<SEC-DOCUMENT>0001654954-21-012962.txt : 20211209
<SEC-HEADER>0001654954-21-012962.hdr.sgml : 20211209
<ACCEPTANCE-DATETIME>20211209081631
ACCESSION NUMBER:		0001654954-21-012962
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20211209
FILED AS OF DATE:		20211209
DATE AS OF CHANGE:		20211209

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			ASTRAZENECA PLC
		CENTRAL INDEX KEY:			0000901832
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			X0
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-11960
		FILM NUMBER:		211480323

	BUSINESS ADDRESS:	
		STREET 1:		1 FRANCIS CRICK AVENUE
		STREET 2:		CAMBRIDGE BIOMEDICAL CAMPUS
		CITY:			CAMBRIDGE
		STATE:			X0
		ZIP:			CB2 0AA
		BUSINESS PHONE:		011 44 20 7304 5000

	MAIL ADDRESS:	
		STREET 1:		1 FRANCIS CRICK AVENUE
		STREET 2:		CAMBRIDGE BIOMEDICAL CAMPUS
		CITY:			CAMBRIDGE
		STATE:			X0
		ZIP:			CB2 0AA

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ZENECA GROUP PLC
		DATE OF NAME CHANGE:	19930422
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>a0538v.htm
<DESCRIPTION>EVUSHELD US FDA EUA
<TEXT>
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AstraZeneca PLC</font></div>
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1.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
Evusheld US FDA EUA</font></div>
</div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
9 December 2021 07:00 GMT</font></div>
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&#xA0;</font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
<font style="font-style: italic; color: #000000">Evusheld</font><font style="color: #000000">&#xA0;(formerly AZD7442) long-acting antibody
combination</font></font> <font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
authorised for emergency use in the US for pre-exposure prophylaxis
(prevention) of COVID-19</font></div>
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<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
Only antibody therapy authorised in US for pre-exposure prophylaxis
&#xA0;</font></div>
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<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
Pivotal phase III data showed robust efficacy and long-term
protection with one dose in high-risk population</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
AstraZeneca's&#xA0;</font><font style="font-style: italic; color: #000000">Evusheld</font><font style="color: #000000">&#xA0;(tixagevimab co-packaged with cilgavimab), a
long-acting antibody (LAAB) combination, has received emergency use
authorisation (EUA) in the US for the pre-exposure prophylaxis
(prevention) of COVID-19,</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">with
first doses expected to become available very
soon.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The Food and Drug Administration (FDA) granted the EUA
for&#xA0;</font><font style="font-style: italic; color: #000000">Evusheld</font><font style="color: #000000">&#xA0;for pre-exposure prophylaxis of COVID-19 in
adults and adolescents (aged 12 and older who weigh 40kg or more)
with moderate to severe immune compromise due to a medical
condition or immunosuppressive medications and who may not mount an
adequate immune response to COVID-19 vaccination, as well as those
individuals for whom COVID-19 vaccination is not recommended.
Recipients should not be currently infected with or had recent
known exposure to a person infected with
SARS-CoV-2.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Myron J. Levin, MD, Professor of Pediatrics and Medicine,
University of Colorado School of Medicine, US, and principal
investigator on the PROVENT trial, said: "Millions of people in the
US and around the world remain at serious risk for COVID-19 because
their immune systems do not generate a sufficient immune response,
even after receiving all recommended doses of vaccine. I am excited
to offer my patients&#xA0;</font><font style="font-style: italic; color: #000000">Evusheld</font><font style="color: #000000">&#xA0;as an easily-administered new option that
provides long-lasting protection that could help them return to
their everyday lives."</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&amp;D, AstraZeneca, said: "We are proud to play a leading role in
fighting the COVID-19 pandemic and, with&#xA0;</font><font style="font-style: italic; color: #000000">Evusheld,</font><font style="color: #000000">&#xA0;we now have the first antibody therapy
authorised in the US to prevent COVID-19 symptoms before virus
exposure, while also providing long lasting protection with a
single dose. &#xA0;</font><font style="font-style: italic; color: #000000">Evusheld</font><font style="color: #000000">&#xA0;neutralises all previous SARs-CoV-2 variants
to date, and we are working quickly to establish its efficacy
against the new Omicron variant. We thank our clinical trial
participants, the investigators, scientists, and government
agencies and our colleagues at AstraZeneca who have all contributed
to the development of&#xA0;</font><font style="font-style: italic; color: #000000">Evusheld</font><font style="color: #000000">."</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Brian Koffman, MDCM (retired), MS Ed, Co-Founder, Executive Vice
President and Chief Medical Officer of the CLL (Chronic Lymphocytic
Leukemia) Society, US, said: "One of the primary questions I keep
getting asked by patients is 'When can I hug my grandchildren
again?' As a physician and person with a weakened immune system, l
am filled with hope now that&#xA0;</font><font style="font-style: italic; color: #000000">Evusheld</font><font style="color: #000000">&#xA0;will soon be available to those who can't
count on vaccination alone to provide the protection they
need."</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Evusheld</font><font style="color: #000000">&#xA0;is a combination
of two long-acting monoclonal antibodies and is the only antibody
therapy authorised in the US for COVID-19 pre-exposure prophylaxis
and the only COVID-19 antibody delivered as an intramuscular dose
(150mg tixagevimab and 150mg cilgavimab).</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
About 2% of the&#xA0;global&#xA0;population is considered at
increased risk of an inadequate response to a COVID-19
vaccine.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1,2</font><font style="color: #000000">&#xA0;About
seven million people in the US are immunocompromised and may
benefit from&#xA0;</font><font style="font-style: italic; color: #000000">Evusheld</font><font style="color: #000000">&#xA0;for pre-exposure prophylaxis of
COVID-19.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1,3,4</font><font style="color: #000000">&#xA0;This
includes people with blood cancers or other cancers being treated
with chemotherapy, and those taking medications after an organ
transplant or who are taking immunosuppressive drugs for conditions
including multiple sclerosis and rheumatoid
arthritis.</font><font style="font-size: 70%; vertical-align: top; color: #000000">5-9</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The primary data supporting the&#xA0;</font><font style="font-style: italic; color: #000000">Evusheld</font><font style="color: #000000">&#xA0;EUA are from the ongoing PROVENT Phase III
pre-exposure prevention trial, which showed a statistically
significant reduction (77% at primary analysis, 83% at median
six-month analysis) in the risk of developing symptomatic COVID-19
compared to placebo, with protection from the virus continuing for
at least six months. More follow-up is needed to establish the full
duration of protection provided by&#xA0;</font><font style="font-style: italic; color: #000000">Evusheld</font><font style="color: #000000">. Data from the Phase III STORM CHASER
post-exposure trial and the&#xA0;</font><font style="font-style: italic; color: #000000">Evusheld</font><font style="color: #000000">&#xA0;Phase I trial also supported the
EUA.&#xA0;</font><font style="font-style: italic; color: #000000">Evusheld</font><font style="color: #000000">&#xA0;was well-tolerated in the
trials.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
<font style="font-style: italic; color: #000000">Evusheld</font><font style="color: #000000">&#xA0;and SARS-CoV-2 variants</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Studies are underway to provide information on the impact of the
new Omicron variant (B.1.1.529) on&#xA0;</font><font style="font-style: italic; color: #000000">Evusheld.</font><font style="color: #000000">&#xA0;</font><font style="font-size: 70%; vertical-align: top; color: #000000">10,11</font><font style="color: #000000">&#xA0;Of
the Omicron binding site substitutions relevant
to&#xA0;</font><font style="font-style: italic; color: #000000">Evusheld</font><font style="color: #000000">&#xA0;that have been tested to date in preclinical
assays, none have been associated with escape
from&#xA0;</font><font style="font-style: italic; color: #000000">Evusheld</font><font style="color: #000000">&#xA0;neutralisation.</font><font style="font-size: 70%; vertical-align: top; color: #000000">10,11</font><font style="font-style: italic; color: #000000">&#xA0;In
vitro</font><font style="color: #000000">&#xA0;findings
demonstrate&#xA0;</font><font style="font-style: italic; color: #000000">Evusheld</font><font style="color: #000000">&#xA0;neutralises other recent emergent SARS-CoV-2
viral variants, including the Delta and Mu
variants.</font><font style="font-size: 70%; vertical-align: top; color: #000000">10</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Evusheld</font><font style="color: #000000">&#xA0;is being
developed with support from the US government, including federal
funds from the Department of Health and Human Services; Office of
the Assistant Secretary for Preparedness and Response; Biomedical
Advanced Research and Development Authority in partnership with the
Department of Defense; Joint Program Executive Office for Chemical,
Biological, Radiological and Nuclear Defense, under Contract No.
W911QY-21-9-0001.</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
AstraZeneca has agreed to supply the US government with 700,000
doses of&#xA0;</font><font style="font-style: italic; color: #000000">Evusheld</font><font style="color: #000000">. The U.S. government has indicated that it plans
to distribute these doses to states and territories at no cost and
on a pro rata basis.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
AstraZeneca is progressing with filings around the globe for
potential emergency use authorisation or conditional approval
of&#xA0;</font><font style="font-style: italic; color: #000000">Evusheld</font><font style="color: #000000">&#xA0;in both COVID-19 prophylaxis and
treatment.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="text-decoration: underline; color: #000000; font-weight: bold; font-family: Times New Roman; font-size: 13px">
Notes</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
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<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
Evusheld</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 16px"><font style="font-style: italic; color: #000000; font-size: 13px">
Evusheld,&#xA0;</font><font style="color: #000000; font-size: 13px">formerly known as AZD7442 is a
combination of two LAABs -&#xA0;tixagevimab (AZD8895) and
cilgavimab (AZD1061) - derived from B-cells donated by convalescent
patients after SARS-CoV-2 virus. Discovered by Vanderbilt
University Medical Center and&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">licensed
to AstraZeneca in June 2020</font><font style="color: #000000; font-size: 13px">, the human monoclonal antibodies
bind to distinct sites on the SARS-CoV-2 spike
protein</font><font style="font-size: 70%; vertical-align: top; color: #000000">13</font><font style="color: #000000; font-size: 13px">&#xA0;and
were optimised by AstraZeneca with half-life extension and reduced
Fc receptor and complement C1q binding. The half-life extension
more than triples the durability of its action compared to
conventional antibodies and could afford up to 12 months of
protection from COVID-19 following a single
administration;</font><font style="font-size: 70%; vertical-align: top; color: #000000">14-16</font><font style="color: #000000; font-size: 13px">&#xA0;data
from the Phase III PROVENT trial show protection lasting at least
six months.</font><font style="font-size: 70%; vertical-align: top; color: #000000">17</font><font style="color: #000000; font-size: 13px">&#xA0;The
reduced Fc receptor binding aims to minimise the risk of
antibody-dependent enhancement of disease - a phenomenon in which
virus-specific antibodies promote, rather than inhibit, infection
and/or disease.</font><font style="font-size: 70%; vertical-align: top; color: #000000">18</font><font style="color: #000000; font-size: 13px">&#xA0;&#xA0;</font><font style="font-style: italic; color: #000000">Evusheld&#xA0;</font><font style="color: #000000; font-size: 13px">is
delivered as an IM dose of 150mg tixagevimab and 150mg cilgavimab
administered in two separate, consecutive
injections.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
In August 2021, AstraZeneca&#xA0;</font><font style="text-decoration: underline; color: #0000FF">announced</font><font style="color: #000000">&#xA0;that&#xA0;</font><font style="font-style: italic; color: #000000">Evusheld</font><font style="color: #000000">&#xA0;demonstrated
a statistically significant reduction in the risk of developing
symptomatic COVID-19 in the PROVENT trial; efficacy was 83%
compared to placebo in a six-month
analysis&#xA0;</font><font style="text-decoration: underline; color: #0000FF">announced</font><font style="text-decoration: underline; color: #0000FF">&#xA0;</font><font style="color: #000000">on
18 November 2021. In October 2021,
AstraZeneca&#xA0;</font><font style="text-decoration: underline; color: #0000FF">announced</font><font style="color: #000000">&#xA0;positive
high-level results from the&#xA0;</font><font style="font-style: italic; color: #000000">Evusheld</font><font style="color: #000000">&#xA0;TACKLE Phase III outpatient treatment
trial.&#xA0;</font><font style="font-style: italic; color: #000000">Evusheld</font><font style="color: #000000">&#xA0;is also being studied as a potential
treatment for hospitalised COVID-19 patients as part of the
National Institute of Health's&#xA0;</font><font style="text-decoration: underline; color: #0000FF">ACTIV-3
trial</font><font style="color: #000000">&#xA0;and in an additional
collaborator hospitalisation treatment trial.</font></font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
Under the terms of the licensing agreement with Vanderbilt,
AstraZeneca will pay single-digit royalties on future net
sales.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development, and commercialisation of prescription medicines in
Oncology, Rare Diseases, and BioPharmaceuticals, including
Cardiovascular, Renal &amp; Metabolism, and Respiratory &amp;
Immunology. Based in Cambridge, UK, AstraZeneca operates in over
100 countries and its innovative medicines are used by millions of
patients worldwide. Please visit&#xA0;</font><font style="text-decoration: underline; color: #0000FF">astrazeneca.com</font><font style="color: #000000">&#xA0;and
follow the Company on Twitter&#xA0;</font><font style="text-decoration: underline; color: #0000FF">@AstraZeneca</font><font style="color: #000000">.</font></font></div>
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For details on how to contact the Investor Relations Team, please
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References</font></div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">1.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">Oliver, S MD. Data and clinical
considerations for additional doses in immunocompromised people.
ACIP Meeting July 22, 2021. Available at:&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-07/07-COVID-Oliver-508.pdf</font><font style="color: #000000; font-size: 13px">.
[Last accessed: December 2021].</font></font></div>
</div>
</div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-size: 13px; font-family: Times New Roman">2.</font></div>
<div style="text-align: justify; display: table-cell"><font style="color: #000000; font-family: Times New Roman; font-size: 13px">AstraZeneca
data on file.</font></div>
</div>
</div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-size: 13px; font-family: Times New Roman">3.</font></div>
<div style="text-align: justify; display: table-cell"><font style="color: #000000; font-family: Times New Roman; font-size: 13px">Taken
as percentage of U.S Population: 328.2m (2019).</font></div>
</div>
</div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-size: 13px; font-family: Times New Roman">4.</font></div>
<div style="text-align: justify; display: table-cell"><font style="color: #000000; font-family: Times New Roman; font-size: 13px">CDC:
Lower range: adult pneumococcal vaccine (~25% ), mid range: flu
(~48%), upper range: COVID vaccine (~70%).</font></div>
</div>
</div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">5.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">Centers for Disease Control and
Prevention. Altered Immunocompetence. General Best Practice
Guideline for Immunization: Best Practices Guidance of the Advisory
Committee on Immunization Practices. [Online]. Available
at:&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/immunocompetence.html</font><font style="color: #000000; font-size: 13px">.
[Last accessed: December 2021].</font></font></div>
</div>
</div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-size: 13px; font-family: Times New Roman">6.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Boyarsky BJ, et al. Immunogenicity of a Single
Dose of SARS-CoV-2 Messenger RNA Vaccine in Solid Organ Transplant
Recipients.&#xA0;</font><font style="font-style: italic; color: #000000">JAMA.</font><font style="color: #000000">&#xA0;2021; 325
(17):1784-1786.</font></font></div>
</div>
</div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-size: 13px; font-family: Times New Roman">7.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Rabinowich L, et al. Low immunogenicity to
SARS-CoV-2 vaccination among liver transplant
recipients,&#xA0;</font><font style="font-style: italic; color: #000000">Journal of
Hepatology</font><font style="color: #000000">&#xA0;(2021). doi:
https://doi.org/10.1016/ j.jhep.2021.04.020.</font></font></div>
</div>
</div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-size: 13px; font-family: Times New Roman">8.</font></div>
<div style="text-align: justify; display: table-cell"><font style="color: #000000; font-family: Times New Roman; font-size: 13px">Deepak
P, et al. Glucocorticoids and B Cell Depleting Agents Substantially
Impair Immunogenicity of mRNA Vaccines to SARS-CoV-2. medRxiv
[Preprint]. 2021 Apr 9:2021.04.05.21254656. doi:
10.1101/2021.04.05.21254656. PMID: 33851176; PMCID:
PMC8043473.</font></div>
</div>
</div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-size: 13px; font-family: Times New Roman">9.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Simon D, et al. SARS-CoV-2 vaccination responses
in untreated, conventionally treated and anticytokine-treated
patients with immune-mediated inflammatory
diseases.&#xA0;</font><font style="font-style: italic; color: #000000">Ann Rheum
Dis</font><font style="color: #000000">. 2021 May 6:
annrheumdis-2021-220461. doi: 10.1136/annrheumdis-2021-220461. Epub
ahead of print. PMID: 33958324.</font></font></div>
</div>
</div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">10.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">ACTIV. National Center for
Advancing Translational Sciences Open Data Portal. SARS-CoV-2
Variants &amp; Therapeutics, All Variants Reported in vitro
Therapeutic Activity. Available at:&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://opendata.ncats.nih.gov/variant/activity</font><font style="color: #000000; font-size: 13px">.
[Last accessed: December 2021].</font></font></div>
</div>
</div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-size: 13px; font-family: Times New Roman">11.</font></div>
<div style="text-align: justify; display: table-cell"><font style="color: #000000; font-family: Times New Roman; font-size: 13px">Bloom
Labs. Available from:</font></div>
</div>
</div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">1.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://twitter.com/jbloom_lab/status/1464005705891868702/photo/1</font><font style="color: #000000; font-size: 13px">&#xA0;[Last
accessed December 2021].</font></font></div>
</div>
</div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-size: 13px; font-family: Times New Roman">12.</font></div>
<div style="text-align: justify; display: table-cell"><font style="color: #000000; font-family: Times New Roman; font-size: 13px">AstraZeneca
data on file.</font></div>
</div>
</div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-size: 13px; font-family: Times New Roman">13.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Dong J, et al. Genetic and structural basis for
recognition of SARS-CoV-2 spike protein by a two-antibody
cocktail.&#xA0;</font><font style="font-style: italic; color: #000000">bioRxiv</font><font style="color: #000000">. 2021; doi:
10.1101/2021.01.27.428529.</font></font></div>
</div>
</div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-size: 13px; font-family: Times New Roman">14.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Robbie GJ, et al. A novel investigational
Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an
extended half-life in healthy adults.&#xA0;</font><font style="font-style: italic; color: #000000">Antimicrob Agents
Chemother</font><font style="color: #000000">. 2013; 57 (12):
6147-53.</font></font></div>
</div>
</div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-size: 13px; font-family: Times New Roman">15.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Griffin MP, et al. Safety, tolerability, and
pharmacokinetics of MEDI8897, the respiratory syncytial virus
prefusion F-targeting monoclonal antibody with an extended
half-life, in healthy adults.&#xA0;</font><font style="font-style: italic; color: #000000">Antimicrob Agents
Chemother</font><font style="color: #000000">. 2017; 61(3):
e01714-16.</font></font></div>
</div>
</div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-size: 13px; font-family: Times New Roman">16.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Domachowske JB, et al. Safety, tolerability and
pharmacokinetics of MEDI8897, an extended half-life single-dose
respiratory syncytial virus prefusion F-targeting monoclonal
antibody administered as a single dose to healthy preterm
infants.&#xA0;</font><font style="font-style: italic; color: #000000">Pediatr Infect Dis
J</font><font style="color: #000000">. 2018; 37(9):
886-892.</font></font></div>
</div>
</div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">17.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">AstraZeneca news release. New
analyses of two AZD7442 COVID-19 trials in high-risk populations
confirm robust efficacy and long-term prevention.&#xA0; Available
at:</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://www.astrazeneca.com/media-centre/press-releases/2021/new-analyses-of-two-azd7442-covid-19-phase-iii-trials-in-high-risk-populations-confirm-robust-efficacy-and-long-term-prevention.html</font><font style="color: #000000; font-size: 13px">.
[Last accessed: December 2021]</font></font></div>
</div>
</div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-size: 13px; font-family: Times New Roman">18.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">van Erp EA, et al.&#xA0;Fc-mediated antibody
effector functions during respiratory syncytial virus infection and
disease.&#xA0;</font><font style="font-style: italic; color: #000000">Front
Immunol</font><font style="color: #000000">. 2019; 10:
548.</font></font></div>
</div>
</div>
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SIGNATURES</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">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.</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">AstraZeneca
PLC</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Date:
<font style="font-weight: bold; font-size: 13px">9 December
2021</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px">By: /s/
Adrian Kemp</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Name:
Adrian Kemp</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Title:
Company Secretary</font></div>
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