Tracking COVID-19 Vaccine Development

“We think it is going to be a virus that stalks the human race for quite a long time to come.” ―Dr. David Nabarro, WHO special envoy


8

Country Vaccinations

― none yet ―


7

VAERS, VSD, PRISM, CISA

Post-Licensure Monitoring of Vaccines

― none yet ―


6

Phase IV Vaccine Trials

Post-Licensure Monitoring of Vaccines

― none yet ―


5

Approval and Licensure

― none yet ―

Existing Drugs Under Study

Know what Cytokine storms are and how they lead to high rates of fatalities even among young people.

1 April 2020, Anakinra, current use: Rheumatoid Arthritis. Being tested versus standard of care on blood oxygenation and systemic cytokine release syndrome in patients with COVID-19 coronavirus infection and acute hypoxic respiratory failure and systemic cytokine release syndrome.

Belgium

19 March 2020, Tocilizumab, current use: Arthritis. This study project includes a single-arm phase 2 study and a parallel observational cohort study, enrolling patients with COVID-19 pneumonia. All the patients enrolled are treated with tocilizumab. Additional: Roche initiates Phase III clinical trial of Actemra/RoActemra.

Italy

30 March 2020, Bacille Calmette-Guérin, current use: Tuberculosis. BCG vaccination to Reduce the impact of COVID-19 in Australian healthcare workers following Coronavirus Exposure (BRACE) Trial.

Australia

27 March 2020, Favipiravir (Avigan), current use: Influenza. Fujifilm Toyama Chemical released the following Information of Avigan Tablet in relation to Covid-19. Favipiravir prevents the propagation of viruses. The drug may potentially have an antiviral effect on the novel coronavirus as it is classified into the same type (single-stranded RNA virus) as influenza virus. However, at this stage, clinical application is under study to obtain clear evidence efficacy and safety.

Japan

18 March 2020, Lopinavir–Ritonavir, current use: HIV. This Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 had disappointing trial results contrary to hope that the pair of HIV drugs (lopinavir and ritonavir) could work.

China

18 March 2020, Hydroxychloroquine, current use: Malaria. Hydroxychloroquine, a less toxic derivative of chloroquine, is effective in inhibiting SARS-CoV-2 infection in vitro. Lab tests have shown it to be effective or helpful against the virus. There is no evidence of that, however, according to WHO.

China

17 March 2020, Hydroxychloroquine, Azithromycin (Z-Pak), current use: Malaria. A small study in France found that most patients taking the drug cleared the coronavirus from their system a lot faster than the control group. Adding azithromycin (Z-Pak) “was significantly more efficient for virus elimination.” A small study in China also found this combination to be "more potent than chloroquine.”

France

25 February 2020, Remdesivir, current use: Ebola. NIH clinical trial of remdesivir to treat COVID-19 begins. Trials are taking place in tthe UK with this anti-viral. Originally developed as an Ebola drug. Appears effective against other viruses. Similar trials carried out in China and the US.

United States

4 March 2020, Hydroxychloroquine, current use: Malaria. The FDA has granted "emergency use" authorisation in the treatment of Covid-19 for a limited number of hospitalised cases.

United States

18 March 2020, Hydroxychloroquine, current use: Malaria. Hydroxychloroquine, a less toxic derivative of chloroquine, is effective in inhibiting SARS-CoV-2 infection in vitro. Lab tests have shown it to be effective or helpful against the virus. There is no evidence of that, however, according to WHO.

China

4 March 2020, Hydroxychloroquine, current use: Malaria. The FDA has granted "emergency use" authorisation in the treatment of Covid-19 for a limited number of hospitalised cases.

United States

18 March 2020, Hydroxychloroquine, current use: Malaria. Hydroxychloroquine, a less toxic derivative of chloroquine, is effective in inhibiting SARS-CoV-2 infection in vitro. Lab tests have shown it to be effective or helpful against the virus. There is no evidence of that, however, according to WHO.

China

Information


4

Clinical Studies with Human Subjects

Phase III Vaccine Trials

Australia

Remestemcel-L ― Phase 2/3 trial with the Cardiothoracic Surgical Trials Network

9 April 2020, Mesoblast. Company's allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L will be formally evaluated in a randomized, placebo-controlled trial in 240 patients with acute respiratory distress syndrome (ARDS) caused by coronavirus infection (COVID-19). This multi-center Phase 2/3 trial will be conducted as a public-private partnership in a collaboration with the Cardiothoracic Surgical Trials Network (CTSN), which was established by the United States National Institutes of Health’s National Heart, Lung and Blood Institute (NHLBI) as a flexible platform for conducting collaborative trials. Mesoblast holds an Investigational New Drug (IND) Application from the United States Food and Drug Administration (FDA) for use of remestemcel-L in the treatment of patients with COVID-19 ARDS, and will provide investigational product for the trial.

M&Ms and Vaccines

Think of like an M&M candy. It has a protein shell on the outside and then on the inside, it's the RNA (single-stranded molecule) or DNA (double-stranded molecule.) In this case, it's RNA. That's what causes the problem. Your immune system doesn't see the RNA inside, it only recognized "the candy coating," which is the protein shell on the outside. When creating a vaccine, the first step is to sequence the DNA in the virus, so that you can start creating the protein shell. When they make vaccines, they take a lot of virus, think of M&Ms, and they smash them up and they melt away the chocolate. What's in the vaccine is that protein shell, bits of pieces of that protein shell, because that's what your immune system needs to learn that's not supposed to be in your body. So, when it sees that protein shell later, it attacks it and eliminates it. ―Dr. David Persse, Houston Health Department

“Unlike bacteria, viruses cannot copy themselves. Viruses use the machinery of the host.”


3

Clinical Studies with Human Subjects

Phase II Vaccine Trials

United States

VIR-7831, VIR-7832 ― Phase 2 clinical trials within three to five months

6 April 2020, Vir. GSK and Vir Biotechnology collaboration to use Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventative options. Initial focus will be the development of specific antibody candidates identified by the Vir platform, VIR-7831 and VIR-7832, that have demonstrated high affinity for the SARS-CoV-2 spike protein and are highly potent in neutralising SARS-CoV-2 in live virus-cellular assays. The companies plan to proceed directly into a phase 2 clinical trial within the next three to five months. Will also utilise Vir’s CRISPR screening and machine learning approach.

Quote

“The virus has no obligation to go quietly into the night.” ―Ian Haydon


2

Clinical Studies with Human Subjects

Phase I Vaccine Trials

United States

RNA; mRNA ― LUNAR-COV19
9 April 2020, Arcturus Therapeutics Ltd.

Arcturus Therapeutics will initiate a human clinical trial for its Covid-19 vaccine, also known as LUNAR-COV19 this summer of 2020, which plans to enroll up to 76 healthy volunteer adults including elderly individuals, with follow-up over several months to evaluate extent and duration of immune response. LUNAR-COV19 is a very low dose, potential single-shot, self-replicating mRNA vaccine that is free from any viral material or co-adjuvants. Preclinical in vitro data shows that administration of LUNAR-COV19 generates effective expression of the COVID-19 virus spike protein – the antigen to which protective antibodies will be formed. LUNAR-COV19 (LBP)

United States

NVX-CoV2373 ― SARS-CoV-2 candidate for Phase 1 clinical trial

8 April 2020, Novavax. Company has identified an ideal coronavirus vaccine candidate . First clinical human trial slated for mid-May. In pre-clinical animal trials, NVX-CoV2373 has proven it can produce immune responses and high levels of antibodies against COVID-19. This ideal vaccine candidate was selected from a number of constructs. The NVX-CoV2373 clinical development plan combines a Phase 1/Phase 2 approach to allow rapid advancement during the current coronavirus pandemic. The Phase 1 clinical trial is a placebo-controlled observer blinded study of ~130 healthy adults and includes assessment of dosage amount and number of vaccinations. The trial is expected to begin in mid-May with preliminary immunogenicity and safety results in July.

Canada

DPX-COVID-19 ― IMV Inc. updates on the development of COVID-19 vaccine

30 March 2020, IMV

IMV, a biotech company based in Canada, announced its intent to create a vaccine candidate for COVID-19 based off DPX-Survivac, a T-cell activating immunotherapy antigen vaccine currently being tested in trials for effectiveness against recurrent ovarian cancer, advanced and recurrent solid tumors, and survivin-expressing diffuse large B-cell lymphoma DLBCL. They are developing a phase 1 clinical study of 48 healthy subjects and plans to begin the trail in the summer of 2020. DPX (LBP)


United States

INO-4800 ― Human testing on second coronavirus vaccine candidate begins

6 April 2020, Innovio Pharmaceuticals. After FDA approval, first phase of clinical testing set to begin this week with 40 healthy adult volunteers. Each volunteer will receive two doses of the drug, INO-4800, four weeks apart. Initial immune responses and safety data expected by late summer. Preclinical data has shown promising immune response results across multiple animal models. The drug is a DNA vaccine designed to prevent COVID-19 infection. Preclinical results consistent with a completed phase one vaccine study for MERS, which is also caused by a coronavirus. Funded by the Bill and Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations.

Australia

ChAdOx1, INO-4800 ― CSIRO starts pre-clinical trials for two COVID-19 vaccine candidates

2 April 2020, CSIRO. In strategic partnership with the Coalition for Epidemic Preparedness Innovations (CEPI), the Commonwealth Scientific and Industrial Research Organisation (CSIRO) has begun the first stage of testing for the vaccine candidates from the University of Oxford called ChAdOx1 nCoV-19 and Inovio Pharmaceuticals Inc. called INO-400. The vaccine ChAdOx1 is an adenovirus vaccine vector developed at Oxford’s Jenner Institute.

United States

Ad26 SARS-CoV-2, SARS-CoV-2 mRNA-1273 ― HHS Accelerates Clinical Trials

30 March 2020, HHS. The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), will support non-clinical studies and a Phase 1 clinical trial of Janssen’s COVID-19 investigational vaccine, Ad26 SARS-CoV-2. The Phase 1 clinical trial is set to begin no later than fall of 2020 with the goal of making COVID-19 vaccine available for emergency use in the United States in early 2021. At the same time, BARDA will collaborate with Moderna to prepare now for Phase 2 and 3 clinical trials of a vaccine known as SARS-CoV-2 mRNA-1273, being developed by Moderna and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

POV

On Moderna trial: “The idea behind this vaccine involves a relatively new strategy. All vaccines attempt to train the immune system to respond to an invader before it has breached the gates. Usually, that means injecting a weakened pathogen or part of one into a healthy person. Instead of injecting me with protein derived from the virus, the researchers jabbed me with genetic material encoding such a protein. If my body absorbs this code and carries out its instructions, some of my cells will produce a single protein from the virus. That should prompt my immune system to create antibodies against the viral molecule. The idea is that those antibodies would protect against the real virus.” ―Ian Haydon


United States

Lead Vaccine Candidate ― J&J aiming to initiate a Phase 1 clinical study in September 2020

30 March 2020, Johnson & Johnson. Company constructed and tested multiple vaccine candidates using the Janssen AdVac® technology. identified a lead COVID-19 vaccine candidate (with two back-ups). Aiming to initiate a Phase 1 clinical study in September 2020, with clinical data expected to be available by the end of the year. This could allow vaccine availability for emergency use in early 2021. The typical vaccine development process involves a number of different research stages, spanning 5 to 7 years, before a candidate is even considered for approval.

United Kingdom

ChAdOx1 nCoV-19 ― Oxford vaccine programme starts clinical trial recruitment

27 March 2020, Oxford University. Vaccine based on an adenovirus vaccine vector and the SARS-CoV-2 spike protein. Chosen as the most suitable vaccine technology for a SARS-CoV-2 (COVID-19) vaccine as it can generate a strong immune response from one dose and it is not a replicating virus, so it cannot cause an ongoing infection in the vaccinated individual. This also makes it safer to give to children, the elderly and anyone with a pre-existing condition such as diabetes. Already in production but won’t be ready for some weeks still.

China

Ad5-nCoV ― Phase 1 Clinical Trial for CanSinoBIO’s investigational vaccine against COVID-19

17 March 2020, CanSinoBio. Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) candidate “Ad5-nCoV”, developed by CanSino Biologics Inc. and Beijing Institute of Biotechnology (BIB) approved for Phase 1 Clinical Trial. Also been successfully applied to develop the globally innovative vaccine against Ebola virus. Results from pre-clinical animal studies show that the vaccine candidate can induce strong immune response in animal models. (LBP)

United States

mRNA-1273 ― First shot for potential COVID-19 vaccine administered

16 March 2020, NIH. First shot in trial for a potential vaccine for the novel coronavirus administered in a trial at the Kaiser Permanente Washington Health Research Institute in Seattle. It aims to enroll 45 healthy adults over a six-week period. This is a phase one trial, the first of multiple steps in the clinical trial process. The vaccine mRNA-1273 was developed by the NIH and its collaborators at Moderna Inc., based in Cambridge, Mass. It took only about two months for Moderna to develop the vaccine and ship it to the NIH. However, under the best case scenario, vaccine won't be ready for 12 to 18 months.

Therapeutics

COVID-19 Therapeutics refers to methods and means of alleviating symptoms so carriers can have milder symptoms and so overall mortality rate can be lowered. (CDC, WHO)

9 April 2020, MultiStem. There is no FDA approved and effective medicine for ARDS. The current standard of care is to place patients on a ventilator, which forces oxygen into the lungs to keep the patient alive. Currently MultiStem is the only investigational therapy that has shown promise for the treatment of ARDS that has been granted Fast Track designation by the FDA.

United States


1

Laboratory and Animal Studies

Exploratory Stage, Pre-Clinical Stage, IND Application

India, Australia

Partnership between Indian Immunologicals and Griffith University in Australia

8 April 2020, Indian Immunologicals. Partners intend to create a live attenuated vaccine using codon de-optimisation technology, which would offer longer protection with a single dose. The technology looks promising for developing a vaccine for prophylactic, active, single-dose immunisation against coronavirus in humans, with an enhanced safety profile. Company site here.

United Kingdom

VLP ― Multiple vaccine candidates based vaccine platform ADDomer

7 April 2020, Imophoron. UK biotech company has produced multiple COVID-19 vaccine candidates. The platform ADDomer© is a synthetic, self-assembling, nature-inspired virus-like particle (VLP). Currently at pre-clinical stage, vaccines based on the ADDomer© will need to be studied in human clinical trials once they have completed pre-clinical tests. Pre-clinical trials are to begin within weeks.Vaccines based on the ADDomer platform are likely to require no adjuvant, no refrigeration and have reduced risk of side effects.

United States

PittCoVacc ― Vaccine in first peer-reviewed trial effective on mice

2 April 2020, University of Pittsburgh. Human trials still in the planning stages. Currently applying for FDA approval. "PittCoVacc" (Pittsburgh Coronavirus Vaccine) works by injecting lab-made pieces of viral protein into the body to help it build an immunity. Just like a flu shot. When tested in mice, there was a surge on the number of antibodies capable of neutralizing the deadly SARS-CoV–2 virus two weeks after delivery. Drug administered through a microneedle array, a Band-Aid like patch made up of 400 tiny microneedles. Here's their peer-reviewed paper.

China

RNA; LNP-encapsulated mRNA cocktail encoding RBD ― The first demonstration of virus-like particles expressed from a modified mRNA cocktail

7 March 2020, Fudan University, Shanghai JiaoTong University, and RNACure Biopharma

A joint research team from Fudan University, Shanghai JiaoTong University, and RNACure Biopharma is developing a messenger RNA (mRNA) vaccine against COVID-19. They are employing two strategies to develop mRNA vaccines against COVID-19: to use mRNA to express the receptor-binding domain of the spike protein of COVID-19 to induce neutralizing-antibodies in human body, and to formulate mRNAs that can instruct the host to produce virus-like particles (VLPs), with morphological and structural features similar to those of native COVID-19 viruses and activate immune responses. mRNA vaccines (LBP)


United States

Pre-clinical testing under way using tobacco plant technology

1 April 2020, Kentucky BioProcessing. British American Tobacco’s US bio-tech subsidiary, Kentucky BioProcessing (KBP), is developing a potential vaccine for COVID-19 and is now in pre-clinical testing. If testing goes well, BAT is hopeful that, with the right partners and support from government agencies, between 1 and 3 million doses of the vaccine could be manufactured per week, beginning in June.

Canada

VLPs ― First shot for potential COVID-19 vaccine administered

12 March 2020, Medicago. Virus-Like Particle (VLPs) of the coronavirus successfully produced just 20 days after obtaining the SARS-CoV-2 gene. Production of VLPs is the first step in developing a vaccine against COVID-19 before preclinical testing for safety and efficacy. VLPs mimic the native structure of viruses, allowing them to be easily recognized by the immune system. However, they lack core genetic material which makes them non-infectious and unable to replicate.

Canada

Antibody Therapy ― AbCellera and Lilly to collaborate

12 March 2020, AbCellera, Lilly. Will select from 500+ unique antibodies isolated from one of the first U.S. patients who recovered from COVID-19 to create antibody therapeutics for treatment and prevention of COVID-19. The collaboration will leverage AbCellera's rapid pandemic response platform, developed under the DARPA Pandemic Prevention Platform (P3) Program, and Lilly's global capabilities for rapid development, manufacturing and distribution of therapeutic antibodies.


China and United Kingdom

COVID-19 S-Trimer ― Clover and GSK Research Collaboration

24 February 2020, GlaxoSmithKline, Clover Biopharmaceuticals and Xiamen Innovax

Clover Biopharmaceuticals has entered into a research collaboration with GSK for its protein-based coronavirus vaccine candidate, COVID-19 S-Trimer (trimeric SARS-CoV-2 spike (S)-protein subunit). The trimeric S protein of SARS-CoV-2 is responsible for binding to host cell surface receptor ACE2 and subsequent viral entry, making it the primary target antigen for vaccine development. GSK will provide Clover with its pandemic adjuvant system for further evaluation of S-Trimer in preclinical studies. GSK also has partnered with Chinese company Xiamen Innovax Biotech and offered its vaccine adjuvant technology to the company. COVID-19 S-Trimer (LBP)

United States

Horsepox vaccine with percutaneous administration ― Southern Research, Tonix team to develop potential vaccine against COVID-19

26 February 2020, Tonix Pharmaceuticals and Southern Research

Biopharmaceuticals company Tonix is partnering with Southern Research to develop a COVID-19 vaccine candidate based on the company’s horsepox vaccine platform, TNX-1800, that has the potential to serve as a vector for vaccines to protect against other infectious agents. Horsepox has efficacy as a vaccine and good tolerability in mice and cynomolgus macaques that is closely related to vaccinia vaccines which have been engineered to express coronavirus proteins and to elicit vaccine responses successfully in the past. Horsepox (LBP)

United States

gp96-based vaccine ― Heat Biologics launches program to develop vaccine against COVID-19

3 March 2020, Heat Biologics

Heat Biologics, Inc. has formally launched a program within its wholly-owned subsidiary, Zolovax, Inc., to develop a vaccine using its immune activating gp96 vaccine platform for treating or preventing infection from the SARS-CoV-2 coronavirus that causes COVID-19. It is a platform that has been shown to induce a potent immune response and effectiveness in the induction of mucosal immunity in several infectious disease models. gp96 vaccine (LBP)

Israel

Modified avian coronavirus vaccine ― Israeli Scientists’ Coronavirus Vaccine in Just Weeks

28 February 2020, MIGAL Galilee Research Institute

Galilee Research Institute is planning to create a new COVID-19 vaccine candidate by adapting its research in developing a vaccine for the genetically-similar avian coronavirus Infectious Bronchitis Virus (IBV). Their goal is to produce the vaccine for next 8-10 weeks, to achieve safety approval in 90 days, and in discussion with partners that can help accelerate the human trials. . This will be an oral vaccine, making it particularly accessible to the general public. Avian coronavirus (LBP)


United States

Re-purposed SARS vaccine for COVID-19; S1 or RBD protein vaccine candidate

9 April 2019, Baylor College of Medicine

Researchers at the Baylor College of Medicine have a shelved vaccine from the 2003 SARS outbreak that could be repurposed for use in the COVID-19 pandemic. The experience they gained for years in developing the SARS vaccine has provided them with time-saving, parallel and rapid-switch strategies as well as critical scientific information that may help accelerate the development of a safe and effective COVID-19 vaccine. They are also developing an S1 or RBD protein vaccine as a targeted vaccine candidate for COVID-19. SARS vaccine (LBP)

United States

Adenovirus-based vector vaccine candidate for COVID-19

11 March 2020, Greffex, Inc.

Greffex, Inc., a leading genetic engineering company, revealed its completion of a COVID-19 vaccine candidate. Instead of using a living or killed virus for its vaccine, the company used an adenovirus-based vector vaccine. The vaccine candidate has already entered the animal testing stage as required by the U.S. government Food and Drug Administration. The company has committed free distribution of the vaccine to the other countries once approved by the government. Adenovirus-based vector vaccine (LBP)

Russia

mRNA vaccine candidate ― BIOCAD started working on mRNA vaccine against coronavirus

19 March 2020, BIOCAD

Russian biotech company BIOCAD announced it is developing an mRNA vaccine candidate for COVID-19 based on previous pipelines for mRNA-oncovaccines creation, where the company has a great expertise. Three vaccine options are planned to be developed and animal testing is scheduled for late April. The short development period is granted by its mRNA basis. Unlike the traditional vaccines that are based on reorganized proteins, manufacturing of small molecules drugs takes less than five to six months. mRNA vaccine (LBP)


United States

Intranasal COVID-19 vaccine ― Altimmune Completes First Development Milestone

28 February 2020, Altimmune

Altimmune has developed a COVID-19 vaccine candidate, using the same technology they used to build their influenza vaccine, NasoVAX. The COVID-19 vaccine would be delivered intranasally in a single dose. Because intranasal delivery directs the immune response where it is needed most to protect against respiratory infection including the likely site of initial viral attack, they believe that the clinical profile of NasoVAX is particularly relevant to COVID-19. Altimmune already begins the animal testing, and clinical testing is slated for August 2020 or later. COVID-19 vaccine would be delivered intranasally (LBP)

Australia

Protein subunit; S protein clamp ― The molecular clamp platform

17 January 2020, University of Queensland

The University of Queensland has developed a process that can synthesize the surface proteins while “clamping” them into shape, making it easier for the immune system to induce a response that recognizes them on the virus surface. This synthetic antigen can then be purified and rapidly manufactured into a vaccine, within 16 weeks from pathogen identification. Surface Proteins (LBP)

United States

Oral Vaccine platform ― Vaxart Announces Initiation of Coronavirus Vaccine Program

31 January 2020, Vaxart, Inc.

Vaxar, Inc. a clinical-stage biotechnology company developing oral recombinant vaccines administered by tablet rather than by injection, has initiated a program to develop a coronavirus vaccine candidate based on its proprietary oral vaccine platform, VAAST. Under the program, they plan to generate vaccine candidates based on the published genome of the 2019 Novel Coronavirus (2019-nCoV) and evaluate them in preclinical models for their ability to generate both mucosal and systemic immune responses. Of particular interest will be the mucosal immune responses, as coronavirus is primarily an infection of the respiratory tract. Oral Vaccine platform (LBP)


United States and India

Deoptimized live attenuated virus ― Serum Institute ties up with US biotech firm to develop vaccine against COVID-19

19 February 2020, Codagenix and Serum Institute of India

Serum Institute of India (SII) has an algorithm, with which it has designed several coronavirus vaccine candidate genomes, in which four candidates will be tested in mice to understand the safety and efficacy of the vaccine before it can be used for testing in human clinical trials. In a matter of days after the virus was first isolated, the novel coronavirus genome was available in the public domain. Codagenix has designed multiple coronavirus vaccine candidate genomes using its proprietary deoptimisation technology due to open-source data sharing among scientists and public health agencies. The vaccine viruses will be grown and tested in vivo by laboratories suitable for containment prior to clinical trials. Deoptimization technology (LBP)

Italy

DNA-based vaccine ― Covid-19 vaccine ready on pre-clinical models

17 March 2020, Takis Biotech

The partnership between Takis Biotech and Applied DNA Sciences has resulted in four DNA vaccine candidates for COVID-19. It is a genetic vaccine, which contains only a fragment of DNA that is safe and induces response from the immune system. It is based on the technology called electroporation, which consists of the injection into the muscle followed by a very short electrical impulse which facilitates its entry into the cells and activates the immune system. Takis expects preclinical testing results in April 2020, and if the results are satisfactory, the vaccine could already be tested on humans in Autumn. DNA-based vaccine (LBP)

Hong Kong

Live-attenuated ― CEPI partners with University of Hong Kong to develop COVID-19 vaccine

18 March 2020, University of Hong Kong

CEPI will provide initial funding to HKU to undertake preclinical testing of their vaccine candidate and will consider additional funding for further clinical testing pending results of these preclinical studies. Researchers at HKU have created a live-attenuated influenza vaccine platform, a vaccine candidate using a weakened version of the flu virus and have adapted it to express the surface protein of the COVID-19 virus. This approach has previously been used to develop preclinical vaccine candidates against MERS. Live-attenuated (LBP)


United Kingdom

Self-amplifying RNA vaccine ― Scores of Imperial researchers are racing to create a vaccine to combat the coronavirus COVID-19.

20 March 2020, Imperial College London

Within 14 days of getting the sequence from China, Professor Robin Shattock and his team in Imperial College London’s Department of Infectious Disease developed a candidate vaccine. Since 10 February, they have been testing the vaccine on animals and planning to move to clinical trials in the summer. The self-amplifying RNA vaccine works by effectively injecting new genetic code into a muscle, instructing it to make a protein found on the surface of coronavirus, which triggers a protective immune response. According to Professor Robin Shattock, if all goes well, the vaccine could be available sometime next year. It is also possible by having a kind of technology that can generate a vaccine with a speed. Self-amplifying RNA vaccine (LBP)

United States

Gene-encoded antibody vaccine, non-viral nanoparticle delivery ― Collaboration of Sorrento and SmartPharm to develop novel gene-encoded antibody vaccine for COVID-19

23 March 2020, SmartPharm Therapeutics and Sorrento Therapeutics

Sorrento Therapeutics, Inc. and SmartPharm Therapeutics Inc. announced a research and development collaboration to develop a next-generation, gene-encoded antibody vaccine for COVID-19 that will utilize monoclonal antibodies against SARS-CoV-2 virus discovered and/or generated by Sorrento that will be encoded into a gene for delivery utilizing SmartPharm’s non-viral nanoparticle platform. This gene-encoded monoclonal antibody delivery platform or Gene MAb™ bypasses the in vitro antigen production process and potential for vaccine-induced side-effects in immunized individuals, which is especially important in susceptible populations like the elderly, where antigen-based vaccines are significantly less effective for the prevention of respiratory infections such as influenza or coronavirus. The companies expect that this novel approach will enable faster progression to clinic, pending agreement with the FDA. Gene-encoded antibody vaccine (LBP)

France and United States

RNA; mRNA ― Collaboration of Sanofi Pasteur and Translate Bio to Develop a Novel mRNA Vaccine Candidate Against COVID-19

27 March 2020, Sanofi Pasteur and Translate Bio

Translate Bio has begun producing multiple mRNA constructs and will use its mRNA platform to discover, design and manufacture SARS-CoV-2 vaccine candidates, and Sanofi will provide deep vaccine expertise and support from its external research networks to advance vaccine candidates for potential further development. mRNA vaccines offer an innovative approach by delivering a nucleotide sequence encoding the antigen or antigens selected for their high potential to induce a protective immune response. It also represent a potentially innovative alternative to conventional vaccine approaches for several reasons, which potentially enables the development of vaccines for disease areas where vaccination is not a viable option today. Additionally, a desired antigen or multiple antigens can be expressed from mRNA without the need to adjust the production process offering maximum flexibility and efficiency in development. mRNA vaccines (LBP)


Canada

Pan-coronavirus vaccine candidate, targeting COVID-19, SARS, and MERS, spike protein

31 March 2020, VBI Vaccines / National Research Council of Canada

VBI Vaccines Inc. announced a collaboration with the National Research Council of Canada (NRC), to develop a pan-coronavirus vaccine candidate, targeting COVID-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS). This collaboration will combine VBI’s viral vaccine expertise, eVLP technology platform, and coronavirus antigens with the NRC’s uniquely-designed COVID-19 antigens and assay development capabilities to identify the most immunogenic vaccine candidate for further development. Pan-coronavirus (LBP)

United States

HaloVax, a joint venture of Voltron Therapeutics and Hoth Therapeutics to harness new technology for rapid COVID-19 vaccine development

6 April 2020, Voltron Therapeutics and Hoth Therapeutics

Voltron announced that HaloVax is preparing to take its COVID-19 vaccine into animal trials this month, hoping to start a safety testing in people soon, after the preclinical work is completed. It is one of the several product candidates emerging from newly formed alliances that are focused on harnessing new technology to speed up vaccine development. VaxCelerate, the Voltron candidate developed at MGH, is designed to quickly generate and test “self-assembling” vaccines that spark immune responses to viruses. Rather than one of the chemical adjuvants that are commonly employed by vaccine developers, the experimental COVID-19 vaccine uses a heat shock protein to activate the immune system. The vaccine will also include a variable component that targets specific characteristics of COVID-19. VaxCelerate (LBP)

China

RNA; mRNA vaccine ― Novel coronavirus vaccine starts animal trials

10 February 2020, China CDC/Tongji University and Stermina

The mRNA vaccine was co-developed by the CDC, Shanghai-based Tongji University School of Medicine and Stermirna Therapeutics Co., Ltd. has been tested on animals. The vaccine samples were injected into more than 100 mice, as an initial screening of candidate vaccine. To ensure the the safety of the vaccine in human clinical trials, there will be toxicity tests on larger animals such as monkeys. mRNA vaccine (LBP)

Diagnostics

COVID-19 Diagnostics refers to methods for quickly and effectively detecting the disease in the first place. Currently, there are two types for laboratory testing for the respiratory coronavirus disease 2019 (COVID-19) and the associated SARS-CoV-2 virus. One is detecting the presence of virus. The other one is detecting antibodies produced in response to infection. The presence of viruses is confirmed by RT-PCR, which detects the coronavirus' RNA. Detection of antibodies (serology) can be used both for diagnosis and population surveillance. (CDC, WHO)


0

Genome Sequencing

France

Genome ― Whole genome of the coronavirus, 2019-nCoV Sequenced

30 January 2020, Institut Pasteur. The first institution in Europe to sequence the virus. Sequenced at the Institut Pasteur's Mutualized Platform for Microbiology (P2M), which performs genome sequencing on bacterial, viral, fungal and parasite strains.

Norway

Funding ― CEPI announces funding for three programmes to develop nCoV-2019 vaccines

23 January 2020, CEPI. Coalition for Epidemic Preparedness Innovations will fund nCoV-2019 vaccine development efforts, building on existing partnerships with Inovio (Nasdaq: INO) and The University of Queensland (located in Brisbane, Australia), Moderna, Inc., (Nasdaq: MRNA) and the U.S. National Institute of Allergy and Infectious Diseases.

China

Genome ― Chinese authorities shared the full sequence of the coronavirus genome

11 January 2020, NCBI. Chinese health authorities identified more than 40 human infections as part of this outbreak that was first reported on December 31. Preliminary identification of the novel coronavirus announced by WHO on January 9. The GenBank record of Wuhan-Hu-1 includes sequence data, annotation and metadata from the virus isolated from a patient believed to have contracted the disease in a Hubei province seafood market.


Acronyms

IND - Investigational New Drug Application

VAERS - Vaccine Adverse Event Reporting System

VSD - Vaccine Safety Datalink

PRISM - Post-Licensure Rapid Immunization Safety Monitoring

CISA - Clinical Immunization Safety Assessment Project

Names of individual contributors, unless anonymity is requqested, with links to their sites will be added to this list as soon your submissions are verified and added to the timeline. Thank you for your patience.


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DOH COVID-19 Hotlines ☎️ 1555 (PLDT, Smart, Sun, TNT) ☎️ (02) 894-26843 (894-COVID)

National Center for Mental Health 📱 0917-899-USAP (8727) ☎️ 8-989-USAP (8727)


COVID-19 Local Government Response in the Philippines


👍Market on wheels 👍Teamwork with Pasig 👍Food vouchers 👍Foodpack redemption site 👍Trinx bikes and helmets 👍Modular tents and military cot beds isolation centers 👍Free shuttles for healthworkers and frontliners 👍Anti-panic buying and Anti-hoarding measures 👍Deployment of grocery watchers 👍Surface disinfection

👍Mobile palengke 👍Teamwork with Valenzuela 👍Drones for disinfection 👍Financial aid to vendors, tricycle, jeepney drivers 👍Pasig Bike for frontliners 👍Anti-Panic Buying and Hoarding Ordinance

👍Temporary shelter for health workers 👍Deployment of e-trikes for frontliners 👍School isolation rooms 👍Anti-Hoarding, Profiteering and Cartel Ordinance 👍Ordinance financial assistance for employees and job order workers 👍Tarpaulins for public information 👍Disinfection operation 👍Manila Infectious Disease Control Center

👍 Financial assistance for tricycle and jeepney drivers 👍Food packs for batang Makatizens 👍 Shuttle buses for OsMak personnel

👍Ordinance on San Juan City curfew 👍COVID19 ward at San Juan Medical Center 👍Distribution of food packs

👍 Medical screening for fishing crew 👍 Additional compensation sa Contract of Service (COS), Job Orders (JOs) 👍 Training center turned into temporary shelters for frontliners 👍 Distribution of relief packs

👍 Kadiwa on Wheels 👍 Simultaneous decontamination operation in all barangays 👍 Rooms for frontliners offered by student dormitory 👍 Basketball courts as quarantine facilities for PUIs 👍 Distribution of food packs

👍 Online medical consultatons 👍 Seminar on social distancing 👍 Distribution of vitamins, medicines for diabetes, hypertension, and tuberculosis, and contraceptives

👍 Misting operations 👍 Social amelioration package for displaced residents working in malls 👍 Rice distribution for city residents

👍 Mobile Palengke 👍 City Ordinance Imposing City-Wide Curfew 👍 Shuttle services for medical personnel and frontliners 👍 Release of 13th month pay for City Hall employees 👍 Food assistance for PUMs and PUIs

👍 Disinfection of police stations and community precints 👍 Window-hour scheme for residents going to the market 👍 Distribution of relief goods 👍 Early release of 13th month (midyear) bonus to permanent LGU employees 👍 Free health kits for senior citizens

👍 Distribution of grocery package 👍 Palengke on Wheels

👍 Disinfection drive 👍 Free shuttle for frontline workers 👍 Early release of city hall employees' end of month salary 👍 Virtual Mental Health and Psychological Support 👍 Anti-Panic Buying Ordinance 👍 Installation of Automatic Disinfectant Sprayer in National Road

👍 Disinfection operations 👍 Free transportation for frontliners 👍 Distribution of food packs

👍 Mobile palengke 👍 Eggs and vouchers for tricycle and pedicab drivers 👍 Disinfection and Sanitation

👍 Mobile market 👍 Use of DOE e-trike for frontliners

👍 Relief goods 👍 Temporary Pamilihang Bayan sa harap ng Munisipyo


© The New Co-operator™ Creative Commons. Some rights reserved.

Co-operative Marque

Cooperative Healthcare


A public health advocacy by The New Co-operator™


DOH COVID-19 Hotlines ☎️ 1555 (PLDT, Smart, Sun, TNT) ☎️ (02) 894-26843 (894-COVID)

National Center for Mental Health 📱 0917-899-USAP (8727) ☎️ 8-989-USAP (8727)


Get in touch


We are affiliated with the following co-operative primary and federations. If you have questions about their services during this time of national health emergency due to COVID-19, you may get in touch using the contact form below.

And Jesus went about all the cities and villages, teaching in their synagogues, and preaching the gospel of the kingdom, and healing every sickness and every disease among the people. ―Matthew 9:35

Cooperative Service LineYear
CHMFHealth Maintenance Organization2014
CISPLife and Non-Life Insurance1974
PCCPhilippine Cooperative Center1995
MutualCapitalCooperative Advocacy2019

© The New Co-operator™ Creative Commons. Some rights reserved.

Research on COVID-19 Vaccine Development

Codon de-optimisation ⯈ Indian Immunologicals and Griffith University in Australia

8 April 2020, Indian Immunologicals. Partners intend to create a live attenuated vaccine using codon de-optimisation technology, which would offer longer protection with a single dose. The technology looks promising for developing a vaccine for prophylactic, active, single-dose immunisation against coronavirus in humans, with an enhanced safety profile. Company site here.

VLP ⯈ Multiple vaccine candidates based vaccine platform ADDomer

7 April 2020, Imophoron. UK biotech company has produced multiple COVID-19 vaccine candidates. The platform ADDomer© is a synthetic, self-assembling, nature-inspired virus-like particle (VLP). Currently at pre-clinical stage, vaccines based on the ADDomer© will need to be studied in human clinical trials once they have completed pre-clinical tests. Pre-clinical trials are to begin within weeks.Vaccines based on the ADDomer platform are likely to require no adjuvant, no refrigeration and have reduced risk of side effects.

INO-4800 ⯈ Human testing on second coronavirus vaccine candidate begins

6 April 2020, Innovio Pharmaceuticals. After FDA approval, first phase of clinical testing set to begin this week with 40 healthy adult volunteers. Each volunteer will receive two doses of the drug, INO-4800, four weeks apart. Initial immune responses and safety data expected by late summer. Preclinical data has shown promising immune response results across multiple animal models. The drug is a DNA vaccine designed to prevent COVID-19 infection. Preclinical results consistent with a completed phase one vaccine study for MERS, which is also caused by a coronavirus. Funded by the Bill and Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations.

VIR-7831, VIR-7832 ⯈ Phase 2 clinical trials within three to five months

6 April 2020, Vir. GSK and Vir Biotechnology collaboration to use Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventative options. Initial focus will be the development of specific antibody candidates identified by the Vir platform, VIR-7831 and VIR-7832, that have demonstrated high affinity for the SARS-CoV-2 spike protein and are highly potent in neutralising SARS-CoV-2 in live virus-cellular assays. The companies plan to proceed directly into a phase 2 clinical trial within the next three to five months. Will also utilise Vir’s CRISPR screening and machine learning approach.

ChAdOx1, INO-4800 ⯈ CSIRO starts pre-clinical trials for two COVID-19 vaccine candidates

2 April 2020, CSIRO. In strategic partnership with the Coalition for Epidemic Preparedness Innovations (CEPI), the Commonwealth Scientific and Industrial Research Organisation (CSIRO) has begun the first stage of testing for the vaccine candidates from the University of Oxford called ChAdOx1 nCoV-19 and Inovio Pharmaceuticals Inc. called INO-400. The vaccine ChAdOx1 is an adenovirus vaccine vector developed at Oxford’s Jenner Institute.

PittCoVacc ⯈ Vaccine in first peer-reviewed trial effective on mice

2 April 2020, University of Pittsburgh. Human trials still in the planning stages. Currently applying for FDA approval. "PittCoVacc" (Pittsburgh Coronavirus Vaccine) works by injecting lab-made pieces of viral protein into the body to help it build an immunity. Just like a flu shot. When tested in mice, there was a surge on the number of antibodies capable of neutralizing the deadly SARS-CoV–2 virus two weeks after delivery. Drug administered through a microneedle array, a Band-Aid like patch made up of 400 tiny microneedles. Here's their peer-reviewed paper.

Ad26 SARS-CoV-2, SARS-CoV-2 mRNA-1273 ⯈ HHS Accelerates Clinical Trials

30 March 2020, HHS. The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), will support non-clinical studies and a Phase 1 clinical trial of Janssen’s COVID-19 investigational vaccine, Ad26 SARS-CoV-2. The Phase 1 clinical trial is set to begin no later than fall of 2020 with the goal of making COVID-19 vaccine available for emergency use in the United States in early 2021. At the same time, BARDA will collaborate with Moderna to prepare now for Phase 2 and 3 clinical trials of a vaccine known as SARS-CoV-2 mRNA-1273, being developed by Moderna and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

Lead Vaccine Candidate ⯈ J&J aiming to initiate a Phase 1 clinical study in September 2020

30 March 2020, Johnson & Johnson. Company constructed and tested multiple vaccine candidates using the Janssen AdVac® technology. identified a lead COVID-19 vaccine candidate (with two back-ups). Aiming to initiate a Phase 1 clinical study in September 2020, with clinical data expected to be available by the end of the year. This could allow vaccine availability for emergency use in early 2021. The typical vaccine development process involves a number of different research stages, spanning 5 to 7 years, before a candidate is even considered for approval.

ChAdOx1 nCoV-19 ⯈ Oxford vaccine programme starts clinical trial recruitment

27 March 2020, Oxford University. Vaccine based on an adenovirus vaccine vector and the SARS-CoV-2 spike protein. Chosen as the most suitable vaccine technology for a SARS-CoV-2 (COVID-19) vaccine as it can generate a strong immune response from one dose and it is not a replicating virus, so it cannot cause an ongoing infection in the vaccinated individual. This also makes it safer to give to children, the elderly and anyone with a pre-existing condition such as diabetes. Already in production but won’t be ready for some weeks still.

WHO ⯈ 44 COVID-19 vaccine candidates

20 March 2020, WHO. There are a total of 44 candidate vaccines in clinical evaluation listed in its draft landscape of COVID-19 candidate vaccines.

Ad5-nCoV ⯈ Phase 1 Clinical Trial for CanSinoBIO’s investigational vaccine against COVID-19

17 March 2020, CanSinoBio. Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) candidate “Ad5-nCoV”, developed by CanSino Biologics Inc. and Beijing Institute of Biotechnology (BIB) approved for Phase 1 Clinical Trial. Also been successfully applied to develop the globally innovative vaccine against Ebola virus. Results from pre-clinical animal studies show that the vaccine candidate can induce strong immune response in animal models. (LBP)

mRNA-1273 ⯈ First shot for potential COVID-19 vaccine administered

16 March 2020, NIH. First shot in trial for a potential vaccine for the novel coronavirus administered in a trial at the Kaiser Permanente Washington Health Research Institute in Seattle. It aims to enroll 45 healthy adults over a six-week period. This is a phase one trial, the first of multiple steps in the clinical trial process. The vaccine mRNA-1273 was developed by the NIH and its collaborators at Moderna Inc., based in Cambridge, Mass. It took only about two months for Moderna to develop the vaccine and ship it to the NIH. However, under the best case scenario, vaccine won't be ready for 12 to 18 months.

VLPs ⯈ First shot for potential COVID-19 vaccine administered

12 March 2020, Medicago. Virus-Like Particle (VLPs) of the coronavirus successfully produced just 20 days after obtaining the SARS-CoV-2 gene. Production of VLPs is the first step in developing a vaccine against COVID-19 before preclinical testing for safety and efficacy. VLPs mimic the native structure of viruses, allowing them to be easily recognized by the immune system. However, they lack core genetic material which makes them non-infectious and unable to replicate.

Antibody Therapy ⯈ AbCellera and Lilly to collaborate

12 March 2020, AbCellera, Lilly. Will select from 500+ unique antibodies isolated from one of the first U.S. patients who recovered from COVID-19 to create antibody therapeutics for treatment and prevention of COVID-19. The collaboration will leverage AbCellera's rapid pandemic response platform, developed under the DARPA Pandemic Prevention Platform (P3) Program, and Lilly's global capabilities for rapid development, manufacturing and distribution of therapeutic antibodies.

Genome ⯈ Whole genome of the coronavirus, 2019-nCoV Sequenced

30 January 2020, Institut Pasteur. The first institution in Europe to sequence the virus. Sequenced at the Institut Pasteur's Mutualized Platform for Microbiology (P2M), which performs genome sequencing on bacterial, viral, fungal and parasite strains.

Funding ⯈ CEPI announces funding for three programmes to develop nCoV-2019 vaccines

23 January 2020, CEPI. Coalition for Epidemic Preparedness Innovations will fund nCoV-2019 vaccine development efforts, building on existing partnerships with Inovio (Nasdaq: INO) and The University of Queensland (located in Brisbane, Australia), Moderna, Inc., (Nasdaq: MRNA) and the U.S. National Institute of Allergy and Infectious Diseases.

Genome ⯈ Chinese authorities shared the full sequence of the coronavirus genome

11 January 2020, NCBI. Chinese health authorities identified more than 40 human infections as part of this outbreak that was first reported on December 31. Preliminary identification of the novel coronavirus announced by WHO on January 9. The GenBank record of Wuhan-Hu-1 includes sequence data, annotation and metadata from the virus isolated from a patient believed to have contracted the disease in a Hubei province seafood market..

Research ⯈ Existing Drugs Under Study

27 March 2020, Favipiravir (Avigan), current use: Influenza. Fujifilm Toyama Chemical released the following Information of Avigan Tablet in relation to Covid-19. Favipiravir prevents the propagation of viruses. The drug may potentially have an antiviral effect on the novel coronavirus as it is classified into the same type (single-stranded RNA virus) as influenza virus. However, at this stage, clinical application is under study to obtain clear evidence efficacy and safety.

18 March 2020, Lopinavir–Ritonavir, current use: HIV. This Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 had disappointing trial results contrary to hope that the pair of HIV drugs (lopinavir and ritonavir) could work.

18 March 2020, Hydroxychloroquine, current use: Malaria. Hydroxychloroquine, a less toxic derivative of chloroquine, is effective in inhibiting SARS-CoV-2 infection in vitro. Lab tests have shown it to be effective or helpful against the virus. There is no evidence of that, however, according to WHO.

17 March 2020, Hydroxychloroquine, Azithromycin (Z-Pak), current use: Malaria. A small study in France found that most patients taking the drug cleared the coronavirus from their system a lot faster than the control group. Adding azithromycin (Z-Pak) “was significantly more efficient for virus elimination.” A small study in China also found this combination to be "more potent than chloroquine.”

4 March 2020, Hydroxychloroquine, current use: Malaria. The FDA has granted "emergency use" authorisation in the treatment of Covid-19 for a limited number of hospitalised cases.

25 February 2020, Remdesivir, current use: Ebola. NIH clinical trial of remdesivir to treat COVID-19 begins. Trials are taking place in tthe UK with this anti-viral. Originally developed as an Ebola drug. Appears effective against other viruses. Similar trials carried out in China and the US.

Research ⯈ COVID-19 Diagnostics

COVID-19 Diagnostics refers to methods for quickly and effectively detecting the disease in the first place. Currently, there are two types for laboratory testing for the respiratory coronavirus disease 2019 (COVID-19) and the associated SARS-CoV-2 virus. One is detecting the presence of virus. The other one is detecting antibodies produced in response to infection. The presence of viruses is confirmed by RT-PCR, which detects the coronavirus' RNA. Detection of antibodies (serology) can be used both for diagnosis and population surveillance. (CDC, WHO) Submissions pending review.

Research ⯈ COVID-19 Treatment

COVID-19 Treatment refers to methods and means of alleviating symptoms so carriers can have milder symptoms and so overall mortality rate can be lowered (CDC, WHO) Submissions pending review.

Research ⯈ A Note on M&Ms and Vaccines

Think of like an M&M candy. It has a protein shell on the outside and then on the inside, it's the RNA (single-stranded molecule) or DNA (double-stranded molecule.) In this case, it's RNA. That's what causes the problem. Your immune system doesn't see the RNA inside, it only recognized "the candy coating," which is the protein shell on the outside. When creating a vaccine, the first step is to sequence the DNA in the virus, so that you can start creating the protein shell. When they make vaccines, they take a lot of virus, think of M&Ms, and they smash them up and they melt away the chocolate. What's in the vaccine is that protein shell, bits of pieces of that protein shell, because that's what your immune system needs to learn that's not supposed to be in your body. So, when it sees that protein shell later, it attacks it and eliminates it. ―Dr. David Persse, Houston Health Department

Research ⯈ Thanks To Our Contributors

Research and Development Staff of the PPE Healthcare Division, The Powertech Company. Names of individual contributors, unless anonymity is requqested, will be added to this list as soon your submissions are verified and added to the timeline. Thank you for your patience.

Research ⯈ Thanks To Our Sponsors

The Powertech Company, 100% Renewable. Lampara Non-Governmental Organization (NGO). Investment Research Group of Altius Asia Group Inc. StDomainhost.com, A Domain Name Register, Inc. Company.

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