(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 more than 38 million and crippled the global economy.
Below are the main details of the British vaccine.
TYPE
* 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.
DOSAGE AND PROTECTION DURATION
* 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.
EXPECTED COST/PRICING
* 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.TESTING
* AstraZeneca had to pause global trials on Sept. 6 after anunexplained illness in a participant. * Most trials have since resumed, although the United Stateshas widened its investigation. President Donald Trump is pushingfor a vaccine to be fast-tracked before November’s presidentialelections. * 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.
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
* 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. * Delivery of the first doses was expected between Septemberand October to Americans and Britons, as per the deals signed byAstraZeneca.
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
* More than 3 billion doses.
TIE-UPS
* 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.
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)
