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Transparency is Key to Ensure the Public’s Confidence in COVID-19 Vaccine

With promising phase III clinical trial results and subsequent Emergency Use Authorization (EUA) submissions for vaccine candidates developed by BioNTech/Pfizer and Moderna, it is anticipated the first effective medicines against the SARS-CoV-2 virus, the virus that causes COVID-19, may reach the public before year’s end. Notably, the pace of vaccine development has been unprecedented, as vaccine development normally spans a decade. This has naturally caused many to have concerns about the safety of these soon to arrive vaccines. The availability of an effective and safe vaccine trusted by the public is imperative, as in most countries infections are rapidly spreading at rates faster than this past spring. Therefore, it is vital that key agencies, such as the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), as well as influential infectious disease experts, inform the public on how safety is being monitored amongst vaccine candidates to provide reassurance and prompt vaccine participation.

COVID-19 vaccine EUA submission guidelines

Officials from the committees Center of Biologics Evaluation and Research and Vaccines and Related Biological Products, within the FDA, previously met with experts from the CDC, National Institute of Health (NIH), and Biomedical Advanced Research and Development Authority (BARDA). This meeting, held on October 22, 2020, created guidelines for companies requesting EUAs for COVID-19 vaccines (1). With regard to the safety and efficacy data requirements, there are two important general criteria that need to be met. First, there must be scientific evidence collected from sufficiently powered and controlled clinical trials that suggests the vaccine candidate will be effective to prevent infection from SARS-CoV-2. Second – and likely the most important for those with safety concerns – the data must showcase that both the known and potential benefits of their vaccine will outweigh any known and potential risks.

Potential risks that concern the public

The major safety concern centers around mistrust due to the speed and lack of transparency of the developed vaccines. The current vaccine candidates are using an RNA-based technology against the “spike” protein of SARS-CoV-2 to elicit an immune response. Like the concept of all vaccines, this will allow our immune systems to make antibodies against this protein so that upon subsequent exposure, our immune cells can recognize the virus and mount a swift and effective immune response. However, an RNA platform has never been the basis of any current FDA approved vaccines to date (2), leaving reasonable concerns that there could be unforeseen adverse events, and the expedited timeline for vaccine development is not sufficient to delineate let alone detect any potential side effects. Furthermore, there is concern whether the timeline allows for enough time to evaluate vaccine effectiveness, which is essential for the favorable benefit-risk determination required.

Addressing the publics’ fears

To curb these concerns, the publicly available requirements for EUA read as follows. All vaccine developers must have clinical data collected from an endpoint of a well-designed placebo-controlled phase 3 clinical trial that shows at least 50% efficacy against preventing COVID-19 infection. A median of at least two months of safety follow-up is required, which is a more stringent criterion than usual. In addition, companies must obtain the efficacy and safety data requirements, as stated above, through sufficiently powered (i.e. adequate number of subjects) trials. Lastly, sponsors are expected to continue their trials until full approval, which includes the standard six-month active safety follow-up analysis.

Infectious disease experts and public health officials have also tried to dampen the fear surrounding COVID-19 vaccine development. Dr. Saad Omer, director of the Yale Institute for Global Health and key member for a group within the World Health Organization evaluating the safety of COVID-19 vaccines, suggested that the compressed timeline of vaccine development is due to higher efficiency of the process rather than cutting corners (3). For example, most developers ran combined phase 1 and 2 clinical trials and have already begun preparations for high-scale manufacturing. He also commented that since current trials are event-driven trials and are defining efficacy as whether those exposed can become infected by SARS-CoV-2, the current rates of infection and chances of exposure in the United States are speeding up the trial. In essence, trials are reaching the minimum number of participants and results much quicker. With regard to unknown adverse events, by using a RNA-based vaccine platform, thus far, side effect symptoms have been injection site pain and low grade fever, which are common to vaccines in general. The more stringent two-month safety requirement, as well as the expanded plans being set in place by the CDC and FDA to monitor vaccine safety, is likely sufficient to dampen concerns, especially since serious adverse events surrounding any vaccine usually cluster within the first months after administration.


With once again rising cases of COVID-19, it is more important than ever that a safe and effective vaccine become available. Therefore, it is crucial that the FDA, in addition to other public health offices and key infectious disease experts continue to publicize factual, unbiased data that is easily digestible to the general public. This will ensure the public has the confidence in making an informed decision about a COVID-19 vaccine, with the overall hopeful outcome to defeat COVID-19.

About the author:

Lindsay Gurska Lindsay Gurska is a Cell Biology PhD trainee at Albert Einstein College of Medicine. She is interested in pursuing a career in science communication. Her current interest is in writing and creating promotional content for the therapeutic landscape.


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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 CellScience 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

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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.

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Imre Berger

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Sina Bavari, PhD

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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).

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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

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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.