{"id":1021058,"date":"2021-11-16T20:29:10","date_gmt":"2021-11-17T01:29:10","guid":{"rendered":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=1021058"},"modified":"2021-11-16T20:29:14","modified_gmt":"2021-11-17T01:29:14","slug":"pfizer-seeks-fda-authorization-for-covid-19-pill","status":"publish","type":"post","link":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/pfizer-seeks-fda-authorization-for-covid-19-pill\/","title":{"rendered":"Pfizer Seeks FDA Authorization For COVID-19 Pill"},"content":{"rendered":"<aside class=\"mashsb-container mashsb-main mashsb-stretched\"><div class=\"mashsb-box\"><div class=\"mashsb-count mash-medium\" style=\"float:left\"><div class=\"counts mashsbcount\">14<\/div><span class=\"mashsb-sharetext\">SHARES<\/span><\/div><div class=\"mashsb-buttons\"><a class=\"mashicon-facebook mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/www.facebook.com\/sharer.php?u=https%3A%2F%2Fwww.conservativenewsdaily.net%2Fbreaking-news%2Fpfizer-seeks-fda-authorization-for-covid-19-pill%2F\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Facebook<\/span><\/a><a class=\"mashicon-twitter mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/twitter.com\/intent\/tweet?text=&amp;url=https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=1021058&amp;via=ConservNewsDly\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Twitter<\/span><\/a><a class=\"mashicon-subscribe mash-medium mash-nomargin mashsb-noshadow\" href=\"#\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Subscribe<\/span><\/a><div class=\"onoffswitch2 mash-medium mashsb-noshadow\" style=\"display:none\"><\/div><\/div>\n            <\/div>\n                <div style=\"clear:both\"><\/div><\/aside>\n            <!-- Share buttons by mashshare.net - Version: 4.0.47--><p class=\"p1\">Drug company Pfizer has submitted its COVID-19 pill treatment to the U.S. Food and Drug Administration (FDA) for authorization to be used for certain people.<\/p>\n<p class=\"p1\">On Tuesday, Pfizer <a href=\"https:\/\/www.pfizer.com\/news\/press-release\/press-release-detail\/pfizer-seeks-emergency-use-authorization-novel-covid-19\">announced<\/a> that \u201cit is seeking Emergency Use Authorization (EUA) of its investigational oral antiviral candidate, PAXLOVID\u2122 [\u2026] for the treatment of mild to moderate COVID-19 in patients at increased risk of hospitalizations or death.\u201d&nbsp;<\/p>\n<p>\u201cIf authorized or approved, PAXLOVID would be the first oral antiviral of its kind \u2026 that could be prescribed as an at-home treatment to high-risk patients at the first sign of infection, potentially helping patients avoid severe illness which can lead to hospitalization and death,\u201d the announcement noted.<\/p>\n<p class=\"p1\">The Wall Street Journal <a href=\"https:\/\/www.wsj.com\/articles\/pfizer-asks-fda-to-authorize-covid-19-pill-paxlovid-11637089791?mod=hp_lead_pos6\">reported<\/a>, \u201cInitial supplies of Pfizer\u2019s pill would be limited. Pfizer projects it will manufacture more than 180,000 courses of treatment this year, and plans to increase production to at least 50 million courses next year.\u201d<\/p>\n<p class=\"p1\"><em>\u201cWith more than 5 million deaths and countless lives impacted by this devastating disease globally, there is an urgent need for life-saving treatment options. The overwhelming efficacy achieved in our recent clinical study of PAXLOVID, and its potential to help save lives and keep people out of the hospital if authorized, underscores the critical role that oral antiviral therapies could play in the battle against COVID-19,\u201d said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. \u201cWe are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the U.S. FDA on its review of our application, along with other regulatory agencies around the world.\u201d<\/em><\/p>\n<p class=\"p1\">As previously&nbsp;<a href=\"https:\/\/www.dailywire.com\/news\/pfizer-announces-promising-results-of-new-covid-pill\">reported<\/a>&nbsp;by The Daily Wire, Pfizer announced results from an interim analysis reportedly showing its new pill designed to treat COVID-19 minimized the risk of death or hospitalization by 89%.<\/p>\n<p class=\"p1\">In an announcement, the company&nbsp;<a href=\"https:\/\/www.pfizer.com\/news\/press-release\/press-release-detail\/pfizers-novel-covid-19-oral-antiviral-treatment-candidate\">stated<\/a>&nbsp;at the time:<\/p>\n<p>PAXLOVID\u2122 [\u2026]&nbsp;was found to reduce the risk of hospitalization or death by 89% compared to placebo in non-hospitalized high-risk adults with COVID-19In the overall study population through Day 28, no deaths were reported in patients who received&nbsp;PAXLOVID\u2122&nbsp;as compared to 10 deaths in patients who received placeboPfizer plans to submit the data as part of its ongoing rolling submission to the U.S. [Food and Drug Administration] for Emergency Use Authorization (EUA) as soon as possible<\/p>\n<p class=\"p1\">\u201cIf authorized or approved, PAXLOVID will be administered at a dose of 300mg (two 150mg tablets) of [the pill] with one 100mg tablet of ritonavir, given twice-daily for five<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Drug company Pfizer has submitted its COVID-19 pill treatment to the U.S. Food and Drug Administration (FDA) for authorization to be used for certain people.On Tuesday, Pfizer announced that \u201cit is seeking Emergency Use Authorization (EUA) of its investigational oral antiviral candidate, PAXLOVID\u2122 [\u2026] for the treatment of mild to moderate COVID-19 in patients at increased risk of hospitalizations or death.\u201d\u00a0\u201cIf authorized or approved, PAXLOVID would be the first oral antiviral of its kind \u2026 that could be prescribed as an at-home treatment to high-risk patients at the first sign of infection, potentially helping patients avoid severe illness which can lead to hospitalization and death,\u201d the announcement noted.The Wall Street Journal reported, \u201cInitial supplies of Pfizer\u2019s pill would be limited. Pfizer projects it will manufacture more than 180,000 courses of treatment this year, and plans to increase production to at least 50 million courses next year.\u201d\u201cWith more than 5 million deaths and countless lives impacted by this devastating disease globally, there is an urgent need for life-saving treatment options. The overwhelming efficacy achieved in our recent clinical study of PAXLOVID, and its potential to help save lives and keep people out of the hospital if authorized, underscores the critical role that oral antiviral therapies could play in the battle against COVID-19,\u201d said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. \u201cWe are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the U.S. FDA on its review of our application, along with other regulatory agencies around the world.\u201dAs previously\u00a0reported\u00a0by The Daily Wire, Pfizer announced results from an interim analysis reportedly showing its new pill designed to treat COVID-19 minimized the risk of death or hospitalization by 89%.In an announcement, the company\u00a0stated\u00a0at the time:PAXLOVID\u2122 [\u2026]\u00a0was found to reduce the risk of hospitalization or death by 89% compared to placebo in non-hospitalized high-risk adults with COVID-19In the overall study population through Day 28, no deaths were reported in patients who received\u00a0PAXLOVID\u2122\u00a0as compared to 10 deaths in patients who received placeboPfizer plans to submit the data as part of its ongoing rolling submission to the U.S. [Food and Drug Administration] for Emergency Use Authorization (EUA) as soon as possible\u201cIf authorized or approved, PAXLOVID will be administered at a dose of 300mg (two 150mg tablets) of [the pill] with one 100mg tablet of ritonavir, given twice-daily for five days,\u201d the Tuesday announcement added.Earlier this month, President Joe Biden said, \u201cIf authorized by the FDA we may soon have pills that treat the virus in those who become infected,\u201d noting, \u201cWe\u2019ve already secured millions of doses. The therapy would be another tool in our toolbox to protect people from the worst outcomes of COVID.\u201dAs The Daily Wire reported, in a separate agreement announced on Tuesday, Pfizer will also permit its COVID-19 pill treatment to be manufactured and sold in countries that might not be able to otherwise afford the treatment.\u00a0The deal includes Pfizer working with Medicines Patent Pool (MPP), \u201ca United Nations-backed public health organization working to increase access to life-saving medicines for low- and middle-income countries.\u201d\u00a0Through the agreement, MPP will be able to \u201cfacilitate additional production and distribution of the investigational antiviral, pending regulatory authorization or approval, by granting sub-licenses to qualified generic medicine manufacturers, with the goal of facilitating greater access to the global population.\u201d\u00a0In a\u00a0statement\u00a0about the arrangement, Pfizer said it will allow other companies to provide its COVID pill, along with ritonavir, with which it is administered, to 95 countries, which would include up to around 53% of the population of the world.\u00a0The company noted that \u201c[t]his includes all low- and lower-middle-income countries and some upper-middle-income countries in Sub-Saharan Africa as well as countries that have transitioned from lower-middle to upper-middle-income status in the past five years,\u201d adding that it \u201cwill not receive royalties on sales in low-income countries and will further waive royalties on sales in all countries covered by the agreement while COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization.\u201dThe Daily Wire is one of America\u2019s fastest-growing conservative media companies and counter-cultural outlets for news, opinion, and entertainment. Get inside access to The Daily Wire by becoming a member.<\/p>\n","protected":false},"author":95,"featured_media":2315279,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_mo_disable_npp":"","fifu_image_url":"","fifu_image_alt":"","footnotes":""},"categories":[],"tags":[],"class_list":["post-1021058","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/1021058","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/users\/95"}],"replies":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/comments?post=1021058"}],"version-history":[{"count":0,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/1021058\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media\/2315279"}],"wp:attachment":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media?parent=1021058"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/categories?post=1021058"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/tags?post=1021058"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}