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>>> Vaccine Trials Advance in Race for Virus Protection

As tests of proposed shots show gains, cheap drug provides life-saving benefits.


Bloomberg

By Cristin Flanagan, Riley Griffin, Robert Langreth


https://www.bloomberg.com/features/2020-coronavirus-drug-vaccine-status/?srnd=premium


The global push to develop coronavirus vaccines is accelerating, with companies in China, Europe and the U.S. reporting positive developments in trials of their shots.

Early tests of experimental coronavirus vaccines from Pfizer Inc. and BioNtech SE, Moderna Inc. and a partnership of Oxford and AstraZeneca Plc have shown favorable immune responses in people and animals. CanSino Biologics has received authorization for a limited deployment of its shot among the Chinese military. The U.S. government is working with a number of pharmaceutical companies under its “Operation Warp Speed” program, with the aim of securing shots by the end of the year.

Meanwhile, a low-cost, widely used anti-inflammatory drug has become the first treatment to show life-saving results against Covid-19. Dexamethasone reduced deaths among severely ill patients in a University of Oxford study, even as antimalarial medicines touted by President Donald Trump stumbled.

With more than 150 vaccines under development and close to as many drugs being examined, not every experimental program is included here. The tracker will add new ones as they start or advance in trials, gain significant backing or show promise. Almost all of these efforts are in the early stages, meaning that the gold standard of data?clinical trials with "blinded" placebo and therapy groups?is still hard to come by. With loosened rules and a desire to get solutions to market quickly, it's important to cast a skeptical eye on too-good-to-be-true data.

Recently Updated
Novavax, NVX-CoV2373
Moderna, mRNA-1273
Legend
Preclinical Test tube and animal experiments
Phase 1 Testing in small groups for safety
Phase 2 Larger tests for effectiveness
Phase 3 Large-scale efficacy and safety trials
Authorized Results vetted by regulators in preparation for use; includes emergency use authorizations
Vaccines
Vaccines give broad parts of the population some level of immunity and are considered crucial to ending the pandemic. They also take longer to develop, in part because they must be proven to be extremely safe since they're given to healthy people. While some researchers say a vaccine could be ready by the end of the year, others say it could take far longer.

COMPANY

Oxford University, AstraZeneca Plc
NAME
ChAdOx1 nCov-19
RECENTLY UPDATED
Phase 3
The vaccine is made from a harmless virus that’s been altered to produce the surface spike protein from SARS-CoV-2.

LATEST NEWS
With human trials underway, the U.S. government has pledged as much as $1.2 billion, and the company plans to produce as many as 30 million doses available in the U.K. by September. Other groups are moving to line up access elsewhere.

COMPANY

Moderna Inc.
NAME
mRNA-1273
PROGRESS
Phase 2
Moderna's mRNA-1273 uses messenger RNA to prompt the body to make a key protein from the virus, creating an immune response.

LATEST NEWS
Moderna expects a phase 3 trial to begin July 27. Chief Executive Officer Stephane Bancel has told Bloomberg that efficacy data could be available by Thanksgiving. Moderna will receive as much as $483 million from the U.S.

COMPANY

CanSino Biologics Inc.
NAME
Ad5-nCoV
PROGRESS
Phase 2
CanSino's vaccine was developed alongside China's military and is genetically engineered with a replication-defective mutant virus.

LATEST NEWS
CanSino's vaccine has received a special authorization to be used by China's military after a study showed it generated an immune response. President Xi Jinping says the country will make any vaccine available as a global public good.

COMPANY

BioNTech SE, Pfizer Inc.
NAME
multiple candidates
PROGRESS
Phase 2
BioNTech's BNT162 is another messenger RNA vaccine platform that the German company is developing with Pfizer. In China, BioNTech is co-developing vaccines with Shanghai Fosun Pharmaceutical Group.

LATEST NEWS
One of the companies' vaccine candidates has shown promising antibody responses. Further testing in up to 30,000 people may start as early as July.

COMPANY

Sinovac Biotech Ltd
NAME
No name yet
RECENTLY UPDATED
Phase 3
The vaccine uses inactivated virus, which can help the body develop antibodies to the pathogen without risking infection.

LATEST NEWS
Sinovac has begun human trials in China. The company says its vaccine candidate can neutralize different strains of the virus.

COMPANY

China National Biotec Group Co., Beijing Institute of Biological Products
NAME
No name yet
PROGRESS
Phase 3
The vaccine uses inactivated virus, which can help the body develop antibodies to the pathogen without risking infection.

LATEST NEWS
With phase 2 trials complete, a vaccine could be available as soon as the end of this year, according to an official report in May.

COMPANY

Novavax Inc.
NAME
NVX-CoV2373
PROGRESS
Phase 2
Novavax's vaccine is meant to create antibodies that block a protein "spike" that the virus uses to infect its host.

LATEST NEWS
Novavax has received $1.6 billion from the U.S. government as it prepares for a final-stage study as early as this fall.

COMPANY

Johnson & Johnson
NAME
No name yet
PROGRESS
Preclinical
J&J is working on an unnamed adenovirus-based vaccine as well as two backups.

LATEST NEWS
J&J accelerated plans for human studies and aims to make up to 1 billion doses by the end of 2021. J&J has said its vaccine could be ready for emergency use by January, and it has received $456 million from the U.S.

COMPANY

Sanofi, GlaxoSmithKline Plc
NAME
No name yet
PROGRESS
Preclinical
Sanofi is working on a vaccine using technology already employed in one of its flu vaccines, which could speed development and production.

LATEST NEWS
France's Sanofi has partnered with the U.K.'s Glaxo on a project backed by U.S. funding. The companies plan to start human trials in the second half of this year. Sanofi is also developing an mRNA vaccine with Translate Bio.

COMPANY

Inovio Pharmaceuticals Inc.
NAME
INO-4800
RECENTLY UPDATED
Phase 1
Inovio's experimental vaccine uses DNA to activate a patient's immune system.

LATEST NEWS
Inovio says an early trial showed positive immune responses but investors complained about a lack of detail.

COMPANY

Merck & Co.
NAME
No names yet
PROGRESS
Preclinical
Merck's two vaccine candidates employ exisiting technology behind its Ebola virus shot and a measles virus vector platform discovered by the Pasteur Institute, respectively.

LATEST NEWS
Merck has partnered with AIDS researchers to develop a vaccine using technology already employed in its Ebola virus shot. The company has also agreed to buy biotech Themis, gaining a vaccine candidate that uses an existing measles virus vector platform.

COMPANY

Imperial College London
NAME
No name yet
PROGRESS
Phase 1
When injected, the RNA vaccine candidate delivers genetic instructions to muscle cells to make the "spike" protein on the surface of the coronavirus.

LATEST NEWS
Researchers have received U.K. funding and have begun human trials.


Antivirals

Antiviral drugs work by stopping the virus from replicating or infecting cells. They can include everything from complex biotechnology therapies to older generics. Other examples of antivirals include many HIV drugs, treatments for hepatitis C, and the influenza treatment Tamiflu.

COMPANY

Gilead Sciences Inc.
DRUG
Remdesivir
PROGRESS
Authorized
Remdesivir targets genetic material called RNA and is meant to stop SARS-CoV-2 from replicating. Tried without success as an Ebola drug, it's complex to manufacture and for now has to be given intravenously.

LATEST NEWS
The FDA issued an emergency use authorization after early study results showed that remdesivir sped up patients' recoveries. More recently, the company has said that remdesivir may have a mortality benefit. While other trials have shown mixed results, governments are stepping up efforts to secure the drug.

COMPANY

AstraZeneca Plc, Eli Lilly & Co., Regeneron Pharmaceuticals Inc., GlaxoSmithKline Plc, Vir Biotechnology Inc. and others
DRUG
Anti-Covid Antibodies
PROGRESS
Preclinical
Antibodies discovered by drugmakers can mimic an immune-system response to the virus, for example by blocking the so-called spike protein that the coronavirus uses to infect human cells.

LATEST NEWS
Several companies have begun human trials of antibody treatments, with others rushing to line up their own by the end of summer.

COMPANY

Merck & Co.
DRUG
EIDD-2801
PROGRESS
Preclinical
The antiviral drug discovered at Emory University inhibits the replication of multiple RNA viruses.

LATEST NEWS
Preclinical studies found the drug induced mutations causing a range of coronaviruses to make catastrophic errors when they replicate. Merck CEO Kenneth Frazier told Bloomberg it has the potential to be easier to use than Gilead's remdesivir.

COMPANY

Takeda Pharmaceutical Co.
DRUG
Convalescent plasma (TAK-888)
PROGRESS
Preclinical
Takeda is exploring whether blood plasma from recovered Covid-19 patients, which can contain infection-fighting antibodies, can be used against the illness. Similar treatments have shown promise in treating other serious infections.

LATEST NEWS
The Japanese drugmaker plans to start clinical trials in July and could file for approval of a treatment in some regions by the end of the year. U.S. studies will be done with the NIH.

COMPANY

Zhejiang Hisun Pharmaceutical Co.
DRUG
Favipiravir
PROGRESS
Authorized
Favipiravir is a flu medicine that is branded and sold as Avigan by FujiFilm Holdings Corp. in Japan. Favipiravir also targets viral RNA to stop the spread of the virus.

LATEST NEWS
An early study of favipiravir found potential benefits. Russia has shipped a version to hospitals across the country.


COMPANY

Generic drugs made by Teva Pharmaceutical Industries Ltd., Mylan NV, Sanofi, Novartis AG, Bayer AG and others
DRUG
Hydroxychloroquine, chloroquine
PROGRESS
Phase 3
Hydroxychloroquine and chloroquine are anti-malarial drugs that have been tested in other viral outbreaks, generally without success. Years old, they're available as lower-cost generics.

LATEST NEWS
Once touted by President Donald Trump, hydroxychloroquine has suffered a series of trial failures. The FDA has pulled its U.S. authorization for use against the virus.


Indirect therapies

These therapies don't directly treat or prevent the virus, but can help patients who have fallen ill by mitigating the disease's effects, such as difficulty breathing or severe inflammatory responses. Such treatments, including a promising generic steroid, could help some of the sickest hospitalized patients.

COMPANY

Generic drugs made by Mylan NV, Hikma Pharmaceuticals Plc and others
DRUG
Dexamethasone
RECENTLY UPDATED
Phase 3
The low-cost steroid is already widely used to treat a range of ailments including rheumatism, asthma and allergies. It's among a number of anti-inflammatories being studied to help patients cope with a powerful overreaction of the immune system, sometimes called a cytokine storm.
LATEST NEWS
The 60-year-old medicine reduced deaths among patients needing breathing assistance, according to University of Oxford researchers.

COMPANY

Regeneron Pharmaceuticals Inc. and Sanofi; Roche Holding AG
DRUG
Kevzara; Actemra
PROGRESS
Phase 2
Rheumatoid arthritis drugs that target a pathway known as interleukin-6 or IL-6 can affect inflammation.These medicines could help very sick Covid-19 patients in respiratory distress.
LATEST NEWS
Regeneron and Sanofi stopped a study in patients who needed mechanical ventilation when it became clear Kevzara didn't work any better than placebo. Meanwhile, Roche's Actemra has shown possible benefits in some patients.

COMPANY

Incyte Corp., Novartis AG; Eli Lilly & Co.
DRUG
Jakafi; Baricitinib
PROGRESS
Phase 3
Jakafi, or Jakavi as it's called outside the U.S., belongs to a class of drugs known as JAK inibitors that target inflammation and repress cellular proliferation. Baricitinib, marketed by the brand-name Olumiant, also belongs to the class of drugs.
LATEST NEWS
In April, Incyte and Novartis started a trial of Jakafi to address a potential deadly reaction to the disease, in which a patient's immune system kicks into dangerous overdrive. Lilly and the NIH are studying baricitinib with remdesivir in hospitalized patients. A late-stage Lilly-sponsored study started enrolling patients in June to test barictinib on its own in such patients.

COMPANY

Kiniksa Pharmaceuticals, I-Mab, Humanigen, Roivant Sciences Inc., Sanofi
DRUG
Mavrilimumab, lenzilumab, others
RECENTLY UPDATED
Phase 2
To mitigate the complications of cytokine storm, companies are developing antibodies against human granulocyte-macrophage colony stimulating factor or GM-CSF, a cytokine responsible for inflammation. Some of these medicines are also being developed for rheumatoid arthritis.
LATEST NEWS
Various studies are underway after earlier results showed some patients treated with mavrilimumab had their fevers resolve and did not need mechanical ventilation.

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