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
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