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(Adds removal of a study group of children from the UK trial)
Dec 14 (Reuters) – AstraZeneca removed a study
subgroup with children from a trial of your experiment
COVID-19 Vaccine in Britain, US Clinical Trial Records
showed on Monday, as the pharmacist seeks to gather
evidence on the efficacy of the vaccine.
AstraZeneca and the University of Oxford, once leaders in the
race to develop a COVID-19 vaccine, have been overtaken by
Pfizer and German partner BioNTech after a
series of stumbles, including a global pause in rehearsals and
divergent data for different dose regimens.
The following are details of the Oxford-AstraZeneca vaccine
effort.
TYPE OF VACCINE
* Called AZD1222 or ChAdOx1 nCoV-19, the vaccine is a
recombinant
viral vector vaccine, which means that a virus is used as a means of
deliver the vaccine.
* Use a weakened version of a common chimpanzee cold
virus
encoding instructions for producing proteins from the novel
coronavirus to generate an immune response and prevent
infection.
DOSE, PROTECTION DURATION AND STORAGE
* Two regimens are being tested: one in which recipients receive
two
full doses, and another with a half dose followed by a full dose
dose.
* The first half-dose regimen was found to be 90% effective
in a
subset of test subjects. The success rate was 62% with the
originally planned two full doses, based on interim data.
* The immune response could last at least a year.
* The vaccine can be stored, transported and handled in
normal
refrigerated for at least six months, so
logistically easier to transport than Pfizer’s vaccine.
EXPECTED DOSE PRICE
* Italy’s Ministry of Health said in June that the vaccine
cost
about 2.5 euros ($ 2.80) per dose in Europe.
* AstraZeneca has said that it will be able to manufacture the
vaccine
at a few dollars per dose.
* The price in Latin America is not expected to exceed $ 4 per
dose.
* Serum Institute of India has said it would price the
vaccine in
$ 3 per serving for India and other emerging economies.
* Sources told Reuters it could cost between $ 4 and $ 5 per dose in
Bangladesh.
* Costs in other regions have not yet been disclosed.
* AstraZeneca has said that it would not benefit from the vaccine.
during
pandemic, but a Financial Times report in October
showed that the company can declare when it considers that the pandemic
they have ended their deals for the vaccine.
* AstraZeneca will seek to benefit from richer countries
at
“appropriate time”.
TESTS AND DATA
* Trials combining the vaccine with Sputnik V from Russia
Start
before the end of the year, and Russia wants to jointly produce the
new vaccine if effective.
* Widely divergent performance with different dose regimens
has
asked for more clarity on the efficacy of the vaccine, which averaged
70.4%, well below the vaccines from Pfizer and Moderna Inc.
* Serum Institute of India will continue to test two
dose
vaccine regimen.
* AstraZeneca had to pause global testing on September 6 after a
Unexplained illness in a participant.
* The vaccine trial in the United States resumed in
October
after other countries had finished their hiatus.
* AZD1222 produces an immune response in both the elderly and the young
adults, and also led to lower adverse responses among
elderly, AstraZeneca said in October.
* The vaccine also precisely follows genetic instructions.
programmed into it by its developers, according to an analysis
by independent scientists.
* Brazil said in October that a test volunteer had died.
* A source told Reuters that the Brazilian trial would have been
suspended if the volunteer who died had received COVID-19
vaccine, although death was reported to be suicide.
* In July, data from early phase trials published in The
Lancet
showed that the vaccine was safe and produced an immune response.
GLOBAL TRIALS
Below are other regions where the vaccine is tested.
in progress or in planning: (in alphabetical order of regions)
REGION STAGE OF STATE VOLUNTEERS EXPECTED DATA
COMPLETION OF DEVELOPMENT
Brazil Phase III Recruitment, 10,300 First Data, September 2021 (https://bit.ly/2GAeB4K)
early rebooted posted at (https://bit.ly/2I4BNIz)
after a break, with afternoon
at the beginning of November participant
September 18
years and
higher
Chile Unknown Start Unknown Unknown Unknown
China Unknown To start Unknown Unknown Unknown
India Phase II / III Ongoing, 1,600 Not in seven months
early rebooted available from August (https://bit.ly/3nAwXTC)
after a pause, with
in early participant
September 18
years and
higher
Japan Phase I / II active, No 256 No November 2021 (https://bit.ly/3nAnImj)
recruitment. advance available
Rebooted, with
after pause participant
early 18
September years and
higher
Kenya Phase Ib / II Ongoing 400 Not in approximately
available two years early (https://bit.ly/362fsUy)
, with
participant
s 18 years
years and
major, and
could just
register
health care
workers
Peru Unknown Start Unknown Unknown Unknown
Russia Phase III suspended, 100 not in March 2021 (https://bit.ly/36NKpxr)
on hold early applicable
even with
Russian participant
approval s 18 years
subsequent years and
pause in majors
September
Russia, in Unknown Not Yet Unknown Unknown Unknown (https://bit.ly/2KljQ9F)
recruitment combination number of
with Sputnik older adults
V 18 and
higher
South Africa Phase I / II Active, no 2,130 First data December 2021 (https://bit.ly/2Gy8mhS)
recruitment. enrolled, was
Rebooted with both anticipated
after an HIV-free hiatus in the fourth quarter of 2020,
in Ted’s early adults, but the
September and village director
living with the researcher
HIV told Reuters
that
effectiveness
the results can
not be ready
for months
UK Phase I / II active, # 1,090 Initial data October 2021 (https://bit.ly/3n81UxJ)
enrolled recruitment, read at (https://bit.ly/2HY2pe5)
with July 2020
participant
s aged
between 18
and 55
UK Phase II / III Recruitment, 12,390 Early September 2021 data (https://bit.ly/34EOHVj)
early rebooted posted at (https://bit.ly/2HSU37G)
after a break, with afternoon
at the beginning of November participant
September 18
years and
higher. as well
It includes
HIV
infected
adults in
a group.
Previously
included
children
above 5
years of
years.
USA With Phase III Recruitment, 40,000 First Data, Feb 2023 (https://bit.ly/30O4XCl)
global sites rebooted early early
at the end, with in H1 2021
October participant
after a hiatus at 18
in the early years and
September Major
DATA AND REGULATORY CALENDAR
* The lead developer had said in July that the vaccine could be
rolled
at the end of the year, but the delivery and testing period has
It has been rejected.
* Experts have predicted that a safe and effective vaccine could
drink
12-18 months to develop.
* Read data sent to regulators around the world for
look for
approval.
REGULATORY REVIEWS
(Latest first)
REGION / PRESENTATION OF REGULATOR / R FORMAL STATE ALSO
SEE APPLICATION
India / Central Accelerated launched at Presented by
Drugs Standard reviews December and it’s serum
Control looking for more data Institute [nL4N2IN0M7
Organization to make a decision
on emergency
authorisation
Britain/Medicine Rolling Launched in late Not submitted
s and Healthcare review Oct, and will look
Products at all data to
Regulatory determine which
Agency dosing regimen is
best to use
Canada/Health Rolling Launched in Oct Not submitted
Canada submission
Europe/European Rolling Launched in Oct Not submitted
Medicines Agency review
* The World Health Organization expects to make decisions on
whether to give emergency use approval to COVID-19 vaccines,
including AstraZeneca’s, in the coming weeks, its chief
scientist said on Friday.
TARGET DOSES/GLOBAL CAPACITY OF SUPPLY
* More than 3 billion doses are planned.
* The company will have as many as 200 million doses by the
end of
2020, and 700 million doses could be ready globally as soon as
the end of the first quarter of 2021.
* Currently, AstraZeneca is keeping the vaccine frozen in
large
containers and will only add a final ingredient, put it into
vials and refrigerate it when the vaccine gets closer to
approval.
TIE-UPS
* Even before studies showed any signs of efficacy,
AstraZeneca
had signed several supply and manufacturing deals around the
world.
* It has also joined with IQVIA to speed up testing.
* AstraZeneca has been granted protection from future
liability
claims related to the vaccine by most of the countries with
which it has struck supply agreements, a senior executive told
Reuters in July.
MANUFACTURING DEALS
(Most recent first)
FIRM BASED IN DEAL VALUE FOR FURTHER
CSL Ltd Australia Undisclosed Additional 20
million requested by
Australian
government,
approximately 30
million doses
already being
manufactured
Halix B.V. Netherlands Undisclosed Commercial
manufacture of the
vaccine
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. $87 million 300 million doses
BioSolutions
Serum India Undisclosed One billion doses
Institute of for low and
India middle-income
countries. 400
million before
end-2020 were
expected previously
Oxford UK Undisclosed Manufacturing
Biomedica unknown number of
doses
SUPPLY DEALS
(Most recent first)
REGION/GROUP DOSES FUNDING EXPECTED FURTHER
DELIVERIES
Philippines 2.6 million Undisclosed Shipment expected
in May
Thailand Addition under Previously First batch
further agreement approved budget expected to be
unknown, of 6 billion available in {nL4N2IC2R6]previously 26 baht ($ 199 mid-2021
million doses millions)
Bangladesh 30 million Undisclosed “As long as the
The Serum Institute of Vaccine is ready “
India
Argentina 22 million Undisclosed Depends on lawsuits
to be successful
and getting
necessary
approvals
Chile 14.4 million Undisclosed Unknown
Spain 31.6 million undisclosed between December 2020
part of a European and June 2021
Union scheme
Switzerland 5.3 million Undisclosed Unknown
Indonesia 100 million Undisclosed First batch
It is expected to be
available for the first
mid 2021
Canada Up to 20 million Undisclosed Unknown
dose
Australia “Enough” for Undisclosed Strangers
population of 25
million, free of
cost
300 million Europeans, with 750 million at the end of 2020
Euro union option for 300
100 million additional doses
million
Latin production initially estimated in the first half of 2021
America, 150 million doses, 600 million dollars
excluding and eventually for the first
Brazil earns at least 400 150 million
million doses
Japan 120 million doses Undisclosed 30 million doses
by March 2021
China targets undisclosed annual publication by end of 2020
production
capacity of in
minus 100 million
dose this year,
and at least 200
million doses per
the end of the next
year
South Korea 20 million undisclosed shipments
start no later
what march, and
vaccines can
start at first
half of next year
Russia Unknown Undisclosed Unknown
Israel Unknown Undisclosed Unknown
Brazil initially received $ 356 million Unknown
100 million doses
1 billion serum, undisclosed 400 million before
Institute of unspecified number at the end of 2020 were
India’s dose will be expected
to India previously
Epidemic 300 million $ 750 million, some before the end
answer with $ 383 of 2020
CEPI CEPI Group
and vaccine
alliance
GAVI
United 300 million $ 1.2 billion It was before
States expected for October.
2020
United 100 million 84 million 4 million in 2020.
Kingdom pounds before around 30
million doses were
expected with
initial deliveries[nL8N2IO2YJ[nL8N2IO2YJ[nL8N2IO2YJ[nL8N2IO2YJ
for September / October. 2020.
Initial supply to
they come from Europe.
(Sources: Reuters reports, press releases, clinical trial
registries, medical journals, World Health Organization)
(Reporting by Pushkala Aripaka, Tanishaa Nadkar and Aakash
Jagadeesh Babu in Bangalore; Edited by Jason Neely, Bill
Berkrot, William Maclean)
(c) Copyright Thomson Reuters 2020. Click for restrictions: https://agency.reuters.com/en/copyright.html
