AstraZeneca says it will submit its AZD1222 COVID-19 vaccination for FDA emergency use authorization after phase 3 trial results found the vaccine to be 79% effective at preventing symptomatic COVID-19 and 100% effective at preventing severe disease and hospitalization.
This interim safety and efficacy analysis was based on 32,449 participants accruing 141 symptomatic cases of COVID-19. The trial had a 2:1 randomisation of vaccine to placebo.
Vaccine efficacy was consistent across ethnicity and age. Notably, in participants aged 65 years and over, vaccine efficacy was 80%, according to AstraZeneca.
The vaccine was well tolerated, and the independent data safety monitoring board (DSMB) identified no safety concerns related to the vaccine. The DSMB conducted a specific review of thrombotic events, as well as cerebral venous sinus thrombosis (CVST) with the assistance of an independent neurologist. The DSMB found no increased risk of thrombosis or events characterised by thrombosis among the 21,583 participants receiving at least one dose of the vaccine. The specific search for CVST found no events in this trial.
Ann Falsey, Professor of Medicine, University of Rochester School of Medicine, US, and co-lead Principal Investigator for the trial, said: “These findings reconfirm previous results observed in AZD1222 trials across all adult populations but it’s exciting to see similar efficacy results in people over 65 for the first time. This analysis validates the AstraZeneca COVID-19 vaccine as a much-needed additional vaccination option, offering confidence that adults of all ages can benefit from protection against the virus.”
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “These results add to the growing body of evidence that shows this vaccine is well tolerated and highly effective against all severities of COVID-19 and across all age groups. We are confident this vaccine can play an important role in protecting millions of people worldwide against this lethal virus. We are preparing to submit these findings to the US Food and Drug Administration and for the rollout of millions of doses across America should the vaccine be granted US Emergency Use Authorization.”
AstraZeneca will continue to analyze the data and prepare for the primary analysis to be submitted to the US Food and Drug Administration for Emergency Use Authorization in the coming weeks. In parallel, the primary analysis will be submitted for publication in a peer-reviewed journal.
Amongst participants in the interim analysis, approximately 79% were white/Caucasian, 8% black/African American, 4% native American and 4% Asian, and 22% of participants were Hispanic.
Approximately 20% of participants were 65 years and over, and approximately 60% had co-morbidities associated with an increased risk for progression of severe COVID-19, such as diabetes, severe obesity or cardiac disease.
This AstraZeneca-led US Phase III trial included two doses administered at a four week interval. Previous trials have shown that an extended interval of up to 12 weeks demonstrated greater efficacy, which was also supported by immunogenicity data. This evidence suggests administration of the second dose with an interval longer than four weeks could further increase efficacy and accelerates the number of people who can receive their first dose.
The vaccine can be stored, transported and handled at normal refrigerated conditions (2-8 degrees Celsius or 36-46 degrees Fahrenheit) for at least six months and administered without the need for preparation within existing healthcare settings.
AstraZeneca continues to engage with governments, multilateral organizations and collaborators around the world to ensure broad and equitable access to the vaccine at no profit for the duration of the pandemic.