Development of AstraZeneca’s COVID-19 vaccine hits speed bumps

PUBLISHED: Mon, 14 Dec 2020 14:13:44 GMT
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Dec 14 (Reuters) – AstraZeneca has removed a study
sub-group with children from a trial of its experimental
COVID-19 vaccine in Britain, U.S. clinical trial registers
showed on Monday, as the drugmaker seeks to gather unifying
evidence on the vaccine’s efficacy.
AstraZeneca and Oxford University, once front-runners 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 trials 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, meaning a virus is used as a means of
delivering the vaccine.
* It uses a weakened version of a chimpanzee common cold
virus
that encodes instructions for making proteins from the novel
coronavirus to generate an immune response and prevent
infection.

DOSAGE, PROTECTION DURATION AND STORAGE
* Two regimens are being tested: one in which recipients get
two
full doses, and another with half a dose followed by a full
dose.
* The half-dose first regimen was found to be 90% effective
in a
subset of trial subjects. The success rate was 62% with the
originally planned two full doses, based on interim data.

* Immune response could last at least a year.
* The vaccine can be stored, transported and handled at
normal
refrigerated conditions for at least six months, making it
logistically easier to transport than Pfizer’s vaccine.

EXPECTED DOSAGE PRICE
* Italy’s health ministry said in June the vaccine would
cost
about 2.5 euros ($2.80) per dose in Europe.
* AstraZeneca has said it will be able to manufacture the
vaccine
at a few dollars per dose.
* Pricing in Latin America is not expected to exceed $4 per
dose.

* Serum Institute of India has said it would price the
vaccine at
$3 per dose for India and other emerging economies.

* Sources told Reuters it could cost $4 to $5 per dose in
Bangladesh.
* Costs in other regions have not yet been disclosed.
* AstraZeneca has said it would not profit from the vaccine
during
the pandemic, but a report from the Financial Times in October
showed the company can declare when it considers the pandemic to
have ended in its deals for the vaccine.
* AstraZeneca will look to profit from wealthier countries
at the
“appropriate time”.

TESTING AND DATA

* Trials combining the vaccine with Russia’s Sputnik V will
start
by the end of the year, and Russia wants to jointly produce the
new vaccine if it is proven to be effective.
* Vastly divergent performance with different dose regimens
has
called for more clarity on the vaccine’s efficacy which averaged
70.4%, well below vaccines from Pfizer and Moderna Inc.

* Serum Institute of India will continue to test a two full
dose
regimen of the vaccine.
* AstraZeneca had to pause global trials on Sept. 6 after an
unexplained illness in a participant.
* Trial of the vaccine in the United States resumed in
October
after other countries had ended their pause.

* AZD1222 produces an immune response in both old and young
adults, and also led to lower adverse responses among the
elderly, AstraZeneca said in October.
* The vaccine also accurately follows genetic instructions
programmed into it by its developers, according to an analysis
by independent scientists.
* Brazil said in October that a trial volunteer had died.

* A source told Reuters the Brazilian trial would have been
suspended if the volunteer who died had received the COVID-19
vaccine, although the death was reported to be a suicide.

* In July, data from early-stage trials published in The
Lancet
showed the vaccine was safe and produced an immune response.

GLOBAL TRIALS

Below are other regions where testing of the vaccine is
being carried out or planned: (In alphabetical order of regions)

REGION STAGE OF STATUS VOLUNTEERS DATA EXPECTED
DEVELOPMENT COMPLETION
Brazil Phase III Recruiting, 10,300 First data Sept. 2021 (https://bit.ly/2GAeB4K)
restarted anticipated published in (https://bit.ly/2I4BNIz)
after pause , with late
in early participant November
September s aged 18
years and
older
Chile Unknown To begin Unknown Unknown Unknown

China Unknown To begin Unknown Unknown Unknown

India Phase II/III Ongoing, 1,600 Not In seven months
restarted anticipated available from August (https://bit.ly/3nAwXTC)
after pause , with
in early participant
September s aged 18
years and
older
Japan Phase I/II Active, not 256 Not Nov. 2021 (https://bit.ly/3nAnImj)
recruiting. anticipated available
Restarted , with
after pause participant
in early s aged 18
September years and
older
Kenya Phase Ib/II Ongoing 400 Not In approximately
anticipated available two years (https://bit.ly/362fsUy)
, with
participant
s aged 18
years and
older, and
will only
enrol
healthcare
workers
Peru Unknown To begin Unknown Unknown Unknown

Russia Phase III Suspended, 100 Not March 2021 (https://bit.ly/36NKpxr)
on hold anticipated applicable
till , with
Russian participant
approval s aged 18
following years and
pause in older
September
Russia, in Unknown Not yet Unknown Unknown Unknown (https://bit.ly/2KljQ9F)
combination recruiting number of
with Sputnik adults aged
V 18 and
older
South Africa Phase I/II Active, not 2,130 First data Dec. 2021 (https://bit.ly/2Gy8mhS)
recruiting. enrolled, was
Restarted with both anticipated
after pause HIV-uninfec in Q4 2020,
in early ted adults but the
September and people principal
living with investigator
HIV told Reuters
that
efficacy
results may
not be ready
for months

UK Phase I/II Active, not 1,090 Initial data Oct. 2021 (https://bit.ly/3n81UxJ)
recruiting enrolled, readout in (https://bit.ly/2HY2pe5)
with July 2020
participant
s aged
between 18
and 55
UK Phase II/III Recruiting, 12,390 First data Sept. 2021 (https://bit.ly/34EOHVj)
restarted anticipated published in (https://bit.ly/2HSU37G)
after pause , with late
in early participant November
September s aged 18
years and
older. Also
includes
HIV
infected
adults in
one group.
Previously
included
children
above 5
years of
age.
U.S. with Phase III Recruiting, 40,000 First data Feb. 2023 (https://bit.ly/30O4XCl)
global sites restarted anticipated anticipated
in late , with in H1 2021
October participant
after pause s aged 18
in early years and
September older

DATA AND REGULATORY TIMELINE

* The lead developer had said in July the vaccine could be
rolled
out by year-end, but the delivery and testing timeline has since
been pushed back.
* Experts have predicted a safe and effective vaccine could
take
12-18 months to develop.
* Data read-out submitted to regulators across the world to
seek
approval.

REGULATORY REVIEWS
(Most recent first)

REGION/REGULATOR SUBMISSION/R STATUS FORMAL FURTHER
EVIEW APPLICATION
India/Central Accelerated Launched in Submitted by
Drugs Standard review December and is Serum
Control seeking 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 million)
Bangladesh 30 million from Undisclosed “Whenever the
Serum Institute of vaccine is ready”
India
Argentina 22 million Undisclosed Depends on trials
being successful
and obtaining
necessary
approvals
Chile 14.4 million Undisclosed Unknown
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
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 20 million Undisclosed Shipments would
begin no later
than March, and
vaccinations may
start in the first
half of next year
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 were
India of doses will go expected
to India previously
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 Was earlier
States expected by Oct.
2020
United 100 million 84 million 4 million in 2020.
Kingdom pounds Earlier about 30
million doses were
expected with
initial deliveries [nL8N2IO2YJ
by Sept/Oct. 2020.
Initial supply to
come from Europe.

(Sources: Reuters reporting, media releases, clinical trial
registers, medical journals, World Health Organization)

(Reporting by Pushkala Aripaka, Tanishaa Nadkar and Aakash
Jagadeesh Babu in Bengaluru; Editing by Jason Neely, Bill
Berkrot, William Maclean)

(c) Copyright Thomson Reuters 2020. Click For Restrictions – https://agency.reuters.com/en/copyright.html

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