{"id":1411,"date":"2021-06-04T10:15:57","date_gmt":"2021-06-04T14:15:57","guid":{"rendered":"https:\/\/covidqanda.org\/?p=1411"},"modified":"2021-06-04T10:15:57","modified_gmt":"2021-06-04T14:15:57","slug":"how-does-full-fda-approval-differ-from-emergency-use-authorization","status":"publish","type":"post","link":"https:\/\/covidqanda.org\/?p=1411","title":{"rendered":"How does full FDA approval differ from emergency use authorization?"},"content":{"rendered":"\n

Question:<\/span><\/strong>\u00a0I was just reading<\/a> earlier\u00a0this week that Moderna just applied for full FDA approval, and Pfizer applied last month.\u00a0 How does full FDA approval differ from emergency use authorization?<\/p>\n\n\n\n

Answer:<\/span><\/strong>\u00a0FDA approval– through a process called Biologics License Application (BLA)– differs from FDA emergency use authorization (EUA) in several ways.\u00a0 First, an EUA expires when the public health emergency ends, whereas a BLA has no\u00a0such expiry.\u00a0 \u00a0Second, an EUA can be granted<\/a> with less safety and efficacy data than a BLA.\u00a0 In the case of Pfizer and Moderna, EUA applications included clinical trial data collected during the 3 month period after participants’ 2nd dose.\u00a0 The BLA will include clinical trial data spanning a longer period (at least 6 months).\u00a0 Third, approval of a BLA allows the pharmaceutical company the ability to\u00a0market<\/a> the vaccine in the US.\u00a0 Fourth, BLA approval may provide increased legal standing<\/a> for companies, schools, and other employers\/venues to require COVID vaccination<\/a>.\u00a0 And finally, BLA approval may encourage<\/a> more individuals who are in the “wait and see” category of vaccine acceptance to choose to get the vaccine as soon as possible.\u00a0 For example, a recent Kaiser Family Foundation (KFF) survey<\/a> found that 12% of US adults are in the “wait and see” category.\u00a0 In its May survey, KFF found that among the various incentives discussed, “the one that appears to have the most resonance, particularly for those in the \u201cwait and see\u201d group, is full FDA approval of one or more of the COVID-19 vaccines. About a third (32%) of those who have not been vaccinated, including 44% of those who say they want to \u201cwait and see,\u201d say they would be more likely to get vaccinated if one of the vaccines currently authorized for emergency use received full approval from the FDA.” (Figure<\/strong>)<\/p>\n\n\n\n

Figure: Vaccine Incentives <\/strong>(from KFF<\/a>)<\/p>\n\n\n\n

\"\"<\/figure>\n","protected":false},"excerpt":{"rendered":"

Question:\u00a0I was just reading earlier\u00a0this week that Moderna just applied for full FDA approval, and Pfizer applied last month.\u00a0 How does full FDA approval differ from emergency use authorization? Answer:\u00a0FDA approval– through a process called Biologics License Application (BLA)– differs from FDA emergency use authorization (EUA) in several ways.\u00a0 First, an EUA expires when the […]<\/p>\n","protected":false},"author":1,"featured_media":1412,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"nf_dc_page":"","om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_post_was_ever_published":false},"categories":[50,64],"tags":[206,205,158],"class_list":["post-1411","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-guidelines","category-vaccines","tag-bla","tag-fda","tag-pfizer","fallback-thumbnail"],"jetpack_sharing_enabled":true,"jetpack_featured_media_url":"https:\/\/i0.wp.com\/covidqanda.org\/wp-content\/uploads\/2021\/06\/image-1.png?fit=1573%2C889&ssl=1","_links":{"self":[{"href":"https:\/\/covidqanda.org\/index.php?rest_route=\/wp\/v2\/posts\/1411","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/covidqanda.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/covidqanda.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/covidqanda.org\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/covidqanda.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1411"}],"version-history":[{"count":1,"href":"https:\/\/covidqanda.org\/index.php?rest_route=\/wp\/v2\/posts\/1411\/revisions"}],"predecessor-version":[{"id":1413,"href":"https:\/\/covidqanda.org\/index.php?rest_route=\/wp\/v2\/posts\/1411\/revisions\/1413"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/covidqanda.org\/index.php?rest_route=\/wp\/v2\/media\/1412"}],"wp:attachment":[{"href":"https:\/\/covidqanda.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1411"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/covidqanda.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1411"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/covidqanda.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1411"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}