Factbox: Development of AstraZeneca's potential coronavirus vaccine

FILE PHOTO: Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed AstraZeneca logo in this illustration taken October 31, 2020. REUTERS/Dado Ruvic

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, while data in October showed the vaccine produces a immune response in both old and young adults.

AstraZeneca is also expected to publish eagerly awaited late-stage, phase III clinical trial data in the coming weeks.

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 46 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 Recruiting, 5,000 anticipated, Sept. 2021 (https://bit.ly/2GAeB4K)

restarted with participants

after pause aged 18 years and

in early older

September

India Phase II/III Ongoing, 1,600 anticipated, In seven months

restarted with participants from August (https://bit.ly/3nAwXTC)

after pause aged 18 years and

in early older

September

Japan Phase I/II Ongoing, 256 anticipated, Sept. 2021 (https://bit.ly/3nAnImj)

restarted with participants

after pause aged 18 years and

in early older

September

Kenya Phase Ib/II Ongoing 400 anticipated, In approximately

with participants two years (https://bit.ly/362fsUy)

aged 18 years and

older, and will

only enrol

healthcare workers

Russia Phase III On hold, 100 anticipated, March 2021 (https://bit.ly/36NKpxr)

paused in with participants

early aged 18 years and

September older

South Africa Phase I/II Ongoing, 2000 anticipated, Dec. 2021 (https://bit.ly/2Gy8mhS)

restarted with 1,950

after pause HIV-uninfected

in early adults and 50

September people living with

HIV

UK Phase I/II Ongoing, 1,090 enrolled, Oct. 2021 (https://bit.ly/3oQGhDq)

restarted with participants (https://bit.ly/2HY2pe5)

after pause aged between 18

in early years and 55 years

September

UK Phase II/III Ongoing, 12,390 anticipated, Aug. 2021 (https://bit.ly/34EOHVj)

restarted with participants (https://bit.ly/2HSU37G)

after pause aged 5 years and

in early older. Also

September includes HIV

infected adults in

one group.

U.S. Phase III Ongoing, 40,051 anticipated, Oct. 2022 (https://bit.ly/30O4XCl)

restarted with participants

in late aged 18 years and

October older

after pause

in early

September

DATA AND REGULATORY TIMELINE

REGULATORY REVIEWS

(Most recent first)

REGION/REGULATOR SUBMISSION/R STATUS FORMAL FURTHER

EVIEW APPLICATION

Britain/Medicine Rolling Launched in late Not submitted

s and Healthcare review Oct

Products

Regulatory

Agency

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 EXPECTED FURTHER

DELIVERIES

Spain 31.6 million as Undisclosed Between Dec. 2020

part of a European and June 2021

Union scheme

Switzerland 5.3 million Undisclosed Unknown

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. 2020

States

United 100 million 84 million By Sept/Oct. 2020

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)

* Called AZD1222 or ChAdOx1 nCoV-19, the vaccine is arecombinant viral vector vaccine. * It uses a weakened version of a chimpanzee common coldvirus that encodes instructions for making proteins from thenovel coronavirus to generate an immune response and preventinfection. * AstraZeneca and Oxford University have said a two-doseregimen showed greater promise, while a single-dose injection isalso being tested in trials. * The vaccine is likely to provide protection for about ayear, CEO Pascal Soriot said in June. * In the first indication of pricing, Italy's healthministry said in June an AZD1222 vaccine would cost about 2.5euros ($2.8) per dose in Europe. * AstraZeneca said in July it will be able to manufacturethe vaccine at a few dollars per dose. * Pricing in Latin America, while still not final, is notexpected to exceed $4 per dose, AstraZeneca's Mexico head saidin August. * The Serum Institute of India said in August it would pricethe vaccine at $3 per dose for India and other emergingeconomies. * Costs in other regions have not been disclosed so far. * AstraZeneca has said it would not profit from the vaccineduring the pandemic, but a report from the Financial Times inOctober showed the company can declare when it considers thepandemic to have ended in its deals for the vaccine. * In addition to manufacturing costs, the company isincurring costs in excess of $1 billion globally, and said inOctober the Oxford vaccine deal allows it to add up to 20% ofmanufacturing costs to cover additional expenses. * Trial of the vaccine in the United States had resumed, thecompany said on Oct. 23, making the region the latest to resumetrials after deep investigations. President Donald Trump ispushing for a vaccine to be fast-tracked before November'spresidential elections. * AstraZeneca had to pause global trials on Sept. 6 after anunexplained illness in a participant. * AZD1222 produces a immune response in both old and youngadults, and also triggers lower adverse responses among theelderly, AstraZeneca said in October. * The vaccine also accurately follows genetic instructionsprogrammed into it by its developers, according to an analysisby independent scientists. * Brazil's health authority said in October that a trialvolunteer had died but added that the trial would continue. * A source told Reuters the trial would have been suspendedif the volunteer who died had received the COVID-19 vaccine,suggesting the person was part of the control group that wasgiven a meningitis jab. [nL1N2HC1O6 * AstraZeneca's CEO said in July that good data had come inon the vaccine, after early-stage trials showed it was safe andproduced an immune response. * The lead developer said in July the vaccine could berolled out by year-end, but there has been some uncertainty overthe timeline since trials were paused. * Experts have predicted a safe and effective vaccine couldtake 12-18 months to develop. * A scientist leading the studies in August said data couldbe given to regulators this year. * Data from early-stage trials was published in The Lancetmedical journal in July. * Data from late-stage studies was expected aroundSeptember, but is now anticipated to come in the next few weeks. * Senior sources in the British government expect that averdict on whether Pfizer's COVID-19 vaccine works will beavailable before AstraZeneca's, the Times reported in October. * Delivery of the first doses was expected between Septemberand October to Americans and Britons, as per the deals signed byAstraZeneca. * More than 3 billion doses. * AstraZeneca has already signed more than a dozen deals tosupply the vaccine and a similar number of manufacturingagreements. It has also joined with IQVIA to speed up testing. * AstraZeneca has been granted protection from futureliability claims related to the vaccine by most of the countrieswith which it has struck supply agreements, a senior executivetold Reuters in July.