TIDMAZN
RNS Number : 4637T
AstraZeneca PLC
25 March 2021
25 March 2021 07:00 GMT
AZD1222 US Phase III primary analysis confirms safety and
efficacy
76% vaccine efficacy against symptomatic COVID-19
100% efficacy against severe or critical disease and
hospitalisation
85% efficacy against symptomatic COVID-19 in participants aged
65 years and over
Positive high-level results from the primary analysis of the
Phase III trial of AZD1222 in the US have confirmed vaccine
efficacy consistent with the pre-specified interim analysis
announced on Monday 22 March 2021.
These results have been presented to the independent Data Safety
Monitoring Board . The primary analysis is pre-specified in the
protocol and will be the basis for a regulatory submission for
Emergency Use Authorization to the US Food and Drug Administration
in the coming weeks.
This primary efficacy analysis included the accrual of 190
symptomatic cases of COVID-19 from the 32,449 trial participants,
an additional 49 cases to the previously announced interim
analysis. Participants were randomised on a 2:1 ratio between the
vaccine and placebo group.
The primary endpoint, vaccine efficacy at preventing symptomatic
COVID-19 was 76% (confidence interval (CI): 68% to 82%) occurring
15 days or more after receiving two doses given four weeks apart.
In addition, results were comparable across age groups, with
vaccine efficacy of 85% (CI: 58% to 95%) in adults 65 years and
older. A key secondary endpoint, preventing severe or critical
disease and hospitalisation, 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.
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "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."
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.
AstraZeneca will also submit the primary analysis for
peer-reviewed publication in the coming weeks.
D8110C00001(1)
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 randomised, double-blind, placebo-controlled
multicentre Phase III trial 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 x10(10) viral particles of AZD1222
or saline placebo four weeks apart.
The pre-specified statistical analysis plan required at least 75
adjudicated cases at interim analysis, and at least 150 adjudicated
cases at primary analysis.
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 .
References
1. Clinicaltrials.gov. A Phase III Randomized, Double-blind,
Placebo-controlled Multicenter Study in Adults to Determine the
Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating
ChAdOx1 Vector Vaccine, for the Prevention of COVID-19. [Online]
Available at:
https://clinicaltrials.gov/ct2/show/NCT04516746?term=NCT04516746&draw=2&rank=1
. Last accessed: February 2021.
Adrian Kemp
Company Secretary
AstraZeneca PLC
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