The vaccine was 85% effective in preventing symptoms in volunteers 65 and older, the company said.
The numbers are not much different from the data the company released in a statement on Monday. As with Monday’s data, the company released it via a press release, not in a peer-reviewed report or as an official submission for review by the U.S. Food and Drug Administration.
“The primary analysis is consistent with our previously published interim analysis and confirms that our COVID-19 vaccine is highly effective in adults, including those aged 65 and older. We look forward to filing our emergency use authorization application in the United States. and prepare for the deployment of millions of doses across America, ”said Mene Pangalos, executive vice president for the company’s biopharmaceutical research, in a statement.
On Tuesday, the Independent Data and Safety Oversight Board (DSMB), which is reviewing data from several Covid-19 vaccine candidates, expressed concern over AstraZeneca’s announcements of its latest findings and, unusually, The National Institute of Allergy and Infectious Diseases publicly announced these concerns.
“We urge the company to work with the DSMB to review efficacy data and ensure that the most accurate and up-to-date efficacy data is released to the public as quickly as possible.
On Monday, AstraZeneca said its Covid-19 vaccine showed 79% effectiveness against symptomatic illnesses and 100% effectiveness against serious illnesses and hospitalization.
The trial of 32,449 volunteers in the United States, Peru and Chile showed that people who received the vaccine were 76% less likely to experience symptoms of coronavirus compared to one-third of participants who received a placebo. The vaccine is given in two doses, four weeks apart.
As with other vaccine trials, the company was looking to see how many vaccinated people showed symptoms of Covid-29 compared to unvaccinated people.
“There were 190 cases in the primary analysis. There are another 14 possible or probable cases to judge, so the total number of cases and the point estimate may fluctuate slightly, ”the company said.
“AstraZeneca will also be submitting the primary analysis for peer-reviewed publication in the coming weeks. ”
And as with other coronavirus vaccine trials, volunteers were not regularly tested for Covid-19, so it’s unclear how many of them may have contracted asymptomatic infections.
“A key secondary endpoint, prevention of serious or critical illness and hospitalization, has been shown to be 100% effective. There were eight cases of severe COVID-19 seen in the primary analysis with all of these cases in the placebo group, ”the company said.
“The vaccine was well tolerated and no vaccine-related safety issues were identified. ”
Earlier this week, NIAID Director Dr Anthony Fauci called the company’s release of premature data an “unforced error” – a sporting term meaning it was their own mistake.
He told ABC’s Good Morning America on Tuesday that the AstraZeneca vaccine “is quite possibly a very good vaccine,” and this situation only casts doubt on the vaccines and possibly contributes to the reluctance about it. vaccines.
Fauci said it wasn’t necessary and the data is “really, really good, but when they put it in the press release it wasn’t quite accurate.”
AstraZeneca, which developed the vaccine with the UK University of Oxford, struggled to accept its vaccine.
It was the first out-of-the-door vaccination in the Western world, entering the arms of volunteers on January 4. But AstraZeneca’s vaccine development hit multiple bumps, from news that two volunteers developed neurological symptoms last fall to a stall in the vaccine rollout in several European countries amid fears it may have caused blood clots
The European Medicines Agency has since said there is no evidence the vaccine can cause blood clots.