<SEC-DOCUMENT>0001654954-21-006114.txt : 20210521
<SEC-HEADER>0001654954-21-006114.hdr.sgml : 20210521
<ACCEPTANCE-DATETIME>20210521062312
ACCESSION NUMBER:		0001654954-21-006114
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20210521
FILED AS OF DATE:		20210521
DATE AS OF CHANGE:		20210521

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:		21946560

	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>a4139z.htm
<DESCRIPTION>ASTRAZENECA COVID-19 VACCINE VAXZEVRIA AUTHORISED FOR EMERGENCY USE IN JAPAN
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AstraZeneca PLC</font></div>
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AstraZeneca PLC</font></div>
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TO EXHIBITS</font></div>
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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-family: Times New Roman; font-size: 13px"><font style="font-weight: bold; color: #000000">AstraZeneca COVID-19
vaccine&#xA0;</font><font style="font-weight: bold; font-style: italic; color: #000000">Vaxzevria</font><font style="color: #000000">&#xA0;</font><font style="font-weight: bold; color: #000000">authorised
for emergency use in Japan</font></font></div>
</div>
</div>
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<font style="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">
21 May 2021 07:00 BST</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="color: #000000">AstraZeneca COVID-19
vaccine&#xA0;</font><font style="font-style: italic; color: #000000">Vaxzevria</font></font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
authorised for emergency use in Japan</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="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
AstraZeneca's COVID-19 vaccine,&#xA0;</font><font style="font-style: italic; color: #000000">Vaxzevria</font><font style="color: #000000">&#xA0;(ChAdOx1-S [Recombinant])</font><font style="font-style: italic; color: #000000">,</font><font style="color: #000000">&#xA0;formerly AZD1222,&#xA0;has been granted a
special approval for emergency use in Japan for active immunisation
of individuals aged 18 years and older, to prevent COVID-19 caused
by 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="color: #000000; font-family: Times New Roman; font-size: 13px">
The Japanese Ministry of Health, Labour and Welfare granted the
approval based on positive Phase III efficacy and safety data from
the Oxford University-led clinical trial programme in the UK,
Brazil and South Africa, and a Phase I/II trial in
Japan.</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">
Japan's&#xA0;Pharmaceuticals and Medical Devices
Agency&#xA0;recommends that the use of&#xA0;</font><font style="font-style: italic; color: #000000">Vaxzevria</font><font style="color: #000000">&#xA0;should be limited to adults and administered
intramuscularly as two 0.5 mL doses given four to 12 weeks apart,
with an interval greater than eight weeks being preferable to
maximise its efficacy. This dosing regimen was shown in clinical
trials to be well-tolerated and effective in preventing symptomatic
COVID-19, with no severe cases and no hospitalisations more than 14
days after the second dose.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font></font></div>
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&#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, said: "We continue to expand global access to our vaccine
and today's approval brings us one step closer to
providing&#xA0;</font><font style="font-style: italic; color: #000000">Vaxzevria</font><font style="color: #000000">&#xA0;to the people of Japan who urgently need
protection from coronavirus. We are proud to have produced a
vaccine for the world, which is playing a leading role in the
global fight against the pandemic, with more than 400 million doses
now supplied by AstraZeneca and sub-licensees to 165
countries."</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">
Production of the vaccine in Japan is already underway, and the
first doses are expected to be available 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="color: #000000; font-family: Times New Roman; font-size: 13px">
The vaccine has been granted a conditional marketing authorisation
or emergency use in more than 80 countries across six continents
and has also received Emergency Use Listing from the World Health
Organization, which accelerates the pathway to access in up to 142
countries through the COVAX Facility.</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="font-style: italic; color: #000000">
Vaxzevria</font><font style="color: #000000">&#xA0;can be stored,
transported and handled at normal refrigerated conditions
(two-eight degrees Celsius/36-46 degrees Fahrenheit) for at least
six months, and administered within existing healthcare
settings.</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 continues to engage with governments, international
organisations and collaborators around the world to ensure broad
and equitable access to the vaccine 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="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-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
Vaxzevria</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">
Vaxzevria</font><font style="color: #000000">&#xA0;(ChAdOx1-S
[Recombinant]), formerly 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.</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; 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="color: #000000; font-family: Times New Roman; 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 in
Oncology 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 astrazeneca.com and follow the Company on Twitter
@AstraZeneca.</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-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Contacts</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">
For details on how to contact the Investor Relations Team, please
click&#xA0;</font><font style="text-decoration: underline; color: #0000FF">here</font><font style="color: #000000">.
For Media contacts, click&#xA0;</font><font style="text-decoration: underline; color: #0000FF">here</font><font style="color: #000000">.</font></font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
References:</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
1. Vosey, M., et al (2021) Safety and efficacy of the ChAdOx1
nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis
of four randomised controlled trials in Brazil, South Africa, and
the UK.&#xA0;</font><font style="font-style: italic; color: #000000">The Lancet.</font><font style="color: #000000">&#xA0;397(10269): 99-111.</font></font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Adrian Kemp</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Company Secretary</font></div>
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<font style="font-weight: bold; color: #000000; 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">&#xA0;</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">21 May
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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