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 64 vaccines in clinical trials on humans, and 19 have reached the final stages of testing. At least 85 preclinical vaccines are under active investigation in animals.
Source: The New York Times
New additions and recent updates | |
---|---|
Dec. 27 | Kazakhstan moves to Phase 3. |
Dec. 24 | Iran enters Phase 1. |
Dec. 23 | Canada approves the Moderna vaccine. |
Dec. 22 | Maryland-based Altimmune enters Phase 1. |
Dec. 21 | The European Union authorizes the Pfizer-BioNTech vaccine. |
Dec. 19 | Kazakhstan moves to Phase 2. |
Dec. 18 | The F.D.A. authorizes Moderna’s vaccine for emergency use. |
Dec. 18 | Cuba’s Soberana 2 vaccine moves to Phase 2. |
Dec. 17 | Japan’s Shionogi launches a Phase 1/2 trial. |
Dec. 17 | South Korea’s GeneOne enters Phase 1/2. |
Leading vaccines | ||||
---|---|---|---|---|
Developer | Type | Phase | Status | |
Pfizer-BioNTech | mRNA | 3 | Approved in Canada and other countries. Emergency use in U.S. and other countries. Approved by EMA. | |
Moderna | mRNA | 3 | Approved in Canada. Emergency use in U.S. | |
Gamaleya | Adenovirus | 3 | Early use in Russia. Emergency use in Belarus, Argentina. | |
CanSino | Adenovirus | 3 | Limited use in China. | |
Johnson & Johnson | Adenovirus | 3 | ||
Oxford-AstraZeneca | Adenovirus | 2,3 | ||
Vector Institute | Protein | 3 | Early use in Russia. | |
Novavax | Protein | 3 | ||
Sinovac | Inactivated | 3 | Limited use in China. | |
Sinopharm-Beijing | Inactivated | 3 | Approved in U.A.E., Bahrain. Limited use in China. | |
Sinopharm-Wuhan | Inactivated | 3 | Limited use in China, U.A.E. |
Below is a list of all vaccines that have reached trials in humans, along with a selection of promising vaccines being tested in animals.
Genetic Vaccines
Vaccines that deliver one or more of the coronavirus’s own genes 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
VACCINE NAME: Comirnaty (also known as tozinameran or BNT162b2 )
EFFICACY: 95%
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.
BioNTech researchers began designing the vaccine, which now has the generic name tozinameran and the brand name Comirnaty, 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, Comirnaty 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 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 other countries across the world have also given emergency authorization for Comirnaty, including Argentina, Chile, Costa Rica, Ecuador, Kuwait, Mexico, Panama, and Singapore. The European Union signed off on the vaccine on Dec. 21. Meanwhile, Bahrain, Canada, Saudi Arabia and Switzerland gave the vaccine full approval.
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, for example, while the European Union arranged to purchase 200 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.
Pfizer and BioNTech expect to manufacture over 1.3 billion doses worldwide by the end of 2021.
For more details, see How the Pfizer-BioNTech Vaccine Works.
Updated Dec. 24
Pfizer-BioNTech
vaccine
BRITAIN AND
THE E.U.
SWITZERLAND
CANADA
U.S.
KUWAIT
BAHRAIN
U.A.E.
MEXICO
PANAMA
SAUDI
ARABIA
COSTA RICA
SINGAPORE
ECUADOR
ARGENTINA
CHILE
Approved
Early, limited or
emergency use
PHASE 3
APPROVED IN CANADA EMERGENCY USE IN U.S.
VACCINE NAME: mRNA-1273
EFFICACY: 94.5%
DOSE: 2 doses, 4 weeks apart
TYPE: Muscle injection
STORAGE: 30 days with refrigeration, 6 months at –4°F (–20°C)
On Dec. 18., the F.D.A. gave emergency use authorization for a vaccine made by the Boston-based company Moderna. The decision cleared the way for 5.9 million doses to be distributed across the United States starting over the weekend. The Moderna vaccine is the second one authorized by the F.D.A., coming a week after the vaccine made by Pfizer and BioNTech. Canada approved the vaccine on Dec. 23.
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 from the coronavirus. In March, the scientists were the first to put a Covid-19 vaccine into human trials. After those studies yielded promising results, Phase 3 testing on 30,000 volunteers began on July 27.
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.
On the business side, Moderna lost a patent dispute in July over some of their vaccine technology. The following month, the company stated 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 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. 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 and Qatar.
For more details, see How Moderna’s Vaccine Works.
Updated Dec. 23
Moderna vaccine
CANADA
U.S.
Approved
Early, limited or
emergency use
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)
In 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 moved ahead with its work in Germany, seeing responses to the vaccine in mice and then 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.
Updated Dec. 14
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 2
VACCINE NAME: ZyCoV-D
EFFICACY: Unknown
DOSE: 3 doses, 4 weeks apart
TYPE: Skin injection
STORAGE: Stable at room temperature for three months
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. A Phase 3 trial is expected to begin soon. 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 Dec. 26
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 all 38 volunteers.
Inovio is embroiled in several lawsuits with stockholders and a company partner. On Sept. 28, the F.D.A. put the vaccine on a partial hold due to questions about the delivery device. On Nov. 16, Inovio said that the F.D.A. had given them permission to move forward. They are now running Phase 2 trials in the United States as well as in China and South Korea.
Updated Dec. 26
PHASE 1 PHASE 2 COMBINED PHASES
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 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.
PHASE 1 PHASE 2 COMBINED PHASES
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. Singapore reached an agreement with Arcturus to spend up to $175 million to acquire vaccines when they’re ready.
Updated Dec. 17
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
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.
Updated Dec. 22
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
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; 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 EARLY USE IN RUSSIA, ELSEWHERE
VACCINE NAME: Sputnik V (formerly 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 they deliver stronger protection together than either does on its own. AstraZenecia registered a Phase 1 trial for the combination on Dec. 24.
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.
Updated Dec. 26
Gamaleya’s
Sputnik V
vaccine
RUSSIA
BELARUS
ARGENTINA
Approved
Early, limited or
emergency use
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: Unknown
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. In 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.
Johnson & Johnson launched a Phase 3 trial in September. On Oct. 12, the company announced it was pausing the trial to investigate an adverse reaction in a volunteer. The trial resumed eleven days later. Although Johnson & Johnson initially set out to recruit 60,000 volunteers, it capped the trial at 45,000 in December. Results are expected in January.
In August, the federal government agreed to pay Johnson & Johnson $1 billion for 100 million doses if the vaccine is approved. 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 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, instead of just one.
For more details, see How the Johnson & Johnson Vaccine Works.
Updated Dec. 18
PHASE 2 PHASE 3 COMBINED PHASES
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 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. In 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 (where it’s known as Covishield). In addition, AstraZeneca 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 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 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. But on Dec. 26, the chief executive of AstraZeneca told the Sunday Times that new data showed that the vaccine had an efficacy rate just as high as Moderna or Pfizer-BioNTech, and was 100 percent protective against severe disease. He said that the data would soon be forthcoming. Meanwhile, the Telegraph reported that the British government was planning to start injecting millions of doses of the vaccine on Jan. 4.
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. 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 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.
On Dec. 7, the Serum Institute of India announced it was applying to the Indian government for emergency use authorization of the ChAdOx1 vaccine. In India, the vaccine is known as Covishield.
For more details, see How the Oxford-AstraZeneca Vaccine Works.
Updated Dec. 18
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. 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, 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
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 a Phase 1 trial in August.
Updated Aug. 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. The vaccine is expected to be ready for approval by the end of 2021.
Updated Sept. 29
PHASE 1
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. 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 from the United States government to support their research, and on September 30 they registered a Phase 1 trial.
Updated Aug. 27
PHASE 1
The California-based company ImmunityBio launched a Phase 1 trial 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 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 from the coronavirus. The chairman and C.E.O. of ImmunityBio is billionaire Patrick Soon-Shiong, the owner of the Los Angeles Times.
Updated Dec. 11
PHASE 1
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 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
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
PRECLINICAL
The Swiss company Novartis will manufacture a vaccine based on a gene therapy treatment 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: 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 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. According to newspaper reports, the EpiVacCorona trials had already begun by then. 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.
Updated Dec. 18
PHASE 3
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.
After getting promising results from preliminary studies in monkeys and humans, Novavax launched a Phase 2 trial 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 a Phase 3 trial enrolling up to 15,000 volunteers in the United Kingdom. It is expected to deliver results in early 2021. A larger Phase 3 trial in the United States is expected to launch by the end of December.
In September Novavax reached an agreement 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. They also have an agreement to deliver 40 million doses to Australia and another to deliver 10.7 million doses to New Zealand.
Updated Dec. 17
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. by the end of 2020.
Updated Dec. 23
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.
Updated Nov. 20
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. In December, the Finlay Vaccine Institute moved to a Phase 2 trial to gauge the strength of the immune response.
Updated Dec. 18
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.
Updated Dec. 11
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. If trials confirm that the vaccine works, they hope to potentially make a billion doses a year.
Updated Nov. 16
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
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, and Phase 2 trials are expected to commence by the end of the year.
Updated Sept. 29
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 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.
Updated Oct. 13
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.
Updated Aug. 20
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.
Updated Dec. 26
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 ?
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
On Dec. 10, a vaccine from Australia’s University of Queensland was the first to be abandoned after entering a clinical trial. Cancelling the vaccine meant the collapse of a $1 billion deal with the Australian government for 51 million doses.
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 Dec. 10
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: 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; Institut Pasteur Lille; 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; University of Alberta; 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 Dec. 22
Inactivated or Attenuated Coronavirus Vaccines
Vaccines created from weakened coronaviruses or coronaviruses that have been killed with chemicals.
Inactivated
virus
PHASE 3 LIMITED USE IN CHINA
VACCINE NAME: CoronaVac (formerly PiCoVacc)
EFFICACY: Over 50 percent
DOSE: 2 doses, 2 weeks apart
TYPE: Muscle injection
STORAGE: Refrigerated
Sinovac Biotech, a private Chinese company, developed an inactivated vaccine called CoronaVac. On Dec. 23, researchers in Brazil announced that a Phase 3 trial there showed it had an efficacy of over 50 percent, and the day after Turkey held a press conference to report an efficacy of 91 percent. But neither country shared detailed results. Sinovac is expected to share combined Phase 3 results in early January.
In June the company announced that Phase 1/2 trials on 743 volunteers found no severe adverse effects and produced an immune response. 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 July, 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.
Meanwhile, Sinovac has been preparing to manufacture the vaccine for global distribution, reaching an agreement to supply Indonesia with at least 40 million doses by March 2021. 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. In December Sinovac said it expected to manufacture 300 million doses in 2020 and increase their capacity to an annual production of 600 million doses.
For more details, see How the Sinovac Vaccine Works.
Updated Dec. 26
PHASE 3
APPROVED IN U.A.E., BAHRAIN LIMITED USE IN CHINA
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 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 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 the Beijing Institute vaccine, announcing it had an efficacy rate of 86 percent. The government rapidly set up clinics across the country 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, 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 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 in China had received the vaccines. On Nov. 25, Sinopharm announced 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. 22
Sinopharm and
Beijing Institute
vaccine
CHINA
BAHRAIN
U.A.E.
Approved
Early, limited or
emergency use
PHASE 3 LIMITED USE IN CHINA, U.A.E.
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 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.
Updated Dec. 17
Sinopharm and
Wuhan Institute
vaccine
CHINA
U.A.E.
Approved
Early, limited or
emergency use
PHASE 3
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 and hamsters found that it provided protection against infection. In June, Covaxin became the first coronavirus vaccine created in India to go into clinical trials.
The phase 1/2 trial showed that the vaccine didn’t cause any serious side effects while producing antibodies to the coronavirus. On Oct. 23, the company announced they were initiating a Phase 3 trial. Bharat expects results in early 2021 and anticipates distributing the vaccine next June. On Dec. 22, the company announced a partnership with Pennsylvania-based Ocugen to develop Covaxin for the United States market.
Updated Dec. 24
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. In 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 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. 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 Dec. 22
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 the Phase 3 trial, anticipating approval by March.
Updated Dec. 27
PHASE 1
Shenzhen Kangtai Biological Products is a Chinese company that makes vaccines for diseases such as hepatitis B and measles. In August, AstraZeneca reached an agreement with them to supply China with their mRNA vaccine. In October Shenzen Kangtai launched 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.
Updated Dec. 9
PHASE 1
On Nov. 5, Turkey’s Erciyes University announced they had begun injecting volunteers with an inactivated coronavirus vaccine. 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 and that Phase 2 would begin by the end of the month.
Updated Dec. 22
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 of their coronavirus vaccine was registered on Nov. 6, which is planned to begin in the United Kingdom in January.
Updated Dec. 14
PHASE 1
At the end of December, Iran launched its first clinical trial of a coronavirus vaccine. Although the government did not name the company that created the vaccine in its announcement, the Iranian pharmaceutical company Shafa Pharmed Pars is listed on the World Health Organization’s roster of companies developing coronavirus vaccines. It has developed a two-dose inactivated coronavirus vaccine. Iran Press reported that the Phase 1 trial will recruit 56 volunteers.
Updated Dec. 24
PRECLINICAL
Other inactivated or attenuated coronavirus vaccines in active preclinical development include vaccines from: 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
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.
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.
Leave a Reply