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Health News

Factbox: Development of AstraZeneca's potential coronavirus vaccine

(Reuters) - AstraZeneca’s experimental COVID-19 vaccine is one of the most advanced candidates in the race against the novel coronavirus.

FILE PHOTO: A test tube labeled with the vaccine is seen in front of AstraZeneca logo in this illustration taken, September 9, 2020. REUTERS/Dado Ruvic

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 more than 38 million and crippled the global economy.

Below are the main details of the British vaccine.

TYPE

DOSAGE AND PROTECTION DURATION

EXPECTED COST/PRICING

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 (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 (bit.ly/3nAwXTC)

after pause aged 18 years and

in older

September

Japan Phase I/II Ongoing, 12 estimated, with Sept. 2021 (bit.ly/3nAnImj)

restarted participants aged

after pause 18 years and older

in

September

Russia Phase III On hold, 100 estimated, with March 2021 (bit.ly/36NKpxr)

paused in participants aged

September 18 years and older

South Africa Phase I/II Ongoing, 2000 estimated, Dec. 2021 (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 (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 (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

Canada submission

Europe/European Rolling Launched in Oct Not submitted

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

Bioscience, supply the vaccine

SCG in Thailand and

other nations in

southeast Asia

Albany U.S. Undisclosed Produce millions of

Molecular doses through

Research sterile finishing

services at its

manufacturing plant

in Albuquerque, New

Mexico

Oxford UK 15 million Unknown doses for

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

substance used in

the vaccine at its

Maryland facility.

AZ’s second deal

with firm

Foundation Mexico Undisclosed Latin American

of Mexican supply with

billionaire Argentina, excluding

Carlos Slim Brazil, could reach

250 million

mAbxience of Argentina Undisclosed Initially producing

the INSUD 150 million doses

Group for Latin America,

excluding Brazil

Kangtai Bio China Undisclosed Annual production

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

BioSolutions million second deal with AZ

SK South Korea Undisclosed Undiluted solutions

Bioscience of the vaccine until

early 2021

R-Pharm Russia Undisclosed Unknown doses

Daiichi Japan Undisclosed Unknown doses

Sankyo

Fundação Brazil $127 About 30 million

Osvaldo Cruz million doses

(Fiocruz)

Symbiosis Scotland Undisclosed Clinical trial

Pharmaceutic supply

al

Cobra U.S. Undisclosed One million doses

Biosciences per month

Catalent U.S. Undisclosed Vial filling and

packaging capacity

at its manufacturing

facility in Anagni,

Italy

Emergent U.S. $87 million 300 million doses

BioSolutions

Serum India Undisclosed One billion doses

Institute of for low and

India middle-income

countries, with 400

million before

end-2020

Oxford UK Undisclosed Manufacturing

Biomedica unknown number of

doses

SUPPLY DEALS

(Most recent first)

REGION/GROUP DOSES FUNDING DELIVERIES FURTHER

Switzerland 5.3 million Undisclosed Unknown [nFWN2H60RR]

Indonesia 100 million Undisclosed First batch

expected to be

available by first

half of 2021

Thailand Unknown Undisclosed First batch

expected to be

available in

mid-2021

Canada Up to 20 million Undisclosed Unknown

doses

Australia “Enough” for Undisclosed Unknown

population of 25

million, free of

cost

European 300 million, with 750 million By end-2020

Union option of euros for 300

additional 100 million doses

million

Latin Initially produce Estimated at First half 2021

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

by March 2021

China Aims for annual Undisclosed By end-2020

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

Russia Unknown Undisclosed Unknown

Israel Unknown Undisclosed Unknown

Brazil Initially receive $356 million Unknown

100 million doses

Serum One billion, Undisclosed 400 million before

Institute of unspecified number end-2020

India of doses will go

to India

Epidemic 300 million $750 million, Some before end-

response with $383 from 2020

group CEPI CEPI

and Vaccine

alliance

GAVI

United 300 million $1.2 billion By Oct

States

United 100 million 84 million By Sept/Oct

Kingdom pounds

(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 and Aakash Jagadeesh Babu in Bengaluru; Editing by Jan Harvey, Mark Potter, Louise Heavens, Alexander Smith and Kirsten Donovan

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