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.
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 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 x1010 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.
Print Page
Email to a Friend
