{"id":122159,"date":"2021-09-30T22:48:04","date_gmt":"2021-09-30T22:48:04","guid":{"rendered":"https:\/\/fin2me.com\/?p=122159"},"modified":"2021-09-30T22:48:04","modified_gmt":"2021-09-30T22:48:04","slug":"pfizer-board-member-gottlieb-says-covid-vaccine-approval-for-young-kids-by-halloween-is-still-possible","status":"publish","type":"post","link":"https:\/\/fin2me.com\/business\/pfizer-board-member-gottlieb-says-covid-vaccine-approval-for-young-kids-by-halloween-is-still-possible\/","title":{"rendered":"Pfizer board member Gottlieb says Covid vaccine approval for young kids by Halloween is still possible"},"content":{"rendered":"<ul>\n<li>Dr. Scott Gottlieb told CNBC it is still possible the FDA will approve Pfizer and BioNTech&#x27;s Covid-19 vaccine for young kids by Halloween.<\/li>\n<li>Pfizer submitted initial trial data for kids ages 5 to 11 to the FDA on Tuesday, and the company should file a formal application needed for emergency use approval &quot;shortly,&quot; he said.<\/li>\n<li>&quot;I wouldn&#x27;t foreclose the possibility that this could be out in October,&quot; the former FDA commissioner said.<\/li>\n<\/ul>\n<p>In this article<\/p>\n<ul>\n<li><span>PFE<\/span><button class=\"AddToWatchlistButton-watchlistButton\"><span><\/span><\/button><\/li>\n<\/ul>\n<p>Dr. Scott Gottlieb told CNBC on Wednesday it is still possible the Food and Drug Administration will approve Pfizer and BioNTech&#x27;s Covid-19 vaccine for young kids by Halloween.<\/p>\n<p>&quot;I wouldn&#x27;t foreclose the possibility that this could be out in October,&quot; said Gottlieb, who sits on Pfizer&#x27;s board and served as FDA commissioner for two years under the Trump administration. <\/p>\n<p>Pfizer submitted initial Covid vaccine trial data for kids ages 5 to 11 to the FDA on Tuesday, and the company should file a formal application needed for emergency use approval &quot;shortly,&quot; Gottlieb said in an interview on\u00a0&quot;Squawk Box&quot; on Wednesday.<\/p>\n<p>The Food and Drug Administration has a lot of experience with the Pfizer vaccine, Gottlieb noted, adding the Covid shot for young kids is the same two-dose regimen as adults but is administered in smaller doses. The agency has already cleared the shots for Americans age 12 and up.<\/p>\n<p>&quot;They&#x27;ve seen a lot of clinical data,&quot; he said. &quot;I&#x27;ve long said October is a possibility but it is an optimistic possibility. If it slips, it could slip to mid-November.&quot;<\/p>\n<p>Gottlieb&#x27;s comments come a day after the Wall Street Journal reported that regulatory clearance of the Pfizer vaccine for children 5 to 11 years old may not come until November.<\/p>\n<p>Last week, Pfizer released new data that showed a two-dose regimen of 10 micrograms \u2014 a third the dosage used for teens and adults \u2013 is safe and generates a &quot;robust&quot; immune response in a clinical trial of kids ages 5 to 11. <\/p>\n<p>Pfizer was expected to request emergency use authorization for use of the vaccine in young kids by the end of this month, but now the company says it will file an application &quot;in the coming weeks.&quot;<\/p>\n<p>That may mean the shots may not be available until November if the FDA spends as much time reviewing the data for that age group as it did for 12- to 15-year-olds. Pfizer and BioNTech requested expanded use of their shot in adolescents on April 9 and were authorized by the FDA on May 10.<\/p>\n<p>A Pfizer spokesperson declined to comment on a timeline for approval, saying the company cannot speculate on when exactly the FDA would make a decision whether or not to authorize use of the vaccine.<\/p>\n<p>&quot;We are still on track to file a formal application for EUA very soon,&quot; Pfizer spokeswoman Jerica Pitts told CNBC.<\/p>\n<p>The approval couldn&#x27;t come any sooner as kids start the new school year with the delta variant surging across America and many parents are anxious to get their younger children vaccinated. The strain has led to a surge in U.S. hospitalizations, including\u00a0among young kids\u00a0who are currently ineligible to get vaccinated.<\/p>\n<h2>CNBC Health &amp; Science <\/h2>\n<p>Read CNBC&#x27;s latest global coverage of the Covid pandemic:<\/p>\n<p>Fauci says data from NIH&#x27;s mix-and-match Covid vaccine booster trials will soon be ready<\/p>\n<p>White House says more than 400,000 Americans received a Covid booster shot at pharmacies over the weekend <\/p>\n<p>Unvaccinated United Airlines&#x27; staff faces firings as early as today as deadline for Covid shots passes<\/p>\n<p>Ford\u00a0asks union and\u00a0salaried\u00a0employees to submit vaccination status\u00a0\u00a0\u00a0 \u00a0<\/p>\n<p>Unvaccinated\u00a0Americans falsely say the need\u00a0for booster shots proves\u00a0Covid\u00a0vaccines\u00a0don&#x27;t work, Kaiser survey shows\u00a0\u00a0<\/p>\n<p>Source: <a href=\"https:\/\/www.cnbc.com\/2021\/09\/29\/pfizer-covid-vaccine-gottlieb-says-fda-approval-for-young-kids-by-halloween-possible.html\" target=\"_blank\" rel=\"noopener\">Read Full Article<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Dr. Scott Gottlieb told CNBC it is still possible the FDA will approve Pfizer and BioNTech&#x27;s Covid-19 vaccine for young kids by Halloween. Pfizer submitted [&#8230;]<\/p>\n","protected":false},"author":3,"featured_media":122158,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v21.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Pfizer board member Gottlieb says Covid vaccine approval for young kids by Halloween is still possible - Fin2me<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/fin2me.com\/business\/pfizer-board-member-gottlieb-says-covid-vaccine-approval-for-young-kids-by-halloween-is-still-possible\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pfizer board member Gottlieb says Covid vaccine approval for young kids by Halloween is still possible - Fin2me\" \/>\n<meta property=\"og:description\" content=\"Dr. Scott Gottlieb told CNBC it is still possible the FDA will approve Pfizer and BioNTech&#x27;s Covid-19 vaccine for young kids by Halloween. 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