Coronaviruses without preventive vaccines are the Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV), and the novel coronavirus SARS-CoV-2, which is causing COVID-19 disease in humans.
As of February 24, 2020, the US Food and Drug Administration (FDA) has not approved any preventive or therapeutic vaccines for use against the SARS, MERS or the SARS-CoV-2 coronaviruses.
Coronavirus Vaccine Candidates Conducting Human Clinical Trials:
- INO-4700 MERS-CoV is a DNA plasmid vaccine that expresses the MERS CoV spike (S) glycoprotein. Inovio expects to advance INO-4700 into a Phase 2 field study in the Middle East and Africa where outbreaks have been observed, with full funding from CEPI. On January 6, 2020, the company says this is the most advanced vaccine candidate for MERS. The Wistar Institute announced January 23, 2019, that they are part of the Inovio team. Wistar brings the experience and suitability of its DNA technology platform to rapidly translate a vaccine against an emerging virus.
- GLS-5300 MERS-CoV Vaccine - The GLS-5300 MERS-CoV product is a DNA vaccine candidate, which allows for rapid design and production in response to emerging infectious diseases. Underscoring the potential for rapid deployment of DNA vaccines, GLS-5300 was advanced into the clinic within nine months of preclinical vaccine candidate selection. GLS-5300 was co-developed by GeneOne Life Science Inc. and Inovio Pharmaceuticals. GLS-5300 is administered intramuscularly using the CELLECTRA® delivery device. A July 24, 2019, Phase 1 first-in-human clinical trial. Initial findings from the trial were published in The Lancet Infectious Diseases.
- ChAdOx1 MERS-CoV Vaccine - ChAdOx1 MERS is a vaccine candidate to treat Middle East Respiratory Syndrome Coronavirus (MERS-CoV). The ChAdOx1 MERS vaccine consists of the replication-deficient simian adenovirus vector ChAdOx1, containing the MERS Spike protein antigen. The first-in-human trial is now being conducted in Oxford in UK healthy adult volunteers. The vaccine will be administered intramuscularly. This is an open-label, dose-escalation phase 1b trial to assess the safety and immunogenicity of the candidate ChAdOx1 MERS vaccine in healthy Middle Eastern adult volunteers aged 18-50.
- MVA MERS (Modified Vaccinia virus Ankara) is a vaccine candidate that contains the full-length spike gene of MERS-CoV. MVA MERS vaccines are produced with tPA, but either the mH5 or F11 promoter driving expression of the spike gene. In this phase I first-in-human clinical trial, healthy volunteers in two different dose cohorts will be vaccinated twice with the candidate vaccine MVA-MERS-S. A subgroup will additionally receive a late booster vaccination. A second phase 1b study is a two-center study in approximately 160 healthy adults aged 18-55 years. The study is to assess the safety and immunogenicity of MVA-MERS-S_DF-1. The study is not yet recruiting.
SARS-CoV-2 Vaccine Development News:
- February 24, 2020 - Moderna, Inc. announced that it has released the first batch of mRNA-1273, the Company’s vaccine against the novel coronavirus, for human use. Vials of mRNA-1273 have been shipped to the NIAID, a part of the NIH to be used in the planned Phase 1 study in the U.S.
- February 24, 2020 - Clover and GSK announce research collaboration to evaluate the coronavirus (COVID-19) vaccine candidate with the pandemic adjuvant system.
- February 21, 2020 - A University of Queensland research team has met a key milestone in their fast-tracked research to develop a vaccine for the coronavirus SARS-CoV-2 and the disease COVID-19. Researchers said the early research had gone ‘as expected’ and the material created had the properties which allowed the team to proceed with vaccine development. The work in the lab shows the feasibility of using UQ’s ‘molecular clamp’ technology to engineer a vaccine candidate that could be more readily recognized by the immune system, triggering a protective immune response. The next stage is to produce this on a larger scale needed for additional testing, to determine its effectiveness against the virus.
- February 20, 2020 - Houston-based Greffex Inc., scientists have completed the coronavirus vaccine candidate and should now move to animal testing by the necessary government agencies. In September 2019, Greffex received an $18.9 million contract from the National Institute of Health's National Institute for Allergy and Infectious Diseases to develop new treatments for infectious threats, according to a news release. With the development of this Greffex Vector Platform, we overcame two obstacles: interference by viral genes and contamination by helper viruses. We have been using our flexible vector to investigate and develop the production of gene therapy vectors and specific immune suppression products.
- February 19, 2020 - Researchers from The University of Texas at Austin and the National Institutes of Health have made a critical breakthrough toward developing a vaccine for the 2019 novel coronavirus by creating the first 3D atomic-scale map of the part of the virus that attaches to and infects human cells.
- February 18, 2020 - The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response announced today its engagement of Sanofi Pasteur to use its recombinant DNA platform to produce a recombinant 2019 novel coronavirus vaccine to prevent SARS-CoV-2 infections.
- February 13, 2020 – Israel based Vaxil announce it has successfully identified a coronavirus (COVID-19) vaccine candidate based on unique and patent-protected signal peptide technology, utilizing Vaxil’s proprietary VaxHitTM bioinformatics platform. The Vaccine Candidate’s design is also based on successful in vivo experiments testing a tuberculosis signal peptide vaccine.
- February 13, 2020 - Codagenix, Inc. announced a collaboration with the Serum Institute of India, Ltd. to rapidly co-develop a live-attenuated vaccine against the emergent coronavirus. The company says a live-attenuated vaccine has multiple advantages, including mounting an immune response to multiple antigens of the virus and the ability to scale for mass production. Codagenix uses viral deoptimization to synthesize "rationally designed," live-attenuated vaccines. Codagenix's technology allows for the rapid generation of multiple vaccine candidates against emerging viruses, starting with only the digital sequence of the viral genome.
- February 11, 2020 - Johnson & Johnson announced that it's Janssen Pharmaceutical Companies will further expedite its investigational coronavirus vaccine program through expanded collaboration with the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health & Human Services.
- February 10, 2020 - Moderna said 'the first clinical batch of mRNA-1273, including fill and finishing of vials, was completed on February 7, 2020. This mRNA vaccine was designed and manufactured in 25 days and is undergoing analytical testing prior to release to the NIH for use in their planned Phase 1 clinical trial in the USA. mRNA-1273 is an mRNA vaccine candidate encoding for the viral Spike (S) protein. The S protein complex is necessary for membrane fusion and host cell infection and has been the target of vaccines against the coronaviruses responsible for Middle Eastern Respiratory Syndrome and Severe Acute Respiratory Syndrome. Previously, Moderna announced in an SEC filing on January 21, 2020, they are working with the National Institutes of Health (NIH), the National Institute of Allergy and Infectious Diseases (NIAID), and the Vaccine Research Center a new collaboration to develop an mRNA vaccine against the novel coronavirus.
- February 7, 2020 - Applied DNA Sciences Subsidiary, LineaRx, and Takis Biotech Collaborate for Development of a Linear DNA Vaccine Candidate Against Wuhan Coronavirus 2019-nCoV. Expanded Joint Development Agreement Serves as Basis for Preclinical Linear DNA Vaccine; Linear DNA Platform Will be the Production Framework.
- February 6, 2020 - Generex Biotechnology announced that the company is working with third-party groups and government agencies to reactivate the previously robust research and development to generate Ii-Key peptide vaccines against pandemic viruses. The patented NuGenerex Immuno-Oncology (Formerly Antigen Express) Ii-Key technology uses synthetic peptides that mimic essential protein regions from a virus that is chemically linked to the 4-amino acid Ii-Key to ensure robust immune system activation.
- February 5, 2020 - Imperial College London Professor Shattock announced that his team could move towards trials on animals as early as next week and then onto humans within a matter of months. “We have successfully generated our novel coronavirus vaccine candidate in the lab – just 14 days from getting the genetic sequence to generating the candidate in the lab. This will go into the first animal experiments on February 10th. "If this work is successful, and if we secure further funding, the vaccine could enter into clinical studies (with human participants) in early Summer 2020.”
- February 3, 2020 - iBio, Inc. and Beijing CC-Pharming Ltd. announced their collaboration to develop and test a new 2019-nCoV vaccine to be manufactured using iBio’s FastPharming System™. Originally built in 2010 with funding from the Defense Advanced Research Projects Agency (DARPA), part of the U.S. Department of Defense, iBio’s FastPharming Facility was part of the “Blue Angel” initiative to establish facilities capable of rapid delivery of medical countermeasures in response to a disease pandemic.
- February 3, 2020 - GSK announced a new collaboration with CEPI aimed at helping the global effort to develop a vaccine for the 2019-nCoV virus. GSK will make its established pandemic vaccine adjuvant platform technology available to enhance the development of an effective vaccine against 2019-nCoV.
- The UK Government’s Department of Health and Social Care announced on February 3, 2020, an additional £20 million funding to CEPI to further our mission to advance vaccines against epidemic threats. The funding comes amid the rapid global spread of the outbreak of a novel coronavirus, 2019-nCoV. The funding was announced by UK Health Secretary Matt Hancock to support our work to develop a wide range of vaccine candidates and platform technologies against emerging infectious diseases. The UK Government says it is also in initial stages of talks between NIHR and UKRI regarding plans to run a rapid research call to support the global response to 2019-nCoV.
- February 3, 2020 - Vaxart Oral Vaccine Enters 2019-nCoV Development Competition. The oral vaccine platform may offer potential advantages when developing coronavirus vaccines. Vaxart recently published results from an influenza challenge study, which demonstrated that its oral tablet vaccine primarily protects through mucosal immunity, which is a potential key factor when targeting mucosal pathogens, such as this new coronavirus. Per the press release, Vaxart plans to develop vaccine candidates based on the published genome of the 2019-nCoV and evaluate the same in preclinical studies for the ability to generate both mucosal and systemic immune responses.
- CureVac and CEPI partner to develop a rapid-response coronavirus vaccine development platform targeting the 2019-nCoV. Vaccine development effort receives up to $8.3 million in funds.
- Inovio Pharmaceuticals announced the Coalition for Epidemic Preparedness Innovations has awarded Inovio a grant of up to $9 million to develop a vaccine against the recently emerged strain of coronavirus (2019-nCoV). The latest grant was aimed at funding development of Inovio’s INO-4800, through phase 1 human testing. On January 30, 2020, Beijing Advaccine Biotechnology Co. announced a collaboration with Pennsylvania-based Inovio Pharmaceuticals, Inc. to advance the development in China of the INO-4800 vaccine candidate, which is targeted against the novel coronavirus named 2019-nCoV.
- Novavax, Inc. had developed a vaccine for MERS in 2013. Its successful history with coronavirus makes the company a potential winner in case of an outbreak caused by the new coronavirus. The company has also started developing a vaccine for the same.
- Dr. Paul Stoffels, Johnson & Johnson’s chief scientific officer said to CNBC he believes the drugmaker can create a vaccine in the coming months to fight against the fast-spreading coronavirus. Dr. Stoffels said the pharmaceutical company needed to start from scratch on this vaccine, much like how it operated in the Zika outbreak. Though Johnson & Johnson could shave two to three months off of that due to technological advances, he said. “We are going to take an approach with at least five different constructs and different partners and collaborations all over the world in order to see which part of the virus we can use to make an effective vaccine and develop a model that we can invest in."
- MERS-CoV RBD Vaccine candidate (RBD219-N1) - Baylor College of Medicine's MERS vaccine development started in 2011 with support from the NIAID/NIH and in partnership with the New York Blood Center, The University of Texas Medical Branch at Galveston, Walter Reed Army Institute of Research and Immune Design, a therapeutic vaccine product development company. The group has successfully manufactured, under cGMP, the first receptor binding protein antigen against SARS-CoV, the SARS-CoV RBD Vaccine. Like the SARS-CoV RBD Vaccine, the comparative advantage of the MERS-CoV RBD Vaccine is its efficacy in terms of eliciting protective neutralizing antibodies together with its safety in terms of maximal reduction of eosinophilic immune enhancement. NIH - Optimization of the Production Process and Characterization of the Yeast-Expressed SARS-CoV Recombinant Receptor-Binding Domain (RBD219-N1), a SARS Vaccine Candidate.
- The University of Saskatchewan’s Vaccine and Infectious Disease Organization-International Vaccine Centre, also known as VIDO-InterVac, has received permission from the Public Health Agency of Canada to focus on the 2019-nCoV threat.
- The University of Queensland has been commissioned to fast-track a vaccine to help control the new coronavirus outbreak. Queensland is one of three groups commissioned to develop a vaccine against the virus, known as nCoV-2019, by the Coalition for Epidemic Preparedness Innovations. Paul Young, head of Queensland’s School of Chemistry and Molecular Biosciences, said the university had developed a new way to rapidly generate vaccines from analyses of viruses’ genetic sequence information. He said the team hoped to develop a vaccine in the next six months for distribution to first responders, helping to prevent medics from becoming infected and accelerating the disease’s spread. Dr. Keith Chappell, from UQ’s School of Chemistry and Molecular Biosciences and the Australian Institute for Bioengineering and Nanotechnology, said the key to the speedy development of this potential vaccine was the 'molecular clamp' technology, invented by UQ scientists and patented by UniQuest.
- Aethlon Medical Inc. is the developer of the patented Aethlon Hemopurifier, a clinical-stage immunotherapeutic device that removes exosomes and life-threatening viruses from the human circulatory system. The U.S. HHS has established an initiative to support platform technology medical countermeasures with broad-spectrum capabilities. Based on preclinical studies and human treatment experiences, the Aethlon Hemopurifier® defines this initiative. To date, Hemopurifier therapy has been administered to individuals infected with the Ebola virus, Hepatitis C virus, and HIV. In the case of Ebola, a remarkable response to a single administration of Hemopurifier therapy, a comatose physician with multiple organ failures at the time.
Coronavirus Vaccine Development Overview
The need for human coronavirus vaccines was first identified in the mid-1960s. Over the past 10 years, however, gaps in our scientific understanding remain.
The emergence of a highly pathogenic coronavirus (CoV) in the Middle East has sparked new interest in human coronaviruses around the world. MERS-CoV was identified in 2012, almost 10 years after the highly fatal human SARS-CoV emerged from China in 2003.
During 2012, a subunit vaccine, RBD-S, started development to prevent severe acute respiratory syndrome (SARS) caused by SARS coronavirus (SARS-CoV), which is classified by the US NIH as a category C pathogen. This vaccine is comprised of a recombinant receptor-binding domain (RBD) of the SARS-CoV spike (S) protein and formulated on alum, together with a synthetic glucopyranosyl lipid A.
The initial coronavirus vaccine development effort (prototype RBD219 N1) was launched in 2012, by a research team which included Dr. Peter J. Hoetz, with Baylor Medical Center, in Houston, Texas.
Previous efforts to create a vaccine for SARS-CoV have utilized a number of approaches. In general, the potential vaccines can be classified into six types: viral vector-based vaccine, DNA vaccine, subunit vaccine, nanoparticle-based vaccine, inactivated-whole virus vaccine and live-attenuated vaccine, which are discussed in detail.
Vaccines based on whole, inactivated SARS-CoV, spike subunits, recombinant viruses expressing SARS-CoV proteins, DNA plasmids expressing SARS-CoV proteins, or virus-like particles (VLPs) have all been tested in vitro and in vivo.
And research on MERS-CoV vaccination strategies is in the early stages. However, early studies using a modified vaccinia virus and spike subunit vaccines have been shown to induce MERS-CoV-neutralizing antibodies in mice.
An effective MERS-CoV vaccine is required to induce both robust humoral and cell-mediated immunities, particularly antibody responses are crucial for the survival of the vaccinated hosts (Du et al., 2016b). Previous studies indicated that the level of serum neutralizing antibodies correlated positively with the reduction of lung pathogenesis, which increased the survival of animals challenged with MERS-CoV (Zhao et al., 2015; Zhang et al., 2016).
Therefore, most of the MERS-CoV vaccine candidates are still based on the full length or part of the S protein.
On February 5, 2020, JAMA published a new study from genetic sequencing data, it appears that there was a single introduction into humans followed by the human-to-human virus spread. This novel virus shares 79.5% of the genetic sequence with SARS-CoV and has 96.2% homology to a bat coronavirus. In addition, 2019-nCoV shares the same cell entry receptor, ACE2, with SARS-CoV.
And on February 15, 2020, the CDC announced it had grown the COVID-19 virus in cell culture, which is necessary for further studies, including for additional genetic characterization. The cell-grown virus was sent to NIH’s BEI Resources Repository for use by the broad scientific community to develop preventive and therapeutic vaccines.
Coronavirus Vaccine FAQs
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Content sources on this webpage include, but are not limited to, the WHO, the CDC, industry studies, and clinicalTrials.gov. The content was Fact-Checked by Dr. Robert Carlson and other healthcare professionals on February 23, 2020. Precision Vax's digital network includes Coronavirus Today.com, Precision Vaccinations.com, Zika News.com, and Vax-Before-Travel.com.