By Ana Rivas, Peter Loftus and Alberto Cervantes
Some 200 Covid-19 vaccines are in development around the world,
according to the World Health Organization, each one promising to
protect people from the deadly coronavirus and allow them to go
back to work and school.
Now, nearly a dozen are starting or nearing the final stage of
testing. Depending on the results, some companies say their
vaccines could be greenlighted for use as soon as this year.
The Front-Runners
A vaccine candidate by Moderna Inc. and one developed jointly by
Pfizer and partner BioNTech SE, have shown very positive
preliminary trial results and are on track for potential U.S.
regulatory clearance by the end of 2020. Both use a novel
gene-based technology to provoke an immune response. The University
of Oxford and AstraZeneca PLC also have an experimental shot in
final-stage testing.
Regulations for vaccine development and rollout vary world-wide.
Chinese institutions have four vaccine candidates in the final
stages of testing. Russia in August became the first country in the
world to approve a state-developed vaccine -- which it did before
any advanced clinical testing -- and has since approved a second
one with plans for a third under way. Russia, China and the United
Arab Emirates are allowing some of their citizens to get vaccinated
before clinical trials wrap up.
Many vaccines that show promise in early testing fail during the
final round. Trials involving two of the top-runners, developed by
AstraZeneca and Johnson & Johnson, have been paused or halted
because of illness in two study subjects -- developments that
aren't unusual in large clinical trials. While final-stage testing
may stretch for months or even years to continue to track safety
and the durability of protection, positive interim results from
Phase 3 may be enough for a vaccine to start getting regulatory
approval for mass production and distribution in the meantime.
Several of the leading vaccine candidates expect interim results
this fall.
The Oxford/AstraZeneca vaccine is designed to provide protection
by delivering into a person's cells the genetic code for the spikes
protruding from the new coronavirus. Then the cells can produce the
spike proteins, generating an immune response that would be able to
fight off the coronavirus.
Delivering those genetic instructions is a weakened, harmless
version of a virus that causes the common cold in chimpanzees. In
early testing, the vaccine successfully produced immune responses
in humans with only minor side effects.
In early September, AstraZeneca suspended trials globally for
its vaccine candidate after a woman in the U.K. experienced
illness. The company resumed its U.K. study after investigating the
incident, but a U.S. study aiming to enroll 30,000 subjects and
other late-stage trials under way in Brazil and South Africa are
still on hold.
-- Production capacity estimate: AstraZeneca aims to make two billion doses
available world-wide, and has said that one billion may be available this
year.
The Moderna vaccine also uses a gene-based technology to provoke
an immune response, though the code it delivers takes the form of
messenger RNA. Those molecules, commonly referred to as mRNA, are
the body's molecular couriers ferrying DNA instructions for making
proteins. The vaccine delivers to cells mRNA for making the
coronavirus's spike protein.
Moderna and the U.S. National Institute of Allergy and
Infectious Diseases are testing a two-dose shot. The shot has shown
to be highly effective at protecting people from Covid-19 symptoms,
according to a preliminary analysis of results from final-stage
testing announced in mid-November. The 30,000 person trial
continues in the U.S.
It was the first candidate to enter human testing in the U.S.
The vaccine produced an immune response in early-stage testing and
was generally well-tolerated, with minor side effects observed in
test subjects. An mRNA vaccine has never been approved for any
disease.
-- Production capacity estimate: 500 million to one billion doses a year
starting in 2021.
The vaccine developed by Pfizer and German partner BioNTech SE
also uses mRNA. Phase 3 testing began in the U.S. in July,
enrolling about 30,000 people, and will expand overseas to include
about 120 sites. The vaccine reached a development milestone in
early November, proving to be more effective than expected at
protecting people from Covid-19, putting it on track for regulatory
clearance by the end of the year.
The timeline suggests the vaccine could go into distribution in
November or December, after U.S. health regulators conduct a
review, though it will take months for the companies to make enough
doses for the general population.
The U.S. government has agreed to pay Pfizer and BioNTech nearly
$2 billion for 100 million doses.
-- Production capacity estimate: up to 100 million doses world-wide by the
end of 2020, and about 1.3 billion by the end of 2021.
China's state-owned Sinopharm is developing two vaccines with
the government agencies Wuhan Institute of Biological Products and
Beijing Institute of Biological Products. Both are based on an
older vaccine-making technique.
The group has entered agreements to conduct testing in several
countries, including Pakistan and the United Arab Emirates. The
Wuhan Institute has drawn concern over its safety record, including
over some of its vaccines for children.
The government says it started what it calls "emergency use" of
some of its Covid-19 vaccines on medical workers and border
inspection officials in late July. In mid-September, the U.A.E.
government said it authorized a Sinopharm shot to be used on its
front-line medical workers, becoming the first country outside
China to approve emergency use of a Chinese Covid-19 vaccine
candidate. Chinese officials have said they aim to make a vaccine
available to the public before the end of the year.
-- Production capacity estimate: about 220 million doses a year.
Sinovac, a private Chinese company, began its final-stage trial
in July in São Paulo, Brazil, where it is testing its vaccine to
take advantage of a higher infection rate. Sinovac has also struck
a deal with Indonesian state-owned pharmaceutical holding company
PT Bio Farma to make up to 250 million vaccine doses each year for
the Indonesian public, according to China's state news agency.
-- Production capacity estimate: about 300 million doses a year at a Beijing
plant.
CanSino's vaccine is aimed initially at the Chinese military.
Chinese company CanSino developed the shot with the military based
on a weakened virus behind the common cold. A Phase 1 study was
conducted in March in Wuhan, the early epicenter of Covid-19. The
shot got government clearance in June for military use for one
year.
-- Production capacity estimate: 100 million to 200 million doses a year
starting in 2021.
Johnson & Johnson is developing a vaccine that uses a
weakened form of a common-cold virus, known as an adenovirus. A
single dose of this vaccine provoked a strong immune response in
early animal testing. The company in September started a
60,000-person global study, which could be the largest late-stage
clinical trial of a Covid-19 vaccine. On Oct. 12, Johnson &
Johnson said it paused all of its clinical trials because of
unexplained illness in a study volunteer, while an independent
data-safety monitoring board reviews what happened.
The study had been planned at nearly 215 locations in the U.S.
and eight other countries where transmission rates are high,
including Brazil, Chile and South Africa.
-- Production capacity estimate: one billion world-wide by the end of 2021,
including 100 million doses for the U.S., with an option for an
additional 200 million, and 30 million doses for the U.K., with an option
for an additional purchase of up to 22 million.
The Russian state-owned Gamaleya Research Institute is
developing a vaccine based on a combination of two adenoviruses,
which it has already tested on volunteers. Russia effectively
approved use of the vaccine in early August, though trials are
ongoing. In mid-November, the Russian government said early results
from a large-scale trial of 40,000 volunteers showed high efficacy
against Covid-19 -- 92% -- and no unexpected adverse side effects.
The data aren't peer-reviewed.
-- Production capacity estimate: 500 million doses a year, with mass
production starting September 2020.
Novavax's vaccine consists of two shots given 21 days apart that
deliver proteins resembling the spike jutting out from the new
coronavirus. Researchers hope the proteins will trigger the
production of antibodies and immune cells that can fight off the
coronavirus.
The shots also contain a component, called an adjuvant, to boost
the immune response. In early-stage testing, the vaccine was
generally well-tolerated and produced promising numbers of
antibodies. The company in late September started a 10,000-person
Phase 3 study in the U.K. A separate U.S. Phase 3 study is expected
to begin in October.
-- Production capacity estimate: 100 million doses for use in the U.S., with
delivery beginning by the end of this year, and a global manufacturing
capacity of over 2 billion doses annually when at full capacity in 2021.
Bharat Biotech of India, in collaboration with the Indian
Council of Medical Research, has developed a vaccine, Covaxin,
using an inactivated virus strain. A university in India said a
Phase 3 trial of the vaccine began there in mid-November.
Jonathan D. Rockoff, Chao Deng, Raffaele Huang, Yan Wu, Georgi
Kantchev, Jared S. Hopkins and Dasl Yoon contributed to this
article.
Write to Ana Rivas at ana.rivas@wsj.com, Peter Loftus at
peter.loftus@wsj.com and Alberto Cervantes at
Alberto.Cervantes@wsj.com
(END) Dow Jones Newswires
November 16, 2020 08:49 ET (13:49 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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