a1114k
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 December 2020
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
20-F X Form 40-F __
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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): ______
Indicate
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.
AstraZeneca’s COVID-19 vaccine authorised in
UK
This announcement contains inside information
30 December 2020 07:00 GMT
AstraZeneca's COVID-19 vaccine authorised for emergency supply in
the UK
Working with the UK government, first vaccinations to begin early
in the New Year
Regulatory interactions continue around the world for next
approvals
AstraZeneca's COVID-19 vaccine has been approved for emergency
supply in the UK, with the first doses being released today so that
vaccinations may begin early in the New Year.
The UK Medicines and Healthcare products Regulatory Agency (MHRA)
has provided authorisation for emergency supply
of COVID-19 Vaccine
AstraZeneca, formerly AZD1222,
for the active immunisation of individuals 18 years or older. The
authorisation recommends two doses administered with an
interval of between four and 12 weeks. This regimen was shown in
clinical trials to be safe and effective at preventing symptomatic
COVID-19, with no severe cases and no hospitalisations more than 14
days after the second dose.
AstraZeneca is working with Public Health England and National
Health Service England to support the deployment and roll out of
the vaccine in the UK, in line with the MHRA and the UK's Joint
Committee on Vaccination and Immunisation dosing
recommendation. The Company aims to supply millions of doses
in the first quarter as part of an agreement with the government to
supply up to 100 million doses in total.
Pascal Soriot, Chief Executive Officer, said: "Today is an
important day for millions of people in the UK who will get access
to this new vaccine. It has been shown to be effective,
well-tolerated, simple to administer and is supplied by AstraZeneca
at no profit. We would like to thank our many colleagues at
AstraZeneca, Oxford University, the UK government and the tens of
thousands of clinical trial participants."
Matt Hancock, UK Secretary of State for Health and Social Care,
said: "This is a moment to celebrate British innovation - not only
are we responsible for discovering the first treatment to reduce
mortality for Covid-19, this vaccine will be made available to some
of the poorest regions of the world at a low cost, helping protect
countless people from this awful disease. It is a tribute to the
incredible UK scientists at Oxford University and AstraZeneca whose
breakthrough will help to save lives around the world. I want to
thank every single person who has been part of this British success
story. While it is a time to be hopeful, it is so vital everyone
continues to play their part to drive down
infections."
Professor Andrew Pollard, Director of the Oxford Vaccine Group and
Chief Investigator of the Oxford Vaccine Trial, said: "The
regulator's assessment that this is a safe and effective vaccine is
a landmark moment, and an endorsement of the huge effort from a
devoted international team of researchers and our dedicated trial
participants. Though this is just the beginning, we will start to
get ahead of the pandemic, protect health and economies when the
vulnerable are vaccinated everywhere, as many as possible as soon
possible."
The decision to approve the vaccine was taken under Regulation 174
of the Human Medicine Regulations 2012, which enables rapid
emergency regulatory approvals to address significant public health
issues such as a pandemic. This is the first authorisation for this
vaccine.
The MHRA's decision was based on independent advice from its
Commission on Human Medicines following a rolling review of trial
data that included an interim analysis of the Phase III programme
led by the University of Oxford. The data were also published
in The
Lancet on 8 December 2020.
Additional safety and efficacy data for the vaccine will continue
to accumulate from ongoing clinical trials. AstraZeneca continues
to work with regulatory authorities around the world to support
their ongoing rolling reviews for emergency supply or conditional
marketing authorisation 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- and middle-income countries.
AstraZeneca is working with its global partners to continue
building manufacturing capacity of up to three billion doses of the
vaccine globally in 2021 on a rolling basis, pending regulatory
approvals. 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, multilateral
organisations and collaborators around the world to ensure broad
and equitable access to the vaccine at no profit for the
duration of the pandemic.
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.
The interim analysis for efficacy was based on 11,636 participants
accruing 131 symptomatic infections from the UK and Brazil Phase
III trials conducted by Oxford University.
As announced on 23
November 2020, the primary
efficacy endpoint based on a pooled analysis showed that the
vaccine was 70.4% (confidence interval: 54.8% to 80.6%) effective
at preventing symptomatic COVID-19 occurring more than 14 days
after receiving two doses of the vaccine. A secondary efficacy
endpoint of prevention of severe disease demonstrated no cases of
severe infections or hospitalisations in the vaccine
group.
The safety data published so far is from over 20,000 participants
enrolled across four clinical trials in the UK and Brazil and South
Africa. The Lancet publication confirmed that AZD1222 was well
tolerated and that there were no serious safety events confirmed
related to the vaccine. The participants were from diverse racial
and geographic groups who are healthy or have stable underlying
medical conditions. This analysis provides safety data on 74,341
person-months of follow-up after first dose (median 3.4 months) and
29,060 person-months of follow-up after two doses (median 2.0
months). The overall reported rates of serious adverse events were
0.7% in the vaccine group and 0.8% in the control
group.
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.
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:
30 December
2020
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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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