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 causes COVID-19 disease in humans.
The need for human coronavirus vaccines was first identified in the mid-1960s. 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.
As of March 29, 2020, the US Food and Drug Administration has not approved any preventive or therapeutic coronavirus vaccines for use against the SARS, MERS or SARS-CoV-2 coronaviruses.
SARS-CoV-2 Coronavirus Vaccine Candidates - Conducting Human Clinical Trials
Phase 1 clinical trials generally take between 12-18 months to complete, with the primary objective of determining the optimized vaccine dose that can be given safely, without causing serious side effects.
- Phase 1 study - mRNA-1273 SARS-CoV-2 Vaccine - March 16, 2020 - Moderna, Inc. announced that the first participant has been dosed in the Phase 1 study of the Company’s mRNA vaccine (mRNA-1273) against the novel coronavirus (SARS-CoV-2). This Phase 1 study is being conducted by the National Institutes of Health under its own Investigational New Drug application.
- RNA vaccine development is a very promising field but has yet to yield a licensed product. A major challenge has been figuring out how to deliver the RNA vaccine into the cell so it survives – our bodies naturally want to destroy foreign RNA molecules, says Wellcome trust.
- Phase 1 study - INO-4800 DNA Coronavirus Vaccine - March 12, 2020 - INOVIO Pharmaceuticals, Inc. announced that it has received a new $5 million grant from the Gates Foundation to accelerate the testing and scale-up of CELLECTRA® 3PSP proprietary smart device for the intradermal delivery of INO-4800, a DNA vaccine for COVID-19 disease.
- Ology Bioservices announced it will work with Inovio Pharmaceuticals to manufacture Inovio's DNA vaccine (INO-4800) for the prevention of infection with the SARS-CoV-2 coronavirus virus.
- Phase 1 study - Adenovirus Type 5 Vector vaccine candidate (“Ad5-nCoV”), co-developed by CanSinoBIO and Beijing Institute of Biotechnology, was approved to enter into Phase 1 Clinical Trial on March 17, 2020. It is currently the first novel coronavirus vaccine for COVID-19 at this stage in China. The vaccine candidate is built upon CanSinoBIO’s adenovirus-based viral vector vaccine technology platform.
The primary indicator is to see whether there are adverse reactions seven days after injection, and the secondary indicators are whether adverse reactions are observed 28 days after injection or severe adverse reactions six months after the injection. Researchers will also look for anti-S antibody immunoglobulin G, neutralizing antibodies against SARS-CoV-2, neutralizing antibodies against Ad5 and specific T-cell responses as secondary indicators.
SARS-CoV-2 Coronavirus Vaccine Candidates - Preclinical Study
- BNT162 - Companies: Pfizer and BioNTech - Status: Clinical testing is expected to begin in April 2020.
- Self-amplifying RNA vaccine - Company: Imperial College London - Status: Animal testing is underway; the researchers aim to begin clinical trials in the summer of 2020.
- No name announced - Companies: Johnson & Johnson and BARDA - Status: J&J says they plan to have a vaccine candidate by the end of March, with human trials starting in November 2020.
- Plant-based COVID-19 vaccine - Company: Medicago - Status: The company says their vaccine is in the pre-clinical testing stage, and they expect to begin human testing in July or August of 2020.
- No name announced - Company: Novavax - Status: Noravax hopes to begin clinical testing in the late spring of 2020.
- Ii-Key peptide COVID-19 vaccine - Company: Generex Biotechnology - Status: Generex said they wanted to produce a vaccine candidate that could be tested in humans within 90 days.
- Oral recombinant COVID-19 vaccine - Company: Vaxart - Status: The company plans to initiate a Phase 1 clinical study early in the second half of 2020.
MERS-CoV 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.
March 2020: SARS-CoV-2 Coronavirus Vaccine Development News:
Coronavirus Vaccine Development Overview
There are 5 approaches currently being taken by various organizations deploying different technologies to develop a vaccine against SARS-CoV-2.
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.
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.
Real-time COVID-19 disease outbreak news is available at Coronavirus Today.com.
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 March 28, 2020. Precision Vax's digital network includes Coronavirus Today.com, Precision Vaccinations.com, Zika News.com, and Vax-Before-Travel.com.