(Reuters) – AstraZeneca’s experimental COVID-19 vaccine is one of the most advanced candidates in the race against the novel coronavirus.
The British drugmaker has signed several supply and manufacturing deals with companies and governments around the world as it gets closer to reporting early results of a late-stage clinical trial.
Developed by the University of Oxford and licensed to AstraZeneca in April, the vaccine is expected to be one of the first from big pharma to secure regulatory approval, along with Pfizer and BioNTech’s candidate.
Although drugmakers and researchers are also working on various treatments, vaccines are at the heart of the long-term fight to stop the virus, which has killed more than a million people, infected nearly 37 million and crippled the global economy. [nL4N2AY3AS]
Below are the main details of the British vaccine.
TYPE
DOSAGE AND PROTECTION DURATION
TESTING
GLOBAL TRIALS
(In alphabetical order of geographies)
REGION STAGE OF STATUS VOLUNTEERS EXPECTED COMPLETION
DEVELOPMENT
Brazil Phase III Ongoing, 5,000 estimated, Sept. 2021 (https://bit.ly/2GAeB4K)
restarted with participants
after pause aged 18 years and
in older
September
India Phase II/III Ongoing, 1,600 estimated, In seven months
restarted with participants from August (https://bit.ly/3nAwXTC)
after pause aged 18 years and
in older
September
Japan Phase I/II Ongoing, 12 estimated, with Sept. 2021 (https://bit.ly/3nAnImj)
restarted participants aged
after pause 18 years and older
in
September
Russia Phase III On hold, 100 estimated, with March 2021 (https://bit.ly/36NKpxr)
paused in participants aged
September 18 years and older
South Africa Phase I/II Ongoing, 2000 estimated, Dec. 2021 (https://bit.ly/2Gy8mhS)
restarted with 1,950
after pause HIV-uninfected
in adults and 50
September people living with
HIV
UK Phase II/III Ongoing, 12,330 estimated, Aug. 2021 (https://bit.ly/34EOHVj)
restarted with participants
after pause aged 5 years and
in older
September
U.S. Phase III On hold, 30,000 estimated, Oct. 2022 (https://bit.ly/30O4XCl)
paused in with participants
September aged 18 years and
older
DATA AND REGULATORY TIMELINE
REGULATORY REVIEWS
(Most recent first)
REGION/REGULATOR SUBMISSION/R STATUS FORMAL FURTHER
EVIEW APPLICATION
Canada/Health Rolling Launched in Oct Not submitted [nL1N2GT0PY]
Canada submission
Europe/European Rolling Launched in Oct Not submitted [nL4N2GS2I4]
Medicines Agency review
TARGET DOSES/GLOBAL CAPACITY
TIE-UPS
MANUFACTURING DEALS
(Most recent first)
FIRM BASED IN DEAL VALUE FOR FURTHER
Siam Thailand Undisclosed Manufacture and [nL4N2H32KR]
Bioscience, supply the vaccine
SCG in Thailand and
other nations in
southeast Asia
Albany U.S. Undisclosed Produce millions of [nL4N2G02ZF]
Molecular doses through
Research sterile finishing
services at its
manufacturing plant
in Albuquerque, New
Mexico
Oxford UK 15 million Unknown doses for [nL4N2FY2E4]
Biomedica pounds to large-scale
reserve commercial
manufacturi manufacture under
ng expanded deal
capacity,
further 35
million
pounds plus
costs
payable in
certain
situations
Catalent U.S. Undisclosed Making the drug [nL4N2DS2XW]
substance used in
the vaccine at its
Maryland facility.
AZ’s second deal
with firm
Foundation Mexico Undisclosed Latin American [nL1N2FF01U]
of Mexican supply with
billionaire Argentina, excluding
Carlos Slim Brazil, could reach
250 million
mAbxience of Argentina Undisclosed Initially producing [nL1N2FF01U]
the INSUD 150 million doses
Group for Latin America,
excluding Brazil
Kangtai Bio China Undisclosed Annual production [nL4N2F82GT]
capacity of at least
100 million doses
this year, and at
least 200 million
doses by end-2021
Emergent U.S. $174 Undisclosed doses in [nL3N2EY2LF]
BioSolutions million second deal with AZ
SK South Korea Undisclosed Undiluted solutions [nL3N2ES288]
Bioscience of the vaccine until
early 2021
R-Pharm Russia Undisclosed Unknown doses [nL5N2EO2S4]
Daiichi Japan Undisclosed Unknown doses [nL4N2E319J]
Sankyo
Fundao Brazil $127 About 30 million [nL1N2E403I]
Osvaldo Cruz million doses
(Fiocruz)
Symbiosis Scotland Undisclosed Clinical trial [nL4N2E12U2]
Pharmaceutic supply
al
Cobra U.S. Undisclosed One million doses [nL8N2DT1YB]
Biosciences per month
Catalent U.S. Undisclosed Vial filling and [nL4N2DS2XW]
packaging capacity
at its manufacturing
facility in Anagni,
Italy
Emergent U.S. $87 million 300 million doses [nL4N2DO2U1]
BioSolutions
Serum India Undisclosed One billion doses [nL4N2DH3LY]
Institute of for low and
India middle-income
countries, with 400
million before
end-2020
Oxford UK Undisclosed Manufacturing [nL4N2DL1B3]
Biomedica unknown number of
doses
SUPPLY DEALS
(Most recent first)
REGION/GROUP DOSES FUNDING DELIVERIES FURTHER
Thailand Unknown Undisclosed First batch [nL4N2H32KR]
expected to be
available in
mid-2021
Canada Up to 20 million Undisclosed Unknown [nT5N2FK009]
doses
Australia “Enough” for Undisclosed Unknown [nL4N2FK44P]
population of 25
million, free of
cost
European 300 million, with 750 million By end-2020 [nL8N2FT5QW]
Union option of euros for 300 [nL8N2DQ0GG]
additional 100 million doses
million
Latin Initially produce Estimated at First half 2021 [nL1N2FF01U]
America, 150 million doses, $600 million
excluding and eventually for the first
Brazil make at least 400 150 million
million doses
Japan 120 million doses Undisclosed 30 million doses [nL4N2F92XN]
by March 2021
China Aims for annual Undisclosed By end-2020 [nL4N2F82GT]
production
capacity of at
least 100 million
doses this year,
and at least 200
million doses by
the end of next
year
South Korea Unknown Undisclosed Unknown [nL3N2ES288]
Russia Unknown Undisclosed Unknown [nL5N2EO2S4]
Israel Unknown Undisclosed Unknown [nL5N2ER4TW]
Brazil Initially receive $356 million Unknown [nL1N2F82TN]
100 million doses
Serum One billion, Undisclosed 400 million before [nL4N2DH3LY]
Institute of unspecified number end-2020
India of doses will go
to India
Epidemic 300 million $750 million, Some before end- [nFWN2DH0DK]
response with $383 from 2020
group CEPI CEPI
and Vaccine
alliance
GAVI
United 300 million $1.2 billion By Oct [nL4N2D31M3]
States
United 100 million Undisclosed By Sept/Oct [nRSU5972Na]
Kingdom
(Sources: Reuters reporting, press releases, clinical trial registers, World Health Organisation)
($1 = 0.8850 euros)
($1 = 0.8156 pounds)
($1 = 5.6107 reais)
(Reporting by Pushkala Aripaka in Bengaluru; Editing by Jan Harvey, Mark Potter, Louise Heavens and Alexander Smith, Kirsten Donovan)
