The AstraZeneca US Phase III trial of AZD1222 demonstrated
statistically significant vaccine efficacy of 79% at preventing
symptomatic COVID-19 and 100% efficacy at preventing severe disease and
hospitalisation.
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%.
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 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% 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
organisations and collaborators around the world to ensure broad and
equitable access to the vaccine at no profit for the duration of the
pandemic.
D8110C000011
The US Phase III trial, called D8110C00001, was led by
AstraZeneca and funded by the Biomedical Advanced Research and
Development Authority (BARDA), part of the office of the Assistant
Secretary for Preparedness and Response (ASPR) at the US Department of
Health and Human Services (HHS) in collaboration with the Department of
Defense Joint Program Executive Office for Chemical, Biological,
Radiological and Nuclear Defense (JPEO-CBRND) and the Army Contracting
Command, and the National Institute of Allergy and Infectious Diseases
(NIAID), part of the US National Institutes of Health. The
NIAID-supported COVID-19 Prevention Network (CoVPN) participated in the
trial.
D8110C00001 is a Phase III randomised, double-blind,
placebo-controlled multicentre study assessing the safety, efficacy, and
immunogenicity of AZD1222 compared to placebo for the prevention of
COVID-19, in 32,449 participants across 88 trial centres in the US, Peru
and Chile. Trial participants aged 18 years or over who are healthy or
have medically stable chronic diseases and are at increased risk for
being exposed to the SARS-CoV-2 virus and COVID-19 were randomised in a
2:1 ratio to receive two intramuscular doses of either 5 x1010 viral particles of AZD1222 or saline placebo four weeks apart.
AZD1222
AZD1222 was co-invented by the University of Oxford and its spin-out
company, Vaccitech. It uses a replication-deficient chimpanzee viral
vector based on a weakened version of a common cold virus (adenovirus)
that causes infections in chimpanzees and contains the genetic material
of the SARS-CoV-2 virus spike protein. After vaccination, the surface
spike protein is produced, priming the immune system to attack the
SARS-CoV-2 virus if it later infects the body.
In May 2020, AstraZeneca received
support of more than $1bn from BARDA for the development, production
and delivery of the vaccine under an agreement with the US Department of
Defense’s Joint Program Executive Office for Chemical, Biological,
Radiological and Nuclear Defense. The Phase III D8110C00001 trial is
part of this funding agreement.
The vaccine has been granted a conditional marketing authorisation or
emergency use in more than 70 countries across six continents, and with
the Emergency Use Listing granted by the World Health Organization this
accelerates the pathway to access in up to 142 countries through the
COVAX Facility.
BARDA, ASPR, HHS
HHS works to enhance and protect the health and well-being of all
Americans, providing for effective health and human services and
fostering advances in medicine, public health, and social services. The
mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA
invests in the innovation, advanced research and development,
acquisition, and manufacturing of medical countermeasures – vaccines,
drugs, therapeutics, diagnostic tools, and non-pharmaceutical products
needed to combat health security threats. The AstraZeneca vaccine
candidate is one of six BARDA is supporting in development and
manufacturing, and the third BARDA-supported SARS-COVD-2 vaccine
supported to successfully complete a large Phase III trial. To learn
more about BARDA’s support for the COVID-19 pandemic response, visit medicalcountermeasures.gov.
JPEO-CBRND
As part of the Department of Defense, JPEO-CBRND protects the Joint
Force by providing medical countermeasures and defense equipment against
chemical, biological, radiological and nuclear (CBRN) threats.
JPEO-CBRND’s goal is to enable the Joint Force to fight and win
unencumbered by a CBRN environment. JPEO-CBRND facilitates the rapid
response, advanced development, manufacturing and acquisition of medical
solutions, such as vaccines, therapeutics, and diagnostics, to combat
CBRN and emerging threats such as COVID-19. To learn more about
JPEO-CBRND’s COVID-19 response, visit https://www.jpeocbrnd.osd.mil/coronavirus.
NIAID and the CoVPN
The CoVPN was formed by the NIAID at the US National Institutes of
Health, part of the US Department of Health and Human Services, to
respond to the global pandemic. Through the CoVPN, NIAID is leveraging
the infectious disease and community engagement expertise of its
existing research networks and global partners to address the pressing
need for vaccines and antibodies against the SARS-CoV-2 virus. CoVPN
will work to develop and conduct studies to ensure rapid and thorough
evaluation of vaccines and antibodies for the prevention of COVID-19.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery, development and
commercialisation of prescription medicines, primarily for the
treatment of diseases in three therapy areas - Oncology, Cardiovascular,
Renal & Metabolism, and Respiratory & Immunology. Based in
Cambridge, UK, AstraZeneca operates in over 100 countries and its
innovative medicines are used by millions of patients worldwide. Please
visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here.
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