The source The new york timesVaccines 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 67 vaccines in clinical trials on humans, and 20 have reached the final stages of testing. At least 89 preclinical vaccines are under active investigation in animals.
Leading vaccines |
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Developer | How It Works | Phase | Status |
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| Pfizer-BioNTech | mRNA | 23 | Approved in Bahrain, Saudi Arabia, Switzerland. Emergency use in U.S., E.U., other countries. |
| Moderna | mRNA | 3 | Emergency use in U.S., U.K., E.U., others. |
| Gamaleya | Ad26, Ad5 | 3 | Early use in Russia. Emergency use in other countries. |
| Oxford-AstraZeneca | ChAdOx1 | 23 | Emergency use in U.K., E.U., other countries. |
| CanSino | Ad5 | 3 | Limited use in China. |
| Johnson & Johnson | Ad26 | 3 | |
| Vector Institute | Protein | 3 | Early use in Russia. |
| Novavax | Protein | 3 | |
| Sinopharm | Inactivated | 3 | Approved in China, U.A.E., Bahrain. Emergency use in Egypt, Hungary, Jordan. |
| Sinovac | Inactivated | 3 | Emergency use in China, Brazil, others. |
| Sinopharm-Wuhan | Inactivated | 3 | Limited use in China, U.A.E. |
| Bharat Biotech | Inactivated | 3 | Emergency use in India. |
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. For an explanation of eight leading vaccines, see How Covid-19 Vaccines Work.
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. Phase 3 trials are also large enough to reveal evidence of relatively rare side effects.
EARLY OR LIMITED APPROVAL: Many countries have given emergency authorization based on preliminary evidence that they are safe and effective. China, Russia and other countries have begun administering vaccines before detailed Phase 3 trial data has been made public. Experts have warned of serious risks from jumping ahead of these results.
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 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 the trial. After an investigation, the trial may resume or be abandoned.
Genetic Vaccines
Vaccines that deliver one or more of the coronavirus’s own genes into our cells to provoke an immune response.
PHASE 2 PHASE 3 COMBINED PHASES
APPROVED IN SEVERAL COUNTRIES EMERGENCY USE IN U.S., ELSEWHERE
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. 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 ever given by the United States to a coronavirus vaccine.
In January 2020, BioNTech researchers began designing a vaccine. 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.
In March, BioNTech partnered with Pfizer to scale up the research, launching a clinical trial in May. They gave the vaccine the generic name tozinameran and the brand name Comirnaty
The researchers
found that Comirnaty 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 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 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 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 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 of the clinical trials. They determined that the Comirnaty has an efficacy rate of 95 percent. Less than two weeks after the first dose, tozinameran 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 Comirnaty 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 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, with
William Shakespeare, age 81, among the first to receive a dose. On Dec. 13, workers at a Pfizer plant in Kalamazoo, Mich.,
loaded the vaccines 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 Comirnaty authorization.
A growing number of countries have also given emergency authorization for Comirnaty, including
Argentina, Canada,
Chile,
Costa Rica,
Ecuador,
Jordan,
Kuwait,
Mexico,
Panama, and
Singapore. The European Union
signed off on the vaccine on Dec. 21. Meanwhile,
Bahrain,
Saudi Arabia and
Switzerland gave the vaccine full approval. On Dec. 31, the World Health Organization gave Comirnaty an
Emergency Use Listing, which will speed up its authorization in many other countries.
The distribution of Comirnaty 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 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 over the summer to secure another 100 million doses. Later that month, Pfizer and BioNTech
reached an agreement to supply 100 million doses by July 2021.
Meanwhile, Japan made a deal for 120 million doses, while the European Union arranged to purchase 300 million doses. On Dec. 16, BioNTech announced a deal to supply China with 100 million doses. That agreement would make Comirnaty the first Western vaccine on track to be sold in China. On. Jan. 22, Pfizer and BioNTech announced they were providing 40 million doses to COVAX, the global initiative to bring vaccines to low- and middle-income countries.
Pfizer and BioNTech
expect to manufacture 2 billion doses worldwide by the end of 2021.
EMERGENCY USE IN: Argentina, Australia, Canada, Chile, Colombia, Costa Rica, Ecuador, European Union, Iraq, Jordan, Kuwait, Lebanon, Malaysia, Mexico, Oman, Panama, Qatar, Serbia, Singapore, Switzerland, Tunisia, United Arab Emirates, United Kingdom, United States. Emergency use validation from the World Health Organization. Updated Jan. 30
PHASE 3 EMERGENCY USE IN U.S., E.U., ELSEWHERE
DOSE: 2 doses, 4 weeks apart
TYPE: Muscle injection
STORAGE: 30 days with refrigeration, 6 months at –4°F (–20°C)
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. Last January, they began developing a vaccine for the coronavirus.
On Nov. 16, Moderna
announced 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 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 the trial participants still have a strong immune defense against the coronavirus. On Dec. 2, Moderna registered
a trial to test the vaccine on adolescents
between 12 and 18 years of age.
Meanwhile, the company entered deals with several countries to supply the vaccine pending its approval. On Aug. 11, the United States government
awarded 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 in the second quarter of 2021. As of Jan. 26, Moderna had supplied the United States with
30.4 million doses. On Nov. 25, the company reached an agreement with the European Commission
to supply up to 160 million doses. Moderna has made similar deals with other countries including
Canada,
Japan,
Qatar and
South Korea.
Updated Jan. 30
PHASE 3
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)
Last March, the Trump administration unsuccessfully tried to entice CureVac to move its research on a mRNA vaccine from Germany to the United States. The company plowed ahead with its work in Germany, seeing responses to the vaccine in mice and monkeys before launching clinical trials in July. In December, CureVac launched a Phase 3 trial, recruiting up to 36,500 volunteers in Germany.
In November, CureVac negotiated a deal to provide the European Union with
up to 225 million doses of their vaccine. They project manufacturing
up to 300 million doses in 2021 and up to 600 million doses the following year. CureVac has
collaborated 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 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. On Jan. 8, CureVac
announced that it had formed a partnership with pharmaceutical giant Bayer, which would support the vaccine’s development and production.
Updated Jan. 21
PHASE 2 PHASE 3 COMBINED PHASES
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 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 in December. Updated Dec. 8
PHASE 3
VACCINE NAME: ZyCoV-D
EFFICACY: Unknown
DOSE: 3 doses, 4 weeks apart
TYPE: Skin injection
In July, the Indian vaccine-maker Zydus Cadila began testing a DNA-based vaccine delivered by a skin patch. They launched a Phase 2 trial on ZyCoV-D on Aug. 6 and announced at the end of December that it was complete. On Jan. 3 the Indian government gave Zydus Cadila permission to advance to a Phase 3 trial with 30,000 volunteers. In a Dec. 11 interview, company's chairman Pankaj Patel, the company’s chairman, said the company expects to have their vaccine ready for distribution by March 2021. Updated Jan. 3
PHASE 2
VACCINE NAME: INO-4800
EFFICACY: Unknown
DOSE: To be determined
TYPE: Skin injection
STORAGE: Over a year at room temperature
Before the pandemic, the Pennsylvania-based company Inovio developed DNA-based vaccines that are delivered into the skin with electric pulses from a hand-held device. They are running clinical trials for vaccines against a number of diseases, including HIV, Zika, and several forms of cancer. At the start of the pandemic, Inovio developed a DNA vaccine against the spike protein on the coronavirus. A Phase 1 trial, published in December, did not uncover any serious adverse effects, and measured an immune response in all 38 volunteers.
Updated Dec. 26
ABANDONED
Imperial College London researchers have developed a “self-amplifying” RNA vaccine, which boosts production of a viral protein to stimulate the immune system. They began Phase 1/2 trials on June 15, partnering with Morningside Ventures to manufacture and distribute the vaccine through a new company called VacEquity Global Health. On Dec. 18, the researchers announced a collaboration with Enesi Pharma to formulate a solid version of the vaccine that can be implanted in the skin without a needle.
On Jan. 27, Robin Shattuck, the leader of the project,
announced that “it is not the right time to start a new efficacy trial for a further vaccine in the U.K.” Instead of competing with authorized vaccines, they are turning their efforts to making candidates that will work well emerging variants of the coronavirus.
Updated Jan. 28
PHASE 2
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 showed that it protected them against infection. In August, Arcturus launched a Phase 1/2 trial at Singapore General Hospital. On Nov. 9, the company announced 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. On Jan. 6 Arcturus announced that they had permission to start the Phase 2 portion of the trial in both Singapore and the United States. Singapore reached an agreement with Arcturus to spend up to $175 million to acquire vaccines when they’re ready. Updated Jan. 12
PHASE 1 PHASE 2 COMBINED PHASES
Gennova Biopharmaceuticals in India and Seattle-based HDT Bio partnered to develop a vaccine based on self-amplifying RNA. The vaccine, known as HGC019, was able to safely provoke animals to make antibodies to the coronavirus, leading India to grant the companies approval in December to start Phase 1/2 trials. Updated Dec. 12
PHASE 1 PHASE 2 COMBINED PHASES
GeneOne Life Science, a South Korean biotech company, developed a DNA-based vaccine that encodes two proteins from the coronavirus. In December they launched a Phase 1/2 trial with 345 participants. Updated Dec. 17
PHASE 1 PHASE 2 COMBINED PHASES
The Korean company Genexine started testing the safety of a DNA-based vaccine in June. In December, Korea Biomedical Review reported that Genexine got disappointing results from their initial formulation and decided to restart their trials with a modified vaccine. On Jan. 20, the company registered a Phase 1/2 trial. Updated Jan. 20
PHASE 1
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 showed protective effects, and in the Phase 1 trial indicated it was safe in people. On Dec. 21, Xinhua reported that China was building a factory to produce 120 million doses per year. Updated Dec. 22
PHASE 1
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 to test it in humans. Due to delays in funding and manufacturing, the trial is expected to begin in spring 2021. In an interview 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 Dec. 18
PHASE 1
The Canadian company Entos Pharmaceuticals 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 a Phase 1 trial in Canada for their vaccine, called Covigenix VAX-001. Updated Oct. 20
PHASE 1
On Nov. 2, the Canadian company Symvivo announced they had administered a DNA vaccine to their first volunteer in a Phase 1 trial. The DNA is inserted into harmless bacteria, 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
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 a Phase 1 trial to test the safety of the CORVax12. Updated Nov. 13
PHASE 1
Canada’s Providence Therapeutics specializes in messenger RNA vaccines to treat cancer. In response to the pandemic, they developed an mRNA vaccine against the coronavirus. They launched a Phase 1 study of an RNA vaccine in late January. The company expects to move into Phase 2 trials by May. Updated Jan. 28
PRECLINICAL
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 in mice and monkeys and are planning on starting Phase 1 trials in the first quarter of 2021. It would become Sanofi’s second Covid-19 vaccine candidate in clinical trials, along with their protein-based vaccine. Updated Dec. 24
PRECLINICAL
Other genetic vaccines in active preclinical development include vaccines from: Applied DNA Sciences, EvviVax and Takis Biotech; DIOSynVax; Elixirgen Therapeutics; ETheRNA; Globe Biotech; Greenlight Biosciences; Infectious Disease Research Institute and Amyris; Mediphage Bioceuticals; National institute of Chemistry of Slovenia and Kemijski Inštitut; National Research Centre, Egypt; the OPENCORONA Consortia; Providence Therapeutics; Scancell; the Spanish National Center for Biotechnology and the Spanish National Research Council; Vaccibody.
Updated Jan. 14
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 EARLY USE IN RUSSIA, ELSEWHERE
VACCINE NAME: Sputnik V (also known as Gam-Covid-Vac)
EFFICACY: 91.4%
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 with an efficacy rate of 91.4 percent, according to a
Dec. 14 announcement.
Gamaleya produced the vaccine, initially called Gam-Covid-Vac, from a combination of two adenoviruses called Ad5 and Ad26. Both kinds have been tested as vaccines over a number of 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 that a Russian health care regulator had
approved the vaccine, renamed Sputnik V, before Phase 3 trials had even begun. Vaccine experts
decried the move as risky, and Russia later
walked back the announcement, saying that the approval was a “conditional registration certificate,” which would depend on positive results from Phase 3 trials. In addition to Russia, volunteers for the trial were
recruited in Belarus, the
United Arab Emirates, and Venezuela. On Oct. 17, a
Phase 2/3 trial was
launched in India.
On Sept. 4, three weeks after Putin’s announcement, Gamaleya researchers published the results of
their Phase 1/2 trial. In a small study, they found that Sputnik V yielded antibodies to the coronavirus and mild side effects.
On Nov. 11, the Russian Direct Investment Fund
announced the first 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. By December, the trial had reached its final total of 78 cases. The efficacy rate was effectively unchanged, at 91.4 percent. Out of the 78 cases of Covid-19 in the trial, 20 were severe — and all 20 were in volunteers who received the placebo. In addition, the researchers announced that they found no serious side effects from the vaccine. On Dec. 26, the makers of Sputnik V
tweeted that they had found that the vaccine had an efficacy of over 90 percent in people over 60.
In November, the Russian government began offering Sputnik V within Russia in a mass vaccination campaign. But worry that the vaccine was rushed to approval led to
widespread hesitancy in the country. Meanwhile, the trial has continued to gather data. But on Dec. 24, the Associated Press
reported that volunteers who suspected they had received the placebo were dropping out to receive the vaccine now that it’s widely available. The researchers running the trial reduced its planned size from 40,000 to 31,000 participants, causing experts to worry that it would not have enough statistical power to reach strong conclusions about the safety and efficacy of the vaccine. The full details of the trial have yet to be published in a 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 their vaccines to see if the mixture can increase the efficacy of the AstraZeneca vaccine. AstraZeneca
registered a Phase 1 trial for the combination on Dec. 24. In January, Gamaleya researchers also started a trial on a single-dose version of the vaccine, which they dubbed “
Sputnik Light.”
Since the summer, Russia has
negotiated a number of deals to supply other countries with the Sputnik V vaccine, including Brazil,
India, Mexico, and
Venezuela. On Dec. 22, Belarus became
the first country outside of Russia to register Sputnik V. The next day, Argentina
authorized the vaccine for emergency use.
Algeria,
Bolivia,
Hungary, the
Palestinian Authority,
Paraguay,
Serbia,
Turkmenistan, the
United Arab Emirates, and
Venezuela authorized the vaccine in January.
EMERGENCY USE IN: Algeria, Argentina, Belarus, Bolivia, Guinea, Hungary, Iran, Palestinian Authority, Paraguay, Serbia, Turkmenistan, United Arab Emirates, Venezuela. Updated Jan. 30
PHASE 2 PHASE 3 COMBINED PHASES EMERGENCY USE IN BRITAIN, E.U., ELSEWHERE
VACCINE NAME: AZD1222 (also known as Covishield in India)
EFFICACY: 62% to 90%, depending on dosage
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 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 about the results.
Early in the pandemic, Oxford researchers
developed 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. Last April they followed up with a Phase 1/2 trial. The vaccine developers
did not detect 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, and (where it’s known as Covishield). In addition, AstraZeneca later launched Phase 3 trials in Brazil, South Africa, and the
United States.
On Sept. 6, AstraZeneca
halted global trials 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 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 of the U.S. trial.
On Nov. 19, researchers
published 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 people between 56 and 69, and 240 people 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 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 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 on Dec. 11 that it would collaborate with the Russian creators of the Sputnik V vaccine, which is also made from adenoviruses, to see if a combination with Sputnik V might increase the efficacy of the Oxford-AstraZeneca vaccine.
The trial is planned to take place in early 2021 in Ukraine.
Last May, AstraZeneca began securing a series of agreements to provide vaccines to governments should they prove effective. The United States awarded the project
$1.2 billion in support for
300 million doses. In August the European Union reached an agreement for AstraZeneca to deliver
400 million doses if the trials yield positive results. COVAX, an international collaboration to deliver the vaccine equitably across the world, secured
170 million doses. The company has said their total annual manufacturing capacity for the vaccine, if approved, stands at two billion doses.
EMERGENCY USE IN: Argentina, Bangladesh, Bhutan, Brazil, Dominican Republic, El Salvador, European Union, India, Maldives, Mexico, Morocco, Nepal, Pakistan, South Africa, United Kingdom. Updated Jan. 30
PHASE 3 LIMITED USE IN CHINA
VACCINE NAME: Convidecia (also known as Ad5-nCoV)
EFFICACY: Unknown
DOSE: Single dose
TYPE: Muscle injection
STORAGE: Refrigerated
The Chinese company
CanSino Biologics developed Convidecia in partnership with the Institute of Biology at the country’s
Academy of Military Medical Sciences. The vaccine is based on an adenovirus called Ad5. In May, researchers
published promising results from a Phase 1 safety trial on Convidecia, and in July they
reported that their Phase 2 trials demonstrated the vaccine produced a strong immune response. In an unprecedented move, the Chinese military
approved the vaccine on June 25 for a year as a “specially needed drug.” On Nov. 28, the Chief Executive of CanSino Biologics
said in an interview that about 40,000 to 50,000 people had received Convidecia. Starting in August, CanSino began running
Phase 3 trials in
a number of countries, including Pakistan, Russia, Mexico and Chile.
Updated Dec. 22
PHASE 3
VACCINE NAME: Ad26.COV2.S
EFFICACY: 72% in United States, 66% in Latin America, 57% in South Africa
DOSE: 1 dose
TYPE: Muscle injection
STORAGE: Up to two years frozen at –4° F (–20° C), and up to three months refrigerated at 36–46° F (2–8° C).
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, or Ad26 for short.
Johnson & Johnson developed vaccines for Ebola and other diseases with Ad26 and have now made one for the coronavirus. Last March they received
$456 million from the United States government to support their move towards production. The vaccine has provided protection in
experiments on monkeys. Johnson & Johnson began Phase 1/2
trials in July. Unlike other leading vaccines in clinical trials, the company gave one dose, not two.
On Jan. 29, Johnson & Johnson
announced the results of the trial: the vaccine had an efficacy of 72% in the United States, 66% in Latin America, and 57% in South Africa. The lower result in South Africa is likely due to the rise of the B.1.351 variant in that country. But when the company looked at just severe cases of Covid-19, the vaccine had an efficacy against severe disease of 85% in all the regions. That could translate into many lives saved and less pressure on hospitals.
In August, the federal government
agreed to pay Johnson & Johnson $1 billion for 100 million doses if the vaccine is approved, although the company may
fall short of expectations for its initial delivery. The
European Union reached a similar deal on Oct. 8 for 200 million doses, and COVAX, an international collaboration to deliver the vaccine equitably across the world,
secured 500 million doses. The company is aiming for production of 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, instead of just one. The results are expected in early spring.
Updated Jan. 28
PHASE 2
In the spring, the Israel Institute for Biological Research started work 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 that the vaccine, called Brilife, would be going into a Phase 1 trial. The Phase 2 trial, which is recruiting up to 1,000 volunteers, started on Jan. 5. It’s not clear how the trial will fare now that Israel is aggressively vaccinating its citizens with authorized vaccines by Pfizer. Updated Jan. 14
PHASE 1
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 at the end of July. In November, they announced 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
While many vaccines are given as injections, some vaccines can be taken as a pill. Oral vaccines have been approved 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 and other diseases. Last spring 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, 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, they found that the vaccine pill not only
dramatically reduced 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.
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, 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 the company, while a number of shareholder lawsuits were brought against Vaxart, its executives and its board.
Updated Nov. 12
PHASE 1
In 2019, researchers at the University of Hong Kong and Xiamen University created 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 to start clinical trials in partnership with Beijing Wantai Biological Pharmacy. Updated Sept. 9
PHASE 1
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. In January the center
announced that their initial formulation provided disappointing results and are postponing the trial until they update it.
Updated Jan. 13
PHASE 1
The California-based company ImmunityBio created a vaccine using the Ad5 adenovirus, the same one used by CanSinBio and the Gamaleya Institute in Russia. ImmunityBio engineered 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.
The company found that the vaccine
protects monkeys from the coronavirus. ImmunityBio launched a
Phase 1 trial of a Covid-19 vaccine in October in the United States. In January, they launched
another one in South Africa.
The chairman and C.E.O. of ImmunityBio is billionaire
Patrick Soon-Shiong, the owner of the Los Angeles Times.
Updated Jan. 14
PHASE 1
Researchers at City of Hope, a California biomedical research institute, created a vaccine 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 the start of a Phase 1 trial, with hopes for a Phase 2 trial to start in the second quarter of 2021. Updated Nov. 24
PHASE 1
In April, the South Korean biotech company Cellid began to develop a vaccine for Covid-19. The vaccine is based on a combination of two strains of adenoviruses, called Ad5 and Ad35. After testing the vaccine out on monkeys, Cellid entered into a partnership with the South Korean chemical manufacturer LG Chem to manufacture the vaccine. In December, they registered a Phase 1 trial. Updated Dec. 14
PHASE 1
VACCINE NAME: AdCOVID
EFFICACY: Unknown
DOSE: 1 dose
TYPE: Nasal spray
STORAGE: Refrigerated
Maryland-based
Altimmune is a biopharmaceutical company that focuses on developing vaccines delivered by nasal spray. Recently, they’ve tackled influenza and anthrax using this technology. They have now used it to make a nasal spray vaccine for Covid-19, delivering the Ad5 adenovirus to the airway. The company says its nasal spray
may be more effective for blocking the transmission of the virus than vaccines given by injection. On Dec. 22, the company
registered a Phase 1 clinical trial for adults.
Updated Dec. 22
ABANDONED
The American company Merck acquired the Austrian firm Themis Bioscience in June to develop their vaccine, which had been originally developed at Institut Pasteur. The vaccine used a weakened measles virus that carries a gene for the coronavirus spike protein. Researchers launched a Phase 1 trial in August. On Jan. 25, Merck announced it was abandoning the effort, because the vaccine provoked a response that was weaker than a natural infection. Updated Jan. 25
ABANDONED
In addition to its project with Themis, Merck partnered with IAVI on a second viral vector vaccine. It was based on vesicular stomatitis viruses, the same approach Merck successfully used to produce the first approved vaccine for Ebola. They designed their coronavirus vaccine as a pill, which could have made it easier to distribute than syringes for injections. Merck and IAVI received $38 million from the United States government to support their research, and on September 30 they registered a Phase 1 trial. But on Jan. 25, they announced they were abandoning the effort because the vaccine failed to trigger an immune system comparable to what happens in a natural infection of Covid-19. Updated Jan. 25
PRECLINICAL
Other viral vector vaccines in active preclinical development include vaccines from: Ankara University; Icahn School of Medicine at Mount Sinai; ID Pharma; Institut Pasteur Lille; KU Leuven; Meissa Vaccines; Ohio State University and Kazakh National Agrarian University; the Spanish National Center for Biotechnology and the Spanish National Research Council; TheraVectys and Institut Pasteur; Thomas Jefferson University and Bharat Biotech; Tonix Pharmaceuticals; University of Georgia; University of Helsinki, University of Eastern Finland, and Rokote Laboratories Finland; University of Pittsburgh; University of Western Ontario; Valo Therapeutics and University of Helsinki; Vivaldi Biosciences; Walvax Biotechnology, Tsinghua University, and Tianjin Medical University; Washington University; Zydus Cadila.
Updated Jan. 14
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 EARLY USE IN RUSSIA
VACCINE NAME: EpiVacCorona
EFFICACY: Unknown
DOSE: 2 doses, 3 weeks apart
TYPE: Muscle injection
STORAGE: Stable in refrigerator for up to two years
On Aug. 26, the
Vector Institute, a Russian biological research center,
registered a Phase 1/2 trial for a coronavirus vaccine they call EpiVacCorona. The vaccine contains small portions of viral proteins, known as peptides. Less than two months later,
on Oct. 14, Vladimir Putin announced that Russia has granted regulatory approval to the vaccine, making it the second one to receive that designation after the Gamaleya Institute’s Sputnik V vaccine.
A Phase 3 trial
began in November, and as of Dec. 15, the Interfax News Agency
reported that 1,438 volunteers had received the vaccine. In January, Russia
launched a mass vaccination campaign, using EpiVacCorona as well as Sputnik V, an adenovirus-based vaccine. The Vector Institute has yet to announce the details of its Phase trial indicating whether the vaccine is effective or not.
Updated Jan. 21
PHASE 3
VACCINE NAME: NVX-CoV2373
EFFICACY: 89.3% against most variants
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 last March. The company launched trials for a Covid-19 vaccine in May, and the Coalition for Epidemic Preparedness Innovations invested $384 million to support research on the vaccine. In July the U.S. government awarded Novavax another
$1.6 billion to support the vaccine’s clinical trials and manufacturing.
On Jan. 28, Novavax
reported that their United Kingdom trial determined an efficacy rate of 89.3 percent. But in South Africa, the result was just under 50 percent — potentially the result of a new variant there that can evade the antibodies produced by the vaccine. The company is developing a new version of the vaccine that is tailored to the variant.
In September, Novavax reached an
agreement with the Serum Institute of India, a major vaccine manufacturer, that could enable them to produce as many as 2 billion doses a year. If its clinical trials succeed, Novavax expects to deliver 100 million doses for use in the United States in 2021. They also have an agreement with other countries, including one to
the United Kingdom for 60 million doses, with
Canada for 52 million doses, and with
Australia for 51 million doses.
Updated Jan. 30
PHASE 3
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 with 29,000 volunteers in December.
Updated Dec. 2
PHASE 2 PHASE 3 COMBINED PHASES
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 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, 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 with the government of Canada to supply 76 million doses. A
Phase 2/3 trial of the vaccine
began on Nov. 12.
Updated Nov. 24
PHASE 2 PHASE 3 COMBINED PHASES
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 the Coalition for Epidemic Preparedness 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 that the vaccine triggered a high level of antibodies. The announcement was followed by a
Phase 2/3 trial with the GSK adjuvant.
Updated Jan. 2
PHASE 2
In July, researchers at West China Hospital of Sichuan University published a study 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 a Phase 1 trial, and on Nov. 16 they moved to Phase 2 with a study on 960 volunteers. On Jan. 22 they registered another Phase 2 trial with 4000 volunteers. Updated Jan. 24
PHASE 2
In October, Cuba’s Finlay Vaccine Institute launched clinical trials on their second experimental vaccine for the coronavirus, known as Soberana 2. It contains the RBD part of the coronavirus spike protein, which is fused to a standard tetanus vaccine to make it stable. It also uses aluminum hydroxide as an adjuvant to boost the immune system.
Updated Jan. 21
PHASE 2
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 in early October. On Dec. 30, Medigen announced that it had received permission to commence a Phase 2 trial. The first volunteers in the trial were injected in late January. Updated Jan. 26
PHASE 1 PHASE 2 COMBINED PHASES
On Aug. 18, the head of epidemiology at Cuba’s public health ministry announced the country’s first trial of a vaccine of Covid-19. The Finlay Vaccine Institute in Havana began testing a vaccine called Soberana 1. It 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 Dec. 18
PHASE 1 PHASE 2 COMBINED PHASES
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, an approved vaccine for influenza. The companies launched 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 for 100 million doses. On Sept. 18 Sanofi closed another deal
with the European Union for 300 million doses for an unspecified amount, and later reached
an agreement with Canada for up to 72 million doses. In addition, Sanofi agreed to provide
200 million doses 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 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. 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. In the meantime, Sanofi
decided in January to help Pfizer and BioNTech make 100 million doses of their vaccine.
Updated Jan. 28
PHASE 1 PHASE 2 COMBINED PHASES
SpyBiotech, a company spun off from the University of Oxford, announced in September that the first volunteers in an Australian Phase 1/2 trial were receiving their Covid-19 vaccine. The researchers created the vaccine from a mixture of proteins. Some of the proteins, from hepatitis B viruses, 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
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 in August and
launched a Phase 1/2 trial in November, combining the viral proteins with an
adjuvant made by
Dynavax. On Dec. 29, Biological E and the Coalition for Epidemic Preparedness Innovations
announced a partnership to advance the development and manufacturing of the vaccine, with CEPI initially contributing $5 million to the effort. If trials confirm that the vaccine works, Biological E hopes to make a billion doses a year.
Updated Dec. 29
PHASE 1 PHASE 2 COMBINED PHASES
Shionogi, a Japanese pharmaceutical giant, launched a Phase 1/2 trial of a coronavirus vaccine on Dec. 16. The company developed it in collaboration with the National Institute of Infectious Diseases and Kyushu University. The vaccine is based on a coronavirus protein which is produced in insect cells by genetically altered viruses. Updated Dec. 17
PHASE 1
South Korean vaccine producer EuBiologics launched a Phase 1/2 trial of a protein-based vaccine in late January. Known as EuCorVac-19, the vaccine combines the spike protein with an adjuvant that stimulates the immune system. Updated Jan. 28
PHASE 1
The Australian company Vaxine developed a vaccine that combines viral proteins with an adjuvant that stimulates the immune system. A Phase 1 trial began over the summer. Updated Jan. 2
PHASE 1
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. A Phase 1 trial launched in December. Updated Dec. 17
PHASE 1
Taiwan-based vaccine manufacturer Adimmune got permission to launch a Phase 1 trial on Aug. 20. The vaccine contains the RBD section of the virus’s spike protein. In December, the Taiwan press reported that Adimmune failed to find the right dose of their vaccine and needed to try a new formulation. Updated Dec. 31
PHASE 1
New York-based COVAXX, a subsidiary of United Biomedical, has created a vaccine containing parts of several viral proteins. On Sept. 11 they registered a Phase 1 trial in Taiwan. They have reached an agreement with authorities in Brazil to run their Phase 2/3 trial there, which is slated to begin in February. On Nov. 25, Covaxx announced agreements with countries including Brazil, Ecuador, and Peru to deliver more than 140 million doses for $2.8 billion. In January, the company announced they were also starting preclinical research on a vaccine tailored specifically to newly emerged coronavirus variants that could potentially evade conventional vaccine. Updated Jan. 21
PHASE 1
In the spring, researchers at the University of Tübingen in Germany created a vaccine made of eight parts of two viral proteins, along with an immune-stimulating adjuvant. In September they launched a Phase 1 trial. Updated Sept. 15
PHASE 1
The Center for Genetic Engineering and Biotechnology of Cuba announced on Nov. 26 that it was beginning a Phase 1 trial 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
In addition to their nasal spray vaccine, the Center for Genetic Engineering and Biotechnology of Cuba also launched a separate trial 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
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 a Phase 1 trial at the end of November. Updated Dec. 2
PHASE 1
On Dec. 10, Nanogen Biopharmaceutical in Vietnam began recruiting 60 volunteers for a Phase 1 trial of their protein-based vaccine Nanocovax. Nikkei Asia reported that Nanogen is considering Phase 3 trials in Bangladesh, India, and Indonesia. The company projects the vaccine will become available in Vietnam in mid-2021. Updated Dec. 26
PHASE 1
VACCINE NAME: COVAC
EFFICACY: Unknown
DOSE: 2 doses, 4 weeks apart
TYPE: Muscle injection
The
Vaccine and Infectious Disease Organization at the University of Saskatchewan has developed a vaccine candidate which uses protein subunits to develop immunity against the coronavirus. It was cleared for human testing late last year by the Canadian government. VIDO registered a
Phase 1/2 trial on Jan. 8. If trials proceed as expected, researchers
predict that at least one of their candidates will be ready by late 2021.
Updated Jan. 12
PHASE 1 ?
On July 18, North Korea’s State Commission of Science and Technology announced on their web site 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 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
The vaccine studies offered great promise at first.
Experiments on hamsters 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 Jan. 21
PRECLINICAL
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. At the end of 2020, its creators applied to the F.D.A. for permission to begin clinical trials.
Updated Dec. 22
PRECLINICAL
Other protein-based vaccines in active preclinical development include vaccines from: AdaptVac and Bavarian Nordic; Akston Biosciences; Applied Biotechnology Institute; Artes Biotech; Baiya Phytopharm; BiOMVis and University of Trento; BioVaxys Technology; Chulalongkorn University; City College of New York and TechnoVax; EpiVax; Generex; GeoVax; Heat Biologics; Icosavax and University of Washington; ImmunoPrecise Antibodies; IMV; Instituto Buntantan; Intravacc; IrsiCaixa; Izmir Biomedicine and Genome Center; MIGAL Galilee Research Institute; Nanografi Nano Technology, Middle East Technical University, and Ankara University; Navarrabiomed; NidoVax; OncoGen; Oragenics Osaka University, BIKEN, and National Institutes of Biomedical Innovation, Japan; OSE Immunotherapeutics; Osivax; PDS Biotechnology; Quadram Institute; Saiba; Ufovax; University of Alberta; University of San Martin and CONICET, Argentina; University of Sao Paulo; University of Virginia; Vabiotech; Vaxform; Verndari; Voltron Therapeutics; Walter Reed Army Institute of Research.
Updated Jan. 14
Inactivated or Attenuated Coronavirus Vaccines
Vaccines created from weakened coronaviruses or coronaviruses that have been killed with chemicals.
PHASE 3
APPROVED IN CHINA, ELSEWHERE
VACCINE NAME: BBIBP-CorV
EFFICACY: 79.34%
DOSE: 2 doses, 3 weeks apart
TYPE: Muscle injection
The
Beijing Institute of Biological Products created an inactivated coronavirus vaccine that was put into clinical trials by the state-owned Chinese company
Sinopharm. On Dec. 30, Sinopharm
announced that the vaccine had an efficacy of 79.34 percent, leading the Chinese government to
give it approval. The company has yet to publish the detailed results of their Phase 3 trial.
Last June, Beijing Institute researchers
reported that the vaccine produced promising results in monkeys. A
Phase 1/2 trial then showed that the vaccine didn’t cause any serious side effects and enabled people to make antibodies against the coronavirus. In July a
Phase 3 trial began in the United Arab Emirates in July, and in
Morocco and
Peru the following month.
On Sept. 14, the U.A.E.
gave emergency approval for Sinopharm’s vaccine to use on health care workers, and soon
government officials and others were also receiving it. Less than two months later, on Dec. 9, the U.A.E. gave
full approval to BBIBP-CorV, announcing it had an efficacy rate of
86 percent. The government rapidly
set up clinics across the country where
anyone could receive the vaccine. The neighboring country of
Bahrain, which also participated in the Sinopharm trials, also gave full approval to the vaccine on Dec. 13.
Egypt and
Jordan gave it emergency authorization in January. On Jan. 14,
Hungary announced they reached a deal to buy BBIBP-CorV, pending an authorization. That would make the country the first European nation to use a Chinese vaccine.
In China, meanwhile, the government gave Sinopharm
emergency approval over the summer to inject its vaccine candidates into government officials, health care workers, and other select groups. By November, the chairman of Sinopharm said,
almost a million people in China had received the vaccines.
Sinopharm did not initially comment on the U.A.E.’s announcement that BBIBP-CorV had an efficacy rate of 86 percent. When an executive with the company was later asked about the difference between the U.A.E. estimate and Sinopharm’s own analysis, he said that both were “
real and valid.” The difference was the result of differences in how the trials were run. With China’s approval, BBIBP-CorV looks likely to play a major role in the country’s
planned campaign to vaccinate 50 million people by mid-February.
Updated Jan. 30
PHASE 3 EMERGENCY USE IN CHINA, ELSEWHERE
VACCINE NAME: CoronaVac (formerly PiCoVacc)
DOSE: 2 doses, 2 weeks apart
TYPE: Muscle injection
STORAGE: Refrigerated
Sinovac Biotech, a private Chinese company, developed an inactivated vaccine called CoronaVac in early 2020. In January, researchers in Brazil
announced that it has an overall efficacy of just over 50 percent, the minimum threshold set by many regulatory agencies for authorizing a coronavirus vaccine. Despite the relatively modest efficacy, CoronaVac is being rolled out in a number of countries.
Indonesia gave CoronaVac emergency authorization on Jan. 11, and two days later the president of Indonesia received an injection of CoronaVac on live television. Turkey
authorized the vaccine on Jan. 13, and its president
got vaccinated the next day.
Brazil authorized CoronaVac on Jan. 17.
After creating their vaccine last spring, Sinovac ran a Phase 1/2 trials on 743 volunteers that revealed
no severe adverse effects. Sinovac
published the details of the trial in November in a medical journal, showing a comparatively modest production of antibodies. In July, Sinovac
launched a Phase 3 trial in Brazil, followed by others in
Indonesia and
Turkey.
In that same month, Chinese government gave CoronaVac an emergency approval for limited use. In October, authorities in the eastern Chinese city of Jiaxing announced they were
giving CoronaVac to people in relatively high-risk jobs, including medical workers, port inspectors and public service personnel.
The efficacy of CoronaVac has been the subject of
uncertainty since December. Brazilian researchers initially announced that it was above fifty percent, but held off providing further details. On Dec. 25, the scientists running the CoronaVac trial in Turkey held a press conference to announce that the vaccine had an efficacy of 91 percent. Although a total of 7,371 volunteers were involved in the trial, the efficacy data was based on only 752 volunteers who got a real vaccine and 570 who received the placebo. Such a small number of volunteers may make the efficacy rate less accurate. The Turkish scientists did not share the results in writing.
Two weeks later, researchers in Brazil
announced that CoronaVac has an efficacy of 78 percent. None of the vaccinated volunteers in their Phase 3 trial developed severe or moderate cases of Covid-19. However, shortly afterwards one of the scientists
clarified that the efficacy estimate was based on the vaccine’s performance in just one subgroup of volunteers. The overall efficacy turned out to be lower. The results were based on a study of 12,476 volunteers, over ten times the number of participants on which the Turkish researchers based their estimate. None of the Phase 3 trial results have yet appeared in a medical journal.
Meanwhile, Sinovac has been preparing to manufacture the vaccine for global distribution. In August they reached
an agreement to supply Indonesia with at least 40 million doses, and later made
a deal with Ukraine for 1.8 million doses.
In September, Yin Weidong, the CEO of Sinovac, said the company planned on worldwide distribution of the vaccine in early 2021 — including the United States. Sinovac
said in December that it expected to manufacture 300 million doses in 2020 and increase their capacity to an annual production of 600 million doses.
Updated Jan. 19
PHASE 3 LIMITED USE IN CHINA, U.A.E.
Along with their Beijing Institute vaccine, Sinopharm also tested an inactivated virus vaccine developed by the Wuhan Institute of Biological Products. The Phase 1/2 trial showed 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. In December, Peru briefly paused their Sinopharm trial to investigate neurological problems that one volunteer experienced, but determined that it had nothing to do with the vaccines. With the success of Sinopharm’s BBIBP-CorV vaccine created by Beijing Institute, the fate of the Wuhan candidate was not clear.
LIMITED USE IN: China, United Arab Emirates.
Updated Dec. 30
PHASE 3 EMERGENCY USE IN INDIA
VACCINE NAME: Covaxin (also known as BBV152 A, B, C)
EFFICACY: Unknown
DOSE: 2 doses, 4 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 and
hamsters found that it provided protection against infection. Last June, Covaxin became
the first coronavirus vaccine created in India to go into clinical trials.
On Jan. 3, the Indian government granted Covaxin
emergency authorization. The authorization came despite no release of Phase 3 data showing the vaccine is safe and effective. On Jan. 26, Bharat researchers
reported that antibodies from the Covaxin vaccine can block B.1.1.7, the variant first identified in the United Kingdom in December.
Updated Jan. 30
PHASE 3
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. Last May, they launched a Phase 1 trial on 192 volunteers which indicated the vaccine was safe and produced an immune response. A Phase 2 trial 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 on up to 34,020 volunteers in Brazil and Malaysia. Updated June 23
PHASE 3
The central Asian nation of Kazakhstan began research on a vaccine made from inactivated coronaviruses over the summer. On August 28, their Research Institute for Biological Safety Problems registered a Phase 1 trial on the vaccine, known as QazCovid. On Dec. 19, Kazinform reported that Phase 2 had been completed, showing that the vaccine was safe and produced a promising immune response. The researchers commenced a Phase 3 trial, anticipating approval by March. Updated Dec. 27
PHASE 2
On Nov. 5, Turkey’s Erciyes University announced they had begun injecting volunteers with an inactivated coronavirus vaccine called ERUCOV-VAC. It is the first clinical trial of a coronavirus vaccine developed in Turkey. On Dec. 14, the president of the university said that the Phase 1 trial was complete. Sabah Today reported the following month that Phase 2 trials had begun. Updated Jan. 21
PHASE 1 PHASE 2 COMBINED PHASES
The Chumakov Center at the Russian Academy of Sciences has developed an inactivated coronavirus vaccine. On Oct. 14, the TASS news agency reported that clinical trials of the vaccine would begin in Kirov and St. Petersburg on Oct. 19. On its web site, the center stated that it would finish the first phase of trials the following month. Updated Oct. 14
PHASE 1 PHASE 2 COMBINED PHASES
The French vaccine maker Valneva created a vaccine from chemically inactivated coronaviruses, using an adjuvant from Dynavax. It’s currently the only Western company to be using this traditional method, which is also being pursued in China and India. On Dec. 16, it launched a Phase 1/2 trial in the United Kingdom, with hopes of reaching authorization in the second half of 2021. The British government has already reached an agreement to purchase 60 million doses of the vaccine should it prove safe and effective, with an option to acquire a further 130 million. Updated Jan. 12
PHASE 1
Updated Jan. 21
PHASE 1
New York-based Codagenix develops vaccines based on live attenuated viruses, but with a twist: they create the viruses from scratch. 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 was launched in the United Kingdom in January. Updated Jan. 12
PHASE 1
Shafa Pharmed Pars, an Iranian pharmaceutical company, developed a vaccine made of inactivated coronaviruses. Known as COVIran Barekat, it entered a Phase 1 trial at the end of December. COVIran Barekat is the first vaccine developed in Iran to go into clinical testing. Updated Dec. 29
PRECLINICAL
Other inactivated or attenuated coronavirus vaccines in active preclinical development include vaccines from: Indian Immunologicals and Griffith University; KM Biologics; and Osaka 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
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 called the BRACE to see if the vaccine partly protects against the coronavirus. Updated
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.
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