{"id":1141234,"date":"2021-12-22T09:05:51","date_gmt":"2021-12-22T14:05:51","guid":{"rendered":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=1141234"},"modified":"2021-12-22T09:05:58","modified_gmt":"2021-12-22T14:05:58","slug":"report-fda-could-approve-pfizer-merck-covid-pills-in-next-few-days","status":"publish","type":"post","link":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/report-fda-could-approve-pfizer-merck-covid-pills-in-next-few-days\/","title":{"rendered":"Report: FDA Could Approve Pfizer, Merck COVID Pills In Next Few Days"},"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\">24<\/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%2Freport-fda-could-approve-pfizer-merck-covid-pills-in-next-few-days%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=1141234&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\">A Tuesday report from Bloomberg stated that the U.S. Food and Drug Administration could authorize use of COVID-19 pills by Pfizer and Merck as early as this week.&nbsp;<\/p>\n<p class=\"p1\"><a href=\"https:\/\/www.bloomberg.com\/news\/articles\/2021-12-21\/fda-expected-to-authorize-pfizer-merck-covid-pills-this-week?srnd=premium&amp;sref=KQPtNSUL\">Bloomberg<\/a> spoke with individuals familiar with the topic and reported, \u201c[a]n announcement may come as early as Wednesday, according to three of the people. They asked not to be identified ahead of the authorization and cautioned that the plan could change.\u201d<\/p>\n<p class=\"p1\">\u201cPfizer and Merck pared earlier declines on the news. Merck was trading down 0.7% at 10:43 a.m. in New York, while Pfizer was off 5.1%,\u201d the outlet noted.&nbsp;<\/p>\n<p class=\"p1\">It added, \u201cFDA\u2019s authorizations may include limitations for populations in which they could be used, one of the people familiar with the matter said.\u201d<\/p>\n<p class=\"p1\">Reuters further <a href=\"https:\/\/www.reuters.com\/business\/healthcare-pharmaceuticals\/us-fda-set-authorize-pfizer-merck-covid-19-pills-this-week-bloomberg-news-2021-12-21\/\">reported<\/a>:&nbsp;<\/p>\n<p class=\"p1\">The U.S. Food and Drug Administration is set to authorize COVID-19 treatment pills from both [Pfizer] and [Merck] as early as Wednesday, Bloomberg News reported on Tuesday, citing people familiar with the matter.<\/p>\n<p class=\"paywall\">The U.S. has put in orders of 10 million rounds of Pfizer\u2019s pill and around 3 million of the Merck pill, which is reported to have hazards associated with it.<\/p>\n<p class=\"p1\">As The Daily Wire <a href=\"https:\/\/www.dailywire.com\/news\/fda-panel-recommends-merck-covid-pill\">reported<\/a> last month, an advisory panel for the U.S. Food and Drug Administration (FDA) recommended Merck\u2019s antiviral COVID-19 pill for use in adults who are at a high risk of contracting the virus, although the panel did not all agree on the decision.&nbsp;<\/p>\n<p class=\"p1\">As&nbsp;<a href=\"https:\/\/www.nytimes.com\/2021\/11\/30\/health\/fda-merck-pill-molnupiravir.html\">reported<\/a>&nbsp;by The New York Times:<\/p>\n<p class=\"p1\">The drug, known as molnupiravir, has been shown to modestly reduce the risk of hospitalization and death, predominantly from the&nbsp;Delta, Mu and Gamma&nbsp;variants. The expert panel recommended it for Covid patients who are older or have medical conditions that make them vulnerable to severe illness. The pill could be authorized in the United States within days, and available by year\u2019s end.<\/p>\n<p class=\"p1\">CNBC&nbsp;<a href=\"https:\/\/www.cnbc.com\/2021\/11\/30\/fda-advisory-panel-narrowly-endorses-mercks-oral-covid-treatment-pill-despite-reduced-efficacy.html\">noted<\/a>, \u201cThe FDA\u2019s Antimicrobial Drugs Advisory Committee voted 13 to 10 to recommend emergency authorization of molnupiravir,\u201d adding that it is an 800-milligram pill intended to be \u201ctaken every 12 hours for five days after symptom onset.\u201d<\/p>\n<p class=\"p1\">\u201cMerck originally said the drug was more than 50% effective in preventing hospitalizations and death, but a more full set of data presented to the FDA on Tuesday noted the drug is just 30% effective,\u201d the outlet added.&nbsp;<\/p>\n<p class=\"p1\">Members who did not vote in favor of endorsing the treatment said the aid of the pill was \u201cmodest,\u201d and also cited worries about safety due to the experiments. \u201cThe treatment works by inserting errors into the virus\u2019s genes. Some scientists say there is a theoretical risk that it could trigger mutations in cells as well, potentially causing reproductive harm or a long-term risk of cancer,\u201d the Times reported. &nbsp;<\/p>\n<p class=\"p1\">\u201cI was not convinced that the potential benefit outweighed risk,\u201d Dr. Peter Weina, the director of the Office of Research Protections at the Defense Health Agency, said, per the Times.&nbsp;<\/p>\n<p class=\"p1\">Merck and the FDA noted that women who are pregnant should not get the pill. Kids and pregnant women were not included in the treatment\u2019s clinical trials.&nbsp;<\/p>\n<p class=\"p1\">CNBC added, \u201cMolnupiravir was found to be lethal to embryos in pregnant rats, also causing birth defects and reducing fetal body weight. It also caused other defects that interfered with bone growth in young pups, along with other abnormalities, the data shows.\u201d&nbsp;<\/p>\n<p class=\"p1\">Concern over the drug potentially prompting COVID to mutate in less treatable ways was present.&nbsp;<\/p>\n<p class=\"p1\">While the advisory panel is not the final say in approval, the FDA typically goes in favor of their recommendations. The U.S. Centers for Disease Control and Prevention would also need to approve the pill.&nbsp;<\/p>\n<p class=\"p1\">Last month, Pfizer also <a href=\"https:\/\/www.dailywire.com\/news\/pfizer-seeks-fda-authorization-for-covid-19-pill\">submitted<\/a> its COVID-19 pill treatment to the FDA for authorization to be used for certain people.&nbsp;<\/p>\n<p class=\"p1\">Pfizer&nbsp;<a href=\"https:\/\/www.pfizer.com\/news\/press-release\/press-release-detail\/pfizer-seeks-emergency-use-authorization-novel-covid-19\">announced<\/a>&nbsp;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 class=\"p1\">\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.&nbsp;<\/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=\"p2\">The 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 <a href=\"https:\/\/www.dailywire.com\/subscribe\">member<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>A Tuesday report from Bloomberg stated that the U.S. Food and Drug Administration could authorize use of COVID-19 pills by Pfizer and Merck as early as this week.\u00a0Bloomberg spoke with individuals familiar with the topic and reported, \u201c[a]n announcement may come as early as Wednesday, according to three of the people. They asked not to be identified ahead of the authorization and cautioned that the plan could change.\u201d\u201cPfizer and Merck pared earlier declines on the news. Merck was trading down 0.7% at 10:43 a.m. in New York, while Pfizer was off 5.1%,\u201d the outlet noted.\u00a0It added, \u201cFDA\u2019s authorizations may include limitations for populations in which they could be used, one of the people familiar with the matter said.\u201dReuters further reported:\u00a0The U.S. Food and Drug Administration is set to authorize COVID-19 treatment pills from both [Pfizer] and [Merck] as early as Wednesday, Bloomberg News reported on Tuesday, citing people familiar with the matter.The U.S. has put in orders of 10 million rounds of Pfizer\u2019s pill and around 3 million of the Merck pill, which is reported to have hazards associated with it.As The Daily Wire reported last month, an advisory panel for the U.S. Food and Drug Administration (FDA) recommended Merck\u2019s antiviral COVID-19 pill for use in adults who are at a high risk of contracting the virus, although the panel did not all agree on the decision.\u00a0As\u00a0reported\u00a0by The New York Times:The drug, known as molnupiravir, has been shown to modestly reduce the risk of hospitalization and death, predominantly from the\u00a0Delta, Mu and Gamma\u00a0variants. The expert panel recommended it for Covid patients who are older or have medical conditions that make them vulnerable to severe illness. The pill could be authorized in the United States within days, and available by year\u2019s end.CNBC\u00a0noted, \u201cThe FDA\u2019s Antimicrobial Drugs Advisory Committee voted 13 to 10 to recommend emergency authorization of molnupiravir,\u201d adding that it is an 800-milligram pill intended to be \u201ctaken every 12 hours for five days after symptom onset.\u201d\u201cMerck originally said the drug was more than 50% effective in preventing hospitalizations and death, but a more full set of data presented to the FDA on Tuesday noted the drug is just 30% effective,\u201d the outlet added.\u00a0Members who did not vote in favor of endorsing the treatment said the aid of the pill was \u201cmodest,\u201d and also cited worries about safety due to the experiments. \u201cThe treatment works by inserting errors into the virus\u2019s genes. Some scientists say there is a theoretical risk that it could trigger mutations in cells as well, potentially causing reproductive harm or a long-term risk of cancer,\u201d the Times reported. \u00a0\u201cI was not convinced that the potential benefit outweighed risk,\u201d Dr. Peter Weina, the director of the Office of Research Protections at the Defense Health Agency, said, per the Times.\u00a0Merck and the FDA noted that women who are pregnant should not get the pill. Kids and pregnant women were not included in the treatment\u2019s clinical trials.\u00a0CNBC added, \u201cMolnupiravir was found to be lethal to embryos in pregnant rats, also causing birth defects and reducing fetal body weight. It also caused other defects that interfered with bone growth in young pups, along with other abnormalities, the data shows.\u201d\u00a0Concern over the drug potentially prompting COVID to mutate in less treatable ways was present.\u00a0While the advisory panel is not the final say in approval, the FDA typically goes in favor of their recommendations. The U.S. Centers for Disease Control and Prevention would also need to approve the pill.\u00a0Last month, Pfizer also submitted its COVID-19 pill treatment to the FDA for authorization to be used for certain people.\u00a0Pfizer\u00a0announced\u00a0that \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.\u00a0As 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%.The 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-1141234","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\/1141234","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=1141234"}],"version-history":[{"count":0,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/1141234\/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=1141234"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/categories?post=1141234"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/tags?post=1141234"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}