When candidate vaccines make it to human clinical trials, they first go through phase 1 trials primarily to test the vaccine’s safety, determine dosages and identify any potential side effects in a small number of people. Phase 2 trials further explore safety and start to investigate efficacy on larger groups. The final stage, phase 3 trials, which few vaccines ever make it to, are much larger, involving thousands or tens of thousands of people, to confirm and assess the effectiveness of the vaccine and test whether there are any rare side effects that only show up in large groups. Here is a list of candidates at various stages of clinical trials.
MODERNA (USA) - MRNA VACCINE
This RNA vaccine has been developed by Moderna, in Cambridge, Massachusetts, and funded by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the US National Institutes of Health. The vaccine was tested in phase 1 trials on volunteers at the Kaiser Permanente Washington Health Research Institute in Seattle. Moderna has run phase 2 trials on participants of a wide range of ages and started phase 3 trials in July.
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SINOVAC (CHINA) - INACTIVATED VACCINE
So far, this inactivated vaccine has been tested on primates. It has protected rhesus macaques from contracting the virus in a test conducted three weeks after they were injected with the vaccine. Sinovac recently begun phase 3 trials involving 9,000 volunteers in Brazil.
WUHAN INSTITUTE OF BIOLOGICAL PRODUCTS (CHINA) - INACTIVATED VACCINE
The Wuhan Institute launched phase 3 trials in July in the United Arab Emirates, with 15,000 people scheduled to participate in total.
BEIJING INSTITUTE OF BIOLOGICAL PRODUCTS (CHINA) - INACTIVATED VACCINE
Like the Wuhan Institute, the Beijing institute is also part of China’s state-run Sinopharm Group, and is working on this vaccine with the Chinese Center for Disease Control and Prevention.
Phases 1 & 2
BIONTECH (GERMANY) - MRNA VACCINE
BioNTech, working together with Pfizer, started testing its BNT162 vaccine in humans in global trials initially in Germany, and recently started trials in the USA. BiotNTech has also entered into a € 100 million debt financing agreement with the European Investment Bank in order to scale-up the production of the vaccine in Europe.
BEIJING INSTITUTE OF BIOLOGICAL PRODUCTS (CHINA) - INACTIVATED VACCINE
Like the Wuhan Institute, this institute also belongs to China’s state-run Sinopharm Group, and is working on this vaccine with the Chinese Center for Disease Control and Prevention.
UNIVERSITY OF OXFORD (UK) - VIRAL VECTOR VACCINE
The ChAdOx1 vaccine, developed by the University of Oxford, is testing the vaccine in phase 3 clinical trials with more than 10,000 people from across the UK, including children and the elderly. The vaccine is also being tested in Brazil, and in South Africa recently started the first COVID-19 vaccine trial in Africa. With support from the Coalition for Epidemic Preparedness Innovations (CEPI), AstraZeneca will manufacture 300 million doses of this coronavirus vaccine candidate in anticipation of the vaccine proving to be both safe and effective. If it is, the first doses are expected to be available in late 2020.
BIONTECH (GERMANY) - MRNA VACCINE
BioNTech, working together with Pfizer, started testing its BNT162 vaccine in humans in global trials initially in Germany, and recently started trials in the USA. BiotNTech has also entered into a € 100 million debt financing agreement with the European Investment Bank in order to scale-up the production of the vaccine in Europe. On 27 July, it 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.
CANSINO BIOLOGICS INC. (CHINA) - VIRAL VECTOR VACCINE
The Ad5-nCoV vaccine candidate uses a harmless non-replicating viral vector (essentially a sort of molecular transport) to carry vaccine antigens into the human body – this is the same platform that the vaccine developer CanSino Biologics Inc, based in Tianjin, used for its Ebola vaccine. In its phase 1 trial, 108 participants aged between 18 and 60 years were enrolled and allocated to one of three dose groups. The vaccine was jointly developed with the Institute of Biotechnology of the Academy of Military Medical Sciences. The clinical trial is taking place in Wuhan, China. In July, CanSino Biologics reported that its phase II trials showed that the vaccine produced a strong immune response.
NOVAVAX (USA) - PROTEIN SUBUNIT VACCINE
Novavax is using a nanoparticle technology platform to generate antigens from the protein found on the spikey outer shell of the coronavirus. The company has started testing on people and is anticipating preliminary data in July. The vaccine also received the highest funding from CEPI with a total of US$ 388 million.
ANHUI ZHIFEI LONGCOM BIOPHARMACEUTICAL & INSTITUTE OF MICROBIOLOGY, CHINESE ACADEMY OF SCIENCES (CHINA) - PROTEIN SUBUNIT VACCINE
The protein subunit vaccine candidate is being tested in collaboration with the Second Affiliated Hospital of Chongqing Medical University and Beijing Chao Yang Hospital. Phase 2 studies began in July.
CHINESE ACADEMY OF MEDICAL SCIENCES (CHINA) - INACTIVATED PLATFORM VACCINE
The Institute of Medical Biology at the Chinese Academy of Medical Sciences (IMBCAMS) has previously developed inactivated vaccines for polio and hand-foot-and-mouth disease.
Phase 1/Phase 2
IMPERIAL COLLEGE (UK) - SARNA VACCINE
This vaccine candidate which uses self-amplifying RNA technology (SARNA) has been developed by researchers at Imperial College, in London. The research has received £ 41 million in funding from the UK government. It has also received £ 5 million through philanthropic donations. The clinical trial in the current phase will involve administration of the two-dose vaccine to 300 healthy individuals. Volunteers have already started receiving the first dose of the vaccine. Imperial College has also created VacEquity Global Health, a social enterprise, to develop and distribute low-cost vaccines around the world, including to low- and middle-income countries. It began phase 1/2 trials on June 15 and has partnered with Morningside Ventures to manufacture and distribute the vaccine.
ZYDUS CADILA (INDIA) – DNA-BASED VACCINE
On 3 July Zydus Cadila announced approval to start human phase1/2 trials, making it the second company in India to enter the COVID-19 vaccine race after Bharat Biotech.
ANGES (JAPAN) – DNA-BASED VACCINE
On 30 June, the Japanese biotechnology company AnGes announced it had started safety trials on a DNA-based vaccine, developed in partnership with Osaka University and Takara Bio.
ARCTURUS/DUKE-NUS (USA/SINGAPORE) – mRNA VACCINE
On 21 July, Singapore approved its application for a phase 1/2 trial in humans.
JOHNSON&JOHNSON (USA) – ADENOVIRUS VACCINE
J&J has developed vaccines for Ebola and other diseases with Recombinant Adenovirus Serotype 26 (Ad26) and has now made one for the coronavirus. It launched phase 1/2 trials in July, with hopes of making up to a billion doses in 2021.
BHARAT BIOTECH (INDIA) – INACTIVATED VACCINE
In collaboration with the Indian Council of Medical Research and the National Institute of Virology, Bharat Biotech designed a vaccine called Covaxin based on an inactivated form of the coronavirus. The company launched phase 1/2 trials in July.
CLOVER BIOPHARMACEUTICALS INC., GSK & DYNAVAX *(AUSTRALIA) – PROTEIN-BASED VACCINE
The protein-based COVID-19 S-Trimer vaccine which use GSK’s adjuvant system is now being tested in human clinical trials. This move comes after the promising results during the preclinical stage. The study will be conducted in 150 healthy adults in Australia. Clover has also obtained US$ 3.5 million from CEPI to prepare and launch phase 1 clinical trials.
CUREVAC (GERMANY) - MRNA VACCINE
Based on an RNA platform, CureVac’s vaccine candidate has received € 300 million backing from the German government, € 80 million from the European Commission and € 8.3 million from the CEPI. The two-dose vaccine will be tested in 168 healthy individuals between the ages of 18 and 60. Earlier this year, the Bill & Melinda Gates Foundation also made a commitment to invest US$ 52 million in CureVac to support its platform technology and the construction of a Good Manufacturing Practice (GMP) production facility.
GAMALEYA RESEARCH INSTITUTE (RUSSIA) - VIRAL VECTOR VACCINE
Gamaleya has started a phase 1 clinical trial on this non-replicating viral vector vaccine candidate with two sets of volunteers receiving vaccination since mid-June.
GENEXINE CONSORTIUM (SOUTH KOREA) - DNA VACCINE
This vaccine is being jointly developed by a consortium which includes Genexine, Binex, GenNBio, International Vaccine Institute, Korea Advanced Institute of Science, and Technology and Pohang University of Science and Technology. The vaccine is currently in clinical phase 1/2a with tests being conducted on 190 healthy participants between the age of 18 to 50. Genexine is confident of being able to market the vaccine by the second half of 2021.
INOVIO PHARMACEUTICAL (USA) - DNA VACCINE
Inovio put its INO-4800 DNA vaccine into human trials early in April. So far, it’s the only company with a phase 2 vaccine against the related MERS-CoV coronavirus. The company plans to start human clinical trials in the USA, and shortly after in China and South Korea.
PEOPLE'S LIBERATION ARMY (PLA) ACADEMY OF MILITARY SCIENCES/WALVAX BIOTECH (CHINA) - RNA VACCINE
The vaccine is being tested with two age groups – one with people aged 18-59 years, and another with people 60 and older.
VAXINE (AUSTRALIA) – PROTEIN SUBUNIT VACCINE
Vaxine launched a phase 1 trial in July. Its vaccine combines viral proteins with an adjuvant that stimulates immune cells.
MEDICAGO (CANADA) – PLANT-BASED VIRUS-LIKE-PARTICLE VACCINE
Partly funded by the cigarette manufacturer Philip Morris, Medicago uses a species of tobacco to make vaccines. Virus genes are delivered into leaves, and then plant cells create proteins that mimic those found on viruses. In July, Medicago launched phase 1 trials on a plant-based COVID-19 vaccine in combination with adjuvants from GSK and Dynavax. If this phase is successful, it plans to start phase 2/3 trials in October.
UNIVERSITY OF QUEENSLAND & GSK (AUSTRALIA) - PROTEIN SUBUNIT VACCINE
Researchers at the University of Queensland, in Brisbane, are using a patented vaccine-development technique called a ‘molecular clamp'. They first create a synthetic version of the characteristic 'spike' protein that covers the virus, as this can trigger an immune response in the human body. They then attach a 'clamp' onto this synthetic protein to ensure it remains stable enough to trigger antibodies (the protein would normally denature in the human body). The researchers expect to start human trials in July.
KENTUCKY BIOPROCESSING (USA) – VIRAL PROTEIN VACCINE
Similar to Medicago, this second tobacco-based vaccine is created by engineering a species of tobacco called Nicotiana benthamiana to make viral proteins. Kentucky Bioprocessing used this technique to make a drug called Zmapp for Ebola. After preclinical testing in the Spring, it registered a phase 1 trial for its coronavirus vaccine in July.