Data shows their AZD1222 vaccine met its endpoint and they are preparing regulatory submission for conditional or early approval.
AstraZeneca reported today its investigational COVID-19 vaccine, AZD1222, was 90% efficacious in 1 of their 2 dosing regimens.
With this news, the company is planning to submit their data to regulatory bodies for conditional or early approval.
When the vaccine was given as a half dose, then a full dose 1 month apart, the vaccine had a 90% efficacy. The company also did a second dosing regimen giving participants 2 full doses one month apart, and that showed 62% efficacy. According to AstraZeneca, the combined analysis from both dosing regimens resulted in an average efficacy of 70%.
The data comes from trials performed in the United Kingdom and Brazil. There were a total of 131 COVID-19 cases in the interim analysis. The pooled analysis included data from the COV002 Phase 2/3 trial in the UK and COV003 Phase 3 trial in Brazil. Over 23000 participants are being assessed.
An independent data safety monitoring board determined that the analysis met its primary endpoint showing protection from COVID-19 occurring 14 days or more after receiving 2 doses of the vaccine. They also reports no serious safety events related to the vaccine.
“These findings show that we have an effective vaccine that will save many lives. Excitingly, we’ve found that one of our dosing regimens may be around 90% effective and if this dosing regime is used, more people could be vaccinated with planned vaccine supply,” Professor Andrew Pollard, chief investigator of the Oxford Vaccine Trial at Oxford, said.
The company is looking at a capacity of up to 3 billion doses of the vaccine in 2021 on a rolling basis, pending regulatory approval.
One of the differences between the AstraZeneca vaccine and the Pfizer vaccine is the storage conditions. The former vaccine can be stored, transported and handled at normal refrigerated conditions (2-8 degrees Celsius/ 36-46 degrees Fahrenheit) for at least 6 months and administered within existing healthcare settings. The Pfizer vaccine supply requires they stay at a temperature of -70 degrees Celsius.