Abbreviations and Acronyms:ACE2 (angiotensin-converting enzyme 2), ADE (antibody-dependent enhancement), COVID-19 (coronavirus disease 2019), IL (interleukin), MERS (Middle East respiratory syndrome), MVA (modified vaccinia virus Ankara), NIH (National Institutes of Health), RBD (receptor-binding domain), S (spike), SARS (severe acute respiratory syndrome), SARS-CoV (SARS coronavirus), TLR (Toll-like receptor), VLP (virus-like particle), WHO (World Health Organization)
- •This review briefly summarizes what is currently known about severe acute respiratory syndrome coronavirus 2 and outlines the implications that knowledge may have on vaccine development.
- •This review summarizes current coronavirus disease 2019 (COVID-19) vaccine approaches and issues that must be resolved as we work toward developing safe and effective vaccines to prevent COVID-19.
- •In particular, the vaccines in advanced phase 3 clinical trials are reviewed, and we outline the rationale for their use.
- •We describe potential challenges and a research agenda critical to COVID-19 vaccine development.
Coronavirus disease (COVID-19): Situation Report -162.
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Spike mutation pipeline reveals the emergence of a more transmissible form of SARS-CoV-2.
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Issues in Vaccine Development
WHO target product profiles for COVID-19 vaccines: version 3.
|The ideal vaccine should|
WHO target product profiles for COVID-19 vaccines: version 3.
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Computational Approaches to Accelerate Vaccine Development
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Current Status of Vaccine Development
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|NCT number||Vaccine type||Sponsor/collaborators||Trial phase||Location|
|NCT04299724||Artificial APCs expressing SARS-CoV-2 proteins||Shenzhen Geno-Immune Medical Institute||1||Guangdong, China|
|NCT04383574||Alum-adjuvanted, formalin-inactivated vaccine||Sinovac Research and Development Co, Ltd||1/2||Hebei, China|
|NCT04352608||Alum-adjuvanted, formalin-inactivated vaccine||Sinovac Research and Development Co, Ltd||1/2||Jiangsu, China|
|NCT04450004||Virus-like particle vaccine||Medicago Inc||1||Not provided|
|NCT04412538||Inactivated SARS-CoV-2 vaccine||Chinese Academy of Medical Sciences, West China Second University Hospital, Yunnan Center for Disease Control and Prevention||1/2||Sichuan, China|
|NCT04283461||RNA vaccine: mRNA-1273||National Institute of Allergy and Infectious Diseases||1||United States|
|NCT04405908||Subunit vaccine: spike protein trimer||Clover Biopharmaceuticals AUS Pty Ltd||1||Australia|
|NCT04313127||Vectored vaccine: adenovirus type 5 vector||CanSino Biologics Inc, Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China, Jiangsu Provincial Center for Disease Control and Prevention, Hubei Provincial Center for Disease Control and Prevention, Tongji Hospital||1||Hubei, China|
|NCT04437875||Vectored vaccine: adenovirus type 26 with spike protein||Gamaleya Research Institute of Epidemiology and Microbiology, Ministry of Health of the Russian Federation, Acellena Contract Drug Research and Development||1/2||Russia|
|NCT04368728||RNA vaccines: BNT162a1, BNT162b1, BNT162b2, BNT162c2||BioNTech SE, Pfizer Inc||1/2||United States|
|NCT04341389||Vectored vaccine: adenovirus type 5 vector||Insitute of Biotechnology, Academy of Military Medical Sciences, PLA of China, CanSino Biologics Inc, Jiangsu Provincial Center for Disease Control and Prevention, Hubei Provincial Center for Disease Control and Prevention, Zhongnan Hospital||2||Hubei, China|
|NCT04386252||Artificial APCs expressing SARS-CoV-2 proteins||AIVITA Biomedical, Inc||1/2||United States|
|NCT04368988||Nanoparticle vaccine with Matrix-M adjuvant||Novavax, Inc||1||Australia|
|NCT04324606||Vectored vaccine: chimpanzee adenovirus, ChAdOx1||University of Oxford||1/2||United Kingdom|
|NCT04334980||Oral vaccine: bacTRL-Spike||Symvivo Corporation||1||United States, Canada|
|NCT04405076||RNA vaccine: mRNA-1273||Moderna, Inc, Biomedical Advanced Research and Development Authority||2||United States|
|NCT04400838||Vectored vaccine: chimpanzee adenovirus, ChAdOx1||University of Oxford||2/3||United Kingdom|
|NCT04428073||Vectored vaccine: adeno-associated virus||GeneCure Biotechnologies||1||Not provided|
|NCT04453852||Recombinant protein vaccine with Advax-SM adjuvant||Vaxine Pty Ltd, Central Adelaide Local Health Network Incorporated||1||Australia|
|NCT04398147||Vectored vaccine: adenovirus type 5 vector||CanSino Biologics Inc, Beijing Institute of Biotechnology, Canadian Center for Vaccinology||1/2||Canada|
|NCT04444674||Vectored vaccine: chimpanzee adenovirus, ChAdOx1||University of Witwatersrand, South Africa, South African Medical Research Council, Bill and Melinda Gates Foundation, University of Oxford||1/2||South Africa|
|NCT04449276||Biological: CVnCoV vaccine; Drug: placebo||CureVac AG, Coalition for Epidemic Preparedness Innovations||1||Germany|
|NCT04447781||DNA vaccine: INO-4800||International Vaccine Institute, Coalition for Epidemic Preparedness Innovations, INOVIO Pharmaceuticals||1/2||Not provided|
|NCT04336410||DNA vaccine: INO-4800||INOVIO Pharmaceuticals, Coalition for Epidemic Preparedness Innovations||1||United States|
|NCT04380701||RNA vaccines: BNT162a1, BNT162b1, BNT162b2, BNT162c2||BioNTech RNA Pharmaceuticals GmbH, BioNTech SE||1/2||Germany|
- Chen W.-H.
- Strych U.
- Hotez P.J.
- Bottazzi M.E.
Live Virus Vaccines and Whole Inactivated Vaccines
UQ COVID-19 vaccine shown to induce potent protective response in pre-clinical trials.
Five COVID-19 vaccine candidates in preclinical testing [press release].
Nucleic Acid Vaccines
DRAFT landscape of COVID-19 candidate vaccines – 23 April 2020.
- Kirka D.
Expert Commentary/Look Ahead
- •Concerns over an “S-only” vaccine approach for an RNA virus and the possibility of viral mutation and recombination events13that could diminish or negate the efficacy of first generation vaccines
- •Ongoing research into the optimal balance of vaccine-induced immunity (innate, humoral, cellular) is needed
- •Discussion regarding controlled human challenge models and emergency use authorization approaches to development and use of candidate vaccines
- •Concerns about antibody/vaccine–enhanced disease, as was observed in initial animal studies of SARS-CoV-1 vaccine candidates in both mice and ferrets
- •The likely need for more than one vaccine type: those for immunoimmature (intranasal?); immunosenescent (adjuvanted or high dose?); immunocompromised (immunostimulant?); and pregnant (inactivated?) individuals
- •The unknown efficacy and durability of vaccine-induced protection must be determined and inform vaccine administration regimens; will a “prime-boost” 2-dose strategy be needed? Periodic booster doses? Will vacinees need to be screened for preexisting antibody? Will annual boosters be needed?
- •SARS-CoV-2 will very likely not be the last coronavirus to cause widespread and important human infections. Governments and funders must develop mechanisms for virus surveillance, as well as ongoing antiviral and vaccine development—even in the absence of current infections and beyond normal organizational attention spans
- •A correlate of protection for immunity must be defined, whether for wild virus or vaccine-induced immunity
- •Vaccine manufacturing and distribution capacity must be developed to provide ongoing immediate capacity for vaccine manufacture of new vaccines against novel human pathogens
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Potential Competing Interests: Dr Poland is the chair of a Safety Evaluation Committee for novel investigational vaccine trials being conducted by Merck Research Laboratories and is a consultant on vaccine development for Merck & Co, Inc, Avianax LLC, Adjuvance Technologies Inc, Valneva SE, Medicago Inc, GlaxoSmithKline plc, Sanofi Pasteur, Emergent BioSolutions Inc, Dynavax Technologies, Genentech, Inc, Eli Lilly and Company, Janssen Global Services, LLC, Kentucky BioProcessing, Inc, and Genevant Sciences Corporation. Drs Poland, Ovsyannikova, and Kennedy hold patents related to vaccinia, influenza, and measles peptide vaccines and have received grant funding from ICW Healthcare Ventures for preclinical studies on a peptide-based COVID-19 vaccine. Dr Kennedy has received funding from Merck Research Laboratories to study waning immunity to mumps vaccine. These activities have been reviewed by the Mayo Clinic Conflict of Interest Review Board and are conducted in compliance with Mayo Clinic Conflict of Interest policies. Dr Crooke reports no competing interests.