a1393g
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 November 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 __
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1):
Indicate
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.
AZD1222 vaccine
effective against COVID-19
This announcement contains inside information
23 November 2020 07:00 GMT
AZD1222 vaccine met primary efficacy endpoint in preventing
COVID-19
Two different dosing regimens demonstrated efficacy with one
showing a better profile
No hospitalisations or severe cases of COVID-19 in participants
treated with AZD1222
Positive high-level results from an interim analysis of clinical
trials of AZD1222 in the UK and Brazil showed the vaccine was
highly effective in preventing COVID-19, the primary endpoint, and
no hospitalisations or severe cases of the disease were reported in
participants receiving the vaccine. There were a total of 131
COVID-19 cases in the interim analysis.
One dosing regimen (n=2,741) showed vaccine efficacy of 90% when
AZD1222 was given as a half dose, followed by a full dose at least
one month apart, and another dosing regimen (n=8,895) showed 62%
efficacy when given as two full doses at least one month apart. The
combined analysis from both dosing regimens (n=11,636) resulted in
an average efficacy of 70%. All results were statistically
significant (p<=0.0001). More data will continue to accumulate
and additional analysis will be conducted, refining the efficacy
reading and establishing the duration of protection.
An independent Data Safety Monitoring Board determined that the
analysis met its primary endpoint showing protection from COVID-19
occurring 14 days or more after receiving two doses of the vaccine.
No serious safety events related to the vaccine have been
confirmed. AZD1222 was well tolerated across both dosing
regimens.
AstraZeneca will now immediately prepare regulatory submission of
the data to authorities around the world that have a framework in
place for conditional or early approval. The Company will seek an
Emergency Use Listing from the World Health Organization for an
accelerated pathway to vaccine availability in low-income
countries. In parallel, the full analysis of the interim results is
being submitted for publication in a peer-reviewed
journal.
Professor Andrew Pollard, Chief Investigator of the Oxford Vaccine
Trial at Oxford, said: "These findings show
that we have an effective
vaccine that will save many lives.
Excitingly, we've found that one of our dosing regimens may be
around 90% effective and if this dosing regime is used, more people
could be vaccinated with planned vaccine supply. Today's
announcement is only possible thanks to the
many volunteers in our trial,
and the hard working and
talented team of researchers based around the
world."
Pascal Soriot, Chief Executive Officer, said: "Today marks an
important milestone in our fight against the pandemic. This
vaccine's efficacy and safety confirm that it will be highly
effective against COVID-19 and will have an immediate impact on
this public health emergency. Furthermore, the vaccine's simple
supply chain and our no-profit pledge and commitment to broad,
equitable and timely access means it will be affordable and
globally available, supplying hundreds of millions of doses on
approval."
The pooled analysis included data from the COV002 Phase II/III
trial in the UK and COV003 Phase III trial in Brazil. Over 23,000
participants are being assessed following two doses of either a
half-dose/full-dose regimen or a regimen of two full doses of
AZD1222 or a comparator, meningococcal conjugate vaccine called
MenACWY or saline. The global trials are evaluating participants
aged 18 years or over from diverse racial and geographic groups who
are healthy or have stable underlying medical
conditions.
Clinical trials are also being conducted in the US, Japan, Russia,
South Africa, Kenya and Latin America with planned trials in other
European and Asian countries. In total, the Company expects to
enrol up to 60,000 participants globally.
The Company is making rapid progress in manufacturing with a
capacity of up to 3 billion doses of the vaccine in 2021 on a
rolling basis, pending regulatory approval. The vaccine can be
stored, transported and handled at normal refrigerated conditions
(2-8 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.
COV002
COV002 is a single-blinded, multi-centre, randomised, controlled
Phase II/III trial assessing the safety, efficacy and
immunogenicity of AZD1222 in 12,390 participants in the UK. Trial
participants to date are aged 18 years or over, who are healthy or
have medically stable chronic diseases and are at increased risk
for being exposed to the SARS-CoV-2 virus. Participants receive one
or two intramuscular doses of a half dose (~2.5
x1010 viral
particles) or full dose (~5x1010 viral
particles) of AZD1222 or comparator, meningococcal vaccine MenACWY.
Participants have blood samples drawn and clinical assessments for
safety as well as immunogenicity at multiple timepoints up to one
year post-vaccination. Suspected cases presenting with compatible
symptoms were tested for virological confirmation by COVID-19 PCR.
In addition, weekly swabbing are done for detection of infection
and assessment of vaccine efficacy against
infection.
COV003
COV003 is a single-blinded, multi-centre, randomised, controlled
Phase III trial assessing the safety, efficacy, and immunogenicity
of AZD1222 in 10,300 participants in Brazil. Trial participants to
date are aged 18 years or over, who are healthy or have medically
stable chronic diseases and are at increased risk for being exposed
to the SARS-CoV-2 virus. Participants are randomised to receive two
intramuscular doses of a full dose (~5x1010 viral
particles) of AZD1222 or comparator, meningococcal vaccine MenACWY
as first dose and a saline placebo as second dose. Participants
have blood samples drawn and clinical assessments for safety as
well as immunogenicity at multiple timepoints up to one year
post-vaccination. Suspected cases presenting with compatible
symptoms were tested for virological confirmation by COVID-19
PCR.
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.
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:
23 November 2020
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|