[Sundaycommunity] Massive research and covid trials

[John MacMillan]

Coronavirus Vaccine Tracker

By Carl Zimmer <https://www.nytimes.com/by/carl-zimmer>, Jonathan Corum
<https://www.nytimes.com/by/jonathan-corum> and Sui-Lee Wee
<https://www.nytimes.com/by/sui-lee-wee>Updated Dec. 13, 2020

PHASE 1

PHASE 2

PHASE 3

LIMITED

APPROVED

ABANDONED

40

17

15

5

2

1

Vaccines

testing safety

and dosage

Vaccines

in expanded

safety trials

Vaccines

in large-scale

efficacy tests

Vaccines

in early or

limited use

Vaccines

approved

for full use

Vaccines

abandoned

after trials

Vaccines typically require years of research and testing before reaching
the clinic, but in 2020, scientists embarked on a race to produce safe and
effective coronavirus vaccines in record time. Researchers are currently
testing 58 vaccines in clinical trials on humans, and 15 have reached the
final stages of testing. At least 85 preclinical vaccines are under active
investigation in animals.
New additions and recent updates
Dec. 12 Gennova Biopharmaceuticals
<https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html#gennova>
 and HDT Bio
<https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html#gennova>
enter
Phase 1/2.
Dec. 11 The F.D.A. authorizes the Pfizer-BioNTech
<https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html#pfizer>
vaccine
for emergency use.
Dec. 11 AstraZeneca
<https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html#astrazeneca>
joins
forces with Russia’s Gamaleya Institute
<https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html#gamaleya>
.
Dec. 11 The Chinese Academy of Medical Sciences
<https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html#imb>
moves
to Phase 3.
Dec. 11 Sanofi
<https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html#sanofi2>
 and GSK
<https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html#sanofi2>
announce
disappointing trial results in older adults.
Dec. 10 A vaccine from Australia’s University of Queensland
<https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html#uqueensland>
is
abandoned.
Leading vaccines
DeveloperTypePhaseStatus
Pfizer-BioNTech
<https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html#pfizer>
mRNA 23 Approved in Canada and other countries.
Emergency use in U.S. and other countries.
Moderna
<https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html#moderna>
mRNA 3 Under F.D.A. review.
CanSino
<https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html#cansino>
Adenovirus 3 Limited use in China.
Gamaleya
<https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html#gamaleya>
Adenovirus 3 Early use in Russia.
Johnson & Johnson
<https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html#jnj>
Adenovirus 3
Oxford-AstraZeneca
<https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html#astrazeneca>
Adenovirus 23
Novavax
<https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html#novavax>
Protein 3
Vector Institute
<https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html#vector>
Protein 12 Early use in Russia.
Sinopharm-Beijing
<https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html#beijing>
Inactivated 3 Approved in U.A.E.
Sinopharm-Wuhan
<https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html#sinopharm>
Inactivated 3 Limited use in U.A.E.
Sinovac
<https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html#sinovac>
Inactivated 3 Limited use in China.

Below is a list of all vaccines that have reached trials in humans, along
with a selection of promising vaccines being tested in animals. For an
overview of treatments for Covid-19, see our Coronavirus Drug and Treatment
Tracker
<https://www.nytimes.com/interactive/2020/science/coronavirus-drugs-treatments.html>
.
The Vaccine Testing Process

The development cycle of a vaccine, from lab to clinic.


PRECLINICAL TESTING: Scientists test a new vaccine on cells and then give
it to animals such as mice or monkeys to see if it produces an immune
response.

PHASE 1 SAFETY TRIALS: Scientists give the vaccine to a small number of
people to test safety and dosage, as well as to confirm that it stimulates
the immune system.

PHASE 2 EXPANDED TRIALS: Scientists give the vaccine to hundreds of
people split
into groups, such as children and the elderly, to see if the vaccine acts
differently in them. These trials further test the vaccine’s safety.

PHASE 3 EFFICACY TRIALS: Scientists give the vaccine to thousands of people and
wait to see how many become infected, compared with volunteers who received
a placebo. These trials can determine if the vaccine protects against the
coronavirus, measuring what’s known as the efficacy rate
<https://www.nytimes.com/2020/11/20/health/covid-vaccine-95-effective.html>.
Phase 3 trials are also large enough to reveal evidence of relatively rare
side effects.

EARLY OR LIMITED APPROVAL: Britain and other countries have begun giving
emergency authorization to vaccines based on preliminary evidence that they
are safe and effective. China
<https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html#cansino>
 and Russia
<https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html#gamaleya>,
on the other hand, have authorized vaccines without waiting for the results
of Phase 3 trials, which experts say has serious risks
<https://www.nytimes.com/2020/08/11/health/russia-covid-19-vaccine-safety.html>
.

APPROVAL: Regulators review the complete trial results and plans for a
vaccine’s manufacturing, and decide whether to give it full approval.

COMBINED PHASES: One way to accelerate vaccine development
<https://www.nytimes.com/interactive/2020/04/30/opinion/coronavirus-covid-vaccine.html>
is
to combine phases. Some vaccines are now in Phase 1/2 trials, for example,
which this tracker would count as both Phase 1 and Phase 2.

PAUSED or ABANDONED: If investigators observe worrying symptoms in
volunteers, they can pause
<https://www.nytimes.com/2020/10/14/health/covid-clinical-trials.html> the
trial. After an investigation, the trial may resume or be abandoned
<https://www.nytimes.com/2020/12/11/world/australia/uq-coronavirus-vaccine-false-positive.html>
.

Filter the list of vaccines:
All vaccines Preclinical Phase 1 2 3 Approved Abandoned
Genetic Vaccines

Vaccines that deliver one or more of the coronavirus’s own genes
<https://www.nytimes.com/interactive/2020/04/03/science/coronavirus-genome-bad-news-wrapped-in-protein.html>
into
our cells to provoke an immune response.

DNA

RNA

PHASE 2 PHASE 3 COMBINED PHASES
APPROVED IN SEVERAL COUNTRIES EMERGENCY USE IN U.S., ELSEWHERE
[image: Pfizer logo][image: BioNTech logo]
VACCINE NAME: BNT162b2
<https://www.nytimes.com/interactive/2020/health/pfizer-biontech-covid-19-vaccine.html>
EFFICACY: 95%
<https://www.nytimes.com/2020/11/20/health/covid-vaccine-95-effective.html>
DOSE: 2 doses, 3 weeks apart
TYPE: Muscle injection
STORAGE: Freezer storage only at –94°F (–70°C)

On Nov. 9, New York-based Pfizer and the German company BioNTech made
history by presenting preliminary data indicating that their coronavirus
vaccine was over 90 percent effective
<https://www.nytimes.com/2020/11/09/health/covid-vaccine-pfizer.html?smid=tw-share>.
It was the first time anyone had found such evidence. Just over a month
later, on Dec. 11, the Food and Drug Administration granted it the
first emergency
use authorization
<https://www.nytimes.com/2020/12/11/health/pfizer-vaccine-authorized.html> ever
given by the United States to a coronavirus vaccine.

BioNTech researchers began designing the vaccine in January. They based it
on a genetic molecule called messenger RNA (mRNA). The vaccine contains
genetic instructions for building a coronavirus protein, known as spike.
When injected into cells, the vaccine causes them to make spike proteins,
which then get released into the body and provoke a response from the
immune system.

BioNTech partnered with Pfizer in March to scale up the research, launching
a clinical trial in May. They found
<https://www.nejm.org/doi/full/10.1056/NEJMoa2027906> that the vaccine
caused volunteers to produce antibodies against SARS-CoV-2, as well as
immune cells called T cells that respond to the virus. On July 27, the
companies announced the launch
<https://www.nytimes.com/2020/07/27/health/moderna-vaccine-covid.html> of a
Phase 2/3 trial with 30,000 volunteers in the United States and other
countries including Argentina, Brazil, and Germany. On Sept. 12, Pfizer and
BioNTech announced
<https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-propose-expansion-pivotal-covid-19>
that
they would seek to expand their U.S. trial to 44,000 participants.

Through the summer and into the fall, the world focused more and more of
its attention on the Pfizer-BioNTech trial. In September, Dr. Albert
Bourla, the chief executive of Pfizer, said
<https://www.nytimes.com/2020/09/30/health/pfizer-covid-vaccine.html> the
Phase 3 trial would deliver enough results as soon as October to show if
the vaccine worked or not. President Trump touted their progress, hinting
that a vaccine would be available before the election. But on Oct. 27, Dr.
Bourla announced
<https://www.nytimes.com/2020/10/27/health/pfizer-covid-19-vaccine.html> that
the volunteers in the trial had yet to experience enough cases of Covid-19
to determine if the vaccines work. Finally, on Nov. 8, Pfizer and BioNTech
released preliminary analysis of the first 94 cases.

Over the next month, Pfizer and BioNTech released more data on more cases.
On Dec. 8 the FDA released their independent analysis
<https://www.nytimes.com/2020/12/08/health/covid-vaccine-pfizer.html> of
the clinical trials. They determined that the vaccine has an efficacy rate
of 95 percent. Less than two weeks after the first dose, the vaccine
started protecting volunteers, and the second dose three weeks later
boosted their immune response. The vaccine showed little difference in its
protection of Black, Latino, and white volunteers; likewise, people with
conditions such as obesity or diabetes enjoyed the same level of
protection. The elderly also showed the same efficacy rate as people under
65. While the vaccine caused no serious side effects, it frequently caused
short-lived fatigue, fever, and muscle aches.

These impressive results led rapidly to authorizations across the world. On
Dec. 2, the United Kingdom gave emergency authorization
<https://nyti.ms/3qj8Mue> to Pfizer and BioNTech’s vaccine, becoming the
first Western country to give such an approval to a coronavirus
vaccine. Injections
began on Dec. 8 <https://www.bbc.com/news/uk-55227325>, with William
Shakespeare
<https://www.nytimes.com/2020/12/08/world/william-shakespeare-covid-vaccine.html>,
age 81, among the first to receive a dose. On Dec. 13, workers at a Pfizer
plant in Kalamazoo, Mich., loaded the vaccines
<https://www.nytimes.com/live/2020/12/13/world/covid-19-coronavirus/vaccine-distribution-is-about-to-begin-in-the-virus-ravaged-us>
onto
trucks for the first deliveries across the United States. The first
vaccinations were planned for the next day. Pfizer and BioNTech will
deliver an initial shipment of 2.9 million doses to the United States in
the first week after the vaccine’s authorization.

A growing number of other countries across the world have also given
emergency authorization for the Pfizer-BioNTech vaccine, including Kuwait
<https://abcnews.go.com/Health/wireStory/bahrain-approves-chinese-covid-19-vaccine-74699175>
 and Mexico
<https://www.nytimes.com/live/2020/12/11/world/covid-19-coronavirus/mexico-approves-pfizer-vaccine-for-emergency-use-and-other-news-around-the-world>.
Meanwhile, Bahrain
<https://abcnews.go.com/Health/wireStory/bahrain-approves-chinese-covid-19-vaccine-74699175>
,
<https://abcnews.go.com/Health/wireStory/bahrain-approves-chinese-covid-19-vaccine-74699175>
 Canada,
<https://www.nytimes.com/live/2020/12/09/world/covid-19-coronavirus/canada-approves-pfizers-vaccine-after-an-independent-review-and-shots-may-begin-next-week>
 and Saudi Arabia <https://www.arabnews.com/node/1775896/saudi-arabia> gave
the vaccine full approval.

The distribution of the vaccine worldwide will be determined in part by
deals that the companies made starting in the summer with countries around
the world. The Trump administration awarded
<https://www.nytimes.com/2020/07/22/us/politics/pfizer-coronavirus-vaccine.html>
a
$1.9 billion contract in July for 100 million doses. The New York Times
reported in December that the administration passed up the chance
<https://nyti.ms/36UHvqt> to secure another 100 million doses. It will be
difficult for the United States to obtain more of the vaccine quickly,
because other countries have made deals for the next few month’s
production. Japan made a deal
<https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-supply-japan-120-million-doses-their>
for
120 million doses, for example, while the European Union arranged
<https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-potentially-supply-eu-200-million-doses>
to
purchase 200 million doses.

Pfizer and BioNTech expect
<https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-supply-canada-their-bnt162-mrna-based>
to
manufacture over 1.3 billion doses worldwide by the end of 2021.

For more details, see How the Pfizer-BioNTech Vaccine Works
<https://www.nytimes.com/interactive/2020/health/pfizer-biontech-covid-19-vaccine.html>
.
Updated Dec. 13

PHASE 3
[image: Moderna logo][image: National Institutes of Health logo]
VACCINE NAME: mRNA-1273
<https://www.nytimes.com/interactive/2020/health/moderna-covid-19-vaccine.html>
EFFICACY: 94.5%
<https://www.nytimes.com/2020/11/20/health/covid-vaccine-95-effective.html>
DOSE: 2 doses, 4 weeks apart
TYPE: Muscle injection
STORAGE: 30 days with refrigeration, 6 months at –4°F (–20°C)

On Nov. 30, the Boston-based company Moderna announced
<https://www.nytimes.com/2020/11/30/health/covid-vaccine-moderna.html?referringSource=articleShare>
it
was applying to the Food and Drug Administration for an emergency use
authorization, less than a year after it launched the first clinical trial
for a coronavirus vaccine. It is the second application, coming just two
weeks after Pfizer and BioNTech. If Moderna receives the authorization, the
first injections of its vaccine could start on Dec. 21.

Like Pfizer and BioNTech, Moderna makes its vaccine from mRNA. In recent
years, the company has tested mRNA vaccines for a number of diseases, but
they have yet to bring one to market. In January, they began developing a
vaccine for the coronavirus.

The United States government bankrolled Moderna’s efforts, providing nearly
$1 billion in support. In partnership with National Institutes of Health,
they found that the vaccine protects monkeys
<https://www.nytimes.com/2020/07/28/health/coronavirus-moderna-vaccine-monkeys.html>
from
the coronavirus. In March, the scientists were the first to put a Covid-19
vaccine into human trials
<https://www.nytimes.com/2020/03/16/health/coronavirus-vaccine.html>. After
those studies yielded promising results
<https://www.nejm.org/doi/full/10.1056/NEJMoa2022483>, Phase 3 testing on
30,000 volunteers began
<https://www.nytimes.com/2020/07/27/health/moderna-vaccine-covid.html> on
July 27.

On Nov. 16, Moderna announced <https://nyti.ms/2Uy7YmA> the first
preliminary data from the trial, followed by the complete data on Nov. 30.
Out of 196 cases of Covid-19 among trial volunteers, 185 were in people who
received the placebo. And of the 11 vaccinated volunteers who got Covid-19,
none suffered from severe disease. The researchers estimated that the
vaccine had an efficacy rate
<https://www.nytimes.com/2020/11/20/health/covid-vaccine-95-effective.html> of
94.1 percent, far higher than experts had expected when vaccine testing
began. While it’s not clear how long this efficacy will last, Moderna has
found that after three months
<https://www.nytimes.com/live/2020/12/03/world/covid-19-coronavirus/modernas-vaccine-provides-protection-against-covid-19-for-at-least-three-months-a-study-finds>
the
trial participants still have a strong immune defense against the
coronavirus. On Dec. 2, Moderna registered a trial
<https://clinicaltrials.gov/ct2/show/NCT04649151> to test the vaccine on
adolescents between 12 and 18 years
<https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-first-participants-dosed-phase-23-study-covid>
of
age.

On the business side, Moderna lost a patent dispute in July over some of
their vaccine technology. The following month, the company stated
<https://www.axios.com/moderna-coronavirus-vaccine-sec-disclosure-c8c491d1-0395-4c9d-8bf4-792246c6aa34.html>
that
it could not be certain it was the first to make the inventions claimed in
their patents, including its coronavirus vaccine. Meanwhile, the company
has entered deals with several countries to supply the vaccine if it’s
approved. On Aug. 11, the United States government awarded
<https://www.businesswire.com/news/home/20200811005852/en/Moderna-Announces-Supply-Agreement-U.S.-Government-Initial>
the
company an additional $1.5 billion in exchange for 100 million doses if the
vaccine proves safe and effective, following up in December with a deal for
another 100 million doses
<https://www.nytimes.com/live/2020/12/11/world/covid-19-coronavirus/trump-administration-to-buy-another-100-million-doses-of-modernas-covid-19-vaccine>
in
the second quarter of 2021. On Nov. 25, the company reached an agreement
with the European Commission to supply up to 160 million doses
<https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-european-commissions-approval-advance-purchase>.
Moderna has made similar deals with other countries including Canada
<https://investors.modernatx.com/news-releases/news-release-details/canada-exercises-increased-option-20-million-doses-mrna-vaccine>
, Japan
<https://investors.modernatx.com/news-releases/news-release-details/moderna-partners-takeda-and-government-japan-supply-50-million>
 and Qatar
<https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-supply-agreement-ministry-public-health-supply>
.

For more details, see How Moderna’s Vaccine Works
<https://www.nytimes.com/interactive/2020/health/moderna-covid-19-vaccine.html>
.
Updated Dec. 12

PHASE 2 PHASE 3 COMBINED PHASES
[image: AnGes logo][image: Osaka University logo][image: Takara Bio logo]
VACCINE NAME: AG0302-COVID19
EFFICACY: Unknown
DOSE: 2 doses, 2 weeks apart
TYPE: Skin injection
STORAGE: Over a year at room temperature

On June 30, the Japanese biotechnology company AnGes launched
<https://www.japantimes.co.jp/news/2020/06/30/national/science-health/japan-first-coronavirus-vaccine-clinical-test-starts/>
a
Phase 1 trial to test a DNA-based vaccine, developed in partnership with Osaka
University and Takara Bio. The company moved on to a Phase 2/3 trial
<https://clinicaltrials.gov/ct2/show/NCT04655625?> in December.
Updated Dec. 8

PHASE 2
[image: Zydus Cadila logo]
In July, the Indian vaccine-maker Zydus Cadila began testing
<https://twitter.com/ZydusUniverse/status/1278997989382483968> a DNA-based
vaccine delivered by a skin patch. They launched a Phase 2 trial
<http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45306&EncHid=&userName=vaccine>
on
Aug. 6 and are planning
<https://twitter.com/CNBCTV18Live/status/1324218442505859072> a Phase 3
trial to begin in December. In a Dec. 11 interview
<https://health.economictimes.indiatimes.com/news/industry/covid-vaccine-our-vaccine-should-be-ready-by-march-zydus-cadila/79672294>,
company's chairman Pankaj Patel, the company’s chairman, said the company
expects to have their vaccine ready for distribution by March 2021.
Updated Dec. 12

PHASE 2
[image: Inovio logo]
VACCINE NAME: INO-4800
EFFICACY: Unknown
DOSE: To be determined
TYPE: Skin injection
STORAGE: Over a year at room temperature

The American company Inovio has developed DNA-based vaccines which are
delivered into the skin with electric pulses from a hand-held device. They
have vaccines in clinical trials for a number of diseases, and in June they
announced interim data from a Phase 1 trial on Covid-19
<https://www.nytimes.com/2020/06/13/science/vaccine-coronavirus-inovio.html>.
They found no serious adverse effects, and measured an immune response in
34 out of 36 volunteers. Inovio has yet to publish detailed results of
these studies, however, and it is embroiled
<https://www.nytimes.com/2020/08/09/business/coronavirus-vaccine-inovio.html>
in
several lawsuits with stockholders and a company partner. On Sept. 28, the
F.D.A. put the vaccine on a partial hold
<http://ir.inovio.com/news-releases/news-releases-details/2020/INOVIO-Reports-FDA-Partial-Clinical-Hold-for-Planned-Phase-2--3-Trial-of-COVID-19-Vaccine-Candidate-INO-4800/default.aspx>
due
to questions about the delivery device. On Nov. 16, Inovio said that the
F.D.A. had given them permission to move forward
<http://ir.inovio.com/news-releases/news-releases-details/2020/INOVIO-Announces-Initiation-of-Phase-2-Segment-of-its-Phase-23-Clinical-Trial-for-its-COVID-19-DNA-Vaccine-Candidate-INO-4800-Trial-Will-Be-Funded-by-the-U.S.-Department-of-Defense/default.aspx>
with
their Phase 2/3 trial <https://clinicaltrials.gov/ct2/show/NCT04642638>.
They are also running a Phase 2 trial in China
<http://ir.inovio.com/news-releases/news-releases-details/2020/INOVIO-and-Advaccine-Announce-First-Dosing-of-Subject-in-Phase-2-Clinical-Trial-for-COVID-19-DNA-Vaccine-Candidate-INO-4800-in-China/default.aspx>
.
Updated Dec. 10

PHASE 2
[image: CureVac logo]
VACCINE NAME: CVnCoV
EFFICACY: Unknown
DOSE: 2 doses, four weeks apart
TYPE: Muscle injection
STORAGE: Stable at least 3 months at 36–46°F (2–8°C)

In March, the Trump administration unsuccessfully tried to entice CureVac
 to move its research
<https://www.nytimes.com/2020/03/15/world/europe/cornonavirus-vaccine-us-germany.html>
on
a mRNA vaccine from Germany to the United States. The company moved ahead
with its work in Germany and found promising responses in mice
<https://www.curevac.com/en/2020/10/23/curevac-reports-positive-preclinical-data-for-its-covid-19-vaccine-candidate-cvncov/>.
In July, they launched a Phase 1 clinical trial, in which they saw
<https://www.curevac.com/en/2020/11/02/curevac-reports-positive-interim-phase-1-data-for-its-covid-19-vaccine-candidate-cvncov/>
 an encouraging response
<https://www.curevac.com/en/2020/11/02/curevac-reports-positive-interim-phase-1-data-for-its-covid-19-vaccine-candidate-cvncov/>
in
the immune systems of volunteers. In September, the company started a Phase
2 study
<https://clinicaltrials.gov/ct2/show/NCT04515147?term=vaccine&recrs=abdf&cond=COVID-19&phase=0123&sort=nwst&draw=2&rank=1>.
They expect to follow that with a Phase 3 trial in December, which should
yield
<https://www.curevac.com/en/2020/11/30/curevac-announces-financial-results-and-business-updates-for-the-third-quarter-and-first-nine-months-of-2020/>
preliminary
data in the first quarter of 2021.

In November, CureVac negotiated a deal to provide the European Union with up
to 225 million doses
<https://www.curevac.com/en/2020/11/16/european-commission-announces-that-tomorrow-it-will-authorize-the-agreement-with-curevac-for-the-supply-of-up-to-405-million-doses-of-mrna-based-covid-19-vaccine-candidate-cvncov/>
of
their vaccine. They project manufacturing up
<https://www.curevac.com/en/2020/11/17/curevac-establishes-european-based-network-to-ramp-up-manufacturing-of-its-covid-19-vaccine-candidate-cvncov/>
to
300 million doses in 2021
<https://www.curevac.com/en/2020/11/17/curevac-establishes-european-based-network-to-ramp-up-manufacturing-of-its-covid-19-vaccine-candidate-cvncov/>
and
up to 600 million doses the following year. CureVac has collaborated
<https://observer.com/2020/09/tesla-elon-musk-germany-covid19-vaccine-collaboration-curevac/>
with
Elon Musk’s company Tesla on creating mRNA “micro-factories,” which could
potentially be deployed around the world to make billions of doses of the
vaccine. On Nov. 12, the company announced
<https://www.curevac.com/en/2020/11/12/curevacs-covid-19-vaccine-candidate-cvncov-suitable-for-standard-fridge-temperature-logistics/>
that
its vaccine could be kept in a refrigerator at 41 degrees. Other RNA
vaccines made by Pfizer and Moderna have to be kept frozen at chillier
temperatures.
Updated Nov. 30

PHASE 1 PHASE 2 COMBINED PHASES
[image: Imperial College logo][image: Morningside logo]
Imperial College London researchers have developed a “self-amplifying” RNA
vaccine
<https://www.nytimes.com/2020/06/07/world/europe/imperial-college-uk-vaccine-coronavirus.html>,
which boosts production of a viral protein to stimulate the immune system.
They began Phase 1/2 trials on June 15 and have partnered with Morningside
Ventures to manufacture and distribute the vaccine through a new company
called VacEquity Global Health. The researchers expect to know if the
vaccine is effective by the end of the year
<https://www.theguardian.com/society/2020/jul/03/im-cautiously-optimistic-imperials-robin-shattock-on-his-coronavirus-vaccine>
.

PHASE 1 PHASE 2 COMBINED PHASES
[image: Arcturus logo][image: Duke-NUS Medical School logo]
The California-based company Arcturus Therapeutics and Duke-NUS Medical
School in Singapore have developed an mRNA vaccine. It has a
“self-replicating” design that leads to a greater production of viral
proteins. Tests on animals
<https://www.biorxiv.org/content/10.1101/2020.09.03.280446v1> showed that
it protected them against infection. In August, Arcturus launched
<https://ir.arcturusrx.com/news-releases/news-release-details/arcturus-therapeutics-announces-it-has-initiated-dosing-its>
a
Phase 1/2 trial at Singapore General Hospital. On Nov. 9, the company
announced
<https://www.businesswire.com/news/home/20201109005459/en/Arcturus-Therapeutics-Announces-Positive-Interim-ARCT-021-LUNAR-COV19>
that
an interim analysis of the trial showed that the vaccine produced an immune
response that’s in the range of responses seen in people who recovered from
Covid-19. Singapore reached an agreement with Arcturus to spend up to $175
million to acquire vaccines when they’re ready.
Updated Nov. 12

PHASE 1
[image: Genexine logo]
The Korean company Genexine started testing the safety of a DNA-based
vaccine in June. They anticipate moving to Phase 2 trials in the fall.
Updated June 24

PHASE 1
[image: Academy of Military Medical Sciences logo][image: Suzhou Abogen
Biosciences logo][image: Walvax Biotechnology logo]
In June, Chinese researchers at the Academy of Military Medical
Sciences, Suzhou
Abogen Biosciences and Walvax Biotechnology announced they would start
their country’s first safety trials on a mRNA-based vaccine, called ARCoV.
Earlier studies on monkeys reportedly
<https://news.cgtn.com/news/2020-06-26/China-s-first-COVID-19-mRNA-vaccine-approved-for-clinical-trials-RDTXX0jVJK/index.html>
showed
protective effects.
Updated June 26

PHASE 1
[image: Chulalongkorn University logo][image: Chula Vaccine Research Center
logo]
Researchers at Thailand’s Chulalongkorn University have been developing
several potential vaccines for the coronavirus. The furthest along is an
mRNA-based vaccine known as ChulaCov19. On Sept. 29, the Chula Vaccine
Research Center registered a Phase 1 trial
<https://clinicaltrials.gov/ct2/show/NCT04566276> to test it in humans. In
an interview
<https://www.bangkokpost.com/business/1993579/covid-19-spurs-thailands-rise-as-global-medical-hub>
with
the Bangkok Post, the leader of the project said that up to 30 million
doses might be produced for Thailand and six other Asian countries if the
vaccine proved to be safe and effective.
Updated Sept. 30

PHASE 1
[image: entos logo]
The Canadian company Entos Pharmaceuticals <https://www.entospharma.com/> has
created a DNA vaccine for the coronavirus. Most other genetic vaccines
carry the gene for the spike protein on the surface of the virus. Entos
instead chose the gene for nucleocapsid, a protein that sits inside the
virus’s membrane. They are betting it can offer long-lasting immunity. In
October, Entos launched <https://clinicaltrials.gov/ct2/show/NCT04591184> a
Phase 1 trial in Canada for their vaccine, called Covigenix VAX-001.
Updated Oct. 20

PHASE 1
[image: symvivo logo]
On Nov. 2, the Canadian company Symvivo announced
<https://www.businesswire.com/news/home/20201102005496/en/First-Healthy-Volunteer-Dosed-in-Symvivo%E2%80%99s-Phase-1-Clinical-Trial-of-bacTRL-Spike%E2%84%A2-an-Oral-COVID-19-Vaccine-Candidate>
they
had administered a DNA vaccine to their first volunteer in a Phase 1 trial
<https://clinicaltrials.gov/ct2/show/NCT04334980>. The DNA is inserted
into harmless
bacteria <https://www.symvivo.com/covid-19>, which volunteers swallow in a
frozen liquid (the company is working on putting the bacteria into a pill).
When the bacteria reach the intestines, the DNA slips into cells in the gut
lining, which then make viral proteins.
Updated Nov. 3

PHASE 1
[image: OncoSec Immunotherapies logo]
New Jersey-based OncoSec Immunotherapies has developed experimental cancer
treatments that deliver genes into tumors. There, the injected genes
produce a natural signalling molecule called IL-12, which attracts the
attention of immune cells that attack the cancer. In the spring, OncoSec
began adapting their technology to make a vaccine for the coronavirus. The
vaccine, called CORVax12, consists of a loop of DNA that encodes both the
spike protein and IL-12. Causing the body to make extra IL-12 could
potentially enhance the immune system’s ability to make antibodies to the
spike protein. On Nov. 13, the company registered
<https://clinicaltrials.gov/ct2/show/NCT04627675> a Phase 1 trial to test
the safety of the CORVax12.
Updated Nov. 13

PHASE 1 PHASE 2 COMBINED PHASES
[image: Gennova Biopharmaceuticals logo][image: HDT Bio logo]
Gennova Biopharmaceuticals in India and Seattle-based HDT Bio partnered to
develop a vaccine based on self-amplifying RNA. The vaccine, known as HGC019
<https://gennova.bio/mrna-vaccines/>, was able to safely provoke animals to
make antibodies to the coronavirus, leading India to grant the companies
approval
<https://www.business-standard.com/article/current-affairs/gennova-pharma-gets-conditional-permission-for-human-trial-of-covid-vaccine-120120901288_1.html>
in
December to start Phase 1/2 trials.
Updated Dec. 12

PRECLINICAL
[image: Sanofi logo][image: Translate Bio logo]
The French pharmaceutical company Sanofi is developing an mRNA vaccine in
partnership with Translate Bio. They have found that it produces a strong
antibody response
<https://investors.translate.bio/news-releases/news-release-details/sanofi-and-translate-bio-mrna-covid-19-vaccine-candidate-induced>
in
mice and monkeys and are planning on starting Phase 1 trials by December.
It would become Sanofi’s second Covid-19 vaccine candidate in clinical
trials, along with their protein-based vaccine.
Updated Oct. 15

PRECLINICAL

Other genetic vaccines in active preclinical development include vaccines
from: Applied DNA Sciences, EvviVax and Takis Biotech; DIOSynVax; Elixirgen
Therapeutics; ETheRNA; Infectious Disease Research Institute and Amyris;
Mediphage Bioceuticals; the OPENCORONA Consortia; Scancell; the Spanish
National Center for Biotechnology and the Spanish National Research Council.
Updated Sept. 30
Viral Vector Vaccines

Vaccines that contain viruses engineered to carry coronavirus genes. Some
viral vector vaccines enter cells and cause them to make viral proteins.
Other viral vectors slowly replicate, carrying coronavirus proteins on
their surface.

PHASE 3 LIMITED USE IN CHINA
[image: CanSino Biologics logo][image: Academy of Military Medical Sciences
logo]
VACCINE NAME: Ad5-nCoV
EFFICACY: Unknown
DOSE: Single dose
TYPE: Muscle injection
STORAGE: Refrigerated

The Chinese company CanSino Biologics developed a vaccine based on an
adenovirus called Ad5, in partnership with the Institute of Biology at the
country’s Academy of Military Medical Sciences. In May, they published
<https://www.nytimes.com/2020/05/22/health/coronavirus-vaccine-china.html>
promising
results from a Phase 1 safety trial, and in July they reported
<https://www.thelancet.com/lancet/article/s0140-6736(20)31605-6> that their
Phase 2 trials demonstrated the vaccine produced a strong immune response.
In an unprecedented move, the Chinese military approved
<https://www.nytimes.com/2020/07/16/business/china-vaccine-coronavirus.html>
the
vaccine on June 25 for a year as a “specially needed drug.” CanSino would
not say whether vaccination would be mandatory or optional for soldiers.
Starting in August, CanSino began running Phase 3 trials in a number of
countries, including Saudi Arabia
<https://www.arabnews.com/node/1717041/saudi-arabia>, Pakistan
<https://www.reuters.com/article/us-health-coronavirus-pakistan-vaccine/pakistan-launches-phase-iii-trials-for-chinese-cansinobios-covid-19-vaccine-idUSKCN26D16E>
 and Russia <https://www.globaltimes.cn/content/1201811.shtml>.
Updated Sept. 24

PHASE 3 EARLY USE IN RUSSIA
[image: Gamaleya Research Institute logo]
VACCINE NAME: Sputnik 5 (formerly Gam-Covid-Vac)
EFFICACY: 92%
DOSE: 2 doses, 3 weeks apart
TYPE: Muscle injection
STORAGE: Freezer storage. Developing an alternative formulation that can be
refrigerated.

The Gamaleya Research Institute, part of Russia’s Ministry of Health, has
created a vaccine based on two adenoviruses. Preliminary results
<https://rdif.ru/Eng_fullNews/6058/> announced in November indicate that
the vaccine has a high efficacy rate in Phase 3 trials.

Gamaleya produced the vaccine, initially called Gam-Covid-Vac, from
adenoviruses called Ad5 and Ad26. Both kinds have been tested as vaccines
over the years. By combining them, the Russian researchers hoped to avoid a
situation in which the immune system could learn to recognize the vaccine
as a foreign object that needed to be destroyed.

The researchers launched clinical trials in June. On Aug. 11, President
Vladimir V. Putin announced
<https://www.nytimes.com/2020/08/11/world/coronavirus-covid-19.html#link-b092b4d>
that
a Russian health care regulator had approved the vaccine
<https://www.nytimes.com/2020/08/11/world/europe/russia-coronavirus-vaccine.html>,
renamed Sputnik V, before Phase 3 trials had even begun. Vaccine experts
decried
<https://www.nytimes.com/2020/08/11/health/russia-covid-19-vaccine-safety.html>
the
move as risky, and Russia later walked back
<https://abcnews.go.com/International/russia-announces-expanded-trials-coronavirus-vaccine-approved-10/story?id=72497297>
the
announcement, saying that the approval was a “conditional registration
certificate,” which would depend on positive results from Phase 3 trials.
Those trials, initially planned for just 2,000 volunteers, were expanded to
40,000
<https://clinicaltrials.gov/ct2/show/NCT04530396?term=vaccine&recrs=abdf&cond=COVID-19&phase=0123&sort=nwst&draw=2&rank=2>.
In addition to Russia, volunteers were recruited
<https://www.thenational.ae/uae/health/uae-to-host-new-vaccine-trial-for-russia-s-sputnik-v-1.1092478>
in
Belarus, the United Arab Emirates <https://rdif.ru/Eng_fullNews/5889/>, and
Venezuela. On Oct. 17, a Phase 2/3 trial
<http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49102&EncHid=&userName=Sputnik>
 was launched
<https://www.businesswire.com/news/home/20201017005007/en/Dr.-Reddy%E2%80%99s-RDIF-receive-approval-conduct-clinical>
in
India.

On Sept. 4, three weeks after Putin’s announcement, Gamaleya researchers
published the results of their Phase
<https://www.nytimes.com/2020/09/04/health/russia-covid-vaccine.html?smid=tw-share>
1/2
<https://www.nytimes.com/2020/09/04/health/russia-covid-vaccine.html?smid=tw-share>
 trial
<https://www.nytimes.com/2020/09/04/health/russia-covid-vaccine.html?smid=tw-share>.
In a small study, they found that Sputnik yielded antibodies to the
coronavirus and mild side effects. Meanwhile, Russia negotiated
<https://rdif.ru/Eng_fullNews/5783/> agreements to supply the vaccine to
countries including Argentina
<https://www.batimes.com.ar/news/argentina/argentina-agrees-to-buy-25-million-doses-of-russias-covid-19-vaccine.phtml>,
Brazil, India <https://rdif.ru/Eng_fullNews/5787/>, Mexico, and Venezuela
<https://clinicaltrials.gov/ct2/show/NCT04642339>.

On Nov. 11, the Russian Direct Investment Fund announced
<https://www.nytimes.com/live/2020/11/11/world/covid-19-coronavirus-live-updates/russias-vaccine-proves-effective-in-early-trial-data-company-says>
preliminary
evidence from their Phase 3 trial indicating that the vaccine is effective.
Based on 20 cases of Covid-19 among the trial participants, Russian
scientists estimated that the vaccine demonstrated 92 percent efficacy. On
Nov. 24, the vaccine makers followed up
<https://www.nytimes.com/2020/11/24/world/sputnik-vaccine-russia.html> with
an analysis on 39 cases that pointed to the same efficacy rate. They also
claimed that a preliminary analysis on some volunteers who had the vaccine
for a longer period of time showed a 95 percent efficacy rate, but outside
experts questioned that conclusion. As with Moderna and Pfizer, the
Gamaleya Research Institute has yet to follow up on their announcement with
a detailed study in a peer-reviewed scientific journal.

In an unprecedented move in the coronavirus vaccine field, the Gamaleya
Institute joined forces in December with the drugmaker AstraZeneca, which
makes a vaccine with human adenoviruses. The two teams will combine
<https://www.nytimes.com/live/2020/12/11/world/covid-19-coronavirus/british-and-russian-vaccine-makers-are-set-to-begin-clinical-trials-combining-two-vaccines>
their
vaccines to see if they deliver stronger protection together than either
does on its own. The trial is expected to start by the end of 2020.

In early December, the Russian government began a mass vaccination campaign
<https://www.nytimes.com/2020/12/07/world/europe/russia-coronavirus-vaccine.html>
with
the Sputnik V vaccine. But worry that the vaccine was rushed has led to
widespread hesitancy in the country.
Updated Dec. 11

PHASE 3
[image: Johnson & Johnson logo][image: Beth Israel Deaconess Medical Center
logo]
VACCINE NAME: Ad26.COV2.S
EFFICACY: Unknown
DOSE: 1 dose
TYPE: Muscle injection
STORAGE: Stable in refrigerator

A decade ago, researchers at Beth Israel Deaconess Medical Center in Boston
developed a method for making vaccines out of a virus called Adenovirus 26
<https://www.nytimes.com/2020/07/17/health/coronavirus-vaccine-johnson-janssen.html>,
or Ad26 for short. Johnson & Johnson developed vaccines for Ebola and other
diseases with Ad26 and have now made one for the coronavirus. In March they
received $456 million
<https://www.jnj.com/johnson-johnson-announces-a-lead-vaccine-candidate-for-covid-19-landmark-new-partnership-with-u-s-department-of-health-human-services-and-commitment-to-supply-one-billion-vaccines-worldwide-for-emergency-pandemic-use>
from
the United States government to support their move towards production. The
vaccine has provided protection in experiments on monkeys
<https://www.nytimes.com/2020/07/30/health/covid-19-vaccine-monkeys.html>.
Johnson & Johnson began Phase 1/2 trials
<https://www.medrxiv.org/content/10.1101/2020.09.23.20199604v1> in July.
Unlike other leading vaccines in clinical trials, the company gave one
dose, not two.

Johnson & Johnson launched a Phase 3 trial
<https://www.nytimes.com/2020/09/23/health/covid-19-vaccine-johnson-and-johnson.html>
in
September. On Oct. 12, the company announced it was pausing the trial to
investigate an adverse reaction in a volunteer
<https://www.nytimes.com/live/2020/10/12/world/coronavirus-covid#johnson-johnson-halts-coronavirus-vaccine-trial-because-of-sick-volunteer>.
The trial resumed
<https://www.nytimes.com/2020/10/23/health/covid-vaccine-astrazeneca-johnson-and-johnson.html?action=click&module=RelatedLinks&pgtype=Article>
eleven
days later. Although Johnson & Johnson initially set out to recruit 60,000
volunteers for their Phase 3 trial, it was capped at 40,000 in December.
Results are expected in January.

In August, the federal government agreed
<https://www.jnj.com/johnson-johnson-announces-agreement-with-u-s-government-for-100-million-doses-of-investigational-covid-19-vaccine>
to
pay Johnson & Johnson $1 billion for 100 million doses if the vaccine is
approved. The European Union
<https://www.jnj.com/johnson-johnson-announces-european-commission-approval-of-agreement-to-supply-200-million-doses-of-janssens-covid-19-vaccine-candidate>
reached
a similar deal on Oct. 8 for 200 million doses. The company is aiming for
production of at least a billion doses in 2021.

On Nov. 16, Johnson & Johnson announced that they were also launching a
second Phase 3 trial to observe the effects of two doses of their vaccine
<https://www.jnj.com/johnson-johnson-initiates-second-global-phase-3-clinical-trial-of-its-janssen-covid-19-vaccine-candidate>,
instead of just one.
Updated Dec. 10

PHASE 2 PHASE 3 COMBINED PHASES
[image: University of Oxford logo][image: AstraZeneca logo]
VACCINE NAME: AZD1222
EFFICACY: Up to 90%
DOSE: 2 doses, 4 weeks apart
TYPE: Muscle injection
STORAGE: Stable in refrigerator for at least 6 months

On Dec. 8, researchers with the University of Oxford and the
British-Swedish company AstraZeneca published the first scientific paper
<https://doi.org/10.1016/S0140-6736(20)32661-1> on a Phase 3 clinical trial
of a coronavirus vaccine. The trial demonstrated that the vaccine can
protect people from Covid-19, but it left many questions unresolved
<https://www.nytimes.com/live/2020/12/08/world/covid-19-coronavirus/a-new-paper-from-oxford-on-the-astrazeneca-vaccine-does-little-to-answer-the-most-pressing-questions-about-its-data>
about
the results.

Early in the pandemic, Oxford researchers developed
<https://www.nytimes.com/2020/04/27/world/europe/coronavirus-vaccine-update-oxford.html>
the
vaccine by genetically engineering an adenovirus that normally infects
chimpanzees. When they gave the vaccine to monkeys, they found that it
protected
the animals from the disease
<https://www.nytimes.com/2020/07/30/health/covid-19-vaccine-monkeys.html>.
In April they followed up with a Phase 1/2 trial. The vaccine developers did
not detect
<https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31604-4/fulltext>
any
severe side effects in the trial, while observing that the vaccine raised
antibodies against the coronavirus as well as other immune defenses. The
vaccine began Phase 2/3 trials in the United Kingdom and India (where it’s
known as Covishield). In addition, AstraZeneca launched Phase 3 trials in
Brazil, South Africa, and the United States
<https://clinicaltrials.gov/ct2/show/NCT04516746?term=vaccine&recrs=abdf&cond=COVID-19&phase=0123&sort=nwst&draw=2&rank=1>
.

On Sept. 6, AstraZeneca halted global trials
<https://www.nytimes.com/2020/09/08/health/coronavirus-astrazeneca-vaccine-safety.html>
of
the vaccine to investigate one volunteer, who developed a form of
inflammation called transverse myelitis. Within a week, the trials began in
all countries except the United States. Meanwhile, a newspaper in Brazil
reported
<https://www.nytimes.com/live/2020/10/21/world/covid-19-coronavirus-updates/a-vaccine-trial-volunteer-in-brazil-has-died-but-health-authorities-say-the-vaccine-was-not-to-blame>
on
Oct. 21 that a volunteer in the trial there died of Covid-19. While
AstraZeneca did not comment, the Brazil trial was not paused, suggesting
that the volunteer received a placebo. On Oct. 23, the F.D.A. authorized
the restart
<https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/fda-authorises-restart-of-the-covid-19-azd1222-vaccine-us-phase-iii-trial.html>
of
the U.S. trial.

On Nov. 19, researchers published
<https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32466-1/fulltext>
the
first findings from the Phase 2/3 trials in the United Kingdom. They looked
in particular at how people at different ages responded to the vaccine,
studying 160 people aged 18 to 55 years old, 160 between 56 and 69, and 240
70 years or older. They didn’t observe any serious side effects at any age.
Encouragingly, the older volunteers produced about as many antibodies
against the coronavirus as the younger ones.

On Nov. 23, AstraZeneca and Oxford announced
<https://www.nytimes.com/2020/11/23/business/astrazeneca-oxford-coronavirus-vaccine.html>
that
the vaccine had good efficacy, based on a study of the first 131 cases of
Covid-19 in the trials in the United Kingdom and Brazil. The volunteers all
got two doses, but in some cases the first dose was only half strength.
Surprisingly, an initial half-strength dose led to 90 percent efficacy,
while two standard-dose shots led only to 62 percent efficacy. The
researchers speculated that the lower first dose did a better job of
mimicking the experience of an infection, promoting a stronger immune
response. But only after the initial announcement did it become clear that
the low dose version was the result of a mistake
<https://www.nytimes.com/2020/12/08/business/covid-vaccine-oxford-astrazeneca.html?searchResultPosition=1>
in
how the vaccines were measured out, not part of the original plan for the
trial. It also emerged that the low dose was only tried out on volunteers
under 55, raising more questions about how strong the preliminary results
were.

In an unprecedented move in the coronavirus vaccine field, AstraZeneca
announced
<https://www.nytimes.com/live/2020/12/11/world/covid-19-coronavirus/british-and-russian-vaccine-makers-are-set-to-begin-clinical-trials-combining-two-vaccines>
on
Dec. 11 that it would collaborate with the Russian creators of the Sputnik
V vaccine, which is also made from adenoviruses. The two teams will combine
their vaccines to see if they deliver stronger protection together than
either does on its own. The trial is expected to start by the end of 2020.

Starting in May, AstraZeneca secured a series of agreements to provide
vaccines to governments should they prove effective. The United States
awarded the project $1.2 billion
<https://www.nytimes.com/2020/05/21/health/coronavirus-vaccine-astrazeneca.html?searchResultPosition=7>
in
support for 300 million doses
<https://medicalcountermeasures.gov/newsroom/2020/covid-vaccine/>. In
August the European Union reached an agreement for AstraZeneca to deliver 400
million doses
<https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/astrazeneca-concludes-agreement-with-the-european-commission-for-the-supply-of-up-to-400-million-doses-of-azd1222-covid-19-vaccine.html>
if
the trials yield positive results. The company has said their total annual
manufacturing capacity for the vaccine, if approved, stands at two billion
doses.

On Dec. 7, the Serum Institute of India announced
<https://twitter.com/adarpoonawalla/status/1335810817841717249> it was
applying to the Indian government for emergency use authorization of the
ChAdOx1 vaccine. In India, the vaccine is known as Covishield.
Updated Dec. 11

PHASE 1
[image: ReiThera logo][image: Lazzaro Spallanzani National Institute for
Infectious Disease logo]
The Italian biotechnology company ReiThera has developed a Covid-19
vaccine, called GRAd-COV2, that is based on an adenovirus that infects
gorillas. Working in collaboration with the Lazzaro Spallanzani National
Institute for Infectious Diseases in Rome, they launched a Phase 1 trial
<https://clinicaltrials.gov/ct2/show/NCT04528641> at the end of July. In
November, they announced
<https://www.prnewswire.com/news-releases/reithera-announces-its-grad-cov2-covid-19-vaccine-candidate-is-well-tolerated-and-induces-clear-immune-responses-in-healthy-subjects-aged-18-55-years-301179423.html>
that
the vaccine was well tolerated and produced antibodies, opening the way to
a Phase 2/3 trial in the coming months.
Updated Nov. 24

PHASE 1
[image: Vaxart logo]
While many vaccines are given as injections, some vaccines can be taken as
a pill. Oral vaccines have been approved
<https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6132247/> for diseases
including polio, cholera, and typhoid fever. The small San Francisco
company Vaxart specializes in developing oral vaccines. They have created
and tested pills for influenza
<https://doi.org/10.1016/S1473-3099(19)30584-5> and other diseases. Earlier
this year, Vaxart began work on an oral vaccine for Covid-19. It contains
an adenovirus called Ad5 (the same viral vector in CanSinoBio’s vaccine and
in Russia’s Sputnik V).

When Vaxart gave the pill to mice
<https://www.biorxiv.org/content/10.1101/2020.09.04.283853v1>, they
produced antibodies against the coronavirus. Mice don’t suffer symptoms of
Covid-19, however, so the researchers then switched to hamsters, which do.
In an unpublished study
<https://investors.vaxart.com/news-releases/news-release-details/vaxart-announces-positive-hamster-challenge-study-data-its-oral>,
they found that the vaccine pill not only dramatically reduced
<https://investors.vaxart.com/news-releases/news-release-details/vaxart-announces-additional-data-hamster-challenge-study-its>
the
amount of coronavirus in sick hamsters, but also protected them from two
important symptoms of the disease: weight loss and swollen lungs. In
October, the company began giving the pill to volunteers in a Phase 1
clinical trial <https://clinicaltrials.gov/ct2/show/NCT04563702>.

Although none of Vaxart’s vaccines have yet been licensed, the company’s
stock price increased 3,600 percent in the first half of 2020. In June, The
New York Times reported
<https://www.nytimes.com/2020/07/25/business/coronavirus-vaccine-profits-vaxart.html>,
a hedge fund that partly controlled the company sold off most of its
shares, netting over $200 million in profits. In the wake of that
reporting, the Department of Justice began investigating
<https://www.nytimes.com/2020/10/15/business/vaxart-covid-coronavirus-vaccine.html>
the
company, while a number of shareholder lawsuits were brought against
Vaxart, its executives and its board.
Updated Nov. 12

PHASE 1
[image: Merck logo][image: Themis logo][image: Institut Pasteur logo]
The American company Merck acquired the Austrian firm Themis Bioscience in
June and is working on a vaccine originally developed at Institut Pasteur.
The vaccine uses a weakened measles virus that carries a gene for the
coronavirus spike protein. Researchers launched
<https://clinicaltrials.gov/ct2/show/NCT04497298> a Phase 1 trial in August.
Updated Aug. 12

PHASE 1
[image: University of Hong Kong logo][image: Xiamen University logo][image:
Wantai Biopharmaceutical logo]
In 2019, researchers at the University of Hong Kong and Xiamen University
created <https://mbio.asm.org/content/10/5/e02180-19> a nasal-spray vaccine
for the flu based on a genetically weakened form of the influenza virus.
Earlier this year, they engineered the vaccine to produce part of the
coronavirus spike protein as well. On Sept. 9, they received approval
<https://www.hku.hk/press/news_detail_21583.html> to start clinical trials
in partnership with Beijing Wantai Biological Pharmacy.
Updated Sept. 9

PHASE 1
[image: German Center for Infection Research logo]
Three decades ago, the German Center for Infection Research developed a
smallpox vaccine from a harmless virus called Modified Vaccinia Ankara, or
MVA for short. In recent years, they adapted it to create a vaccine for
MERS, a disease caused by another coronavirus. This spring, they made an
MVA-based vaccine for SARS-CoV-2, the coronavirus that is causing the
Covid-19 pandemic. It carries the gene for the spike protein, which is
produced inside cells that it invades. On Sept. 29, the center and a
consortium of German universities registered a Phase 1 trial
<https://clinicaltrials.gov/ct2/show/NCT04569383>. The vaccine is expected
to be ready for approval by the end of 2021.
Updated Sept. 29

PHASE 1
[image: Merck logo][image: International AIDS Vaccine Initiative logo]
In addition to its project with Themis, Merck is partnering with IAVI on a
second viral vector vaccine. It is based on vesicular stomatitis viruses,
the same approach Merck successfully used to produce the first approved
vaccine for Ebola
<https://www.fda.gov/news-events/press-announcements/first-fda-approved-vaccine-prevention-ebola-virus-disease-marking-critical-milestone-public-health>.
They have designed their coronavirus vaccine as a pill, which could
potentially make it easier to distribute than syringes for injections.
Merck and IAVI received $38 million
<https://medicalcountermeasures.gov/newsroom/2020/merck-iavi/> from the
United States government to support their research, and on September 30
they registered a Phase 1 trial
<https://clinicaltrials.gov/ct2/show/NCT04569786>.
Updated Aug. 27

PHASE 1
[image: ImmunityBio logo]
The California-based company ImmunityBio launched a Phase 1 trial
<https://clinicaltrials.gov/ct2/show/NCT04591717> of a Covid-19 vaccine in
October. The vaccine uses the Ad5 adenovirus, the same one used by
CanSinBio and the Gamaleya Institute in Russia. ImmunityBio has engineered
<https://www.biorxiv.org/content/10.1101/2020.07.29.227595v1> the Ad5 virus
to carry genes for two genes from the coronavirus. In addition to the spike
protein, it also carries the gene for a protein called nucleocapsid. The
company hopes that this combination will provoke a strong immune response.
On Dec. 10, the company announced that the vaccine protects monkeys
<https://health.economictimes.indiatimes.com/news/industry/covid-vaccine-our-vaccine-should-be-ready-by-march-zydus-cadila/79672294>
from
the coronavirus. The chairman and C.E.O. of ImmunityBio is billionaire Patrick
Soon-Shiong
<https://immunitybio.com/fda-authorizes-phase-1-trial-of-immunitybios-novel-covid-19-vaccine-candidate-had5-dual-construct-is-designed-to-drive-both-t-cell-and-antibody-immunity/>,
the owner of the Los Angeles Times.
Updated Dec. 11

PHASE 1
[image: Israel Institute for Biological Research logo]
In the spring, the Israel Institute for Biological Research
<https://iibr.gov.il/Pages/Who-We-are.aspx> started work
<https://www.biorxiv.org/content/10.1101/2020.06.18.160655v1> on a
coronavirus vaccine based on vesicular stomatitis viruses. They engineered
the viruses to carry the gene for the coronavirus spike protein. On Oct.
25, the Israeli government announced
<https://www.jpost.com/health-science/israel-to-kick-off-human-trials-of-covid-19-vaccine-candidate-on-nov-1-646904>
that
the vaccine, called Brilife
<https://www.jpost.com/israel-news/israel-names-its-vaccine-candidate-brilife-646254>,
would be going into Phase 1 trials. If the vaccine is successful in Phase 1
and Phase 2 trials, researchers hope to start Phase 3 trials in spring 2021.
Updated Oct. 26

PHASE 1
[image: City of Hope logo]
Researchers at City of Hope, a California biomedical research institute,
created a vaccine <https://www.nature.com/articles/s41467-020-19819-1> based
on a weakened form of a virus called Modified Vaccinia Ankara, or MVA for
short. They added two coronavirus genes to the virus — one for the spike
protein, and one for another protein called nucleocapsid. They hope the
combination will enable the vaccine to produce immunity that’s both fast
and long-lasting. On Nov. 24 they announced
<https://www.businesswire.com/news/home/20201124005423/en/> the start
of a Phase
1 trial <https://clinicaltrials.gov/ct2/show/NCT04639466>, with hopes for a
Phase 2 trial to start in the second quarter of 2021.
Updated Nov. 24

PRECLINICAL
[image: Novartis logo]
The Swiss company Novartis will manufacture a vaccine based on a gene
therapy treatment
<https://www.nytimes.com/2020/05/04/health/gene-therapy-harvard-coronavirus.html>
developed
by the Massachusetts Eye and Ear Hospital, Massachusetts General Hospital
and the Gene Therapy Program at the University of Pennsylvania. A virus
called an adeno-associated virus delivers coronavirus gene fragments into
cells. Phase 1 trials are set to begin in late 2020.
Updated Aug. 24

PRECLINICAL

Other viral vector vaccines in active preclinical development include
vaccines from: Altimmune; Icahn School of Medicine at Mount Sinai;
Intravacc; KU Leuven; Meissa Vaccines; the Spanish National Center for
Biotechnology and the Spanish National Research Council; Thomas Jefferson
University and Bharat Biotechnology; Tonix Pharmaceuticals; University of
Pittsburgh; Vivaldi Biosciences; Washington University.
Updated Oct. 20
Protein-Based Vaccines

Vaccines that contain coronavirus proteins but no genetic material. Some
vaccines contain whole proteins, and some contain fragments of them. Some
pack many of these molecules on nanoparticles.

PHASE 3
[image: Novavax logo]
VACCINE NAME: NVX-CoV2373
EFFICACY: Unknown
DOSE: 2 doses, 3 weeks apart
TYPE: Muscle injection
STORAGE: Stable in refrigerator

Maryland-based Novavax makes vaccines by sticking proteins onto microscopic
particles. They’ve taken on a number of different diseases this way; their
flu vaccine finished Phase 3 clinical trials in March. The company launched
trials for a Covid-19 vaccine in May, and the Coalition for Epidemic
Preparedness Innovations has invested $384 million in the vaccine. In July
the U.S. government awarded Novavax another $1.6 billion to support the
vaccine’s clinical trials and manufacturing
<https://www.nytimes.com/2020/07/07/health/novavax-coronavirus-vaccine-warp-speed.html>
.

After getting promising results
<https://www.nytimes.com/2020/08/04/health/covid-19-vaccine-novavax.html> from
preliminary studies in monkeys and humans, Novavax launched a Phase 2 trial
<https://clinicaltrials.gov/ct2/show/NCT04533399> in South Africa in
August. The blinded, placebo-controlled trial on 2,900 people will measure
not just the safety of the vaccine but its efficacy. The following month,
Novavax launched
<https://www.nytimes.com/2020/09/24/health/covid-19-vaccine-novavax.html> a
Phase 3 trial
<https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-004123-16/GB>
enrolling
up to 15,000 volunteers in the United Kingdom. It is expected to deliver
results
<https://ir.novavax.com/news-releases/news-release-details/novavax-announces-covid-19-vaccine-clinical-development-progress>
in
early 2021. A larger Phase 3 trial
<https://ir.novavax.com/news-releases/news-release-details/novavax-provides-phase-3-covid-19-vaccine-clinical-development>
in
the United States is expected to launch
<https://clinicaltrials.gov/ct2/show/NCT04611802> by the end of December.

In September Novavax reached an agreement
<https://www.reuters.com/article/health-coronavirus-novavax-idUSKBN2661PI> with
the Serum Institute of India, a major vaccine manufacturer, that they said
would enable them to produce as many as 2 billion doses a year. If the
trials succeed, Novavax expects to deliver 100 million doses for use in the
United States by the first quarter of 2021. On Nov. 4 they announced
another agreement to deliver 40 million doses
<https://ir.novavax.com/news-releases/news-release-details/novavax-and-commonwealth-australia-announce-agreement-principle>
to
Australia.
Updated Nov. 30

PHASE 2 PHASE 3 COMBINED PHASES
[image: Medicago logo][image: GSK logo]
VACCINE NAME: CoVLP
EFFICACY: Unknown
DOSE: 2 doses, 3 weeks apart
TYPE: Muscle injection
STORAGE: Stable in refrigerator

Canada-based Medicago, partly funded by the cigarette maker Philip Morris,
grow vaccines in a plant called Nicotiana benthamiana, a wild species
related to tobacco. They deliver virus genes into leaves, and the plant
cells then create protein shells that mimic viruses.

In July, Medicago launched
<https://www.medicago.com/en/newsroom/medicago-begins-phase-i-clinical-trials-for-its-covid-19-vaccine-candidate/>
Phase
1 trials on a plant-based Covid-19 vaccine in combination with adjuvants to
boost the immune system’s response to the viral proteins. In that study
<https://www.medrxiv.org/content/10.1101/2020.11.04.20226282v1>, they found
that an adjuvant made by GSK produced promising levels of antibodies in
volunteers. On Oct. 23, the company announced it had reached an agreement
<https://www.medicago.com/en/newsroom/medicago-signs-agreements-with-the-government-of-canada-to-supply-up-to-76-million-doses-of-its-recombinant-plant-derived-covid-19-vaccine/>
with
the government of Canada to supply 76 million doses. A Phase 2/3 trial
<https://clinicaltrials.gov/ct2/show/NCT04636697> of the vaccine began
<https://www.gsk.com/en-gb/media/press-releases/medicago-and-gsk-announce-start-of-phase-23-clinical-trials-of-adjuvanted-covid-19-vaccine-candidate/>
on
Nov. 12.
Updated Nov. 24

PHASE 3
[image: Anhui Zhifei Longcom logo][image: Institute of Medical Biology at
the Chinese Academy of Medical Sciences logo]
VACCINE NAME: ZF2001
EFFICACY: Unknown
DOSE: 3 doses, 4 weeks apart
TYPE: Muscle injection

The Chinese company Anhui Zhifei Longcom and the Chinese Academy of Medical
Sciences partnered to make a vaccine. Their candidate is composed of an
adjuvant, along with a section of the spike protein called the
receptor-binding domain. They launched Phase 2 trials in July, followed by
a Phase 3 trial
<https://clinicaltrials.gov/ct2/show/NCT04646590?term=vaccine&recrs=abdf&cond=COVID-19&phase=0123&sort=nwst&draw=2&rank=1>
with
29,000 volunteers in December.
Updated Dec. 2

PHASE 2
[image: West China Hospital of Sichuan University logo]
In July, researchers at West China Hospital of Sichuan University published
a study <https://www.nature.com/articles/s41586-020-2599-8> in Nature
describing a vaccine made from the RBD region of the spike protein that
could protect mice and monkeys from the coronavirus. To make the vaccine,
researchers encode the RBD region in a gene, which they insert into a
virus. They then infect insect cells with the virus, causing them to make
the molecule in huge amounts. On Aug. 24, they launched
<http://en.nhc.gov.cn/2020-08/26/c_81483.htm> a Phase 1 trial, and on Nov.
16 they moved to Phase 2
<http://www.chictr.org.cn/showprojen.aspx?proj=64449>.
Updated Nov. 20

PHASE 1 PHASE 2 COMBINED PHASES
[image: Finlay Vaccine Institute logo]
On Aug. 18, the head of epidemiology at Cuba’s public health ministry
announced
<https://www.dw.com/en/cuba-joins-the-race-for-vaccine-against-the-coronavirus/a-54615364>
that
the Finlay Vaccine Institute <https://www.finlay.edu.cu/en/> in Havana
would start a clinical trial on a vaccine for Covid-19. The vaccine,
called Soberana
1 <https://rpcec.sld.cu/ensayos/RPCEC00000332-Sp>, contains a part of the
spike protein, called RBD, along with two extra ingredients: proteins from
a bacteria and aluminum hydroxide. These ingredients, known as adjuvants,
boost the immune system’s response to the coronavirus RBD.
Updated Oct. 28

PHASE 1 PHASE 2 COMBINED PHASES EARLY USE IN RUSSIA
[image: Vector Institute logo]
On Aug. 26, the Vector Institute, a Russian biological research center,
registered <https://clinicaltrials.gov/ct2/show/NCT04527575> a Phase 1/2
trial for a coronavirus vaccine they call EpiVacCorona. The vaccine
contains small portions of viral proteins, known as peptides.
According to newspaper
reports
<https://www.dailymail.co.uk/news/article-8656073/Second-Covid-vaccine-released-Russia-avoids-effects-one.html>,
the EpiVacCorona trials had already begun by then. On October 14
<https://www.cnbc.com/2020/10/14/russia-approves-second-covid-19-vaccine-after-preliminary-trials-.html>,
Vladimir Putin announced that Russia has granted regulatory approval to
EpiVacCorona, making it the second vaccine to receive that designation
after the Gamaleya Institute’s Sputnik V vaccine. Like the Sputnik vaccine,
EpiVacCorona received approval before a Phase 3 trial to demonstrate that
it was safe and effective. That trial is expected to start later this year.
Updated Oct. 14

PHASE 1 PHASE 2 COMBINED PHASES
[image: Sanofi logo][image: GSK logo]
In addition to their mRNA vaccine, Sanofi developed a Covid-19 vaccine
based on viral proteins. They produced the proteins with engineered viruses
that grow inside insect cells. GSK supplemented these proteins with
adjuvants that stimulate the immune system. The vaccine is based on the
same design Sanofi used to create Flublok
<https://sanofiflu.com/flublok-quadrivalent-influenza-vaccine.html>, an
approved vaccine for influenza. The companies launched
<https://www.sanofi.com/en/media-room/press-releases/2020/2020-09-03-07-00-00>
a
Phase 1/2 clinical trial in September.

Sanofi’s vaccine was widely expected to play a major role in tackling the
pandemic. In the United States, Operation Warp Speed selected it as one of
six vaccines to secure in large quantities, reaching a $2.1 billion
agreement
<https://www.nytimes.com/2020/07/31/health/covid-19-vaccine-sanofi-gsk.html>
for
<https://www.nytimes.com/2020/07/31/health/covid-19-vaccine-sanofi-gsk.html>
100
million doses. On Sept. 18 Sanofi closed another deal with the European
Union for 300 million doses
<https://www.sanofi.com/en/media-room/press-releases/2020/2020-09-18-12-52-46>
for
an unspecified amount, and later reached an agreement
<https://www.gsk.com/en-gb/media/press-releases/sanofi-and-gsk-sign-agreements-with-the-government-of-canada-to-supply-up-to-72-million-doses-of-adjuvanted-covid-19-vaccine/>
with
Canada for up to 72 million doses. In addition, Sanofi agreed to provide 200
million doses
<https://www.sanofi.com/en/media-room/press-releases/2020/2020-10-28-07-00-00>
to
COVAX, an international collaboration to deliver the vaccine equitably
across the world. The company expected to move to a Phase 3 trial in
December and potentially seek emergency use authorization in the United
States by spring. The company announced plans to make up to one billion
doses in 2021.

But on Dec. 11, Sanofi and GSK announced
<https://www.nytimes.com/live/2020/12/10/world/covid-19-coronavirus/sanofi-and-glaxosmithkline-delay-plans-for-a-trial-after-experimental-vaccine-fails-in-some-older-patients>
that
their vaccine was proving disappointing. While it provided promising levels
of antibodies in people under 50, older people did not respond as strongly
as they had hoped. They will start a new Phase 2 trial in February with a
different formulation. If they can get sufficiently high antibodies with
the new vaccine, they will move on to Phase 3 studies. That could be a
challenge, because they may not be able to test it against a placebo
<https://www.nytimes.com/2020/12/04/health/covid-vaccine-blood-test.html>.
Instead, they may have to test against one of the vaccines expected to
receive emergency use authorization by then. Sanofi and GSK do not expect
the vaccine to become available before the end of 2021.
Updated Dec. 11

PHASE 1 PHASE 2 COMBINED PHASES
[image: spybiotech logo]
SpyBiotech, a company spun off from the University of Oxford, announced
<https://innovation.ox.ac.uk/news/spybiotech-covid-vaccine/> in September
that the first volunteers in an Australian Phase 1/2 trial
<http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380145&isReview=true>
were
receiving their Covid-19 vaccine. The researchers created the vaccine from
a mixture of proteins. Some of the proteins, from hepatitis B viruses
<https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6921968/>, assemble
themselves into hollow shells. The researchers decorated these shells with
part of the coronavirus spike protein. The Serum Institute of India, which
licensed the technology from SpyBiotech, is running the trials.
Updated Sept. 24

PHASE 1 PHASE 2 COMBINED PHASES
[image: Baylor College of Medicine logo][image: Texas Children’s Hospital
Center for Vaccine Development logo]
[image: Biological E logo][image: Dynavax logo]
After the SARS epidemic in 2002, Baylor College of Medicine researchers
began developing a vaccine that could prevent a new outbreak. Despite
promising early results, support for the research disappeared. Because the
coronaviruses that cause SARS and Covid-19 are very similar, the
researchers revived the project in partnership with the Texas Children’s
Hospital. The researchers have found that the Covid-19 vaccine produces
antibodies in mice. The Indian company Biological E licensed it
<http://www.biologicale.com/news.html> in August and launched
<http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48329&EncHid=&userName=covid-19%20vaccine>
a
Phase 1/2 trial in November, combining the viral proteins with an adjuvant
<https://www.prnewswire.com/news-releases/biological-e-limited-starts-phase-iii-clinical-trial-of-its-covid-19-vaccine-candidate-301173314.html>
made
by Dynavax. If trials confirm that the vaccine works, they hope to
potentially make a billion doses a year.
Updated Nov. 16

PHASE 1
[image: Clover Biopharmaceuticals logo][image: GSK logo][image: Dynavax
logo]
Clover Biopharmaceuticals has developed a vaccine containing the spike
protein from coronaviruses. To further stimulate the immune system, the
company is testing so-called adjuvants made by British drugmaker GSK and
the American company Dynavax. Investments from CEPI
<https://cepi.net/news_cepi/cepi-extends-partnership-with-clover-to-fund-covid-19-vaccine-candidate-through-global-phase-2-3-study-to-licensure/>
will
support the development of manufacturing that could lead to the production
of a billion doses a year. Clover’s formula looks to be especially durable;
the vaccine can sit out at room temperature for a month and remain viable.

Clover launched a Phase 1 trial in June, and in December they announced
<http://www.cloverbiopharma.com/index.php?m=content&c=index&a=show&catid=11&id=53>
that
the vaccine triggered a high level of antibodies. The company is following
up on the promising results by launching a Phase 2 / 3 trial with the GSK
adjuvant by the end of 2020.
Updated Dec. 5

PHASE 1
[image: Vaxine logo]
The Australian company Vaxine developed a vaccine that combines viral
proteins with an adjuvant that stimulates the immune system. A Phase 1 trial
<https://clinicaltrials.gov/ct2/show/NCT04453852?term=vaccine&recrs=adf&cond=COVID-19&phase=0123&sort=nwst&draw=2>
began
over the summer, and Phase 2 trials are expected to commence by the end of
the year.
Updated Sept. 29

PHASE 1
[image: Kentucky BioProcessing logo]
A second plant-based vaccine is in development at Kentucky BioProcessing,
an American subsidiary of British American Tobacco, the maker of Lucky
Strike and other cigarettes. Like Medicago, Kentucky BioProcessing
engineers a wild relative of tobacco called Nicotiana benthamiana to make
viral proteins. The company previously used this technique to make a drug
called Zmapp for Ebola. After preclinical testing in the spring, they
registered <https://clinicaltrials.gov/ct2/show/NCT04473690> a Phase 1
trial for their coronavirus vaccine in July. The trial is scheduled to
start in December.
Updated Dec. 2

PHASE 1
[image: Medigen logo][image: Dynavax logo]
Taiwan-based vaccine maker Medigen is making a vaccine made of a
combination of spike proteins and an adjuvant from Dynavax. After a series
of promising experiments on animals, they began injecting volunteers
for a Phase
1 trial <https://clinicaltrials.gov/ct2/show/NCT04487210> in early October
<https://www.prnewswire.com/news-releases/medigens-covid-19-vaccine-combined-with-dynavaxs-cpg-1018-adjuvant-receives-taiwan-government-subsidy-with-first-participant-dosed-in-early-october-301150814.html>
.
Updated Oct. 13

PHASE 1
[image: AdImmune logo]
Taiwan-based vaccine manufacturer Adimmune got permission to launch a Phase
1 trial <https://focustaiwan.tw/sci-tech/202008200011> on Aug. 20. The
vaccine contains the RBD section of the virus’s spike protein.
Updated Aug. 20

PHASE 1
[image: COVAXX logo]
New York-based COVAXX, a subsidiary of United Biomedical, has created a
vaccine containing parts of several viral proteins. On Sept. 11 they
registered <https://clinicaltrials.gov/ct2/show/NCT04545749> a Phase 1
trial in Taiwan. They have reached an agreement
<https://www.prnewswire.com/news-releases/covaxx-synthetic-multitope-vaccine-selected-for-human-trials-in-brazil-by-dasa-the-largest-diagnostic-company-and-mafra-the-leading-private-vaccine-distributor-301126636.html?tc=eml_cleartime>
with
authorities in Brazil to run their Phase 2/3 trial there. On Nov. 25,
Covaxx announced
<https://www.businesswire.com/news/home/20201125005466/en/COVAXX-Announces-2.8-Billion-Advance-Purchase-Commitments>
agreements
with countries including Brazil, Ecuador, and Peru to deliver more than 140
million doses for $2.8 billion.
Updated Nov. 25

PHASE 1
[image: University of Tübingen logo]
In the spring, researchers at the University of Tübingen in Germany created
<https://www.researchgate.net/publication/341298976_Designing_a_therapeutic_SARS-CoV-2_T-cell-inducing_vaccine_for_high-risk_patient_groups>
a
vaccine made of eight parts of two viral proteins, along with an
immune-stimulating adjuvant. In September they launched
<https://clinicaltrials.gov/ct2/show/NCT04546841?term=vaccine&recrs=abdf&cond=COVID-19&phase=0123&sort=nwst&draw=2&rank=1>
a
Phase 1 trial.
Updated Sept. 15

PHASE 1
[image: Finlay Vaccine Institute logo]
In October, Cuba’s Finlay Vaccine Institute launched clinical trials on
their second experimental vaccine for the coronavirus. Known as Sovereign 2
<https://rpcec.sld.cu/ensayos/RPCEC00000340-Sp>, it contains the RBD part
of the coronavirus spike protein. The RBD fragment is fused
<https://twitter.com/FinlayInstituto/status/1321131664156905476> to a
standard tetanus vaccine, which makes it stable. It also uses aluminum
hydroxide.
Updated Oct. 28

PHASE 1
[image: Centro de Ingeniería Genética y Biotecnología de Cuba logo]
The Center for Genetic Engineering and Biotechnology of Cuba announced
<https://www.facebook.com/CIGBCubaCuba/posts/3382131015238089> on Nov. 26
that it was beginning a Phase 1 trial
<https://rpcec.sld.cu/ensayos/RPCEC00000345-Sp> of a vaccine delivered as a
nasal spray. Known as Mambisa, the vaccine contains a piece of the
coronavirus spike protein called the receptor-binding domain, along with a
protein from the hepatitis B virus that stimulates the immune system. The
name refers to women who fought in Cuba’s nineteenth-century wars of
independence.
Updated Nov. 30

PHASE 1
[image: Centro de Ingeniería Genética y Biotecnología de Cuba logo]
In addition to their nasal spray vaccine, the Center for Genetic
Engineering and Biotechnology of Cuba also launched
<https://www.facebook.com/CIGBCubaCuba/posts/3382131015238089> a separate
trial <https://rpcec.sld.cu/ensayos/RPCEC00000346-Sp> at the end of
November on a vaccine injected into the muscle. It contains a piece of the
coronavirus spike protein called the receptor-binding domain. The vaccine
is called Abadala, named after a poem by the nineteenth-century poet José
Marti.
Updated Nov. 30

PHASE 1
[image: SK Bioscience logo]
SK Bioscience, a South Korean vaccine maker, designed a Covid-19 vaccine
based on pieces of the spike protein of the coronavirus. In August they
found that the vaccine triggers a strong production of antibodies in
monkeys. They launched <https://www.skbioscience.co.kr/en/pr_view.do> a
Phase 1 trial at the end of November.
Updated Dec. 2

PHASE 1 ?
[image: North Korea logo]
On July 18, North Korea’s State Commission of Science and Technology
announced on their web site <http://www.mirae.aca.kp/index.php/Front_en> that
they had started clinical trials on a vaccine based on part of the
coronavirus spike protein. It’s hard to independently evaluate the claim
from the isolated dictatorship. The commission claimed to have tested the
vaccine on animals, but provided no data. Four months after their
announcement, South Korean lawmakers said they had foiled an attempt
<https://uk.reuters.com/article/uk-health-coronavirus-northkorea-idUKKBN28709T>
by
North Korea to hack South Korean companies developing coronavirus vaccines.
So far, North Korea has not released any further information about the
trials they supposedly are running.
Updated Dec. 2

ABANDONED
[image: University of Queensland logo][image: CSL logo]
On Dec. 10, a vaccine from Australia’s University of Queensland was the
first to be abandoned
<https://www.smh.com.au/politics/federal/australian-covid-vaccine-terminated-due-to-hiv-false-positives-20201210-p56mju.html>
after
entering a clinical trial. Cancelling the vaccine
<https://nyti.ms/37XNg5Q> meant
the collapse of a $1 billion deal with the Australian government for 51
million doses
<https://www.uq.edu.au/news/article/2020/09/csl-signs-agreement-australian-government-uq-vaccine-supply>
.

The vaccine studies offered great promise at first. Experiments on hamsters
<https://www.uq.edu.au/news/article/2020/08/uq-vaccine-scientists-report-positive-results-pre-clinical-testing>
showed
that the vaccine protected them from the coronavirus. The university
launched Phase 1 trials in July, combining coronavirus spike proteins with
an adjuvant made by CSL. They were on track to move on to late-stage trials
when they made an unwelcome discovery: some volunteers were getting
positive tests for HIV, even though they were not actually infected with
that virus.

According to early reports, the trouble appears to lie in the way the
researchers designed the vaccine. If spike proteins are not anchored to a
coronavirus, they can unfold. Antibodies to the unfolded spike protein may
not work against folded proteins on real viruses. So the researchers made a
small change to the protein, creating a little clamp at one end to hold the
molecule in its proper shape. Unfortunately, the clamp is similar to a
protein on HIV, which can lead the immune system to make HIV-like
antibodies. People who volunteered for the vaccine trial tested positive on
HIV antibody tests, even though they were perfectly healthy. That discovery
was enough to cause the Australian government to scrap the trial. “It will
no longer feature in Australia’s vaccine plan,” said Prime Minister Scott
Morrison at a press conference to announce the cancellation.
Updated Dec. 10

PRECLINICAL
[image: University of Pittsburgh logo]
A vaccine in development by the University of Pittsburgh, called
PittCoVacc, is a skin patch tipped with 400 tiny needles made of sugar.
When placed on the skin, the needles dissolve and deliver virus proteins
into the body. Its creators are planning to start clinical trials in late
2020.
Updated Aug. 27

PRECLINICAL

Other protein-based vaccines in active preclinical development include
vaccines from: Adaptive Phage Therapeutics; AdaptVac and Bavarian Nordic;
Applied Biotechnology Institute; Artes Biotech; Axon Neuroscience; BiOMVis
and University of Trento; City College of New York and TechnoVax; EpiVax;
GeoVax; Heat Biologics; IBio and CC-Pharming; Icosavax and University of
Washington; ImmunoPrecise Antibodies; IMV; Instituto Butantan; Intravacc;
IrsiCaixa; Izmir Biomedicine and Genome Center; National Autonomous
University of Mexico; Navarrabiomed; NidoVax; OncoGen; Oragenics; OSE
Immunotherapeutics; Osivax; PDS Biotechnology; Pontifical Catholic
University of Chile; Saiba; SK Bioscience; University of Alberta;
University of Amsterdam; University of Georgia and EpiVax; University of
Saskatchewan and VIDO-InterVac; University of Virginia; UNSAM-CONICET;
Vaxform; Vaxil-Bio; VBI Vaccines; Verndari; VIDO-InterVac; Voltron
Therapeutics; Walter Reed Army Institute of Research; Wyss Institute and
Harvard University; Yisheng Biopharma.
Updated Sept. 25
Inactivated or Attenuated Coronavirus Vaccines

Vaccines created from weakened coronaviruses or coronaviruses that have
been killed with chemicals.

Inactivated

virus

PHASE 3
APPROVED IN U.A.E.
[image: Sinopharm logo]
VACCINE NAME: BBIBP-CorV
EFFICACY: 86%
DOSE: 2 doses, 3 weeks apart
TYPE: Muscle injection

The state-owned Chinese company Sinopharm is currently testing two vaccines
based on inactivated coronaviruses. One of them was created by the Beijing
Institute of Biological Products. A Phase 1/2 trial
<https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30831-8/fulltext>
showed
that the vaccine didn’t cause any serious side effects and cause people to
make antibodies against the coronavirus. In July a Phase 3 trial
<http://www.chictr.org.cn/showprojen.aspx?proj=56651> began in the United
Arab Emirates in July, and in Morocco
<https://www.reuters.com/article/us-health-coronavirus-vaccine-sinopharm/peru-morocco-to-test-china-sinopharms-covid-19-vaccine-in-phase-3-trial-idUSKCN25G0G9>
 and Peru <https://clinicaltrials.gov/ct2/show/NCT04612972> the following
month.

On Sept. 14, the U.A.E. gave
<https://www.reuters.com/article/us-health-coronavirus-emirates-vaccine/uae-announces-emergency-approval-for-use-of-covid-19-vaccine-idUSKBN2652OM>
emergency
approval for Sinopharm’s vaccine to use on health care workers, and
soon government
officials
<https://www.aljazeera.com/news/2020/11/3/uae-pm-and-dubai-ruler-receives-coronavirus-vaccine>
and
others were also receiving it. Less than two months later, on Dec. 9, the
U.A.E. gave full approval
<https://www.nytimes.com/2020/12/09/business/china-coronavirus-vaccine-united-arab-emirates.html>
to
the Beijing Institute vaccine, announcing it had an efficacy rate of 86
percent <https://www.wam.ae/en/details/1395302893589>. The government
rapidly set up clinics across the country
<https://www.thenationalnews.com/uae/health/full-list-of-where-you-can-get-the-covid-19-sinopharm-vaccine-in-the-uae-1.1126151>
where
anyone could receive the vaccine. But the government did not release any
details with their announcement, leaving it unclear how they had come to
their conclusions. The neighboring country of Bahrain
<https://www.reuters.com/article/us-health-coronavirus-bahrain/bahrain-approves-registration-for-sinopharm-covid-19-vaccine-idUSKBN28N07Z>,
which also participated in the Sinopharm trials, also gave full approval to
the vaccine on Dec. 13, based on the same data. Tellingly, Sinopharm did
not offer any comment on either announcement.

In China, meanwhile, the government gave Sinopharm emergency approval
<https://www.nytimes.com/2020/11/17/business/china-coronavirus-vaccine-safety.html>
over
the summer to inject both vaccine candidates into government officials,
health care workers, and other select groups. By November, the chairman of
Sinopharm said, almost a million people
<https://www.theguardian.com/world/2020/nov/20/china-has-given-almost-a-million-people-experimental-covid-vaccine-says-company>
in
China had received the vaccines. On Nov. 25, Sinopharm announced
<https://www.nytimes.com/live/2020/11/24/world/covid-19-coronavirus/a-chinese-firm-seeks-permission-to-market-a-vaccine-before-it-has-completed-trials>
it
had filed an application to market its vaccines in China — despite the fact
that it has not yet offered results of its Phase 3 trials to show that the
vaccines are safe and effective.
Updated Dec. 13

PHASE 3 LIMITED USE IN U.A.E.
[image: Sinopharm logo][image: Wuhan logo]
In addition to their Beijing Institute vaccine, Sinopharm also began
testing an inactivated virus vaccine developed by the Wuhan Institute of
Biological Products. The Phase 1/2 trial showed
<https://jamanetwork.com/journals/jama/fullarticle/2769612> that the
vaccine produced antibodies in volunteers, some of whom experienced fevers
and other side effects. The Wuhan version of the vaccine is undergoing
Phase 3 trials in several countries. On Dec. 12, Peru announced
<https://www.wsj.com/articles/peru-halts-trial-for-chinese-covid-19-vaccine-11607807120>
that
it had paused their vaccine trial to investigate neurological problems in
one volunteer. It was not clear which of the two Sinopharm vaccines was
involved.
Updated Dec. 13

PHASE 3 LIMITED USE IN CHINA
[image: Sinovac logo]
VACCINE NAME: CoronaVac
EFFICACY: Unknown
DOSE: 2 doses, 2 weeks apart
TYPE: Muscle injection
STORAGE: Refrigerated

Sinovac Biotech, a private Chinese company, developed an inactivated
vaccine called CoronaVac. In June the company announced that Phase 1/2
trials on 743 volunteers found no severe adverse effects
<https://www.medrxiv.org/content/10.1101/2020.07.31.20161216v1> and
produced an immune response. Sinovac published
<https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30843-4/fulltext>
the
details of the trial in November in a medical journal, showing a
comparatively modest production of antibodies. Only a Phase 3 trial would
demonstrate if that was enough to protect people from Covid-19.

In July, Sinovac launched <http://www.sinovac.com/?optionid=754&auto_id=907> a
Phase 3 trial in Brazil, followed by others in Indonesia
<https://www.reuters.com/article/us-health-coronavirus-indonesia-vaccine/sinovac-launches-phase-3-trial-for-covid-19-vaccine-in-indonesia-reports-phase-2-details-idUSKCN2570E9>
 and Turkey <http://www.sinovac.com/?optionid=754&auto_id=911>. While
Sinovac has yet to release late-stage trial data, on Oct. 19 officials in
Brazil said
<https://fortune.com/2020/10/20/covid-vaccine-china-brazil-testing-ground-safest-most-promising-sinovac/>
that
it was the safest of five vaccines they were testing in Phase 3 trials.

Reuters reported
<https://www.nytimes.com/reuters/2020/08/28/world/asia/28reuters-health-coronavirus-china-vaccines.html>
that
the Chinese government gave the Sinovac vaccine an emergency approval for
limited use in July. In October, authorities in the eastern Chinese city of
Jiaxing announced they were giving CoronVac
<https://www.nytimes.com/live/2020/10/16/world/covid-coronavirus/a-chinese-city-says-it-has-given-some-residents-a-vaccine-and-other-news-from-around-the-world>
to
people in relatively high-risk jobs, including medical workers, port
inspectors and public service personnel.

Meanwhile, Sinovac has been preparing to manufacture the vaccine for global
distribution, reaching an agreement
<https://www.businesswire.com/news/home/20200825005451/en/Sinovac-Signs-Agreement-Bio-Farma-Indonesia-COVID-19>
to
supply Indonesia with at least 40 million doses by March 2021. In September
<https://abcnews.go.com/Health/wireStory/chinese-company-coronavirus-vaccine-ready-early-2021-73217428>,
Yin Weidong, the CEO of Sinovac, said the company planned on worldwide
distribution of the vaccine in early 2021 — including the United States. In
December Sinovac said
<https://www.businesswire.com/news/home/20201206005056/en/Sinovac-Secures-Approximately-500-Million-in-Funding-for-COVID-19-Vaccine-Development>
it
expected to manufacture 300 million doses in 2020 and increase their
capacity to an annual production of 600 million doses.

On Nov. 9, the Brazilian government announced
<https://www.nytimes.com/2020/11/10/world/asia/brazil-china-vaccine-covid19.html>
they
had paused the country’s Sinovac trial the previous month because of an
adverse event. The details of the pause were murky, raising suspicions that
politics were involved. Two days after the announcement, the trial was allowed
to resume
<https://www.nytimes.com/2020/11/11/world/brazil-resumes-chinese-vaccine-trial-after-a-brief-suspension-following-the-death-of-a-volunteer.html>.
The Brazilian trial has recorded enough cases of Covid-19 to let
researchers determine Sinovac’s efficacy. They expect to release their
results by Dec. 15 <https://www.bbc.com/news/world-asia-china-55212787>.
Updated Dec. 9

PHASE 3
[image: Bharat Biotech logo][image: Indian Council of Medical Research
logo][image:
National Institute of Virology logo]
VACCINE NAME: Covaxin (also known as BBV152 A, B, C)
EFFICACY: Unknown
DOSE: 2 doses, 3 weeks apart
STORAGE: At least a week at room temperature

In collaboration with the Indian Council of Medical Research and the National
Institute of Virology, the Indian company Bharat Biotech designed Covaxin,
a vaccine based on an inactivated form of the coronavirus. Studies on
monkeys <https://www.researchsquare.com/article/rs-65715/v1> and hamsters
<https://www.researchsquare.com/article/rs-76768/v1> found that it provided
protection against infection. In June, Bharat’s coronavirus vaccine became the
first created in India
<https://www.reuters.com/article/us-health-coronavirus-india-vaccine/indias-first-covid-19-vaccine-candidate-approved-for-human-trials-idUSKBN24108R>
to
go into clinical trials. While the results of the Phase 1/2 trials have yet
to be published, an executive at Bharat told India Today
<https://www.indiatoday.in/coronavirus-outbreak/story/coronavirus-vaccine-bharat-biotech-covaxin-60-per-cent-effective-launch-in-q2-next-year-mid-2021-exclusive-1742955-2020-11-22>
that
about 85 to 90 percent of the 1,000 volunteers produced antibodies to the
coronavirus and experienced no serious adverse effects due to Covaxin. On
Oct. 23, the company announced
<https://twitter.com/BharatBiotech/status/1319627204637028353> they were
initiating a Phase 3 trial
<http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=48057&EncHid=&userName=CTRI/2020/11/028976>.
Bharat expects results in early 2021 and anticipates distributing the
vaccine next June.
Updated Nov. 23

PHASE 3
[image: Institute of Medical Biology at the Chinese Academy of Medical
Sciences logo]
Researchers at the Institute of Medical Biology at the Chinese Academy of
Medical Sciences, which has invented vaccines for polio and hepatitis A,
created an inactivated coronavirus vaccine. In May, they launched a Phase 1
trial on 192 volunteers which indicated
<https://www.medrxiv.org/content/10.1101/2020.09.27.20189548v1> the vaccine
was safe and produced an immune response. A Phase 2 trial
<https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa1703/5962856>
followed
on 750 volunteers, which led the researchers to select a two-week spacing
between the two doses of the vaccine. In December the researchers launched
a Phase 3 trial <https://clinicaltrials.gov/ct2/show/NCT04659239> on up to
34,020 volunteers in Brazil and Malaysia.
Updated June 23

PHASE 1 PHASE 2 COMBINED PHASES
[image: The Chumakov Center at the Russian Academy of Sciences logo]
The Chumakov Center at the Russian Academy of Sciences has developed an
inactivated coronavirus vaccine. On Oct. 14, the TASS news agency reported
<https://tass.com/society/1212183> that clinical trials of the vaccine
would begin in Kirov and St. Petersburg on Oct. 19. On its web site, the
center stated <http://www.chumakovs.ru/news/> that it would finish the
first phase of trials the following month.
Updated Oct. 14

PHASE 1
[image: Kazakhstan’s Research Institute for Biological Safety Problems logo]
The central Asian nation of Kazakhstan began research
<https://astanatimes.com/2020/08/human-trials-for-kazakh-covid-19-vaccine-to-start-in-september/>
on
a vaccine made from inactivated coronaviruses over the summer. On August
28, their Research Institute for Biological Safety Problems registered
<https://clinicaltrials.gov/ct2/show/NCT04530357?term=vaccine&recrs=adf&cond=COVID-19&phase=0123&sort=nwst&draw=2&rank=1>
a
Phase 1 trial on the vaccine, known as QazCovid.
Updated Aug. 28

PHASE 1
[image: Shenzhen Kangtai Biological Products logo]
Shenzhen Kangtai Biological Products <http://en.biokangtai.com/> is a
Chinese company that makes vaccines for diseases such as hepatitis B and
measles. In August, AstraZeneca reached an agreement
<https://www.reuters.com/article/health-coronavirus-astrazeneca-kangtai-b/astrazeneca-in-deal-with-kangtai-bio-to-supply-potential-covid-19-vaccine-in-china-idUSL4N2F82BI>
with
them to supply China with their mRNA vaccine. In October Shenzen Kangtai
launched <http://www.chictr.org.cn/showprojen.aspx?proj=62350> a Phase 1
trial on 180 volunteers of its own vaccine, based on inactivated
coronaviruses. The company, which is also manufacturing AstraZeneca, has
been dogged by reports of corruption and scandals
<https://www.nytimes.com/2020/12/07/business/china-vaccine-astrazeneca.html?searchResultPosition=1>
.
Updated Dec. 9

PHASE 1
[image: Erciyes University logo]
On Nov. 5, Turkey’s Erciyes University announced
<https://www.aa.com.tr/en/health/turkish-university-tests-covid-19-vaccine-candidate/2033228>
they
had begun injecting volunteers with an inactivated coronavirus vaccine. It
is the first clinical trial of a coronavirus vaccine developed in Turkey.
Updated Nov. 16

PHASE 1
[image: Codagenix logo]
New York-based Codagenix <https://codagenix.com/> develops vaccines based
on live attenuated viruses, but with a twist: they create the viruses from
scratch <https://www.nytimes.com/2020/08/27/health/covid-19-vaccines.html>.
Researchers rewrite the genome of viruses, introducing hundreds of
mutations. Then they manufacture RNA molecules encoding the rewritten
genes. In special host cells, the molecules can give rise to full-blown
viruses. But thanks to their numerous mutations, they are too weak to cause
Covid-19 when they’re delivered in a vaccine. After successful experiments
in animals, a Phase 1 trial of their coronavirus vaccine was registered
<https://clinicaltrials.gov/ct2/show/NCT04619628?term=vaccine&recrs=abdf&cond=COVID-19&phase=0123&sort=nwst&draw=2&rank=1>
on
Nov. 6.
Updated Nov. 10

PRECLINICAL

Other inactivated or attenuated coronavirus vaccines in active preclinical
development include vaccines from: Valneva; Vivaldi Biosciences; Washington
University; Western University.
Updated Nov. 7
Repurposed Vaccines

Vaccines already in use for other diseases that may also protect against
Covid-19. Repurposed vaccines are not included in our vaccine count.

PHASE 3
[image: Murdoch Children’s Research Institute logo]
The Bacillus Calmette-Guerin vaccine was developed in the early 1900s as a
protection against tuberculosis. The Murdoch Children’s Research Institute in
Australia is conducting a Phase 3 trial
<https://www.nytimes.com/2020/04/03/health/coronavirus-bcg-vaccine.html> called
the BRACE to see if the vaccine partly protects against the coronavirus.

OTHER CLINICAL TRIALS

Other repurposed vaccines are in clinical trials being conducted by: the
Bandim Health Project; Crown Coronation (Washington University and partner
universities); Hôpitaux de Paris; Louisiana State University Health
Sciences Center New Orleans; the BADAS Study (Texas A&M University, Baylor
College of Medicine, M.D. Anderson Cancer Center and Cedars-Sinai Medical
Center); India’s National Institute for Research in Tuberculosis;
BCG-CORONA (UMC Utrecht and Radboud University); University of Campinas;
University Health Network, the Serum Institute of India, the Max Planck
Institute for Infection Biology and Verity Pharmaceuticals; Oklahoma
Medical Research Foundation and the University of Oklahoma; Vakzine Projekt
Management.
Updated Sept. 25


Note: Vaccines will be added to the tracker when they reach Phase 1, and
tracked until they succeed or fail.

Did we miss something? To notify The Times of new developments, send
updates to vaccinetracker at nytimes.com.
-------------- next part --------------
An HTML attachment was scrubbed...
URL: <http://lists.integralshift.ca/private.cgi/sundaycommunity-integralshift.ca/attachments/20201213/9e9d2701/attachment-0001.html>