{"id":14170,"date":"2025-12-17T00:00:00","date_gmt":"2025-12-17T05:00:00","guid":{"rendered":"https:\/\/cov19longhaulfoundation.org\/?p=14170"},"modified":"2025-12-16T18:36:41","modified_gmt":"2025-12-16T23:36:41","slug":"fda-not-adding-black-box-warning-to-covid-19-vaccines-commissioner","status":"publish","type":"post","link":"https:\/\/cov19longhaulfoundation.org\/?p=14170","title":{"rendered":"FDA Not Adding ‘Black Box’ Warning To COVID-19 Vaccines: Commissioner"},"content":{"rendered":"\n

John Murphy, M.D., MPH, DPH, President COVID-19 Long-haul Foundation, Authored by Zachary Stieber via The Epoch Times,<\/em><\/p>\n\n\n\n

The Food and Drug Administration is not adding \u201cblack box\u201d warnings to COVID-19 vaccines, even though an agency center recommended it, FDA commissioner Dr. Marty Makary said on Dec. 15<\/p>\n\n\n\n

\u201cWhen it comes to the \u2018black box\u2019 warning, we have no plans to put that on the COVID vaccine,\u201d <\/strong><\/em>Makary said during an appearance on Bloomberg Television.<\/p>\n\n\n\n

Black box warnings are the highest safety-related warnings that FDA officials can place on products. Scenarios warranting their usage include when there is\u00a0an adverse reaction so serious that it is \u201cessential that it be considered in assessing the risks and benefits of using the drug\u201d<\/strong>\u00a0or when there is a serious adverse reaction that can be prevented or reduced by appropriate use of the drug, according to FDA documents.<\/a><\/p>\n\n\n\n

The announcement comes several weeks after FDA officials reported deaths of children following COVID-19 vaccination and concluded<\/a> that at least 10 deaths were related to the vaccines<\/strong>, according to a November memorandum obtained<\/a> by The Epoch Times. The review, which included looking at autopsies, has been broadened<\/a> to other age groups.<\/p>\n\n\n\n

The announcement also came several months after regulators updated language on the vaccine labels for a form of heart inflammation called myocarditis<\/a>. The inflammation was discovered after the FDA first authorized COVID-19 vaccines in December 2020. The updated labels state that the highest observed risk of myocarditis was among young males aged 12 to 24 after receipt of vaccines from Pfizer-BioNTech and Moderna.<\/p>\n\n\n\n

Makary said Monday that an FDA safety and epidemiology center did recommend adding a black box warning to the COVID-19 vaccines, and indicated the recommendation stemmed from the risk of myocarditis.<\/p>\n\n\n\n

But, he said, Dr. Vinay Prasad, the agency\u2019s top vaccine official, and other FDA leaders opted against accepting the recommendation because the dosage people are receiving has changed from the original two doses within weeks or months of each other.<\/p>\n\n\n\n

\u201cWhen you have those two doses three months apart, that\u2019s when you see the side effects go way up, like myocarditis in young people,\u201d <\/strong><\/em>Makary said on Bloomberg.<\/p>\n\n\n\n

\u201cNow that it\u2019s annual, you may not see that same prevalence. So we don\u2019t want to extrapolate findings to today if it\u2019s not transferable.\u201d<\/em><\/p>\n\n\n\n

COVID-19 vaccines had been cleared and recommended for virtually all Americans until Trump administration officials took a series of steps to narrow the clearance and recommendations. They are now only advised<\/a> on an annual basis after consulting with a health care professional and taking into account various factors, including whether people have characteristics such as obesity that could put them at higher risk of severe problems if they contract COVID-19.<\/p>\n\n\n\n

Moderna and Pfizer have<\/a> said<\/a> their vaccines protect people and have favorable safety profiles, a position also held<\/a> by some groups such as the American Academy of Pediatrics.<\/strong><\/p>\n\n\n\n

The academy counts Pfizer and Moderna among its partners.<\/p>\n\n\n\n

Other experts and advocates have called for the removal of COVID-19 vaccines.<\/strong><\/p>\n\n\n\n

Dr. Robert Redfield, former director of the Centers for Disease Control and Prevention, recently told<\/a> The Epoch Times that clearance for them should be withdrawn because the spike protein they deliver is immunotoxic<\/strong>, and that he would not be surprised if, after the FDA finished its investigation, regulators placed a black box on the shots.<\/p>\n","protected":false},"excerpt":{"rendered":"

John Murphy, M.D., MPH, DPH, President COVID-19 Long-haul Foundation, Authored by Zachary Stieber via The Epoch Times, The Food and Drug Administration is not adding \u201cblack box\u201d warnings to COVID-19 […]<\/p>\n","protected":false},"author":2,"featured_media":14173,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[669,445,607,608],"tags":[],"class_list":["post-14170","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-adenovirus-vector-vaccines","category-policies-politics","category-vaccine-news","category-vaccine-safety"],"_links":{"self":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/14170","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=14170"}],"version-history":[{"count":1,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/14170\/revisions"}],"predecessor-version":[{"id":14171,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/14170\/revisions\/14171"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/media\/14173"}],"wp:attachment":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=14170"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=14170"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=14170"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}