COVID PHASE-I VACCINES

The Covid-19 Vaccine Race:

Phase I:

1.BEIJING MINHAI BIOTECHNOLOGY (CHINA)

INACTIVATED VACCINE

A Phase 1 trial of this vaccine started on 2 October, with 180 health people aged over 18 years. The trial is being done in Jiangsu, China.

2.IMMUNITYBIO AND NANTKWEST (USA)

VIRAL VECTOR VACCINE

The company is planning to launch a Phase 1 trial in California this month with people aged up to 55 years. It is an adenovirus (Ad5) vaccine designed to deliver both spike protein and nucleocapsid DNA to drive both cellular and antibody immunity. Earlier this year, it was chosen to be part of Operation Warp Speed to rapidly develop vaccines in the USA.

3.REITHERA (ITALY)

VIRAL VECTOR VACCINE

The Italian biotechnology company ReiThera has developed a COVID-19 vaccine, called GRAd-COV2, based on an adenovirus that infects gorillas. In collaboration with the Lazzaro Spallanzani National Institute for Infectious Diseases, they launched a Phase 1 trial at the end of July.

4.CANSINO BIOLOGICS/ACADEMY OF MILITARY MEDICAL SCIENCES (CHINA)

VIRAL VECTOR VACCINE

This Phase 1 trial will evaluate the safety and immunogenicity of a recombinant adenovirus 5 vectored COVID-19 vaccine (Ad5-nCoV) with two doses and with different administration routes in healthy adults aged 18 years and older. The trial will include 168 healthy adult aged 18 years and older.

5.VAXART (USA)

VIRAL VECTOR VACCINE

Early in 2020, Vaxart began working on an oral vaccine for COVID-19 using an adenovirus called Ad5 to deliver part of the COVID-19 virus into the body to trigger an immune response. In October, they began Phase 1 trials.

6.LUDWIG-MAXIMILIANS UNIVERSITY OF MUNICH (GERMANY)

VIRAL VECTOR VACCINE

On 30 September, Phase 1 testing for this non-replicating viral vector vaccine was approved. The trial will include 30 healthy participants aged between 18 and 55 years.

7.CLOVER BIOPHARMACEUTICALS INC., GSK & DYNAVAX (AUSTRALIA)

PROTEIN SUBUNIT VACCINE

The protein-based COVID-19 S-Trimer vaccine which uses 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 in June. It is planning a Phase 2 trial by the end of 2020.

8.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. Phase 2 trials are expected to start by the end of the year.

9.UNIVERSITY OF QUEENSLAND & CSL LIMITED (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 launched Phase 1 trials in July. In September, the vaccine makers made an agreement with the Australian government to deliver 51 million doses if the vaccine works. They expect their first supply of the vaccines to be ready by mid-2021.

10.MEDIGEN (TAIWAN)

PROTEIN SUBUNIT VACCINE

Taiwan-based vaccine maker Medigen is making a vaccine made of a combination of spike proteins and an adjuvant from Dynavax. Their Phase 1 trial started this month.

11.FINLAY VACCINE INSTITUTE (CUBA)

PROTEIN SUBUNIT VACCINE

On 18 August, Cuba announced that the Finlay Vaccine Institute in Havana would start a clinical trial on a vaccine for COVID-19. The vaccine, called Soberana 1, contains a part of the spike protein, called RBD, along with an adjuvant to boost the immune response. The vaccine will be given in two injections during the trials that will involve 676 people aged between 19 and 80 years and finish in January 2021.

12.VECTOR INSTITUTE (RUSSIA)

PROTEIN SUBUNIT VACCINE

On August 26, a Russian biological research center known as the Vector Institute registered a Phase 1/2 trial for a coronavirus vaccine called EpiVacCorona. On 14 October, Vladimir Putin announced that Russia had granted regulatory approval for this vaccine, even though Phase 3 trials have not yet begun. This is the second COVID-19 vaccine the country has approved so far.

13.WEST CHINA HOSPITAL OF SICHUAN UNIVERSITY (CHINA)

PROTEIN SUBUNIT VACCINE

On 24 August, they got approval to run a Phase 1 trial. The vaccine incorporates recombinant protein grown in insect cells. To make the vaccine, researchers encode the receptor-binding domain (RBD) in a gene, which they insert into a virus. They then infect insect cells with the virus, triggering them to make the molecule in huge amounts. The hospital’s State Key Laboratory of Biological Therapy developed the “insect vaccine”, which seems to stop infection in monkeys without showing any apparent side effects.

14.UNIVERSITY HOSPITAL TUBINGeN (GERMANY)

PROTEIN SUBUNIT VACCINE

Earlier this year, rresearchers at the University of Tubingen in Germany created a vaccine made of viral proteins, along with an immune-stimulating adjuvant. In September they launched a Phase 1 trial.

15.COVAXX (USA)

PROTEIN SUBUNIT VACCINE

COVAXX, a subsidiary of United Biomedical, registered a Phase 1 trial on 11September in Taiwan and plan to run their Phase 2/3 trial in Brazil.

16.MERCK/DOHME/IAVI (USA)

VIRAL VECTOR VACCINE

Merck has joined forces with non-profit organisation IAVI to produce a vaccine candidate that will use the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for Merck’s Ebola Zaire virus vaccine, ERVEBO. The Ebola vaccine worked as well in the elderly as it did in young, healthy adults.

17.MERCK/INSTITUTE PASTEUR (USA)

VIRAL VECTOR VACCINE

Merck acquired the Austrian firm Themis Bioscience in June and is working on a vaccine originally developed at the Institut Pasteur. The vaccine uses the weakened measles virus to carry genetic material into cells. A Phase 1 trial launched in August.

18.BEIJING WANTAI BIOLOGICAL PHARMACY (CHINA)

VIRAL VECTOR VACCINE

In 2019, researchers at the University of Hong Kong and Xiamen University created a nasal-spray vaccine for the flu based on a weakened form of the influenza virus. Now they have engineered the vaccine to produce part of the coronavirus spike protein, which has started Phase 1 trials in partnership with Beijing Wantai Biological Pharmacy.

19.IMPERIAL COLLEGE (UK)

RNA 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 15 June and has partnered with Morningside Ventures to manufacture and distribute the vaccine.

20.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.

21.MEDICAGO (CANADA)

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.