{"id":34912,"date":"2021-05-07T20:27:39","date_gmt":"2021-05-08T03:27:39","guid":{"rendered":"https:\/\/lapost.us\/?p=34912"},"modified":"2021-05-07T20:27:39","modified_gmt":"2021-05-08T03:27:39","slug":"pfizer-biontech-seek-full-fda-approval-of-covid-19-vaccine-2","status":"publish","type":"post","link":"https:\/\/lapost.us\/?p=34912","title":{"rendered":"Pfizer, BioNTech seek full FDA approval of COVID-19 vaccine"},"content":{"rendered":"<p>Pfizer and its German partner company BioNTech announced they started their request for the FDA to grant full approval of their COVID-19 vaccine after having emergency use authorization for almost five months.<\/p>\n<p>The\u00a0<a href=\"https:\/\/click1.email.thehill.com\/gnnnsjwqmccdfjfcdkrmmdnnmwdpcwchhtmqjlpcclrglc_idvymmvhvwydhgbhvdgn.html?a=&amp;b=38960\" target=\"_blank\" rel=\"noopener\" data-saferedirecturl=\"https:\/\/www.google.com\/url?q=https:\/\/click1.email.thehill.com\/gnnnsjwqmccdfjfcdkrmmdnnmwdpcwchhtmqjlpcclrglc_idvymmvhvwydhgbhvdgn.html?a%3D%26b%3D38960&amp;source=gmail&amp;ust=1620519714958000&amp;usg=AFQjCNFS1v_bI6bU5cw119Y2O6rf22VIgA\">companies said<\/a>\u00a0they started their Biologics License Application (BLA) for the FDA to grant full authorization to give their vaccine to those 16 and older.<\/p>\n<p><strong>What does full approval mean?\u00a0<\/strong>With the FDA\u2019s full approval, the Pfizer-BioNTech vaccine could still be given to patients 16 and older after the public health emergency is declared over.<\/p>\n<p>The Pfizer-BioNTech vaccine, which was the first to receive the FDA\u2019s emergency use authorization in December, would become the first vaccine to be granted full approval in the U.S.<\/p>\n<p><strong>What\u2019s next?\u00a0<\/strong>The companies said they intend to submit data for the BLA &#8220;on a rolling basis over the coming weeks&#8221; and request priority review for a decision to be made in six months, instead of the typical 10 months.<\/p>\n<p>Pfizer and BioNTech have to submit data on their manufacturing processes, facilities and pre-clinical and clinical trial data.<\/p>\n<p>A planned decision date will be set after the FDA officially accepts the completed application.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Pfizer and its German partner company&#46;&#46;&#46;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[16,7,5],"tags":[],"class_list":["post-34912","post","type-post","status-publish","format-standard","hentry","category-health","category-u-s-a","category-world"],"_links":{"self":[{"href":"https:\/\/lapost.us\/index.php?rest_route=\/wp\/v2\/posts\/34912","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lapost.us\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lapost.us\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lapost.us\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/lapost.us\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=34912"}],"version-history":[{"count":1,"href":"https:\/\/lapost.us\/index.php?rest_route=\/wp\/v2\/posts\/34912\/revisions"}],"predecessor-version":[{"id":34913,"href":"https:\/\/lapost.us\/index.php?rest_route=\/wp\/v2\/posts\/34912\/revisions\/34913"}],"wp:attachment":[{"href":"https:\/\/lapost.us\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=34912"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lapost.us\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=34912"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lapost.us\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=34912"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}