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BUSINESS | HEALTH CARE | HEALTH

Covid-19 Vaccines: What’s Coming and When?


As countries and companies race to produce a safe and effective coronavirus vaccine, here’s a guide to the front-
runners

By Ana Rivas, Peter Loftus and Alberto Cervantes


Updated Dec. 6, 2020 2:22 pm ET

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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.
The U.K. on Wednesday became the first Western country to approve a
vaccine for emergency use and is preparing to begin distributing a
limited number of shots within days. The U.S. and the European Union
are expected to approve one or more vaccines in December. Chinese
and Russian authorities, meanwhile, have already approved some
state-developed vaccines for “emergency use,” although trials are still
under way.

The Front-Runners
A vaccine candidate by Moderna Inc. and one developed jointly by
Pfizer Inc. and partner BioNTech SE, have shown very positive
preliminary trial results. The Pfizer/BioNTech vaccine was granted
emergency-use authorization in the U.K. on Dec. 2 and is being
reviewed by the Food and Drug Administration in the U.S., where a
similar authorization could come later December. The Moderna
vaccine is also on track for potential U.S. regulatory clearance by the
end of 2020. Both vaccines 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, were paused or halted because
of illness in study subjects—developments that aren’t unusual in large
clinical trials—but the studies have resumed. 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 can
be enough for a vaccine to start getting regulatory approval for mass
production and distribution in the meantime. Some of the leading
vaccine candidates have released interim results, and more are
expected in the coming weeks or months.

Types of vaccines
Genetic-code vaccines deliver specific A virus-based vaccine uses a killed or
genetic instructions teaching the weakened form of the targeted virus
body’s cells to make a protein from to induce an immune response.
the targeted virus, which in turn
Viral vector vaccines use a modified
induces an immune response. One
virus different from the targeted virus
type incorporates a synthetic,
to serve as a carrier of the vaccine
engineered version of messenger
teaching the body’s cells to make a
RNA, or mRNA. These are molecules
protein from the targeted virus.
in the body that ferry DNA
instructions for making immune- Protein-based vaccines incorporate a
inducing proteins. Other gene-based protein from the virus, or something
vaccines use DNA itself. resembling it, that will trigger an
immune response.

University of Oxford/AstraZeneca
AZD1222
Phase 2-3 Preliminary U.K. and Brazil
started study results released
in May in November

2020 ’21 ’22

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 November, AstraZeneca said a preliminary analysis showed the


vaccine was effective at preventing Covid-19 in large clinical trials in
the U.K. and Brazil, and the company planned to seek regulatory
clearance globally. In early September, AstraZeneca had 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, and in October restarted a U.S. study
aiming to enroll 30,000 subjects. Other late-stage trials including
those in Brazil and South Africa have resumed.

• Production capacity estimate: AstraZeneca aims to make up to three


billion doses world-wide in 2021.

Moderna/NIAID
mRNA-1273

Phase 3 Filed for Phase 3


started regulatory clearance expected to close
in July in November in October 2022

2020 ’21 ’22

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: 20 million doses by the end of 2020;


500 million to one billion doses a year starting in 2021.

Pfizer/BioNTech
mRNA, BNT162b2
Phase 3 Approved Phase 3
started in the U.K. expected to close
in July on Dec. 2 in November 2022

2020 ’21 ’22

The vaccine developed by Pfizer and German partner BioNTech SE


also uses mRNA. Phase 3 testing began in the U.S. in July and
expanded overseas to include about 120 sites. The study enrolled
44,000 people. The vaccine reached a development milestone in early
November, proving to be more effective than expected at protecting
people from Covid-19.

In the U.K., the two-shot vaccine will be rolled out in December after
having won regulatory approval.

Pfizer filed for U.S. regulatory clearance on Nov. 20, and a decision
could come by the end of the year. The timeline suggests the vaccine
could go into distribution in 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 50 million doses world-wide by


the end of 2020, and about 1.3 billion by the end of 2021.

Sinopharm
Beijing Institute of Biological Products
Wuhan Institute of Biological Products
Phase 3 started Rollout targeted Phase 3 end
in July by end of the year unknown

2020 ’21 ’22

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
CoronaVac

Phase 3 Rollout Phase 3


launched targeted end
in July by end of the year unknown

2020 ’21 ’22

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 Biologics/Chinese Academy of Military


Medical Sciences
Ad5-nCoV
Cleared for Phase 3 started Phase 3
military use in June for a year in August end unknown

2020 ’21 ’22

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


JNJ-78436735
Phase 3 Expected to Phase 3
started in be available in expected to close
September the U.S. early 2021 in March 2023

2020 ’21 ’22

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 company resumed the large international trial later in October
after concluding there was no evidence the vaccine caused the illness.

The study is being conducted 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.

Gamaleya Research Institute


Gam-COVID-Vac

Registered, Russia started Phase 3


Phase 3 started roll out end
in August in December unknown

2020 ’21 ’22

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
NVX-CoV2373
Phase 3
started in U.S. phase 3 trial is Expected to end in
September expected to start soon January 2022 (U.K.)

2020 ’21 ’22

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 Phase 3 study in the U.K that has
been expanded to include 15,000 people. A separate Phase 3 study in
the U.S. and Mexico is expected to begin in the coming weeks.

• Production capacity estimate: Novavax has said it could produce 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. Novavax said in
October it has experienced some delays from its original timing
estimates.

Bharat Biotech
Covaxin
Phase 3 Next
started steps
in November unknown

2020 ’21 ’22

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.

Anhui Zhifei Longcom Biopharmaceuticals/


Chinese Academy of Sciences
ZF2001
Next
Phase 3 started steps
in December unknown

2020 ’21 ’22

Anhui Zhifei Longcom Biopharmaceuticals began a phase 3 clinical


trial for its recombinant protein vaccine candidate in December,
according to the WHO. State-run China Global Television Network in
November reported that a one-year trial would take place in
Uzbekistan and aim to recruit 5,000 volunteers. Anhui Zhifei is a unit
of private firm Chongqing Zhifei Biological Products. It is co-
developing the vaccine with the Chinese Academy of Sciences, a
government institution.

Medicago/
GlaxoSmithKline
CoVLP
Next
Phase 3 started steps
in December unknown

2020 ’21 ’22

Medicago, a Canadian biopharmaceutical company, has moved its


virus-like particle vaccine to Phase 2/3 trials in Canada and is seeking
to do the same in the U.S., pending approval. from the FDA. Medicago
is developing the vaccine with GlaxoSmithKline PLC.

The vaccine uses Medicago’s technology to produce in plant leaves the


spike protein from the coronavirus. The proteins are made into virus-
like particles that present as antigens to trigger an immune response
to the virus. These virus-like particles are administered with Glaxo’s
adjuvant, a vaccine component that helps boost the immune response
and can reduce the amount of virus-like particle antigen needed for
each dose.

A comprehensive overview of Covid-19 vaccines in development


Search...

STAGE OF
DEVELOPER DEVELOPMENT TYPE_VACCINE PLATFORM

Sinovac Phase 3 Weakened Inactivated


virus

Wuhan Institute of Biological Products/Sinopharm Phase 3 Weakened Inactivated


virus

Beijing Institute of Biological Products/Sinopharm Phase 3 Weakened Inactivated


virus

BharatBiotech Phase 3 Weakened Inactivated


virus

University of Oxford/AstraZeneca Phase 3 Viral vector Non-


Replicating
Viral
Vector

CanSino Biologics/Beijing Institute of Biotechnology Phase 3 Viral vector Non-


Replicating
Viral
Vector

Gamaleya Research Institute Phase 3 Viral vector Non-


Replicating
Viral
Vector

Johnson & Johnson Phase 3 Viral vector Non-


Replicating
Viral
Vector

Novavax Phase 3 Proteins Protein


Subunit

Anhui Zhifei Longcom Biopharmaceutical/Institute of Phase 2/3 Proteins Protein


Microbiology, Chinese Academy of Sciences Subunit

‹ 1 2 3 4 5 6 7 … 22 ›
Showing 1 to 10 of 213 entries
Source: World Health Organization; Last updated: Dec. 2, 2020

Related Video

U.K. Green Lights Pfizer and BioNTech’s Covid-19 Vaccine

The U.K. granted emergency-use authorization for Pfizer and BioNTech’s Covid-19 vaccine and could begin
distribution to the most vulnerable populations within days. Photo: University of Maryland School of Medicine via
AP

—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

Corrections & Amplifications


China National Pharmaceutical Group Co., or Sinopharm, has two
vaccines in Phase 3. An earlier version of this article incorrectly said a
vaccine. (Corrected on Sept. 3)

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