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GAO-20-583SP 1 (2020-05-26)

handle is hein.gao/gaobaebdr0001 and id is 1 raw text is: Science, Technology Assessment, GAO Iand Analytics SCIENCE & TECH SPOTLIGHT: COVID-19 VACCINE DEVELOPMENT What is it? Vaccines protect people from disease by triggering the immune system to produce antibodies that will fight the pathogen attacking the body. In the case of COVID-19, the pathogen is the virus SARS-CoV-2. Developing a vaccine is an expensive, lengthy process that involves a rigorous series of steps to first identify a potential vaccine candidate and then assess it for safety and effectiveness. How does it work? A vaccine can use a virus that has been modified to be safe or a molecule that resembles a part of the virus. Once antibodies are produced, if the vaccinated person is exposed later to the virus, their body will produce those antibodies again, increasing their chances of fighting off infection. Development starts with identifying a target, such as a protein, that can induce an immune reaction. Researchers create a vaccine candidate similar to that target that will induce production of antibodies effective against the virus. The vaccine candidate is then moved through phases of development, assessment, and approvals (fig. 1). Traditional timeline 10-15 years P Phase Ii E Phase III M Potential accelerated timeline with overlapping phases and EUA---- late 2020 or beyond BLA = Biologics License Application EUA = Emergency Use Authorization IND = Investigational New Drug Source: GAO analysis of GAO-20-215SP, FDA, HHS, and Pharmaceutical Research and Manufacturers of America (PhRMA) documentation. I GAO-20-583SP I The vaccine development process typically takes 10 to 15 years under a traditional timeline. Multiple regulatory pathways, such as Emergency Use Authorization, can be used to facilitate bringing a vaccine for COVID-19 to market sooner. Under normal circumstances, the entire process typically takes 10 to 15 years, with more than 65 percent of candidates failing, according to an MIT study. There is an effort to expedite this process for SARS-CoV-2. As of May 15, 2020, there are more than 110 COVID-19 vaccines in development globally; of those, at least three are being developed in the United States with federal funding. These three use different mechanisms to prompt the body to produce antibodies (fig. 2). mRNA coding a SARS-CoV-2 gene Viral protein @ Recombinant SARS-CoV-2 surface protein Fo< rmation of Viral antibodes * Viral vector packaging protein agst SARS-CoV-2 gene SARS-CoV-2 Source: GAO. I GAO-20-583SP Vaccine candidates use different mechanisms, such as those shown above, to prompt the body to produce antibodies against SARS-CoV-2. The first candidate, developed by National Institute of Allergy and Infectious Diseases scientists and their collaborators, uses a molecule called mRNA specifically coded to generate proteins that will induce an immune response. This is a newer method of vaccine development that has shown promise in animals during the preclinical phase. The second candidate uses a recombinant protein, which is produced by genetically engineering bacteria or other cells to produce a protein that mimics part of the spike protein found on the surface of the SARS-CoV-2 virus. The spike protein alone does not cause an infection but may be sufficient to produce an immune response. Recombinant protein vaccines are already being used successfully against other viruses, such as the human papillomavirus (HPV), which can cause cervical cancer. The third candidate uses a virus-adenovirus 26, or Ad26-but researchers have removed its infectious aspects, making it safe as a vector' to deliver a piece of SARS-CoV-2 to trigger a protective immune response. This method is also in clinical trials against HIV and Ebola. How mature is it? The process for developing a new vaccine as outlined by the Food and Drug Administration (FDA) is well established. In the exploratory phase, the target and candidate vaccine are identified. In the preclinical phase, researchers use cells and animals to assess safety and produce evidence of clinical promise, evaluated by the candidate's ability to elicit a protective immune response. GAO-20-583SP COVID-19 Vaccine Development

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