{"id":7935,"date":"2020-09-28T13:15:42","date_gmt":"2020-09-28T19:15:42","guid":{"rendered":"https:\/\/summit-education.com\/blog\/?p=7935"},"modified":"2024-06-14T13:14:24","modified_gmt":"2024-06-14T19:14:24","slug":"covid-19-vaccines-unlocking-the-mystery-of-the-fda","status":"publish","type":"post","link":"https:\/\/blogcontent.summit-education.com\/blog\/general\/covid-19-vaccines-unlocking-the-mystery-of-the-fda\/","title":{"rendered":"COVID-19 Vaccines: Unlocking the Mystery of the FDA"},"content":{"rendered":"<p>[et_pb_section bb_built=&#8221;1&#8243;][et_pb_row][et_pb_column type=&#8221;4_4&#8243;][et_pb_text _builder_version=&#8221;3.19.10&#8243;]<\/p>\n<p><strong><img loading=\"lazy\" decoding=\"async\" class=\" wp-image-7950 alignleft\" src=\"https:\/\/blogcontent.summit-education.com\/wp-content\/uploads\/iStock-1215516118-1024x768.jpg\" alt=\"\" width=\"269\" height=\"202\" srcset=\"https:\/\/blogcontent.summit-education.com\/wp-content\/uploads\/iStock-1215516118-1024x768.jpg 1024w, https:\/\/blogcontent.summit-education.com\/wp-content\/uploads\/iStock-1215516118-300x225.jpg 300w, https:\/\/blogcontent.summit-education.com\/wp-content\/uploads\/iStock-1215516118-768x576.jpg 768w, https:\/\/blogcontent.summit-education.com\/wp-content\/uploads\/iStock-1215516118-1536x1152.jpg 1536w, https:\/\/blogcontent.summit-education.com\/wp-content\/uploads\/iStock-1215516118-510x382.jpg 510w, https:\/\/blogcontent.summit-education.com\/wp-content\/uploads\/iStock-1215516118-1080x810.jpg 1080w, https:\/\/blogcontent.summit-education.com\/wp-content\/uploads\/iStock-1215516118.jpg 2000w\" sizes=\"(max-width: 269px) 100vw, 269px\" \/><\/strong><\/p>\n<p><strong>Written By: Chad Hensel, PT, DPT, MHS, CSCS<\/strong><\/p>\n<p>With the world holding its collective breath for the announcement of a COVID-19 vaccine, this is a good opportunity to shine the spotlight on the typical drug approval process of the F.D.A.\u00a0<\/p>\n<p>One of the main roles of the Food and Drug Administration is approving drugs (including vaccines) and ensuring public safety.\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>This process has many steps:<\/p>\n<ul>\n<li><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-7951 alignright\" src=\"https:\/\/blogcontent.summit-education.com\/wp-content\/uploads\/iStock-1218588433-1024x683.jpg\" alt=\"\" width=\"401\" height=\"268\" srcset=\"https:\/\/blogcontent.summit-education.com\/wp-content\/uploads\/iStock-1218588433-1024x683.jpg 1024w, https:\/\/blogcontent.summit-education.com\/wp-content\/uploads\/iStock-1218588433-300x200.jpg 300w, https:\/\/blogcontent.summit-education.com\/wp-content\/uploads\/iStock-1218588433-768x512.jpg 768w, https:\/\/blogcontent.summit-education.com\/wp-content\/uploads\/iStock-1218588433-1536x1024.jpg 1536w, https:\/\/blogcontent.summit-education.com\/wp-content\/uploads\/iStock-1218588433-2048x1365.jpg 2048w, https:\/\/blogcontent.summit-education.com\/wp-content\/uploads\/iStock-1218588433-1080x720.jpg 1080w\" sizes=\"(max-width: 401px) 100vw, 401px\" \/>Initially, a drug undergoes \u201cpreclinical trials\u201d that are typically conducted in a lab and\/or with animals. This process can last about 1-2 years.<\/li>\n<li>If a drug successfully makes it out of preclinical trials phase and it is showing good data, the drug will receive the green light and will move to clinical trials (human trials).<\/li>\n<li>Clinical Trial Phase 1: Typically conducted on about 20-40 healthy subjects &#8212; these subjects do not have the targeted disease being studied.\u00a0 Phase 1 normally lasts less than one year. The focus of Phase 1 is <em><u>safety<\/u><\/em>. If successful, the drug is moved to Phase 2.<\/li>\n<li>Clinical Trial Phase 2: In this phase, the effects on the subjects with the targeted disease are looked at. These will be controlled trials and usually involve 50-300 subjects.\u00a0 The focus of this phase is effectiveness and it can last up to 2 years. If successful, the drug will move on to Phase 3.<\/li>\n<li>Clinical Trial Phase 3: This is a large-scale trial in which thousands of subjects are used from a variety of backgrounds and geographical locations. This stage is the most important to establish safety and effectiveness. If this phase is successful, the FDA may grant this drug approved. This phase normally can run up to 3 years.<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\" wp-image-7954 alignleft\" src=\"https:\/\/blogcontent.summit-education.com\/wp-content\/uploads\/iStock-1214269987-1024x681.jpg\" alt=\"\" width=\"279\" height=\"186\" srcset=\"https:\/\/blogcontent.summit-education.com\/wp-content\/uploads\/iStock-1214269987-1024x681.jpg 1024w, https:\/\/blogcontent.summit-education.com\/wp-content\/uploads\/iStock-1214269987-300x200.jpg 300w, https:\/\/blogcontent.summit-education.com\/wp-content\/uploads\/iStock-1214269987-768x511.jpg 768w, https:\/\/blogcontent.summit-education.com\/wp-content\/uploads\/iStock-1214269987-1536x1022.jpg 1536w, https:\/\/blogcontent.summit-education.com\/wp-content\/uploads\/iStock-1214269987-2048x1363.jpg 2048w, https:\/\/blogcontent.summit-education.com\/wp-content\/uploads\/iStock-1214269987-1080x719.jpg 1080w\" sizes=\"(max-width: 279px) 100vw, 279px\" \/><\/p>\n<p>\u00a0<\/p>\n<p>As you can see, this process is normally not a fast one.\u00a0 Only in times of a public health crisis (which we are in now), are when the FDA grants expedited studies and accelerated approvals. With several vaccine trials now in Phase 3\u2014it all comes down to the data\u2026<\/p>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>Join me for my live seminar, &#8220;<a href=\"https:\/\/summit-education.com\/c\/GPHACH.1\">A Rehab Professional\u2019s Guide to Pharmacology<\/a>,&#8221; coming to a city near you in 2021!<\/p>\n<p>\u00a0<\/p>\n<p><strong>References:<\/strong><\/p>\n<p><a href=\"http:\/\/www.fda.gov\">www.fda.gov<\/a><\/p>\n<p>Ciccone CD. Pharmacology in rehabilitation. 5th edition, Philadelphia, FA DAVIS 2016.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p><div class=\"et_pb_row et_pb_row_0 et_pb_row_empty\">\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div> Written By: Chad Hensel, PT, DPT, MHS, CSCSWith the world holding its collective breath for the announcement of a COVID-19 vaccine, this is a good opportunity to shine the spotlight on the typical drug approval process of the F.D.A.\u00a0One of the main roles of the Food and Drug Administration is approving drugs (including vaccines) [&hellip;]<\/p>\n","protected":false},"author":34,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","om_disable_all_campaigns":false,"_uf_show_specific_survey":0,"_uf_disable_surveys":false,"footnotes":""},"categories":[1],"tags":[208],"class_list":["post-7935","post","type-post","status-publish","format-standard","hentry","category-general","tag-chensel"],"aioseo_notices":[],"aioseo_head":"\n\t\t<!-- All in One SEO 4.9.9 - aioseo.com -->\n\t<meta name=\"description\" content=\"Written By: Chad Hensel, PT, DPT, MHS, CSCS With the world holding its collective breath for the announcement of a COVID-19 vaccine, this is a good opportunity to shine the spotlight on the typical drug approval process of the F.D.A. 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