Coronavirus Vaccines

World-class scientists have accelerated the clinical trial process to develop a safe and effective coronavirus preventive vaccine. Coronaviruses without preventive vaccines include 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.

The U.S. FDA has not approved any preventive or therapeutic vaccines for use against either SARS, MERS, or SARS-CoV-2 coronaviruses.

However, over 300 clinical studies are seeking participants to evaluate coronavirus vaccine and therapeutic candidates.

Approved for Limited Use in China

• Ad5-nCoV COVID-19 vaccine
  • On June 25, 2020, China's Central Military Commission approved the use of the vaccine by the military for a period of 1-year. The Ad5-nCoV vaccine candidate is a genetically engineered vaccine candidate with the replication-defective adenovirus type 5 as the vector to express SARS-CoV-2 spike protein. The vaccine candidate is built upon CanSinoBIO’s adenovirus-based viral vector vaccine technology platform.
  • A phase 2 study by CanSino Biologics found the vaccine generated antibody and T cell responses and appeared to be safe. The Ad5-vectored COVID-19 vaccine at 5 × 1010 viral particles is safe, and induced significant immune responses in the majority of recipients after a single immunization.

Phase 3 Clinical Trial

• AZD1222 SARS-CoV-2 vaccine
  • Developed by the University of Oxford's Jenner Institute is based on a chimpanzee adenovirus called ChAdOx1. New phase 1/2 study results published in The Lancet confirmed a single dose of AZD1222 resulted in a 4-fold increase in antibodies to the SARS-CoV-2 virus spike protein in 95% of participants one month after injection. In all participants, a T-cell response was induced, peaking by day 14, and maintained 2-months after vaccination. Late-stage Phase II/III trials are currently underway in the UK, Brazil, and South Africa and are due to start in the USA.
• New Crown COVID-19 Vaccine
  • An inactivated new crown vaccine created by Wuhan Institute of Biological Products under the China National Pharmaceutical Group, Sinopharm, and the Wuhan Institute of Virology (WIV) entered clinical trials. On July 17, 2020, Sinopharm initiated a Phase III clinical trial to assess its Covid-19 vaccine candidate in Abu Dhabi, UAE.
• CoronaVac SARS-CoV-2 vaccine
  • Sinovac Biotech Ltd., says the CoronaVac SARS-CoV-2 Vaccine candidate is based on an inactivated pathogen. The phase II clinical trial results show that the vaccine induces neutralizing antibodies 14 days after the vaccination with a 0 and 14-day schedule. The neutralizing antibody seroconversion rate is above 90%, which concludes the vaccine candidate can induce a positive immune response. A phase 3 study will recruit nearly 9,000 healthcare professionals working in COVID-19 specialized facilities in 12 clinical sites, located in several states in Brazil.
• mRNA-1273 SARS-CoV-2 vaccine
  • Moderna's mRNA-1273 is an mRNA vaccine candidate against the SARS-CoV-2 betacoronavirus encoding for a prefusion stabilized form of the Spike protein. Moderna announced a modification to its contract with the BARDA for an additional commitment of up to $472 million to support late-stage clinical development.

Phase 2 Clinical Trial

• BNT162 Vaccine
  • A Phase 1/2 Study to Describe the Safety and Immunogenicity of a COVID-19 RNA Vaccine Candidate (BNT162b1) Interim Report: RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titers in sera increased with the dose level and after a 2nd vaccine dose. On July 22, 2020, Pfizer and BioNTech SE announced an agreement with the U.S. government will receive 100 million doses of BNT162 after Pfizer successfully manufactures and obtains approval or emergency use authorization from the US Food and Drug Administration.
• Russian COVID-19 Vaccine
  • The Russian COVID-19 Vaccine candidate is indicated to build immunity to SARS-CoV-2 the virus which causes COVID-19 disease. Volunteers, who tested a vaccine against the coronavirus two weeks ago at Burdenko military hospital, are feeling well and have not experienced any side effects, the Russian Defense Ministry told reporters on July 7, 2020. Sechenov University announced the completion of the Russia COVID-19 vaccine candidate clinical trial on July 12, 2020.

Phase 1 Clinical Trial

• Ad26.COV2-S vaccine
  • J&J's Janssen Vaccines & Prevention B.V. has accelerated the launch of the Phase 1/2a first-in-human clinical trial of its investigational SARS-CoV-2 vaccine, Ad26COVS1. J&J's Wolk said on July 16, 2020, the Phase 1 trial is expected to enroll more than 1,000 participants, primarily between the ages of 18 and 55 years old, although the company also plans to include a group of people who are 65 years old or older in the early-stage vaccine trial of JNJ-78436735.
• NVX-CoV2373 vaccine
  • NVX-CoV2373 is a prefusion protein coronavirus vaccine candidate made using Novavax’s proprietary nanoparticle technology, Matrix-M, which is an adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies. Novavax Announces $1.6 Billion Funding from the US government's Operation Warp Speed. FUJIFILM Diosynth Biotechnologies announced it has begun production of the first batch of NVX-CoV2373.
• INO-4800 DNA vaccine
  • DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA that are synthesized or reorganized by a computer sequencing technology and designed to produce a specific immune response in the body. INOVIO announced positive interim clinical data of its vaccine candidate against SARS-CoV-2, from the 1st, of two, Phase 1 clinical trial cohorts.
• Sanofi and GSK to join forces to produce a vaccine to fight COVID-19 disease.
  • Candidate vaccine expected to enter clinical trials in the second half of 2020 and, if successful, to be available in the second half of 2021. Sanofi will contribute its S-protein COVID-19 antigen, which is based on recombinant DNA technology. This technology has produced an exact genetic match to proteins found on the surface of the virus, and the DNA sequence encoding this antigen has been combined into the DNA of the baculovirus expression platform, the basis of Sanofi’s licensed recombinant influenza product in the USA. GSK will contribute its pandemic adjuvant technology to the collaboration.
• Vaxart COVID-19 Oral Vaccine
  • Vaxart's vaccine candidate is an oral H1 flu tablet indicated to prevent the new SARS-CoV-2 coronavirus, which causes COVID-19 disease in humans. In preclinical testing, all animals that received one of the Vaxart vaccines had IgG anti-SARS CoV-2 antibodies in serum two weeks after the first vaccination.
• UQ COVID-19 Vaccine
  • The University of Queensland announced on July 13, 2020, it has dosed the initial participant in phase 1 clinical trial in Brisbane, Australia.
• SCB-2019 SARS-CoV-2 Vaccine
  • The Sichuan 'Clover' Biopharmaceuticals SCB-2019 is a recombinant subunit vaccine candidate for the SARS-CoV-2 virus that causes COVID-19 disease. The vaccine is entering into a phase 1 clinical trial in Australia to test the vaccine with two different boosters provided by GSK and Dynavax. Clover Biopharmaceuticals, Inc.'s S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate, similar to other enveloped RNA viruses such as HIV, RSV, and Influenza, CEPI announced it will invest an additional $66 million in Clover’s S-Trimer protein vaccine candidate on July 8, 2020.
• Beijing BBIBP-CorV COVID-19 Vaccine Candidate
  • A randomized, double-blind, placebo parallel controlled phase I/II clinical trial to evaluate the safety and immunogenicity of the new inactivated coronavirus vaccine (2019-CoV) (Vero cells) in healthy people aged 3 years and older
• Covaxin SARS-CoV-2 Vaccine
  • Covaxin is an inactivated SARS-CoV-2 Vaccine candidate. The SARS-CoV-2 virus strain was isolated from an asymptomatic COVID-19 patient at NIV, Pune. The first part of a phase 1 study of Covaxin human trial which began on July 17, 2020, was completed on July 25th, at Post-Graduate Institute of Medical Sciences, Rohtak.

• CVnCoV SARS-CoV-2 Vaccine

  • CureVac's CVnCoV is an mRNA vaccine candidate that utilizes nucleotides without chemical modifications in the mRNA. CureVac signed an mRNA vaccine collaboration agreement with GSK. However, CureVac’s existing COVID-19 mRNA vaccine research program, CVnCoV SARS-CoV-2, is reportedly not included in this agreement.

• CoVLP Vaccine

  • The GSK and Medicago collaboration intends to develop a COVID-19 candidate vaccine combining Medicago’s recombinant Coronavirus Virus-Like Particles (CoVLP) with GSK’s pandemic adjuvant system. CoVLPs mimic the structure of the virus responsible for COVID-19 disease, allowing them to be recognized by the immune system.

• CPI-006 Novel Immunotherapy

  • Corvus is studying an agonistic (immunostimulatory) humanized monoclonal antibody, designated as CPI-006, which has demonstrated a potential new approach to immunotherapy of infectious diseases and cancer. To date, over 90 cancer patients have been treated with CPI-006 in the Corvus Phase 1/1b study, with dosing as high as 24 mg/kg every three weeks.

• AdCOVID Vaccine

  • Altimmune, Inc.'s AdCOVID is an intranasal COVID-19 vaccine candidate designed to guard the respiratory tract from viral invasion and to provide downstream protection against the viral spread through stimulation of both mucosal and systemic antibodies (IgA and IgG) as well as cell-mediated immunity. Altimmune expects to begin the manufacturing of the vaccine candidate during Q3 2020, followed by a Phase 1 clinical trial during Q4 2020.

• VLA2001 Vaccine

  • Valneava's VLA2001 is a Vero-cell based, highly purified inactivated vaccine candidate against the SARS-COV-2 virus, leveraging the manufacturing technology for Valneva’s Japanese Encephalitis Vaccine. On July 20, 2020, Valneva reached an agreement in principle with the UK government to provide up to 100 million doses of its SARS-CoV-2 vaccine candidate, to be manufactured at its facilities in Livingston, Scotland.

Related BCG Vaccine Studies

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 College Medicine, Cedars Sinai Medical Center, and MD Anderson launched a COVID-19 prevention study testing the BCG tuberculosis-approved vaccine. IRB Number 2020-0432F, IRB Approval Date: 06/17/2020. Last update: May 27, 2020.
  • Researchers from the NIAID of the US National Institutes of Health established an association between BCG vaccination and reduced Covid-19 disease mortality rates across the globe on July 9, 2020.

Phase 3 Clinical Trial

• VPM1002 Vaccine - A Phase 3 study is investigating whether the BCG vaccine candidate VPM1002 is also effective in stimulating the human immune system against infection from the SARS-CoV-2 coronavirus.

Phase 1 Clinical Trial

• BCG:CoVac Vaccine - This BCG vaccine is used as a vehicle to deliver distinctive proteins that originate from the SARS-CoV-2 virus surface. The goal is for the human immune system to develop a memory of SARS-CoV-2 and develop immunity.

July 2020: SARS-CoV-2 Coronavirus Vaccine Development News

July 27, 2020 - MediciNova, Inc. announced an agreement with BioComo and Mie University (Japan) for joint development of a SARS-CoV-2 vaccine using BC-PIV, a human parainfluenza virus type 2 vector developed by BioComo and Tetsuya Nosaka, M.D., Ph.D. MediciNova has been granted exclusive worldwide development rights to use BC-PIV for SARS-CoV-2 vaccine development from BioComo and Mie University.

July 24, 2020 - The Vektor State Research Center of Virology and Biotechnology has been granted a Russian health ministry’s permit for clinical tests of its anti-coronavirus vaccine. Russian consumer rights oversight authority’s chief Anna Popova said Vektor had successfully finished pre-clinical tests of an anti-coronavirus vaccine.

July 24, 2020 - CEL-SCI Corporation announced it has concluded animal experiments using its LEAPS COVID 19 conjugate that provides the basis for moving forward into animal challenge studies with live virus SARS-CoV-2 at the University of Georgia Vaccine Center.

July 24, 2020 - To determine whether D614G mediates neutralization-escape that could compromise vaccine efficacy, sera from Spike-immunized mice, nonhuman primates, and humans were evaluated for neutralization of pseudoviruses bearing either D614 or G614 Spike on their surface. In all cases, G614 Spike pseudovirions were moderately more susceptible to neutralization, indicating this is not an escape mutation that would impede current vaccines. Rather, the gain in infectivity provided by D614G came at the cost of making the virus more vulnerable to neutralizing antibodies.

July 23, 2020 - Arcturus Therapeutics Holdings Inc. announced a binding term sheet with the Israeli Ministry of Health to supply the Company’s COVID-19 vaccine candidate, LUNAR-COV19.

July 23, 2020 - Dynavax Technologies Corporation and Medigen Vaccine Biologics Corporation announced their collaboration to develop an adjuvanted vaccine candidate to protect against COVID-19. The collaboration is evaluating the combination of MVC’s stable prefusion form of the SARS-CoV2 recombinant spike protein with Dynavax’s advanced adjuvant CpG 1018™, the adjuvant contained in Dynavax’s U.S. FDA-approved adult hepatitis B vaccine.

July 21, 2020 - Arcturus Therapeutics and Duke-NUS Medical School in Singapore announced that the Clinical Trial Application for COVID-19 vaccine candidate LUNAR-COV19 has been approved to proceed by the Singapore Health Sciences Authority. The differentiated STARR™ mRNA vaccine expected to produce humoral and cellular immunity at very low doses, in humans. New pre-clinical data demonstrate neutralizing antibody titers continue to increase for 50 days after a single administration.

July 20, 2020 - The UK announced it has secured 30 million doses of the experimental BioNTech/Pfizer vaccine, and a deal in principle for 60 million doses of the Valneva vaccine, with an option of 40 million more doses if it was proven to be safe and effective.

July 20, 2020 - Metaclipse was awarded $2.2 million by the National Institute of Allergy and Infectious Diseases to support its efforts to develop a COVID-19 vaccine. Metaclipse is developing an influenza vaccine for the elderly based on a modified influenza virus-like particle (VLP) vaccine approach that incorporates natural adjuvants, called cytokines, which are attached to the surface of VLPs. These modified VLPs are reported to be more effective than unmodified influenza VLPs at generating an immune response to different influenza strains in animals.

July 18, 2020 - According to a report posted on Mirae, the website run by the North's State Commission of Science and Technology, North Korea scientists are conducting clinical trials to develop a vaccine for COVID-19. The report said the vaccine development is led by a medical biology institute under the North's Academy of Medical Science using angiotensin-converting enzyme 2 (ACE2).

July 16, 2020 - OSE Immunotherapeutics announced it will receive a grant of up to €200,000 from Nantes Metropole, the metropolitan area of Nantes community, on Nice France, dedicated to the development of a prophylactic vaccine against the SARS-CoV-2 virus.

July 15, 2020 – Seventy-five countries have submitted expressions of interest to protect their populations and those of other nations through joining the COVAX Facility, a mechanism designed to guarantee rapid, fair, and equitable access to COVID-19 vaccines worldwide.

The 75 countries, which would finance the vaccines from their own public finance budgets, partner with up to 90 lower-income countries that could be supported through voluntary donations to Gavi’s COVAX Advance Market Commitment (AMC).

July 14, 2020 - Medicago announced it began Phase I clinical trials for its plant-derived COVID-19 vaccine candidate yesterday, administering the first doses in healthy human volunteers. Medicago said it is also planning a Phase 2/3 trial to be initiated this October. Unlike traditional vaccination development, Medicago does not use animal products or live viruses to create its products. Instead, it uses Virus-Like Particles (VLPs) that mimic the shape and dimensions of a virus, which allows the body to recognize them and create an immune response in a non-infectious way.

July 14, 2020 - IMV Inc. announced it received an agreement with Health Canada on Phase 1 clinical study design protocol. Two dose levels of DPX-COVID-19 will be tested (25μg or 50μg). DPX-COVID-19 is a formulation of the DPX delivery platform with 4 complimentary peptide antigens that were selected for their high immunogenicity and ability to bind non-overlapping areas on the virus spike. Importantly, our selected targets are located outside of the 614 mutation which, according to recent research, has been demonstrated to increase the coronavirus’s ability to infect cells in vitro and suggested to potentially reduce vaccine-induced immunity.

July 13, 2020 - Altimmune, Inc. announced positive results from the preclinical studies of its intranasal COVID-19 vaccine candidate, AdCOVID. The studies, which were conducted in collaboration with the University of Alabama at Birmingham, showed strong serum neutralizing activity and potent mucosal immunity in the respiratory tract.

July 13, 2020 - Tonix Pharmaceuticals Holding Corp. announced a new preclinical research and option agreement with Kansas State University to develop a vaccine candidate for the prevention of COVID-19 that utilizes a novel live virus vaccine vector platform and the CD40-ligand, also known as CD154 or 5c8 antigen, to stimulate T cell immunity.

July 11, 2020 - Study: a bivalent measles-based COVID-19 vaccine could be the solution for 2 significant public health threats.

July 9, 2020 - CEPI, Gavi, and WHO have launched the COVID-19 Vaccine Global Access Facility (COVAX), part of the ACT Accelerator, working as an end-to-end solution to ensure equitable access to COVID-19 vaccines for all countries, at all levels of development, that wish to participate.

July 9, 2020 - A non-peer-reviewed study found a single dose of YF-S0 vaccine candidate confers protection from lung disease in most vaccinated animals even within 10 days. These results warrant further development of YF-S0 as a potent SARS-CoV-2 vaccine candidate.

July 8, 2020 - The Coalition for Epidemic Preparedness Innovations announced the expansion of its partnership with Sichuan Clover Biopharmaceuticals, Inc. to rapidly advance the development and manufacture of Clover’s protein-based COVID-19 S-Trimer vaccine candidate SCB-2019, which is based on Clover’s proprietary Trimer-Tag© vaccine technology platform.

July 8, 2020 - Voltron Therapeutics, Inc. announced it has initiated preclinical testing of the first construct of its HaloVax Self-Assembling Vaccine (SAV) against COVID-19. The vaccine is built on a base of a heat shock protein (HSP70) that activates the cellular portion of the immune system; this is different from most other vaccine efforts, which have used adjuvants such as alum. The second portion of the vaccine consists of peptides derived from the COVID-19 virus, which are bound to the heat shock protein via Avidin and Biotin. This enables rapid iteration and up-to-date data-informed changes in the peptide sequences to enable swift production and accommodate potential changes in the pathogen itself. The selected immunogenic peptides complete the customized COVID-19 vaccine.

July 8, 2020 – Osivax announced that it has received over EUR 30M in public funding to support the development of universal vaccines against coronavirus and influenza. By targeting the nucleoprotein, a highly conserved antigen with a low mutation rate found in every flu variation, oligoDOM® has the potential to provide lasting immunity regardless of virus mutation. Osivax is deploying the same approach toward a universal coronavirus vaccine to protect against the current virus, SARS-Cov-2, and future coronavirus strains.

July 7, 2020 - GSK and Medicago announce collaboration to develop a novel adjuvanted COVID-19 candidate vaccine.

July 7, 2020 - Study: these results suggest the MSR vaccine system may provide potent protective immunity when utilized to present SARS-CoV-2 antigens.

July 7, 2020 - Corvus Pharmaceuticals, Inc. announced that it has initiated a Phase 1 study to investigate a novel immunotherapy approach for patients with COVID-19. Corvus is studying an agonistic (immunostimulatory) humanized monoclonal antibody, designated as CPI-006, which has demonstrated a potential new approach to immunotherapy of infectious diseases and cancer. In both in vitro and in vivo studies in cancer patients, CPI-006 has demonstrated binding to various immune cells and the inducement of a humoral adaptive immune response – B cell activation and lymphocyte trafficking leading to the production of antigen-specific immunoglobulin (IgM and IgG) antibodies.

July 2, 2020 - The Government of Austria has today formally announced €2 million (US$2.2 million) in funding to the Coalition for Epidemic Preparedness Innovations to support its work to advance the development of COVID-19 vaccines, and enable global equitable access to vaccines once they are proven safe and effective.

July 1, 2020 - Sorrento Therapeutics, Inc. announced that it has published a pre-print publication describing initial pre-clinical results from its COVID-19 vaccination program, which introduced a novel targeted protein vaccine against COVID-19, referred to as T-VIVA-19, is a recombinant fusion protein of the spike protein S1-domain and the Fc portion of the human IgG1 antibody (rS1-Fc). The rS1-Fc was injected into either the vein or the thigh muscle of a mouse. The mice were given a booster shot three weeks later (by the same route as the initial injection) and immune responses to SARS-CoV-2 were examined.

June 2020: SARS-CoV-2 Coronavirus Vaccine Development News

June 30, 2020 - Meissa Vaccines announced that the company has initiated preclinical studies and manufacturing and completed a pre-IND meeting with the U.S. FDA for the development of MV-014-210, a live attenuated vaccine candidate to induce immunity and protect against SARS-CoV-2.

June 29, 2020 - Bharat Biotech announced it has successfully developed COVAXIN, India’s first vaccine candidate for Covid-19, in collaboration with the Indian Council of Medical Research and National Institute of Virology. The Drug Controller General of India- Central Drugs Standard Control Organisation and Ministry of Health & Family Welfare granted permission to initiate Phase I & II Human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response. Human clinical trials are scheduled to start across India in July 2020.

June 29, 2020 - Altimmune, Inc. announced it was awarded $4.7 million from the U.S. Army Medical Research & Development Command to fund its Phase 1/2 clinical trial of T-COVID, an investigational intranasal immune modulator for the treatment of outpatients with early COVID-19.

June 28, 2020 - Brazil's Health Ministry executive secretary Elcio Franco said under the US$127 million deal, the Brazilian government’s public-health institute, the Oswaldo Cruz Foundation (Fiocruz), will acquire the technology and supplies to produce the vaccine, which is being tested in Britain and South Africa, as well as Brazil.

June 28, 2020 - Sinopharm announced it has been found a vaccine to be safe and able to generate high titers of antibodies among participants in phase I and II clinical trials, according to a Weibo posting. All the participants have generated neutralizing antibodies, a measurement of the vaccine’s ability to stimulate a specific immune response to the SARS-CoV-2 coronavirus.

June 23, 2020 - The Phase I/II clinical trials of the world's first inactivated COVID-19 vaccine, developed by Wuhan Institute of Biological Products under the China National Biotec Group (CNBG) affiliated to the China National Pharmaceutical Group (Sinopharm), produced antibodies in every participant.

June 18, 2020 - Tonix Pharmaceuticals Holding Corp. announced an expansion of its strategic collaboration with Southern Research to include a study of T cell immune responses to SARS-CoV-2 in volunteers who have recovered or remain asymptomatic after exposure to COVID-19. The research is part of an ongoing collaboration to develop and conduct animal testing of Tonix’s TNX-1800, which is a live replicating virus vaccine designed to protect against COVID-19. The data will support the interpretation of animal trial results with TNX-1800, which are expected in the fourth quarter of 2020 and subsequent human trials.

June 18, 2020 - Codagenix, Inc. announced the successful synthesis of a readily-scalable live-attenuated vaccine candidate against COVID-19. The vaccine, CDX-005, is currently undergoing safety and efficacy studies in animals and appears markedly attenuated compared to wild-type SARS-CoV-2, with pre-clinical data expected by early July.

June 17, 2020 - CureVac AG announced that the German Health Authority Paul-Ehrlich-Institute and the Belgian Federal Agency for Medicines and Health Products have approved the Phase 1 clinical trial for its CVnCoV vaccine program to prevent SARS-CoV-2 infection. The trial will be conducted in Germany and Belgium. CureVac´s mRNA vaccine candidate CVnCoV utilizes nucleotides without chemical modifications in the mRNA and is designed to provide a strong and balanced activation of the immune system. The mRNA encodes the full-length spike protein of SARS-CoV-2 and is formulated with lipid nanoparticles.

June 11, 2020 - Brazilian officials announced an agreement with China’s Sinovac Biotech to produce its coronavirus vaccine in the state of Sao Paulo, where tests involving 9,000 volunteers are to begin in June 2020.

June 11, 2020 - Japanese biotech AnGes Inc. expects its coronavirus vaccine to be ready as early as the first half of 2021 if it can overcome supply chain and production hurdles, the company’s founder has said. The Osaka-based firm got a headstart in the potential COVID-19 vaccine development by repurposing its hypertension vaccine that had already passed through high safety and regulatory standards and other hurdles.

June 10, 2020 - Panacea Biotec is advancing its response to address the unprecedented challenges of COVID-19 by collaborating with Refana Inc. in the USA to make a Covid-19 vaccine widely accessible around the world in an equitable manner through a Joint Venture company to be based in Ireland. The collaboration aims to bring to patients a whole inactivated virus-based vaccine for Covid-19. The collaboration aims to make more than 500 million doses of the coronavirus prevention vaccine candidate, with over 40 million vaccine doses expected to be available early 2021.

June 7, 2020 - A third COVID-19 vaccine effort is quietly underway at the University of Pittsburg.

June 5, 2020 - The University of Queensland (UQ) today announced that they have entered into a new, significant partnering agreement to accelerate the development, manufacture, and distribution of a COVID-19 vaccine candidate which has been pioneered by researchers at UQ. The initial phase of large-scale production of the UQ COVID-19 vaccine is planned to take place at CSL’s biotech manufacturing facilities in Melbourne, Australia. The UQ COVID-19 vaccine will be combined with Seqirus’ well-established adjuvant technology – MF59® to improve immune response, reduce the amount of antigen needed for each vaccine, and enable more doses to be manufactured more rapidly.

June 4, 2020 - iBio, Inc. announced the initiation of preclinical immunization studies for its new subunit vaccine (“IBIO-201”) combines antigens derived from the SARS-CoV-2 spike protein fused with the Company’s patented lichenase booster molecule (“LicKM”), which is designed to enhance the immune response. The addition of the LicKM booster to a subunit antigen is expected to improve the likelihood of achieving single-dose, prolonged immunity while also increasing manufacturing capacity through increased potency.

June 4, 2020 - Elixirgen Therapeutics, Inc., announced that it concluded on May 18th its pre-Investigational New Drug meeting with the U.S. FDA for the COVID-19 vaccine candidate, EXG-5003. EXG-5003 is a temperature-sensitive, intradermally-injected srRNA (self-replicating RNA) vaccine expressing the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein.

June 1, 2020 - The U.S. Department of HHS announced on a task order worth approximately $628 million has been issued with Emergent BioSolutions to advance manufacturing capabilities and capacity for a potential COVID-19 vaccine as well as therapeutics.

May 2020: SARS-CoV-2 Coronavirus Vaccine Development News

May 28, 2020 - Members of Mass General Brigham have entered into a manufacturing agreement to produce their novel genetic vaccine with AveXis, a Novartis Company. AveXis will begin manufacturing the vaccine this month while AAVCOVID undergoes further safety and efficacy testing in preclinical studies taking place at academic medical institutions including Mass. Eye and Ear.

May 27, 2020 - Merck and Baylor College of Medicine, Houston, Texas, announced an extension of their ongoing collaboration to advance a manufacturing platform to fight Covid-19, designed to accelerate the transition to Phase 1 clinical trials. Merck, along with researchers at Baylor College of Medicine and the Texas Children's Hospital Center for Vaccine Development, is optimizing the production processes to advance two Covid-19 vaccine candidates, including the CoV RBD219-N1 vaccine candidate expected to enter clinical trials later this year.

May 26, 2020 - Merck and IAVI announced a new collaboration to develop an investigational vaccine against SARS-CoV-2 coronavirus. This vaccine candidate will use the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for Merck’s Ebola Zaire virus vaccine, ERVEBO, which was the first rVSV vaccine approved for use in humans. The vaccine candidate is in preclinical development, and clinical studies are planned to start later in 2020.

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.

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.

Coronavirus FAQs

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COVID-19 disease outbreak news is available at Coronavirus Today.

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