FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of March 2021
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
AZD1222 US Ph3 primary analysis confirms efficacy
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.
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.
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
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
25 March
2021
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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