hold up, the vaccine would ease the scheduling of second doses, an issue faced by Delaware and other states.
The third vaccine now being used from Johnson & Johnson requires only one dose and comes with an effectiveness percentage that is comparable to the findings for the AstraZeneca vaccine.
The Biden Administration’s chief medical advisor, Dr. Anthony Fauci has called AstraZeneca’s actions “an unforced error,” but added that people should not worry about the safety of the vaccine.
