Nancy (Najmeh) Jafari, MD, MPH, FAHM
With the coronavirus pandemic, which has now spread to 195 countries and killed more than 16,000, the whole world is eagerly looking forward to development of new vaccines and treatments. Scientists, research organizations, and pharmaceutical companies are working tirelessly to fight back the outbreak by expediting the development of novel coronavirus vaccines and treatments. Among several potential vaccines for Coronavirus, the mRNA-1273, developed by Moderna with the National Institute of Allergy and Infectious Disease (NIAID), successfully started the first stage of the clinical testing on Monday, March 16th. Jennifer Haller was the first volunteers who was dosed at the Kaiser Permanente Washington Health Research Institute in Seattle. It's a very promising news, but it's just the start of a long road. Investigators say that it could take a year or more to have a vaccine for the new coronavirus ready. Now the question is: why is it taking such a long time? Development of any new vaccine/treatment requires a series of pre-clinical and clinical testing. The noble mRNA-1273 has just started the phase 1 of the clinical trial process. In this phase, the investigators plan to enroll 45 healthy volunteer adults ages 18 to 55. Three different doses will be tested, and each volunteer will receive two shots, 28 days apart. The main aim of this phase is to test the safety and appropriate dosage of the vaccine during the one-year follow-up of the volunteers. In the next coming weeks, Moderna will monitor the data and if the safety data indicates that the vaccine is safe, they will ask the Food and Drug Administration (FDA) for permission to move ahead to the phase 2 of clinical trial. The Phase 2 of testing involves enrolling several hundred (300-1000) volunteers. The purpose of this phase is to confirm safety of the vaccine, assess efficacy and potential side effects, and explore the human's response to the vaccine. This phase may take several months to be conducted and requires involvement of several clinical research sites to recruit and conduct testing on volunteers. If the results of the phase 2 are promising, the Phase 3 of the clinical trial will be started with the aim to enroll hundreds to thousands (300-3,000) volunteers. This phase is specifically focused on efficacy of the vaccine, monitoring of adverse reactions, and detecting side effects. This phase may take several months to years to be completed and data may be collected from several clinical research sites across the country (or even around the world). If the results of the phase 3 show that the new vaccine is effective and safe and benefits outweighs risks, a new application will be submitted to the Food and Drug Administration (FDA) for approval. After approving the vaccine, it gets the permission for production and will be available to general public. However, FDA continues to oversee its production and marketing to ensure continuing safety and efficacy (Phase 4). Because of this sophisticated process for vaccine development, many experts predict that the coronavirus vaccine may not be available for another 12-18 months. Today, Moderna announced that "it is possible that under emergency use, a vaccine could be available to some people, possibly including healthcare professionals, in the fall of 2020." Any emergency use would be subject to authorization by the appropriate regulatory agencies to ensure the vaccine is safe and effective before making it available to public. Until then, prevention strategies are the best approach in controlling the infection rate and limiting the number of patients worldwide. To learn how to protect yourself, please visit CDC's website at: https://www.cdc.gov/coronavirus/2019-ncov/prepare/prevention.html Check this video out for more information about mRNA-1273, Moderna's Potential Vaccine Against COVID-19: https://youtu.be/qJlP91xjvsQ
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AuthorNancy Jafari, MD, MPH, FAHM |