{"id":1183808,"date":"2022-01-03T14:35:07","date_gmt":"2022-01-03T19:35:07","guid":{"rendered":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=1183808"},"modified":"2022-01-03T14:35:09","modified_gmt":"2022-01-03T19:35:09","slug":"without-citing-clinical-trials-fda-approves-emergency-use-of-covid-19-boosters-for-children-12-and-up","status":"publish","type":"post","link":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/without-citing-clinical-trials-fda-approves-emergency-use-of-covid-19-boosters-for-children-12-and-up\/","title":{"rendered":"Without Citing Clinical Trials, FDA Approves Emergency Use Of COVID-19 Boosters For Children 12 And Up"},"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\">32<\/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%2Fwithout-citing-clinical-trials-fda-approves-emergency-use-of-covid-19-boosters-for-children-12-and-up%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=1183808&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>The Food and Drug Administration (FDA) announced that COVID-19 boosters for children between the ages of 12 and 15 have been approved for emergency authorized use based on \u201creal-world\u201d data from Israel. The <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/coronavirus-covid-19-update-fda-takes-multiple-actions-expand-use-pfizer-biontech-covid-19-vaccine\">announcement<\/a> came on Monday morning and was criticized by some medical doctors for not citing clinical trials in their approval process.<\/p>\n<p>According to the FDA, \u201cthe protective health benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine to provide continued protection against COVID-19 and the associated serious consequences that can occur including hospitalization and death, outweigh the potential risks in individuals 12 through 15 years of age.\u201d<\/p>\n<p>Based on real-world data from Israel, \u201cincluding safety data from more than 6,300 individuals 12 through 15 years of age who received a booster dose of the vaccine at least 5 months following completion of the primary two-dose vaccination series.\u201d<\/p>\n<p>The FDA claimed that \u201cthere are no new safety concerns following a booster in this population. There were no new cases of myocarditis or pericarditis reported to date in these individuals.\u201d<\/p>\n<p>However, Dr. Ramin Farzaneh-Far, M.D., said that the emergency approval was based \u201csolely on the basis of \u2018real world\u2019 (hopelessly confounded) data from [Israel].\u201d<\/p>\n<p>\u201cNo clinical trials cited, or conducted presumably,\u201d Farzaneh-Far observed. \u201cIn fact the word \u201ctrial\u201d doesn\u2019t even appear in the \u2066@US_FDA \u2069 press release.\u201d<\/p>\n<p dir=\"ltr\" lang=\"en\">Adolescent \u2066<a href=\"https:\/\/twitter.com\/pfizer?ref_src=twsrc%5Etfw\">@pfizer<\/a>\u2069 booster receives EUA solely on the basis of \u201creal world\u201d (hopelessly confounded) data from \ud83c\uddee\ud83c\uddf1<br \/>No clinical trials cited, or conducted presumably. In fact the word \u201ctrial\u201d doesn\u2019t even appear in the \u2066<a href=\"https:\/\/twitter.com\/US_FDA?ref_src=twsrc%5Etfw\">@US_FDA<\/a>\u2069 press release. <a href=\"https:\/\/t.co\/v6fJZbWPfv\">https:\/\/t.co\/v6fJZbWPfv<\/a><\/p>\n<p>\u2014 Ramin Farzaneh-Far MD (@rfsquared) <a href=\"https:\/\/twitter.com\/rfsquared\/status\/1478015176733560835?ref_src=twsrc%5Etfw\">January 3, 2022<\/a><\/p>\n<p>According to a <a href=\"https:\/\/theorg.com\/org\/pepgen\/org-chart\/ramin-farzaneh-far\">biography page<\/a>, Farnzaeh-Far was \u201cChief Medical Officer of Ra Pharmaceuticals from 2016 until it was acquired by UCB in 2020\u201d and is an \u201cexperienced clinical trialist and board-certified cardiologist. He has held academic faculty positions at UCSF and the University of Texas Southwestern Medical Center.\u201d Ramin completed his internal medicine residency at Brigham &amp; Women\u2019s Hospital in Boston and trained in cardiovascular medicine at UCSF.<\/p>\n<p><a href=\"http:\/\/www.vinayakkprasad.com\/\">Dr. Vinay Prasad, M.D. M.P.H<\/a>, a \u201chematologist-oncologist and Associate Professor in the Department of Epidemiology and Biostatistics at the University of California San Francisco,\u201d also criticized the FDA for making the decision without any proof of efficacy.\u201d<\/p>\n<p>\u201cThe FDA EUA for boosting 12 to 15 year olds does not report ANY evidence of efficacy,\u201d Prasad tweeted.<\/p>\n<p>\u201cDeciding to boost millions of kids with [zero] efficacy data with no idea the risk-benefit is favorable is something I never thought I would see from FDA,\u201d he added.<\/p>\n<p dir=\"ltr\" lang=\"en\">Deciding to boost millions of kids with 0 efficacy data with no idea the risk benefit is favorable is something I never thought I would see from FDA<\/p>\n<p>Would not have happened if Gruber\/ Krause still worked there<a href=\"https:\/\/t.co\/4IxCXZw9r4\">https:\/\/t.co\/4IxCXZw9r4<\/a><\/p>\n<p>\u2014 Vinay Prasad, MD MPH \ud83c\udf99\ufe0f\ud83d\udcf7 (@VPrasadMDMPH) <a href=\"https:\/\/twitter.com\/VPrasadMDMPH\/status\/1478023718592933889?ref_src=twsrc%5Etfw\">January 3, 2022<\/a><\/p>\n<p>\u201cThroughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind,\u201d Acting FDA Commissioner Janet Woodcock, M.D., said in a press release.<\/p>\n<p>\u201cWith the current wave of the omicron variant, it\u2019s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask wearing and social distancing to in order to effectively fight COVID-19,\u201d he added.<\/p>\n<p>According to <a href=\"https:\/\/www.statnews.com\/2022\/01\/03\/fda-authorizes-first-covid-19-booster-shot-for-teens-aged-12-to-15\/\">STAT News<\/a>, the Centers for Disease Control and Prevention\u2019s independent panel known as \u201cAdvisory Committee on Immunization Practices\u201d is expected to meet this Wednesday to discuss whether the CDC should advise doctors to \u201curge\u201d the use of the booster shot, or simply let parents known children age 12-15 may receive the dose:<\/p>\n<p><em>A panel of independent experts that advises the Centers for Disease Control and Prevention on vaccination policy is expected to meet within days \u2014 likely Wednesday \u2014 to discuss the policy change. It\u2019s possible the ACIP will issue what\u2019s known as a permissive recommendation \u2014 saying youths aged 12 to 15 may get a booster if they wish, but stopping short of urging them to do so.<\/em><\/p>\n<p><em>If the committee goes this route, it will likely be because of still outstanding questions about the risk of myocarditis and pericarditis \u2014 inflammation of the heart and tissue surrounding the heart, respectively \u2014 that may be associated with getting a booster shot for this age group. The ACIP\u2019s recommendation must be approved by CDC Director Rochelle Walensky before it can come into effect.<\/em><\/p>\n<p>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&nbsp;<a href=\"https:\/\/www.dailywire.com\/subscribe\">member<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Food and Drug Administration (FDA) announced that COVID-19 boosters for children between the ages of 12 and 15 have been approved for emergency authorized use based on \u201creal-world\u201d data from Israel. The announcement came on Monday morning and was criticized by some medical doctors for not citing clinical trials in their approval process. According &#8230;<\/p>\n","protected":false},"author":326,"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-1183808","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\/1183808","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\/326"}],"replies":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/comments?post=1183808"}],"version-history":[{"count":0,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/1183808\/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=1183808"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/categories?post=1183808"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/tags?post=1183808"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}