<SEC-DOCUMENT>0001654954-21-000978.txt : 20210201
<SEC-HEADER>0001654954-21-000978.hdr.sgml : 20210201
<ACCEPTANCE-DATETIME>20210201062458
ACCESSION NUMBER:		0001654954-21-000978
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20210201
FILED AS OF DATE:		20210201
DATE AS OF CHANGE:		20210201

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:		21574227

	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>a5067n.htm
<DESCRIPTION>COVID-19 VACCINE AUTHORISED FOR USE BY THE EU
<TEXT>
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<font style="font-size: 13px; font-family: Times New Roman">1.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-weight: bold; font-family: Times New Roman; font-size: 13px"><font style="color: rgb(0, 0, 0);">
COVID-19 vaccine authorised for use by the EU</font></font></div>
</div>
</div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
1 February 2021 07:00 GMT</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#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">COVID-19 Vaccine
AstraZeneca&#xA0;</font><font style="color: #000000">authorised for
use in the EU</font></font></div>
<div style="text-align: justify; 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="color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca's COVID-19 vaccine has been granted a conditional
marketing authorisation (CMA) in the European Union (EU) for active
immunisation to prevent COVID-19 caused by SARS-CoV-2, in
individuals 18 years of age and older.</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">
Following review of the application, the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency
based its positive opinion on data from a rolling review of trial
data from the primary analysis of the Phase III programme led by
the University of Oxford.&#xA0;</font>Additional safety and
efficacy data for the vaccine will continue to accumulate from
ongoing clinical trials and is expected to be published in the
coming weeks.</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 CHMP recommends two doses of&#xA0;</font><font style="font-style: italic; color: #000000">COVID-19 Vaccine
AstraZeneca</font><font style="color: #000000">, formerly AZD1222,
to be administered at a four- to 12-week interval in people aged 18
years and older. This dosing regimen was shown in clinical trials
to be safe and effective in preventing symptomatic COVID-19, with
no severe cases and no hospitalisations more than 14 days after the
second dose.</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="color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca is working with the EU following the approval of a CMA
for active immunisation to begin across member states.</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="color: #000000; font-family: Times New Roman; font-size: 13px">
Pascal Soriot, Chief Executive Officer, said: "Today's approval
underscores the value of AstraZeneca's COVID-19 vaccine, which is
not only effective and well tolerated, but also easy to administer
and, importantly, protects fully against severe disease and
hospitalisations. We are deeply grateful&#xA0;to Oxford University,
participants in the clinical trials and AstraZeneca colleagues for
their unwavering commitment to providing this lifesaving vaccine to
millions of Europeans."</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="color: #000000; font-family: Times New Roman; font-size: 13px">
Professor Andrew Pollard, Director of the Oxford Vaccine Group and
Chief Investigator on the Oxford vaccine trials, said: "The
approval by the European Commission is an important milestone in
extending access to the Oxford/ AstraZeneca vaccine in our region
and providing further endorsement that, after the rigorous scrutiny
of regulators, the vaccine can be used to help protect populations
from the coronavirus pandemic."</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="color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca continues to work with regulatory authorities around
the world to support their ongoing rolling reviews for emergency
supply or conditional approval during the health crisis.
AstraZeneca is also seeking Emergency Use Listing from the World
Health Organization for an accelerated pathway to vaccine
availability in low-income countries.</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="color: #000000; font-family: Times New Roman; font-size: 13px">
The vaccine can be stored, transported and handled at normal
refrigerated conditions
(two-eight&#xA0;degrees&#xA0;Celsius/36-46&#xA0;degrees&#xA0;Fahrenheit)
for at least six months and administered within existing healthcare
settings.</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="color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca continues to engage with governments, international
organisations and collaborators around the world to ensure broad
and equitable access to the vaccine&#xA0;at no profit for the
duration of the pandemic.</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>
<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">COVID-19 Vaccine
AstraZeneca</font><font style="color: #000000">, formerly
AZD1222</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="font-style: italic; color: #000000">
COVID-19 Vaccine AstraZeneca</font><font style="color: #000000">&#xA0;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.</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="color: #000000; font-family: Times New Roman; font-size: 13px">
CHMP's recommendation was based on an analysis of 23,745
participants&#xA0;aged 18 years and older,&#xA0;accruing 232
symptomatic COVID-19 infections from the UK and Brazil Phase III
trials conducted by Oxford University.</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 safety data published so far is from over 20,000 participants
enrolled across four clinical trials in the UK, Brazil and South
Africa. The publication in&#xA0;</font><font style="font-style: italic; text-decoration: underline; color: #0000FF">The
Lancet</font><font style="color: #000000">&#xA0;confirmed
that&#xA0;</font><font style="font-style: italic; color: #000000">COVID-19 Vaccine
AstraZeneca</font><font style="color: #000000">&#xA0;was well
tolerated and that there were no serious safety events confirmed
related to the vaccine. The participants were from diverse ethnic
and geographic groups who were healthy or had stable underlying
medical conditions.</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="color: #000000; font-family: Times New Roman; font-size: 13px">
In addition to the programme led by Oxford University, AstraZeneca
is conducting a large trial in the US and globally. In total,
Oxford University and AstraZeneca expect to enrol up to 60,000
participants globally.</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="color: #000000; font-family: Times New Roman; font-size: 13px">
The AstraZeneca COVID-19 vaccine has already been granted a CMA or
emergency use in close to 40 countries, spanning four continents
including in the EU, a number of Latin American countries, India,
Morocco and the UK.</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; color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca</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; font-size: 13px">
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 &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; font-size: 13px">astrazeneca.com</font><font style="color: #000000; font-size: 13px">&#xA0;and
follow the Company on Twitter&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">@</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">AstraZeneca</font><font style="color: #000000; font-size: 13px">.</font></font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Contacts</font></div>
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For details on how to contact the Investor Relations Team, please
click&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">here</font><font style="color: #000000; font-size: 13px">.
For Media contacts, click&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">here</font><font style="color: #000000; font-size: 13px">.</font></font></div>
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Adrian Kemp</font></div>
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Company Secretary</font></div>
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AstraZeneca PLC</font></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">01 February
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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