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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 per cent.
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.”
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AstraZeneca will continue to analyse 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 per cent were white/Caucasian, 8 per cent black/African American, 4 per cent Native American, and 4 per cent Asian, and 22 per cent of participants were Hispanic.
Approximately 20 per cent of participants were 65 years and over, and approximately 60 per cent 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 4-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 accelerate 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 organisations, and collaborators around the world to ensure broad and equitable access to the vaccine at no profit for the duration of the pandemic.
Nitin Kapoor, chairman and general director of AstraZeneca Vietnam, said: “This great news once again confirms the high efficacy and good toleration of our vaccine, including for Asian people which made up 4 per cent of this large clinical trial participant pool. We appreciate the Vietnamese government and the Ministry of Health’s trust in our vaccine and science-led decision to carry out the Plan on Immunization against COVID-19 using AstraZeneca COVID-19 vaccine, now has provided protection against the virus for more than 34,000 frontline health workers and counting.”