Jan 3 (Reuters) - India's drugs regulator gave final approval on Sunday for the
emergency-use of a COVID-19 vaccine developed by AstraZeneca and Oxford University. Britain, El
Salvador and Argentina have also approved the vaccine.
Once front-runners in a global race to develop a vaccine, the AstraZeneca and University of
Oxford partnership has been overtaken by Pfizer and German partner BioNTech,
whose vaccine is already being used in Britain and the United States.
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 will be branded COVISHIELD in India and is being manufactured there by partner Serum
Institute of India.
* 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
* India has authorised a two full-dose regime.
* UK authorisation recommends two-dose regime given between four and 12 weeks apart.
* 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.
* In December, Oxford said the vaccine has a better immune response when a two full-dose
regime is
used, citing data from early trials.
* Immune response could last at least a year.
* The vaccine should be effective against the new coronavirus variant, and studies are under
way
to fully probe the impact of the mutation.
* 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.
* AstraZeneca aims to supply millions of doses in the first quarter to Britain and is
working with
the UK government for first vaccinations to begin early in the new year.
EXPECTED DOSAGE PRICE
* Serum Institute of India has said it would price the vaccine at 250 rupees (about $3) per
dose
for India's government and many other countries and at 1,000 rupees for the private
market.
* Pricing in Britain is unknown so far.
* 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.
* 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, but above
the 50% threshold set by many regulators.
* 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 (bit.ly/2GAeB4K)
restarted anticipated published in (bit.ly/2I4BNIz)
after pause , with late
in early participant November
September s aged 18
years and
older
Chile Unknown Wrapped up 2,000 Unknown Unknown
recruitment enrolled China Unknown To begin Unknown Unknown Unknown
India Phase II/III Ongoing, 1,600 Not In seven months
restarted anticipated available from August (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 (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 (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 (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 To begin Unknown Unknown Unknown (bit.ly/2KljQ9F)
combination number of
with Sputnik adults aged
V 18 and
older
South Africa Phase I/II Active, not 2,130 First data Dec. 2021 (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 (bit.ly/3n81UxJ)
recruiting enrolled, readout in (bit.ly/2HY2pe5)
with July 2020
participant
s aged
between 18
and 55
UK Phase II/III Recruiting, 12,390 First data Sept. 2021 (bit.ly/34EOHVj)
restarted anticipated published in (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 (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.
* Data read-out submitted to regulators across the world to seek approval.
* Experts have predicted a safe and effective vaccine could take 12-18 months to develop,
even at
the record speeds.
REGULATORY REVIEWS AND APPROVALS
(Most recent first)
REGION/REGULATOR REVIEW STATUS TYPE OF FORMAL FURTHER
APPROVAL/APPLICATION APPLICATION
India/Central Approved Review launched in Submitted by
Drugs Standard after December and Serum
Control accelerated approval for Institute and
Organisation review two-dose regime approved Argentina/Nationa Approved for Approval for the Approved
l Administrator emergency use vaccine to be
for Food and administered to
Medical people over the age
Technology of 18 in two doses
between four and 12
weeks apart, as per
UK greenlight.
El Approved Approval based on Approved
Salvador/National evidence provided by
Directorate of the developer,
Medicines emergency use
permissions
authorised by other
countries.
Britain/Medicines Approved for Approved in late Submitted and
and Healthcare emergency use December after Approved
Products rolling review was
Regulatory Agency launched in Oct Chile/Public Under review Application for Submitted
Health Institute emergency use
Brazil/Anvisa Under review Application will be Expected to
for two-dose regimen be submitted
by Fiocruz on
Jan. 15
Mexico/COFEPRIS Under review Expected to request Not submitted
emergency
authorization in
January
United States/ Under review Likely be authorised Not submitted
Food and Drug for emergency use in
Administration April
Canada/Health Rolling Review launched in Not submitted
Canada submission Oct, there is still
information and data
to be provided for
review
Europe/European Rolling Review launched in Not submitted
Medicines Agency review for Oct, is seeking more
conditional data and it could be
approval months before an
approval is given
* The World Health Organization expects to make decisions on whether to give emergency use
approval to COVID-19 vaccines, including AstraZeneca's, its chief scientist said in December.
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.
* 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 approvals.
TIE-UPS
* Even before studies showed any signs of efficacy, AstraZeneca had signed several supply
and
manufacturing deals around the world.
* It also joined forces 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.
SUPPLY DEALS
(Most recent first)
REGION/GROUP DOSES FUNDING EXPECTED FURTHER
DELIVERIES
Indonesia 50 million Undisclosed First batch
expected to be
available by first
half of 2021
Malaysia 6.4 million Undisclosed Unknown
Colombia 10 million Undisclosed Unknown
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
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.
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 supply
Bioscience, the vaccine in Thailand
SCG and other nations in
Southeast Asia
Albany U.S. Undisclosed Produce millions of
Molecular doses through sterile
Research finishing services at
its manufacturing plant
in Albuquerque, New
Mexico
Oxford UK 15 million Unknown doses for
Biomedica pounds to large-scale commercial
reserve manufacture under
manufacturin expanded deal
g 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 of Mexico Undisclosed Latin American supply
Mexican with Argentina,
billionaire excluding Brazil, could
Carlos Slim reach 250 million
mAbxience of Argentina Undisclosed Initially producing 150
the INSUD million doses for Latin
Group 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 million Undisclosed doses in
BioSolutions second deal with AZ
SK Bioscience South Korea Undisclosed Undiluted solutions of
the vaccine until early
2021
R-Pharm Russia Undisclosed Unknown doses
Daiichi Japan Undisclosed Unknown doses
Sankyo Fundação Brazil $127 million About 30 million doses
Osvaldo Cruz
(Fiocruz)
Symbiosis Scotland Undisclosed Clinical trial supply
Pharmaceutica
l
Cobra U.S. Undisclosed One million doses per
Biosciences 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 for
Institute of low and middle-income
India countries. 400 million
before end-2020 were
expected previously
Oxford UK Undisclosed Manufacturing unknown
Biomedica number of doses
(Sources: Reuters reporting, media releases, clinical trial registers, regulatory bodies,
medical journals, World Health Organization)
(Reporting by Pushkala Aripaka, Tanishaa Nadkar and Aakash Jagadeesh Babu in Bengaluru; Editing
by William Maclean, Patrick Graham and Carmel Crimmins)
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