Astra Zeneca has recently updated its data on how well its Covid vaccine works. On Wednesday, the company said that the vaccine showed 76% efficacy against symptomatic coronavirus disease and 100% efficacy against severe or critical disease or the need for hospitalization.
The company mentioned that the vaccine was 85% effective in preventing symptoms in volunteers 65 and older.
The numbers that the company showed are not terribly different from data the company released in a statement Monday as the company has released them via news release and not in a peer-reviewed report or as a formal submission for US Food and Drug Administration review.
Mene Pangalos, executive vice president for biopharmaceuticals research for the company, said in a statement, “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.”
We recently released data from our COVID-19 vaccine US Phase III trial. We maintain our commitment to supplying our vaccine broadly and equitably at no profit during the pandemic. pic.twitter.com/a0wLTtLaUc
— AstraZeneca (@AstraZeneca) March 25, 2021
“The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” the NIAID, which has helped AstraZeneca run trials in the US, said.
The independent Data and Safety Monitoring Board (DSMB) on Tuesday said that reviews data from multiple Covid-19 vaccine candidates expressed their concern over AstraZeneca’s announcements on its latest findings, and, unusually, the National Institute of Allergy and Infectious Diseases publicly announced those concerns.
“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.”
On Monday, AstraZeneca said its Covid-19 vaccine showed 79% efficacy against symptomatic disease and 100% efficacy against severe disease and hospitalization.
The trial of 32,449 volunteers in the US, Peru, and Chile showed people who got the vaccine were 76% less likely to have any symptoms of coronavirus compared to the one-third of participants who got 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 got Covid-29 symptoms as compared to unvaccinated people.
“There were 190 cases in the primary analysis. There are 14 additional possible or probable cases to be adjudicated so the total number of cases and the point estimate may fluctuate slightly,” the company said.
“AstraZeneca will also submit the primary analysis for peer-reviewed publication in the coming weeks.”
The volunteers in the vaccine trials were not regularly tested for Covid-19, so it’s unknown that how many may have gotten asymptomatic infections.
The company said, “A key secondary endpoint, preventing severe or critical disease and hospitalization, demonstrated 100% efficacy. 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.”