US Influenza
Oxford / AstraZeneca

Phase 2 / 3

https://www.thelancet.com/journals/la...


(23rd November)

https://www.astrazeneca.com/media-cen...

Viral vector, weakened version, chimpanzee, common cold adenovirus

After vaccination, the surface spike protein is produced

Antibodies

T cells
Interim report, 131 confirmed infections
Positive high-level results
8,000 swabs per week
Therefore picking up asymptomatics
Clinical trials of AZD1222
UK and Brazil data only
Vaccine was highly effective in preventing COVID-19
No hospitalisations or severe cases of the disease were reported in participants receiving the vaccine
Group one, n = 2,741
AZD1222 was given as a half dose
Followed by a full dose
At least one month apart
Vaccine efficacy of 90%
Group 2, n = 8,895
Two full doses at least one month apart
Vaccine efficacy 62 %
Combined analysis from both dosing regimens, n = 11,636
An average efficacy of 70%
All results were statistically significant (p less than = 0.0001)
One in 10,000
More data will continue to accumulate
Refining the efficacy reading
Establishing the duration of protection.
Independent Data Safety Monitoring Board
Met its primary endpoint
Protection from COVID-19 occurring 14 days or more after receiving two doses
No serious safety events related to the vaccine have been confirmed
AZD1222 was well tolerated across both dosing regimens
AstraZeneca immediately prepare regulatory submission
Early approval
Emergency Use Listing from the World Health Organization
For an accelerated pathway to low-income countries
Full analysis of the interim results is being submitted for peer-reviewed journal
Professor Andrew Pollard
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
Pascal Soriot, Chief Executive Officer
Simple supply chain
no-profit pledge
commitment to broad, equitable and timely access means
it will be affordable and globally available
supplying hundreds of millions of doses on approval
Control group
Meningococcal conjugate vaccine called MenACWY
or saline
Participants
Aged 18 years or over
Diverse racial and geographic groups
Healthy or have stable underlying medical conditions
Clinical trials are also being conducted in
US, Japan, Russia, South Africa, Kenya, Latin America
Planned trials in other European and Asian countries
N = 60,000
Manufacturing capacity
3 billion doses in 2021
Storage / transport
2-8 degrees Celsius
36-46 degrees Fahrenheit
For at least six months
Administered within existing healthcare settings
COV002
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
Aged 18 years or over
Healthy or have medically stable chronic diseases and are at increased risk for being exposed to the SARS-CoV-2 virus
Group one
One or two intramuscular doses of a half dose (~2.5 x1010 viral particles)
Comparator, meningococcal vaccine MenACWY.
Group two
Full dose (~5x1010 viral particles)
Comparator, meningococcal vaccine MenACWY.
Clinical assessments for safety as well as immunogenicity
Multiple timepoints
For a year
Weekly swabbing for viral presence
COV003
COV003 is a single-blinded, multi-centre, randomised, controlled Phase III trial in Brazil
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
UK, Oxford / Astrazeneca
The UK has ordered 100m doses
US also
UK government has supplied £65.5m towards the development
Contracts with France, Germany, Italy and the Netherlands, up to 400 million doses
Serum Institute of India, vaccine alliances, production for poorer countries, 1 billion doses
China, Brazil, Japan and Russia have also expressed interest.