COVID-19 vaccine update

Phase 2/3 vaccine:

Organizations: University of Melbourne and Murdoch Children’s Research Institute (Australia); Radboud University Medical Center (The Netherlands); Faustman Lab at Massachusetts General Hospital (MGH) (United States)
Vaccine candidate: Bacillus Calmette-Guerin (BCG) live-attenuated vaccine for COVID-19
Original indication: Tuberculosis (TB) pediatric vaccine
Details: The BCG vaccine has been implicated in helping to combat other infections outside TB by boosting the immune system to fight similar infections. In 2017, the World Health Organization (WHO) reported the BCG vaccine may be effective against leprosy and other nontuberculous mycobacteria such as buruli ulcer disease. Other papers have posited the vaccine is effective in preventing acute respiratory tract infections in elderly patients, other respiratory infection and sepsis. A recent non-peer reviewed paper in the preprint server medRxiv has suggested countries with BCG vaccination programs at childhood are faring better in the fight against COVID-19 compared with countries that do not require BCG vaccination.
Status: The randomized, controlled, Phase 3 BRACE trial in Australia is currently recruiting and aims to recruit 4,170 healthcare workers in hospitals in Australia (NCT04327206). Researchers in The Netherlands launched the randomized, parallel-assignment, phase 3 BCG-CORONA trial on March 31 and plan to enroll 1,500 healthcare workers to receive the BCG vaccine or placebo (NCT04328441). The Faustman Lab is currently evaluating the BCG vaccine’s effectiveness in type 1 diabetes and is seeking funding to launch trial to assess whether the vaccine helps prevent COVID-19 in healthcare workers, according to independent reporting from the New York Times.

Phase 1 vaccine candidates

Company: Moderna
Vaccine candidate: mRNA-1273
Details: Moderna is the Massachusetts-based biotech company behind mRNA-1273, a vaccine candidate developed using prior studies of related coronaviruses, such as severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS).
Study Design: A Phase 1, open-label, dose-ranging clinical trial of 45 healthy participants between 18-55 years old
Institution:Kaiser Permanente Washington Health Research Institute
Status: Recruiting was completed on 19 March 2020
ClinicalTrials.gov Identifier:NCT04283461
Funding: NIAID

Company: CanSino Biologics
Vaccine candidate: Ad5-nCoV
Details: China’s CanSino Biologics has developed a recombinant novel coronavirus vaccine that incorporates the adenovirus type 5 vector (Ad5).
Study Design: A Phase 1 clinical trial of 108 participants between 18 and 60 years old who will receive low, medium, and high doses of Ad5-nCoV
Institution: Tongji Hospital; Wuhan, China
Status: Preliminary safety data from the Phase 1 trial allow the company to plan to initiate a Phase 2 trial, according to a company announcement. No further details were provided. 
Chinese Clinical Trial Registry Identifier:ChiCTR2000030906

Organization: The University of Oxford
Vaccine candidate: ChAdOx1
Details: The Oxford Vaccine Group at the University of Oxford have identified a new vaccine candidate for COVID-19, a chimpanzee adenovirus vaccine vector called ChAdOx1. The team has previously developed a MERS vaccine.  
Status: Recruitment is underway of up to 510 healthy adult volunteers aged 18-55 years to be enrolled in a Phase 1 clinical trial, according to the university. More information on the trial is available here. 

Company:Inovio Pharmaceuticals
Vaccine candidate: INO-4800
Details: Inovio is developing a DNA vaccine for SARS-CoV-2 that is in line with other DNA vaccines the company is developing, such as for the MERS coronavirus. The vaccine is injected intradermally through a device which Inovio plans to scale production of while they wait for results of INO-4800.
Study design: A non-randomized, open label trial of 40 healthy volunteers who will receive one or two intradermal injections (1.0 mg) of INO-4800 at baseline and at 4 weeks, followed by electroporation. 
Status: On 6 April, Inovio announced the start of their Phase 1 clinical trial (NCT04336410) at sites in Philadelphia and Kansas City. 

Pre-clinical vaccine candidates

Companies: Pfizer and BioNTech
Vaccine candidate: BNT162
Details: Pfizer and BioNtech have announced an agreement to collaborate on developing an mRNA-based COVID-19 vaccine originally developed by BioNTech. The companies had previously agreed to develop an mRNA-based influenza vaccine in 2018.
Status: Clinical testing is expected to begin in April 2020

Organization: University of Pittsburgh’s Center for Vaccine Research
Vaccine candidate:PittCoVacc
Details: Researchers at the University of Pittsburgh have received a $4.9 million grant from CEPI to develop a COVID-19 vaccine candidate.
Status: On April 2, University of Pittsburgh School of Medicine scientists announced they had developed a candidate COVID-19 vaccine that is effective in mice, delivered through a fingertip patch. According to a paper published in EBioMedicine, the vaccine creates antibodies in mice that the researchers believe is sufficient to neutralize the virus.

Company:Novavax
Vaccine candidate: No name announced
Details: Biotech company Novavax announced in March that it has produced several recombinant nanoparticle vaccine candidates for COVID-19 and is vetting them in animal testing.
Status: Noravax hopes to begin clinical testing in late spring of 2020. The company noted they are seeing positive results after a few weeks of testing, according to original reporting from a CBS affiliate. 

Company: CureVac
Vaccine candidate: No name announced
Details: CureVac announced they are developing an mRNA-based COVID-19 vaccine “within a few months,” according to a press release.
Status: The company plans to start clinical trials in the summer and have identified two study centers.

Company: Generex Biotechnology
Vaccine candidate: Ii-Key peptide COVID-19 vaccine
Details: Biotech company Generex subsidiary NuGenerex Immuno-Oncology is spearheading a vaccine project to create an Ii-Key peptide vaccine against COVID-19.
Status: In a company press release dated 27 February, Generex said they wanted to produce a vaccine candidate that could be tested in humans “within 90 days.”

Company:Vaxart
Vaccine candidate: Oral recombinant COVID-19 vaccine
Details: Vaxart announced their agreement with Emergent Biosolutions to develop and manufacture their oral recombinant vaccine candidate for COVID-19.
Status: The company plans to initiate a Phase 1 clinical study “early in the second half of 2020,” according to a press release.

Company: Imperial College London
Vaccine candidate: Self-amplifying RNA vaccine
Details: Imperial College London researchers are developing a self-amplifying RNA vaccine for COVID-19. They developed a vaccine candidate within 14 days of receiving the sequence from China.
Status: Animal testing is underway; the researchers aim to begin clinical trials in the summer of 2020.

Company: Medicago
Vaccine candidate: Plant-based COVID-19 vaccine
Detaisl: Medicago, which recently developed a seasonal recombinant quadrivalent virus-like particle (VLP) influenza vaccine, reported they created a coronavirus VLP 20 days after working with the SARS-CoV-2s gene.
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.

Company:Takis Biotech
Vaccine candidate: DNA-based vaccine for COVID-19
Details: The partnership between Takis Biotech and Applied DNA Sciences has resulted in four DNA vaccine candidates for COVID-19.
Status: Takis expects preclinical testing results in April 2020; their final vaccine candidate could begin human testing by fall, according to a company press release.

Companies: Johnson & Johnson and BARDA
Vaccine candidate: No name announced
Details: Johnson & Johnson has announced their intention to develop a COVID-19 vaccine, using their AdVac and PER.C6 systems, which were also used to develop the company’s Ebola vaccine.
Status: J&J says they plan to have a vaccine candidate by the end of March, with human trials starting in November 2020.

Company: Altimmune
Vaccine candidate: Intranasal COVID-19 vaccine
Details: Altimmune has developed a COVID-19 vaccine candidate using the same technology they used build their influenza vaccine, NasoVAX. The COVID-19 vaccine would be delivered intranasally in a single dose.
Status: According to a company press release, animal testing is beginning, and clinical testing is slated for August 2020 or later.


Research in additional vaccine candidates 

Companies:GlaxoSmithKline, Clover Biopharmaceuticals and Xiamen Innovax
Vaccine candidate: COVID-19 S-Trimer
Details: GSK has entered into a collaboration agreement with Chinese company Clover Pharmaceuticals to use its adjuvant technology for Clover’s COVID-19 candidate S-Trimer. GSK also has partnered with Chinese company Xiamen Innovax Biotech and offered its vaccine adjuvanttechnology to the company. 
Status: In a press release, GSK says its S-Trimer candidate is being “rapidly developed,” and pre-clinical studies are being planned.

Company: BIOCAD
Vaccine candidate: mRNA vaccine candidate
Details: Russian biotech company BIOCAD announced it is developing an mRNA vaccine candidate for COVID-19.
Status: BIOCAD said it expects to begin animal testing in April 2020.

Company: Heat Biologics
Vaccine candidate: gp96-based vaccine
Details: The biotech company Heat Biologics announced it is pairing with the University of Miami to use the gp96 heat shock protein backbone to develop at least one COVID-19 vaccine.
Institution: University of Miami Miller School of Medicine
Status: Added to WHO’s draft landscape of COVID-19 vaccines

Companies: CSL and The University of Queensland
Vaccine candidate: Molecular clamp vaccine for COVID-19
Details: Researchers at the University of Queensland have achieved a proof-of-concept vaccine candidate for COVID-19.
Institution: The University of Queensland
Status: In a press release, the university said they will begin further development prior to pre-clinical testing.

Company:Sanofi and Translate Bio
Vaccine candidate: Repurposed SARS vaccine and mRNA vaccine candidate
Details: Sanofi announced in February that is was developing a COVID-19 vaccine candidate under its egg-free, recombinant DNA platform using work from a previous SARS vaccine and in partnership with the Biomedical Advanced Research and Development Authority (BARDA). Sanofi also announced in late March that they were partnering with Translate Bio to create an mRNA vaccine candidate for COVID-19.
Status: The company hopes to have a vaccine candidate for lab testing within 6 months, according to original reporting from STAT. 

Company: ExpreS²ion Biotechnologies
Vaccine candidate: No name announced
Details: Denmark-based ExpreS²ion won a European Union (EU) Horizon 2020 grant to fund a COVID-19 vaccine candidate.
Status: The company said they plan to perform a Phase 1/2a clinical trial and aim to begin clinical testing within 12 months.

Company: University of Saskatchewan Vaccine and Infectious Disease Organization-International Vaccine Centre
Vaccine candidate: No name announced
Details: The University of Saskatchewan’s Vaccine and Infectious Disease Organization-International Vaccine Centre (VIDO-InterVac) is developing a vaccine for COVID-19, recently received $1 million to accelerate COVID-19 vaccine candidate testing.
Status: Preclinical.

Company: EpiVax
Vaccine candidate: Ii-Key peptide vaccine
Details: EpiVax is developing two Ii-Key peptide vaccine candidates against COVID-19.
Status: EpiVax’s CEO said a vaccine could be ready within 5-6 months if the company receives the right level of funding.

Company: Codagenix
Vaccine candidate: Live attenuated COVID-19 vaccine
Details: Codagenix announced in February that it had used the nCoV genome to map out several vaccine candidate genomes for COVID-19.
Status: The company said the next step is to grow and test the vaccine viruses in vivo before initiating clinical trials, but gave no timeline for when testing would begin.

Company: Zydus Cadila
Vaccine candidate: DNA and/or live attenuated recombinant COVID-19 vaccine candidate
Details: India’s Zydus Cadila announced in February they are researching two vaccine candidates for COVID-19. The first would use a DNA vaccine targeting the viral entry membrane protein of the virus, while the second uses a live attenuated recombinant measles virus targeted to COVID-19.
Status: No details have been released at this time.

Company: Sinovac
Vaccine candidate: Formalin-inactivated and alum-adjuvanted candidate vaccine for COVID-19
Details: Sinovac is purportedly working on a formalin-inactivated and alum-adjuvanted candidate vaccine for COVID-19, according to the WHO draft landscape of COVID-19 vaccines.
Status: No details have been released at this time.

Company: Geovax and Bravovax
Vaccine candidate: 
Details: In January, Chinese biotech companies Geovax and Bravovax announced they would collaborate to create a modified vaccinia ankara virus like particles (MVA-VLP) vaccine candidate for COVID-19.
Status: Geovax said it’s currently in the process of narrowing their vaccine candidates down from three to one, and from there will move to testing in humans.

Company: Greffex
Vaccine candidate: Adenovirus-based vector vaccine for COVID-19
Details: Genetic engineering company Greffex is developing an adenovirus-based vector vaccine for COVID-19.
Status: The company recently announced its vaccine candidate has entered the animal testing stage.

Company: Walter Reed Army Institute of Research and United States Army Medical Research Institute of Infectious Diseases
Vaccine candidate: No name announced
Details: Walter Reed, together with the U.S. Army Medical Research Institute of Infectious Diseases, is working on a COVID-19 vaccine. Researchers at Walter Reed had previously developed a MERS vaccine, and is using that work to help them create a vaccine candidate for COVID-19.
Status: Walter Reed has developed several vaccine candidates, and have begun testing in animals, but have not yet indicated when they would begin clinical testing in humans.

Organization: MIGAL Galilee Research Institute
Vaccine candidate: Modified avian coronavirus vaccine
Details: The institute said it plans 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).
Status: On 27 February, the institute said it planned to create the vaccine within the next 8-10 weeks, will seek safety approval within 90 days, and is in discussion with partners for human trials.

Company: AJVaccines
Vaccine candidate: No name announced
Details: In March, Danish-based vaccine manufacturer AJVaccines said they would use modern antigen technology to develop a COVID-19 vaccine candidate that would have a “high protection with a low reactogenicity and favorable safety profile.”
Status: The company has not given a timeline for further development or testing.

Organization: Baylor College of Medicine
Vaccine candidate: Re-purposed SARS vaccine for COVID-19; S1 or RBD protein vaccine candidate
Details: Researchers at the Baylor College of Medicine say they have a shelved vaccine from the 2003 SARS outbreak that could be repurposed for use in the COVID-19 pandemic. They are also developing an S1 or RBD protein vaccine as a targeted vaccine candidate for COVID-19.
Status: The university has not released details on developing or testing at this time.

Organization: Institut Pasteur
Vaccine candidate: No name announced
Details: Institut Pasteur is partnering with the Coalition for Epidemic Preparedness Innovations (CEPI) to develop a COVID-19 vaccine candidate.
Status: No other details have been released at this time.

Company: Tonix Pharmaceuticals and Southern Research
Vaccine candidate: Horsepox vaccine with percutaneous administration
Details: Biopharmaceuticals company Tonix is partnering with Southern Research to develop a COVID-19 vaccine candidate based on the company’s horsepox vaccine, TNX-1800, is working
Status: Tonix hasn’t offered a timeline for further development or testing.

Organizations: Fudan University, Shanghai JiaoTong University, and RNACure Biopharma
Vaccine candidate: mRNA vaccine candidate for COVID-19
Details: Fudan University has entered into a partnership with Shanghai JiaoTang University, and RNACure to develop a COVID-19 mRNA vaccine candidate. They are using two methods to develop an mRNA-based vaccine: using mRNA to express the receptor-binding domain of the spike protein of COVID-19 to induce neutralizing-antibodies, and developing mRNAs that can instruct the host to produce virus-like particles similar to SARS-CoV-2.
Status: No details on further development or testing are available at this time.

Company: Arcturus Therapeutics and Duke-NUS Medical School
Vaccine candidate: No name announced
Details: Arcturus and Duke are partnering to develop a COVID-19 vaccine candidate that uses Arcturus’ self-replicating RNA and nanoparticle non-viral delivery system.
Status: The companies have not released further details about development or testing.

Organization: Peter Doherty Institute for Infection and Immunity
Vaccine candidate: No name announced
Details: The Doherty Institute has received $3.2 million from the Jack Ma foundation to accelerate the creation of a COVID-19 vaccine with an active and passive platform.
Status: No other details have been released at this time.

Organization: Tulane University
Vaccine candidate: The Tulane National Primate Research Center has launched a COVID-19 research program to help develop a vaccine candidate.
Status: The organization has not established a timeline for testing, but has indicated it will use a primate model for animal testing.

Company: Sorrento Therapeutics, Inc. and SmartPharm Therapeutics Inc.
Vaccine candidate: Gene-encoded antibody vaccine candidate
Details: In late March, Sorrento Therapeutics announced a collaboration with SmartPharm Therapeutics to develop a next-generation, gene-encoded antibody vaccine for COVID-19.
Status: In a press release, SmartPharm Therapeutics said it hopes to have a candidate within several months.

Organization: University of Bristol (Imophoron)
Vaccine candidate: No name announced
Details: On 7 April, Imophoron, a spin-out company from the University of Bristol’s BrisSynBio research center, has announced it is producing several vaccine candidates for COVID-19 using its ADDomer platform.
Status: Vaccine development is in a pre-clinical stage, according to a press release from the university.

Company: IMV
Vaccine candidate: DPX-COVID-19
Details: 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.
Status: The company is developing a phase 1 clinical study of 48 healthy subjects and plans to begin the trial in the summer of 2020, according to a press release.

Reference source: Regulatory Affairs Professionals Society (RAPS)