Fundraising net proceeds go to COVID-19 Solidarity Response Fund for WHO

The race for COVID-19 vaccines: the three front-runners

Getting a safe and effective COVID-19 vaccine from concept to approval in under a year is a remarkable scientific achievement that many doubted possible. As of date, there are 51 COVID-19 vaccine candidates in human clinical trials, and 13 are currently in advanced phase 3 trials1 of which 3 have already reported positive results2-4 and 1 was granted a temporary authorization for emergency use in the UK5 and in the US7. The Medicines & Healthcare Products Regulatory Agency (MHRA) in the UK was the first to grant the first Emergency Use Authorization (EUA) following a worldwide phase 3 trial to the COVID-19 vaccine from Pfizer/BioNTech, followed by the US Food and Drugs Administration (FDA) one week later. Other vaccine candidates, from Moderna/NIAID and AstraZeneca/University of Oxford, have also been submitted for US and European emergency regulatory approval and further regulatory decisions across the globe are expected in the coming days and weeks.

Pfizer/BioNTech vaccine

The Pfizer/BioNTech vaccine was the first vaccine to show positive early results from phase 3 trials and is the fastest vaccine to go from concept to reality. It is a new type of vaccine that contains the genetic instructions in the form of messenger RNA (mRNA) to produce the spike protein of SARS-CoV-2. The mRNA is encapsulated in lipid nanoparticles that help deliver the mRNA into the cells and prevent it from being degraded. The primary efficacy analysis of the phase 3 trial, based on 170 cases of COVID-19, demonstrated a vaccine efficacy rate of 95%2. Efficacy was consistent across age (including elderly people who are most vulnerable to COVID-19), gender, race, and ethnicity demographics included in the trials. Overall, the vaccine was well tolerated with no serious safety concerns reported during clinical trials although concerns about the risk of allergic reactions have arisen after the UK has started a mass vaccination campaign under EUA. The vaccine is given as two injections, 21 days apart. Immunity begins to kick in after the first dose, though a full protective effect is reached only seven days after the second dose. The limitation of this vaccine is that it must be kept at £ 70°C during shipment and storage to maintain optimal efficacy, making its distribution more difficult.

Moderna/NIAID vaccine

The Moderna/National Institute of Allergy and Infectious Diseases (NIAID) vaccine is also an mRNA vaccine containing the genetic instructions to produce the SARS-CoV-2 spike protein. The vaccine is injected twice 4-weeks apart and it has shown an efficacy rate of 94.1%, based on 196 cases of COVID-193. Once again, efficacy was consistent across age, race and ethnicity, and gender demographics. A significant advantage with the Moderna/NIAID vaccine is its improved storage stability. The vaccine lasts for up to 30 days in household refrigerators, up to 12 hours at room temperature, and is stable up to six months at £ 20°C. Thus, compared to the Pfizer/BioNTech vaccine, Moderna/NIAID vaccine has the advantage that it can be distributed using widely available vaccine delivery and storage infrastructures.

AstraZeneca/University of Oxford vaccine

The AstraZeneca/University of Oxford vaccine is based on a common cold virus called adenovirus that is engineered to express the SARS-CoV-2 spike protein. This vaccine was the first one to have detailed data from phase 3 trial published in a peer-reviewed journal6 thereby having its data widely and transparently available to the public. The study found that the vaccine was 62% effective at preventing COVID-19 when administrated as two similar doses one month apart. Interestingly, when volunteers were given a half dose followed by a full dose a month later, vaccine efficacy rose to 90%. However, this group did not include anyone over the age of 55, raising concerns that the higher efficacy may reflect the exclusion of an age group that is particularly vulnerable to COVID-19. Additional data will be required to clarify whether an initial lower dose could indeed confer better protection. Safety and efficacy data have now been submitted to regulators around the world. Compared to the vaccines from Pfizer/BioNTech and Moderna/NIAID, the technology used in the AstraZeneca/University of Oxford vaccine carries key advantages including the fact that the vaccine can be stored between 2°C to 8°C and can be produced, transported, and stored cheaply. Therefore, it can be effectively transported to undeveloped or developing countries. It is unclear what dosing AstraZeneca/University of Oxford are recommending their application requests for approval.

About the author: 

Lúcia Moreira Teixeira is an expert in Immunology driven by a personal passion for science and the ambition to translate ground-breaking science into innovative life-changing immunotherapies. She is interested in immuno-oncology, autoimmune and infectious diseases. She strongly believes researchers should engage more in science communication. Find her on twitter – @LMTimmunol – or LinkedIn – www.linkedin.com/in/moreirateixeiralucia.

References

  1. WHO. Draft Landscape of COVID-19 Candidate Vaccines. (Publication of December 2, 2020). https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines
  1. Pfizer November 18, 2020. Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints. https://www.businesswire.com/news/home/20201118005595/en/
  1. Moderna November 30, 2020. Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization.

https://www.businesswire.com/news/home/20201130005506/en/

  1. AstraZeneca November 23, 2020. AZD1222 vaccine met primary efficacy endpoint in preventing COVID-19. https://www.astrazeneca.com/media-centre/press-releases/2020/azd1222hlr.html
  1. Pfizer December 2, 2020. Pfizer and BioNTech Achieve First Authorization in the World for a Vaccine to Combat COVID-19.

https://www.businesswire.com/news/home/20201201006304/en/

  1. Voysey, M. et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet (2020). https://doi.org/10.1016/S0140-6736(20)32661-1
  2. FDA December 11, 2020. FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine.

https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19

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James E. Crowe, Jr., MD,

Director, Vanderbilt Vaccine Center; Professor, Pediatrics and Pathology, Microbiology and Immunology, Ann Scott Carell Chair; Founder, IDBiologics

Dr. Crowe’s laboratory has a broad portfolio of work in the area of viral immunology and antibody sciences, with the goal to discover mechanisms of immunity important to developing new therapeutics and vaccines.

Dr. Crowe received his MD degree from the University of North Carolina at Chapel Hill, where he also completed his pediatrics residency. Following his clinical training, Dr. Crowe received five years of post-doctoral training in the laboratory of Infectious Diseases at the NIH. He completed infectious diseases fellowship training in 1996 at Vanderbilt and has run an independent laboratory at Vanderbilt since that time. He is currently Professor of Pediatrics and of Pathology, Microbiology and Immunology, and the Ann Scott Carell Chair, Vanderbilt University Medical Center. The laboratory’s work has been published in over 300 publications in high-quality science journals including Cell, Science and Nature, and leading medical journals including the New England Journal of Medicine and JAMA. Dr. Crowe was elected to the National Academy of Medicine in 2014 and the National Academy of Inventors in 2017. He has been the recipient of investigator awards from the March of Dimes, American Society for Microbiology, Pediatric Infectious Diseases Society, and Society for Pediatric Research. He was awarded the Judson Infectious Daland Prize of the American Philosophical Society, the Oswald Avery Award of the IDSA, the E. Mead Johnson Award for Excellence in Pediatrics, the Outstanding Investigator Award of the American Federation for Medical Research, the Norman J. Siegel Award of the American Pediatric Society, the Samuel Rosenthal Prize for Excellence in Academic Pediatrics, the Stanley J. Korsmeyer Award of American Society for Clinical Investigation, the Distinguished Medical Alumnus Award from UNC School of Medicine, Chapel Hill, NC. He is an elected Fellow of AAM, AAAS, ASCI, and AAP, IDSA, APS, and others. His research team was selected as the Best Academic Research Team at the 11th Annual Vaccine Industry Excellence Awards. He was awarded the inaugural 2019 Merck Future Insight Prize, a 1M Euro prize shared with Pardis Sabeti. 

He is the Founder of IDBiologics, Inc., an early-stage biotech company developing human monoclonal antibodies for infectious diseases.

Daniel Chen, MD, PhD

CMO, IGM Bioscience

Daniel S. Chen, MD, PhD, is the Chief Medical Officer for IGM Biosciences, and former Vice President, Global Head of Cancer Immunotherapy Development at Genentech/Roche.  He received a BS degree in Biology from the Massachusetts Institute of Technology (1990), a PhD in Microbiology & Immunology (1996), and MD (1998) from the University of Southern California. His PhD work and publications focused on “Early Events in Coronavirus Infection.”

Daniel completed an Internal Medicine Residency and Medical Oncology Fellowship at Stanford University (2003). He went on to complete a Post-doctoral fellowship with Mark Davis in Immunology, where he was a Howard Hughes Medical Institute Associate. He also ran the metastatic melanoma clinic at the Stanford Cancer Center from 2003-2006. In that time, he studied human anti-cancer immune responses pre- and post-cancer vaccination and cytokine administration to determine why anti-tumor immune responses were not more clinically effective. He received a U19 grant to develop better immunologic tools to interrogate human immune responses and ultimately patented the MHC cellular microarray to detect and functionally characterize antigen-specific T cell states.

He continued as Adjunct Clinical Faculty at Stanford from 2006-2016, where he cared for melanoma patients. At Genentech from 2006-2018, Daniel focused on the clinical development of anti-angiogenic and immune-modulatory targeted therapies in both early and late development, as well as the diagnostic tools to aid their development. This included leading the clinical development for atezolizumab, a PD-L1 inhibitor, from the time the program was in research through IND, Phase I, Phase II, Phase III, to filing and approvals in multiple indications worldwide. At IGM, Daniel focuses on the development of novel engineered multivalent and multispecific therapeutics. He is a reviewer for Nature, Immunity, and Clinical Cancer Research, serves on the Board of Directors for SITC, co-chair of the CRI cancer Immunotherapy consortium, gave the keynote presentation at the AACR NCI EORTC Annual Meeting 2014 and presented at the US Congressional Briefing on Immuno Oncology in 2017. He has continued to publish with academic and industry collaborators in the field of cancer immunotherapy, including the often-referenced Chen and Mellman manuscripts, “Elements of cancer immunity and the cancer-immune set point” and “Oncology meets Immunology: The Cancer-Immunity Cycle.”

Imre Berger

Founding Director, Max Planck Bristol Centre; Chair in Biochemistry and Chemistry; University of Bristol UK

Imre Berger was trained as a biochemist and synthetic biologist at Leibniz University and Medical School (MHH) in Hannover (Germany), at MIT (Cambridge, USA), and at ETH Zurich (Switzerland). Imre’s team develops enabling methods for DNA delivery and genome engineering, engineers synthetic vaccines and nanosensors and researches the structure and mechanism of multiprotein complexes in human health and disease. After Group Leader posts at ETH (2005) and EMBL (2007), Berger joined Bristol as Full Professor of Biochemistry (2014) with a joint appointment in Chemistry (2019). He is Founding Director of the Max Planck Centre for Minimal Biology in Bristol, Director of the BBSRC/EPSRC research center for synthetic biology BrisSynBio and Co-director of the Bristol Biodesign Institute BBI.

Imre Berger holds international patents for DNA and protein technologies, co-founded three biotech companies, and received numerous distinctions, notably the Swiss Technology Award, the W.A. DeVigier Foundation Award, and a Wellcome Trust Senior Investigator Award for his innovative research. Since 2019, he is an Investigator of the European Research Council (ERC).

Prof. Berger has participated in leading roles in numerous European Commission (EC) projects, including the pan-European structural biology infrastructure INSTRUCT. He has been Coordinator of the EC FP7 HEALTH ComplexINC project enhancing production tools for complex biologics in academic and industrial R&D (2011-2016) and is partner in the EPSRC funded Innovative Future Vaccine Manufacturing Research Hub.

Sina Bavari, PhD

CSO, Edge BioInnovation Consulting and Management; former CSO, Scientific Director US Army Medical Research Institute of Infectious Diseases (USAMRIID)

Dr. Sina Bavari is the co-founder of Healion Bio. He is one of the lead (non-gov) scientific adviser to the World Health Organization on SARSCoV-2. He has spent over 30 years developing rapid response diagnostics, prophylaxis, therapeutics, and vaccines for some of the world’s deadliest infectious diseases. Prior to co-founding Healion Bio, Dr. Bavari founded Edge BioInnovation Consulting and Mgt. and was the Chief Scientific Officer and Scientific Director at USAMRIID (US Army Research Institute of Infectious Diseases), where he spent over twenty years leading the discovery and development of vaccines, therapeutics, and diagnostics or diseases such as SARS and MERS CoVs, Ebola, Marburg, Zika, Smallpox, Sudan, Nipah, alpha viruses, Anthrax and many others. He has worked extensively with the FDA to successfully develop clinically proven countermeasures for many so-called envelope viruses like SARS-CoV-2. Dr. Bavari has contributed to ~20 drug development candidates such as Remdesivir, 30 patents, and many IND filings. He has trained over 70 scientists and managed over 500 scientists and supporting staff. His work has resulted in over 350 publications in many of the leading scientific journals including Nature, Nature Medicine, Cell, Cell Hosts, New England Journal of Medicine and many others. He has degrees from USC, and the University of Nebraska where he received his PhD in Immunotoxicology and Pharmaceutical Science.

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Ralph Rogers, MD

Assistant Professor of Medicine, Clinician Educator, Infectious Diseases, Warren Alpert Medical School of Brown University

Ralph Rogers, MD is an infectious disease specialist at the Lifespan Cancer Institute. He earned his medical degree from The Warren Alpert Medical School of Brown University where he also completed his residency and fellowship in infectious diseases. Dr. Rogers is Assistant Professor of Medicine, Clinician Educator Division of Infectious Diseases Warren Alpert Medical School of Brown University. He is a member of the Infectious Diseases Society of America (IDSA), the American Society for Microbiology (ASM) and the American Society of Transplantation (AST).

John Sninsky, PhD

Consultant, Translational Sciences

John J. Sninsky, PhD is a translational medicine consultant with deep understanding of diagnostics and diagnostics paired with medicine intervention. John has served in senior management positions in small and large CLIA service laboratories and in vitro diagnostic kit companies including Cetus, Roche Molecular Systems, Celera, Quest and CareDx. He was a member of the pioneering Cetus team that developed and optimized PCR technology for research and diagnostic use; specifically, the virology team developed the HIV, HTLV, HPV, HCV and HBV PCR assays. John put in place a surveillance initiative for viral variants and presented at the first FDA PMA advisory meeting for HIV PCR approval.

Timothy J. O’Leary, MD, PhD

Adjunct Professor, Pathology, University of Maryland School of Medicine; Former Chief Research and Development Officer, Veterans Affairs

Timothy O’Leary, MD, is Adjunct Professor of Pathology at the University of Maryland and served as Chief Research and Development Officer (CRADO) of the Department of Veterans Affairs from 2013-2015. He holds a doctorate in physical chemistry from Stanford University and a medical degree from the University of Michigan.

He is certified in anatomic pathology by the American Board of Pathology and in molecular genetic pathology by the American Board of Pathology and the American Board of Medical Genetics. Prior to his VA service, O’Leary chaired the Department of Cellular Pathology and Genetics at the Armed Forces Institute of Pathology for more than 15 years. He joined VA in 2004 and served as Director of Biomedical Laboratory Research and Development, Director of Clinical Sciences Research and Development, and Deputy CRADO prior to his appointment as CRADO. O’Leary also served as a reserve member of the Public Health Service Commissioned Corps from 1979 to 2010, serving two tours on active duty. His research interests include genomics, proteomics, and ultrasensitive detection of biological toxins. He has served on numerous federal panels and advisory committees, including the Health and Human Services Clinical Laboratory Improvement Advisory Committee and the Food and Drug Administration Hematology and Devices Panel. O’Leary, the holder of four patents, has authored or co-authored more than 190 journal articles and numerous book chapters and technical reports. He is a past president of the Association for Molecular Pathology and served as editor-in-chief for the Journal of Molecular Diagnostics.