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 July 2020
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
COVID-19 vaccine
AZD1222 showed robust immune responses in all participants in Phase
I/II trial
20 July 2020 14:40 BST
COVID-19 vaccine AZD1222 showed robust
immune responses in all participants in Phase I/II
trial
Interim data showed strong antibody and T-cell
responses
Interim results from the ongoing Phase I/II COV001 trial, led by
Oxford University, showed AZD1222 was tolerated and generated
robust immune responses against the SARS-CoV-2 virus in all
evaluated participants.
COV001 is a blinded, multi-centre, randomised controlled Phase I/II
trial with 1,077 healthy adult participants, aged 18-55 years. It
assessed a single dose of AZD1222 against a comparator
meningococcal conjugate vaccine, MenACWY. Ten participants also
received two doses of AZD1222 one month apart.
The results published in The
Lancet confirmed a single
dose of AZD1222 resulted in a four-fold increase in antibodies to
the SARS-CoV-2 virus spike protein in 95% of participants one month
after injection. In all participants, a T-cell response was
induced, peaking by day 14, and maintained two months after
injection.
Neutralising activity against SARS-CoV-2 (as assessed by the MNA80
assay) was seen in 91% of participants one month after vaccination
and in 100% of participants who received a second dose. The levels
of neutralising antibodies seen in participants receiving either
one or two doses were in a similar range to those seen in
convalescent COVID-19 patients. Strong correlations were observed
across neutralisation assays.
The early safety responses confirmed that transient local and
systemic reactions were common in the AZD1222 group and were
comparable to previous trials and other adenoviral vector
vaccines.1-4 They
included temporary injection site pain and tenderness,
mild-to-moderate headache, fatigue, chills, feverishness, malaise
and muscle ache. No serious adverse events were reported with
AZD1222, and reactions were lessened with the use of prophylactic
paracetamol, a pain killer, and occurred less frequently after a
second dose.
Professor Andrew Pollard, Chief investigator of the Oxford Vaccine
Trial at Oxford University and co-author of the trial, said: "The
interim Phase I/II data for our coronavirus vaccine shows that the
vaccine did not lead to any unexpected reactions and had a similar
safety profile to previous vaccines of this type. The immune
responses observed following vaccination are in line with what we
expect will be associated with protection against the SARS-CoV-2
virus, although we must continue with our rigorous clinical trial
programme to confirm this. We saw the strongest immune response in
participants who received two doses of the vaccine, indicating that
this might be a good strategy for vaccination."
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "We are encouraged by the Phase I/II interim data
showing AZD1222 was capable of generating a rapid antibody and
T-cell response against SARS-CoV-2. While there is more work to be
done, today's data increases our confidence that the vaccine will
work and allows us to continue our plans to manufacture the vaccine
at scale for broad and equitable access around the
world."
Late-stage Phase II/III trials are currently underway in the UK,
Brazil and South Africa and are due to start in the US. Trials will
determine how well the vaccine will protect from the COVID-19
disease and measure safety and immune responses in different age
ranges and at various doses.
In parallel, AstraZeneca continues to fulfil its commitment for
broad and equitable access to the vaccine, should late-stage
clinical trials prove successful. So far, commitments to supply
more than two billion doses of the vaccine have been agreed with
the UK, US, Europe's Inclusive Vaccines Alliance, the Coalition for
Epidemic Preparedness, Gavi the Vaccine Alliance and Serum
Institute of India.
Financial considerations
Today's announcement is not anticipated to impact the Company's
financial guidance for 2020 as expenses to progress the vaccine are
anticipated to be offset by funding by governments and
international organisations.
Immune correlates of protection to
COVID-19 disease5
Correlates of protection for a vaccine against COVID-19 have not
yet been defined. High levels of neutralising antibodies have been
demonstrated in individuals who have recovered from SARS-CoV-2
infection. In addition, emerging data suggest that a T-cell
response could play an important role in mitigation of the disease.
Some individuals who have been infected with the virus but remained
asymptomatic, have developed a robust T-cell response with an
absence of detectable antibodies. Rapid induction of antibodies and
T-cells against the SARS-CoV-2 virus may be important in protection
against COVID-19.
COV001
COV001 is a Phase I/II single-blinded randomised controlled trial
to determine safety, immunogenicity and efficacy of the COVID-19
vaccine candidate AZD1222 in up to 1,077 healthy adults in five
trial centres in the UK. Participants aged 18-55 years received
either a single dose or two doses of AZD1222 at
5x1010 viral
particles, or a single dose of a meningococcal conjugate
vaccine MenACWY as control vaccine.
Participants had blood samples drawn and clinical assessments for
safety as well as immunogenicity at day 0, 28 and will also be
followed at day 184 and 364. In addition, participants enrolled in
the Phase I component of the study and in the two dose groups, had
visits at 3, 7, 14 and 28 days after each vaccination.
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/NYSE: 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.
References
1. Antrobus, R.D., et al., Clinical
assessment of a novel recombinant simian adenovirus ChAdOx1 as a
vectored vaccine expressing conserved Influenza A antigens. Mol
Ther, 2014. 22(3): p. 668-74.
2. Coughlan, L., et al., Heterologous Two-Dose Vaccination with
Simian Adenovirus and Poxvirus Vectors Elicits Long-Lasting
Cellular Immunity to Influenza Virus A in Healthy Adults.
EBioMedicine, 2018.
3. Wilkie, M., et al., A phase I trial evaluating the safety and
immunogenicity of a candidate tuberculosis vaccination regimen,
ChAdOx1 85A prime - MVA85A boost in healthy UK adults. Vaccine,
2020. 38(4): p. 779-789.
4. Folegatti, P.M., et al., Safety and immunogenicity of a
candidate Middle East respiratory syndrome coronavirus
viral-vectored vaccine: a dose-escalation, open-label,
non-randomised, uncontrolled, phase 1 trial. The Lancet Infectious
Diseases, 2020.
5. Sekine, T., et al., Robust T cell immunity in convalescent
individuals with asymptomatic or mild COVID-19. BioRxiv, 2020.
preprint doi:
https://doi.org/10.1101/2020.06.29.174888.
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:
20 July
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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