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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 February 2021
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
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by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1):
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by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ______
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by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information
to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.
Yes __
No X
If
“Yes” is marked, indicate below the file number
assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca PLC
INDEX
TO EXHIBITS
1.
COVID-19 vaccine authorised for use by the EU
1 February 2021 07:00 GMT
COVID-19 Vaccine
AstraZeneca authorised for
use in the EU
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.
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. 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.
The CHMP recommends two doses of COVID-19 Vaccine
AstraZeneca, 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.
AstraZeneca is working with the EU following the approval of a CMA
for active immunisation to begin across member states.
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 to Oxford University,
participants in the clinical trials and AstraZeneca colleagues for
their unwavering commitment to providing this lifesaving vaccine to
millions of Europeans."
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."
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.
The vaccine 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.
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.
COVID-19 Vaccine
AstraZeneca, formerly
AZD1222
COVID-19 Vaccine AstraZeneca 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.
CHMP's recommendation was based on an analysis of 23,745
participants aged 18 years and older, accruing 232
symptomatic COVID-19 infections from the UK and Brazil Phase III
trials conducted by Oxford University.
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 The
Lancet confirmed
that COVID-19 Vaccine
AstraZeneca 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.
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.
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.
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.
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:
01 February
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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