{"id":78461,"date":"2025-08-13T00:59:16","date_gmt":"2025-08-13T00:59:16","guid":{"rendered":"https:\/\/www.newsbeep.com\/us\/78461\/"},"modified":"2025-08-13T00:59:16","modified_gmt":"2025-08-13T00:59:16","slug":"fda-may-pull-authorization-of-pfizer-covid-shot-for-children-under-5","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/us\/78461\/","title":{"rendered":"FDA may pull authorization of Pfizer Covid shot for children under 5"},"content":{"rendered":"<p>A nurse prepares doses of the Pfizer vaccine during a COVID-19 vaccination event at Josephine&#8217;s Southern Cooking in Chatham, Illinois, Dec. 30, 2021.<\/p>\n<p>Brian Cassella | Tribune News Service | Getty Images<\/p>\n<p>The Food and Drug Administration is considering revoking its authorization of <a href=\"https:\/\/www.cnbc.com\/quotes\/PFE\/\" rel=\"nofollow noopener\" target=\"_blank\">Pfizer<\/a>&#8216;s Covid-19 vaccine for healthy children under the age of 5, the drugmaker confirmed to CNBC on Tuesday.\u00a0<\/p>\n<p>The move could leave many kids with no available shot against the virus, as jabs from <a href=\"https:\/\/www.cnbc.com\/quotes\/MRNA\/\" rel=\"nofollow noopener\" target=\"_blank\">Moderna<\/a> and <a href=\"https:\/\/www.cnbc.com\/quotes\/NVAX\/\" rel=\"nofollow noopener\" target=\"_blank\">Novavax<\/a> are cleared for more limited populations. While Covid typically <a href=\"https:\/\/www.mayoclinic.org\/diseases-conditions\/coronavirus\/in-depth\/coronavirus-in-babies-and-children\/art-20484405\" target=\"_blank\" rel=\"nofollow noopener\">causes mild symptoms<\/a> in most children, others, such as infants under 1 or those with certain health conditions, can be at a higher risk of severe illness and hospitalization.<\/p>\n<p>If the FDA pulls the authorization, it would add to a string of recent efforts by U.S. health agencies to change and undermine immunization policy since Health and Human Services Secretary Robert F. Kennedy Jr., a prominent vaccine skeptic, took the helm. HHS did not immediately respond to a request for comment.<\/p>\n<p>The FDA told Pfizer it might not renew its longstanding emergency use authorization for children ages 6 months to 4 years, the company said in a statement. Pfizer said it has requested the authorization to remain in place for the upcoming fall and winter season and is &#8220;currently in discussions with the agency on potential paths forward.&#8221;<\/p>\n<p>The company said that the FDA&#8217;s &#8220;deliberations&#8221; are not related to the safety and efficacy of the shot, &#8220;which continues to demonstrate a favorable profile.&#8221;<\/p>\n<p>The Guardian first <a href=\"https:\/\/www.theguardian.com\/us-news\/2025\/aug\/09\/pfizer-covid-vaccine-fda-children-dfa\" target=\"_blank\" rel=\"nofollow noopener\">reported<\/a> on the FDA&#8217;s potential move.\u00a0<a href=\"https:\/\/www.cnbc.com\/quotes\/MRNA\/\" rel=\"nofollow noopener\" target=\"_blank\">Moderna<\/a> is working with the Centers for Disease Control and Prevention to boost supplies of its own Covid shot for children, the Guardian reported Saturday.<\/p>\n<p>In July, the FDA granted <a href=\"https:\/\/feeds.issuerdirect.com\/news-release.html?newsid=5090085430616980&amp;symbol=MRNA#:~:text=Overview-,Moderna%20Receives%20Full%20U.S.%20FDA%20Approval%20for%20COVID%2D19%20Vaccine,for%20COVID%2D19%20disease.%22\" target=\"_blank\" rel=\"nofollow noopener\">full approval<\/a> to Moderna&#8217;s Covid vaccine for children \u2014 but only for those with one more more health conditions that may put them at increased risk of severe illness if they become infected. The shots from both Moderna and Pfizer use messenger RNA technology.<\/p>\n<p>Kennedy has targeted those vaccines in the past, <a href=\"https:\/\/static01.nyt.com\/newsgraphics\/documenttools\/b3ab45ec074c9eff\/c583e080-full.pdf\" target=\"_blank\" rel=\"nofollow noopener\">filing a petition in May 2021 demanding<\/a> that the agency revoke authorization of the jabs.\u00a0\u00a0<\/p>\n<p>Meanwhile, <a href=\"https:\/\/www.cnbc.com\/quotes\/NVAX\/\" rel=\"nofollow noopener\" target=\"_blank\">Novavax<\/a>&#8216;s protein-based shot has never been available for children under 12.\u00a0<\/p>\n<p>In May, Kennedy announced that the Centers for Disease Control and Prevention has removed its recommendation of Covid vaccines for healthy children and pregnant women.\u00a0<\/p>\n<p>But in updated guidance days later, the CDC said the <a href=\"https:\/\/www.cdc.gov\/vaccines\/hcp\/imz-schedules\/child-adolescent-notes.html\" target=\"_blank\" rel=\"nofollow noopener\">shots &#8220;may&#8221; be given to those kids<\/a> if a doctor agreed that it was necessary. Covid vaccines during pregnancy are now listed as &#8220;No Guidance\/Not Applicable,&#8221; where they were previously recommended for all pregnant adults.<\/p>\n","protected":false},"excerpt":{"rendered":"A nurse prepares doses of the Pfizer vaccine during a COVID-19 vaccination event at Josephine&#8217;s Southern Cooking in&hellip;\n","protected":false},"author":2,"featured_media":78462,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[27],"tags":[2602,244,448,28,122,4000,2601,27188,55342,5243,247,788,55341,2603,797,21,39144],"class_list":["post-78461","post","type-post","status-publish","format-standard","has-post-thumbnail","category-business","tag-biotech-and-pharmaceuticals","tag-biotechnology","tag-breaking-news-business","tag-business","tag-business-news","tag-covid-19","tag-health-care-industry","tag-moderna-inc","tag-novavax-inc","tag-pfizer-inc","tag-pharmaceuticals","tag-robert-f-kennedy-jr","tag-secretary-of-health-and-human-services","tag-social-issues","tag-u-s-department-of-health-and-human-services","tag-united-states","tag-vaccinations"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/78461","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/comments?post=78461"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/78461\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media\/78462"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media?parent=78461"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/categories?post=78461"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/tags?post=78461"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}