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 SARS-CoV-2 vaccine development landscape includes innovative platforms such as nucleic acid (DNA and RNA), virus-like particle, peptide, viral vector (replicating and non-replicating), recombinant protein, live attenuated virus and inactivated virus approaches.
As of May 23, 2020, the U.S. FDA has not approved any preventive or therapeutic vaccines for use against the SARS, MERS, or SARS-CoV-2 coronaviruses. However, over 300 clinical studies are seeking participants to evaluate vaccine candidates.
SARS-CoV-2 Coronavirus Vaccine Candidates: Human Clinical Trials
Phase 4 Clinical Trial
- BCG - Bacille Calmette-Guerin is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis. Texas A&M, Baylor, MD Anderson launched a COVID-19 prevention study testing the BCG tuberculosis-approved vaccine
Phase 3 Clinical Trial
- VPM1002 - A Phase 3 study is investigating whether the BCG vaccine candidate VPM1002 is also effective against infection with SARS-CoV-2. The large-scale study is to be carried out at several hospitals in Germany and will include older people and health care, workers.
Phase 2 Clinical Trial
Phase 1 Clinical Trials
May 2020: SARS-CoV-2 Coronavirus Vaccine Development News
May 22, 2020 - Sinovac Biotech announced it received approval from authorities to conduct both Phase I and Phase II human clinical trials in China. The Phase I clinical trial, which evaluates the safety, tolerance, and preliminary immunogenicity of CoronaVac, commenced in April 2020. After preliminary observation of the safety profile of CoronaVac in the Phase I study, the Phase II clinical trial commenced in May 2020. The Phase II clinical trial evaluates the immunogenicity and safety of CoronaVac in a larger population in order to define dosage, regimen, and immunization schedule.
May 22, 2020 - Employees of the national research center for epidemiology and microbiology of the Ministry of Health of Russia (NITsEM) tested their vector vaccine against COVID-19, and the experiment was successful: there is immunity, no negative effects were found, Interfax reported Director of the Center Academician of the Russian Academy of Sciences Alexander Gunzburg.
May 20, 2020 - CanSino Biologics Inc. and Precision NanoSystems announced a co-development agreement of an mRNA lipid nanoparticle (mRNA-LNP) vaccine against COVID-19. The parties will leverage PNI's proprietary RNA vaccine platform, comprising of lipid nanoparticle delivery system and the NanoAssemblr® manufacturing technology, to rapidly advance a COVID-19 mRNA-LNP vaccine candidate towards human clinical testing.
May 20, 2020 - Thailand announced it will begin testing the mRNA (messenger RNA) vaccine in monkeys next week after successful trials in mice, said Taweesin Wisanuyothin, spokesman for the government’s Centre for COVID-19 Situation Administration. The Thai vaccine is being developed by the National Vaccine Institute, the Department of Medical Science, and Chulalongkorn University’s vaccine research center.
May 20, 2020 - Bharat Biotech and Thomas Jefferson University of Philadelphia have signed an exclusive deal to develop a new vaccine candidate for COVID-19 invented at Jefferson. The novel vaccine was developed using an existing deactivated rabies vaccine as a vehicle for coronavirus proteins. This is in part because this vehicle or carrier vaccine is known to produce a strong immune response, and is approved for the whole population including children and pregnant women.
May 18, 2020 - Vir Biotechnology, Inc. announced the publication of research findings from the company’s efforts to develop therapeutics for COVID-19 in the May 18, 2020 issue of the journal Nature. The paper, entitled “Cross-neutralization of SARS-CoV and SARS-CoV2 by a human monoclonal antibody” (Pinto, et al., Nature), details the identification and characterization of S309, an antibody isolated from a patient who recovered from severe acute respiratory syndrome (SARS) in 2003, which has been shown to prevent SARS-CoV-2 live virus infection of cells. Vir is advancing two clinical development candidates based on the S309 antibody as potential therapeutics for COVID-19, VIR-7831, and VIR-7832, in collaboration with GlaxoSmithKline.
May 14, 2020 - Medicago announced that its vaccine candidate for COVID-19 induced a positive antibody response only 10 days after a single dose in mice.
May 12, 2020 - GreenLight Biosciences announced it has closed a $17M special purpose funding round to build out its scalable mRNA production capability targeting the production of billions of doses of COVID-19 vaccine. In addition to expanding its manufacturing capacity, GreenLight is developing several differentiated mRNA vaccine candidates against SARS-CoV2, the virus responsible for COVID-19.
May 11, 2020 - Novavax, Inc. announced that the Coalition for Epidemic Preparedness Innovations will invest up to $384 million of additional funding, on top of $4 million it invested in March, to advance the clinical development of NVX-CoV2373, Novavax’ coronavirus vaccine candidate against the SARS-CoV-2 coronavirus.
May 11, 2020 - Themis and ABL Europe announced today that they have signed an agreement under which ABL will manufacture Themis’ SARS-CoV-2 vaccine candidate in preparation for clinical trials. The vaccine is being developed using a proprietary measles virus vaccine platform technology, which is licensed exclusively to Themis by the Institut Pasteur in Paris.
May 8, 2020 - Arcturus Therapeutics Holdings Inc. announced new supportive preclinical data, providing evidence for an adaptive cellular (CD8+ cells) and balanced (Th1/Th2) immune response data from the Company’s COVID-19 vaccine program (LUNAR-COV19). These new results augment previously disclosed preclinical data demonstrating a strong antibody response (anti-spike protein IgG and 100% virus neutralization at a very low vaccine dose) from the program.
May 7, 2020 - Translate Bio announced the Sanofi Pasteur collaboration pursuing the development of a novel mRNA vaccine for COVID-19. Multiple COVID-19 vaccine candidates are being evaluated in vivo for immunogenicity and neutralizing antibody activity to support lead candidate selection and the companies have the goal of initiating a first-in-human clinical trial in the fourth quarter of 2020.
May 6, 2020 - A new pilot-scale production of a purified inactivated SARS-CoV-2 virus vaccine candidate (PiCoVacc), reported it induced SARS-CoV-2-specific neutralizing antibodies in mice, rats, and non-human primates. These antibodies neutralized 10 representative SARS-CoV-2 strains, suggesting a possible broader neutralizing ability against SARS-CoV-2 strains. Three immunizations using two different doses (3 μg or 6 μg per dose) provided partial or complete protection in macaques against the SARS-CoV-2 challenge, respectively, without observable antibody-dependent enhancement of infection.
May 4, 2020 – Arcturus Therapeutics and Catalent announced a partnership to support the expected manufacture of Arcturus’ COVID-19 mRNA vaccine candidate (LUNAR-COV19), intended to protect against the SARS-CoV-2 coronavirus. LUNAR-COV19 utilizes Arcturus’ self-transcribing and replicating mRNA (STARR™) technology and the Company’s LUNAR® lipid-mediated delivery to produce an extraordinarily low dose, potential single shot COVID-19 vaccine.
April 2020: SARS-CoV-2 Coronavirus Vaccine Development News
April 30, 2020 - Vaxart, Inc. announced that it has obtained positive pre-clinical results for its COVID-19 vaccine candidates. In January 2020, Vaxart initiated a program to develop a COVID-19 vaccine based on its VAASTTM oral vaccines platform. In this second round of preclinical testing, all animals received two doses of the Vaxart vaccines, two weeks apart. Antibody responses in all vaccinated groups were statistically significant compared to the untreated controls.
April 28, 2020 - Dr. Jeffrey Cirillo at the Texas A&M Health Science Center is leading a group of world-renown institutions in a phase 4 BCG vaccine clinical trial that could prevent COVID-19 disease cases in just 6-months. This phase 4 vaccine study will include 1,800 participants and researchers from Harvard’s School of Public Health, the University of Texas MD Anderson Cancer Center in Houston, Cedars Sinai Medical Center in Los Angeles, and the Baylor College of Medicine in Houston.
April 27, 2020, Moderna, Inc. announced that it has submitted an application to the U.S. FDA for the company’s mRNA vaccine candidate (mRNA-1273), which is targeted against the SARS-CoV-2 coronavirus, to be evaluated in Phase 2 and late-stage clinical studies.
April 23, 2020 - Emergent BioSolutions Inc. announced an agreement whereby Emergent will deploy its contract development and manufacturing services to support the manufacturing of J&J’s lead vaccine candidate for COVID-19 that leverages the AdVac® and PER.C6® technologies from the Janssen Pharmaceutical Companies of J&J.
April 23, 2020 - ReiThera, LEUKOCARE, and Univercells announce pan-European consortium for the fast-track development of a single-dose adenovirus-based COVID-19 vaccine.
April 22, 2020 – Valneva SE and Dynavax Technologies Corporation announced their collaboration to initiate a vaccine program for the current coronavirus, COVID-19. Valneva is leveraging its technology and platform capabilities to develop an inactivated, whole virus vaccine candidate against the current coronavirus threat. Dynavax is providing CpG 1018, the adjuvant contained in U.S. FDA-approved HEPLISAV-B vaccine, to support the development of Valneva´s COVID-19 vaccine candidate.
April 21, 2020 - UK health secretary Matt Hancock announced human trials of a potential coronavirus vaccine developed at Oxford University are to begin on Thursday. The team will enroll healthy volunteers aged between 18 – 55, who, if they pass screening, will be the first humans to test the new vaccine, called ChAdOx1 nCoV-19.
April 21, 2020 - Vaxart, Inc. announced that it has obtained positive pre-clinical results for its COVID-19 vaccine candidates, with several of the vaccine candidates generating immune responses in all tested animals after a single dose. On March 18, 2020, Vaxart entered into an agreement with Emergent BioSolutions Inc. for development services to prepare for cGMP production of an oral COVID-19 vaccine.
April 16, 2020 - Dynavax Technologies and Sinovac Biotech Ltd. announced that they have entered into a collaboration to evaluate the combination of Sinovac’s chemically inactivated coronavirus vaccine candidate, with Dynavax’s advanced adjuvant, CpG 1018 ™.
April 16, 2020 - The Coalition for Epidemic Preparedness Innovations has granted $6.9 million funding to INOVIO to work with the Korea National Institute of Health for a Phase 1/2 clinical trial of INOVIO's COVID-19 vaccine candidate (INO-4800) in South Korea.
April 14, 2020 - Sanofi and GSK join forces in unprecedented vaccine collaboration to fight COVID-19 disease. Sanofi will contribute its S-protein COVID-19 antigen, which is based on recombinant DNA technology. GSK will contribute its proven pandemic adjuvant technology to the collaboration.
April 14, 2020 – NantKwest and ImmunityBio, Inc., clinical-stage immunotherapy companies within the NantWorks family of companies, announced they are in active discussions with the U.S. FDA for vaccines and therapeutics to combat COVID-19.
April 8, 2020 - Novavax, Inc. announced it has identified a coronavirus vaccine candidate, NVX-CoV2373, a stable, prefusion protein made using Novavax’ proprietary nanoparticle technology, and will initiate a first-in-human trial in mid-May. Novavax’ proprietary Matrix-M™ adjuvant will be incorporated with NVX-CoV2373 in order to enhance immune responses and stimulate high levels of neutralizing antibodies.
April 6, 2020 - OncoSec Medical Incorporated announced that Providence Cancer Institute is pursuing a first-in-human Phase 1 clinical trial of OncoSec's novel DNA‑encodable, investigational vaccine, CORVax12, which is designed to act as a prophylactic vaccine to prevent COVID-19. CORVax12 consists of OncoSec's existing product candidate, TAVO™ (interleukin-12 or "IL-12" plasmid), in combination with an immunogenic component of the SARS-CoV-2 virus recently developed by researchers at NIH's National Institute of Allergy and Infectious Diseases ("NIAID") and licensed to OncoSec on a non-exclusive basis.
April 2, 2020 - University of Pittsburgh School of Medicine scientists today announced a potential vaccine against SARS-CoV-2, the new coronavirus causing the COVID-19 pandemic. When tested in mice, the vaccine, delivered through a fingertip-sized patch, produces antibodies specific to SARS-CoV-2 at quantities thought to be sufficient for neutralizing the virus. The paper appeared today in EBioMedicine, which is published by The Lancet and is the first study to be published after critique from fellow scientists at outside institutions that describes a candidate vaccine for COVID-19.
April 2, 2020 – Applied DNA Sciences Inc. and Takis Biotech announced an expansion of their COVID-19 vaccine development program to include a 5th vaccine candidate. Production of all vaccine candidates is expected to be completed this month. All vaccine candidates have also been approved by Italy’s Ministry of Health for preclinical animal testing that is scheduled to begin in late April 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.
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.
COVID-19 disease outbreak news is available at CoronavirusToday.com
Note: 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. Precision Vax's digital network includes CoronavirusToday.com, PrecisionVaccinations.com, ZikaNews.com, and Vax-Before-Travel.com.