{"id":1471186,"date":"2022-05-11T08:29:41","date_gmt":"2022-05-11T12:29:41","guid":{"rendered":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=1471186"},"modified":"2022-05-11T08:29:45","modified_gmt":"2022-05-11T12:29:45","slug":"heres-why-the-fda-restricted-the-use-of-johnson-johnsons-covid-19-vaccine","status":"publish","type":"post","link":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/heres-why-the-fda-restricted-the-use-of-johnson-johnsons-covid-19-vaccine\/","title":{"rendered":"Here\u2019s Why the FDA Restricted the Use of Johnson &#038; Johnson\u2019s COVID-19 Vaccine"},"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\">26<\/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%2Fheres-why-the-fda-restricted-the-use-of-johnson-johnsons-covid-19-vaccine%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=1471186&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--><div><\/div>\n<p id=\"mntl-sc-block_1-0\" class=\"comp mntl-sc-block mntl-sc-block-html\">\n<em>Fact checked on May 6, 2022 by Rich Scherr, a journalist and fact-checker with more than three decades of experience.<\/em>\n<\/p>\n<p id=\"mntl-sc-block_1-0-2\" class=\"comp mntl-sc-block mntl-sc-block-html\">\nJohnson &#038; Johnson&#8217;s COVID-19 vaccine is now restricted to only a select group of people, the U.S. Food and Drug Administration announced Thursday. The vaccine&#8217;s emergency use authorization is limited to people ages 18 and older for whom other vaccines are not accessible or appropriate, or for people who would not get a COVID-19 vaccine otherwise.\n<\/p>\n<p id=\"mntl-sc-block_1-0-4\" class=\"comp mntl-sc-block mntl-sc-block-html\">\nIn a <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/coronavirus-covid-19-update-fda-limits-use-janssen-covid-19-vaccine-certain-individuals\" data-component=\"link\" data-source=\"inlineLink\" data-type=\"externalLink\" data-ordinal=\"1\">statement<\/a> announcing the change, the FDA said the new limitations are due to an increased risk of of the blood clotting condition thrombosis with thrombocytopenia syndrome (TTS), a rare but potentially fatal side effect that can occur one to two weeks following the J&#038;J vaccine.\n<\/p>\n<p id=\"mntl-sc-block_1-0-6\" class=\"comp mntl-sc-block mntl-sc-block-html\">\n&#8220;We recognize that the Janssen [Johnson &#038; Johnson] COVID-19 vaccine still has a role in the current pandemic response in the United States and across the global community,&#8221; Peter Marks, MD, PhD, director of the FDA&#8217;s Center for Biologics Evaluation and Research, said in the statement. &#8220;Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals.&#8221;\n<\/p>\n<p id=\"mntl-sc-block_1-0-8\" class=\"comp mntl-sc-block mntl-sc-block-html\">\nThe J&#038;J vaccine was initially<a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-and-cdc-lift-recommended-pause-johnson-johnson-janssen-covid-19-vaccine-use-following-thorough\" data-component=\"link\" data-source=\"inlineLink\" data-type=\"externalLink\" data-ordinal=\"1\"> paused<\/a> in April 2021, also over concerns of TTS, to give health officials time to review more data. The pause was lifted a few days later.\n<\/p>\n<p id=\"mntl-sc-block_1-0-10\" class=\"comp mntl-sc-block mntl-sc-block-html\">\nThe new restrictions are due to the &#8220;robustness&#8221; of the FDA&#8217;s safety surveillance systems and the agency&#8217;s &#8220;commitment to ensuring that science and data guide\u2026decisions,&#8221; Dr. Marks said. &#8220;The agency will continue to monitor the safety of the Janssen COVID-19 and all other vaccines, and as has been the case throughout the pandemic, will thoroughly evaluate new safety information.&#8221;\n<\/p>\n<p id=\"mntl-sc-block_1-0-12\" class=\"comp mntl-sc-block mntl-sc-block-html\">\nHere&#8217;s what to know about the new restrictions placed on the J&#038;J vaccine, including why it has been limited and who may still receive it.\n<\/p>\n<p><span class=\"heading-toc\" id=\"toc-who-can-still-get-the-jj-vaccine\"><\/span> <\/p>\n<p id=\"mntl-sc-block_1-0-17\" class=\"comp mntl-sc-block mntl-sc-block-html\">\nAccording to FDA guidance, the people in the following groups may still receive the J&#038;J vaccine:\n<\/p>\n<ul id=\"mntl-sc-block_1-0-19\" class=\"comp mntl-sc-block mntl-sc-block-html\">\n<li>People who experienced an anaphylactic reaction after having an mRNA COVID-19 vaccine, like those made by Moderna or Pfizer-BioNTech<\/li>\n<li>People who have personal concerns with receiving mRNA vaccines and would otherwise not receive a COVID-19 vaccine<\/li>\n<li>People who would not get vaccinated for COVID-19 because of limited access to mRNA COVID-19 vaccines<\/li>\n<\/ul>\n<p id=\"mntl-sc-block_1-0-21\" class=\"comp mntl-sc-block mntl-sc-block-html\">\nIn a <a href=\"https:\/\/www.cnn.com\/2022\/05\/05\/health\/fda-johnson-johnson-vaccine-eua\/index.html#:~:text=The%20agency%20confirmed%20to%20CNN%20that%20the%20updated%20authorization%20also%20applies%20to%20booster%20doses\" data-component=\"link\" data-source=\"inlineLink\" data-type=\"externalLink\" data-ordinal=\"1\">statement to <i>CNN<\/i><\/a>, the FDA confirmed that the J&#038;J vaccine restrictions extend to booster doses of the J&#038;J vaccine, as well.\n<\/p>\n<p id=\"mntl-sc-block_1-0-23\" class=\"comp mntl-sc-block mntl-sc-block-html\">\nThe CDC&#8217;s Advisory Committee on Immunization Practices hinted to these sentiments in December 2021, when it <a href=\"https:\/\/www.cdc.gov\/media\/releases\/2021\/s1216-covid-19-vaccines.html\" data-component=\"link\" data-source=\"inlineLink\" data-type=\"externalLink\" data-ordinal=\"1\">preferentially recommended<\/a> the use of mRNA vaccines over the J&#038;J shot for all people over the age of 18 in the U.S. Later, in March 2022, the CDC also recommended those who received a primary dose of the J&#038;J vaccine <a href=\"https:\/\/www.health.com\/condition\/infectious-diseases\/coronavirus\/mrna-booster-johnson-johnson-vaccine\" data-component=\"link\" data-source=\"inlineLink\" data-type=\"internalLink\" data-ordinal=\"2\">should opt for an mRNA booster dose<\/a>.\n<\/p>\n<p id=\"mntl-sc-block_1-0-25\" class=\"comp mntl-sc-block mntl-sc-block-html\">\nHealth experts, too, stand firm in choosing mRNA vaccines over the J&#038;J shot, due to smaller risk and higher efficacy. &#8220;We&#8217;ve always recommended that, if you initially go with the Johnson &#038; Johnson vaccine, you&#8217;re better off getting the Moderna or Pfizer booster shot,&#8221; Thomas Russo, MD, professor and chief of infectious disease at the University at Buffalo in New York, told <i>Health<\/i>. &#8220;While the risks of TTS after the J&#038;J vaccine are low, they&#8217;re not zero and we have other options.&#8221;\n<\/p>\n<p><span class=\"heading-toc\" id=\"toc-why-is-jjs-vaccine-restricted\"><\/span> <\/p>\n<p id=\"mntl-sc-block_1-0-30\" class=\"comp mntl-sc-block mntl-sc-block-html\">\nThe FDA specifically cited an increased risk of TTS, a rare and potentially fatal blood-clotting condition, as the reason for the limitations on the J&#038;J vaccine.\n<\/p>\n<p id=\"mntl-sc-block_1-0-32\" class=\"comp mntl-sc-block mntl-sc-block-html\">\nIn April 2021, about two months after the J&#038;J vaccine was granted emergency use authorization, the <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/joint-cdc-and-fda-statement-johnson-johnson-covid-19-vaccine\" data-component=\"link\" data-source=\"inlineLink\" data-type=\"externalLink\" data-ordinal=\"1\">CDC and FDA issued a joint statement<\/a> on incidences of a &#8220;rare and severe type of blood clot&#8221; showing up in individuals who had recently received the J&#038;J vaccine. The type of blood clot, called a cerebral venous sinus thrombosis (CVST), <a href=\"https:\/\/newsroom.heart.org\/news\/cvst-and-blood-clots-potentially-related-to-the-j-j-covid-19-vaccine-know-the-symptoms\" data-component=\"link\" data-source=\"inlineLink\" data-type=\"externalLink\" data-ordinal=\"2\">occurs in the venous sinuses of the brain<\/a>. The CVSTs were seen in combination with thrombocytopenia, or low blood platelet levels.\n<\/p>\n<p id=\"mntl-sc-block_1-0-34\" class=\"comp mntl-sc-block mntl-sc-block-html\">\nAt the time of the joint statement\u2014which also initiated a pause on administration of the vaccine\u2014six cases of TTS had been observed, all in women ages 18-48, and all within two weeks after the vaccine was received. The pause was lifted 10 days later.\n<\/p>\n<p id=\"mntl-sc-block_1-0-36\" class=\"comp mntl-sc-block mntl-sc-block-html\">\nAccording to the most recent data from the Vaccine Adverse Event Reporting System (VAERS), there have been 60 confirmed cases of TTS\u2014including the original six\u2014and nine fatalities out of more than <a href=\"https:\/\/covid.cdc.gov\/covid-data-tracker\/#vaccinations_vacc-people-onedose-pop-5yr\" data-component=\"link\" data-source=\"inlineLink\" data-type=\"externalLink\" data-ordinal=\"1\">18.7 million<\/a> J&#038;J shots administered.\n<\/p>\n<p id=\"mntl-sc-block_1-0-38\" class=\"comp mntl-sc-block mntl-sc-block-html\">\nAccording to Dr. Russo, the restriction really comes down to safety. &#8220;We have alternative vaccine options with better safety profiles,&#8221; he said, adding that the restrictions don&#8217;t necessarily outlaw the J&#038;J vaccine. &#8220;[It&#8217;s] just stronger wording that the mRNA vaccines are preferred.&#8221;\n<\/p>\n<p id=\"mntl-sc-block_1-0-40\" class=\"comp mntl-sc-block mntl-sc-block-html\">\nAnd it seems that&#8217;s been the general consensus across the U.S. recently anyway. &#8220;Over the last several months across the country, very little Johnson &#038; Johnson vaccine has been used,&#8221; William Schaffner, MD, an infectious disease specialist and professor at the Vanderbilt University School of Medicine, told <i>Health<\/i>. &#8220;There&#8217;s not much [J&#038;J] vaccine that has been initiated as part of the national and global vaccination program.&#8221;\n<\/p>\n<p><span class=\"heading-toc\" id=\"toc-what-if-youve-already-gotten-the-jj-vaccine\"><\/span> <\/p>\n<p id=\"mntl-sc-block_1-0-43\" class=\"comp mntl-sc-block mntl-sc-block-html\">\nIf you recently received the Johnson &#038; Johnson vaccine, it&#8217;s a good idea to keep an eye out for any symptoms that may pop up. &#8220;If people have already gotten the J&#038;J vaccine, they can be alert to the presence of severe headache or neurological deficits,&#8221; Amesh A. Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, told <i>Health<\/i>.\n<\/p>\n<p id=\"mntl-sc-block_1-0-45\" class=\"comp mntl-sc-block mntl-sc-block-html\">\nIn their joint statement on the pause, the FDA and CDC urged people who received the J&#038;J vaccine and who later went on to develop severe headaches, abdominal pain, leg pain, or shortness of breath within three weeks of vaccination to contact a healthcare provider.\n<\/p>\n<p id=\"mntl-sc-block_1-0-47\" class=\"comp mntl-sc-block mntl-sc-block-html\">\nBut, for people who received the J&#038;J vaccine months ago and didn&#8217;t experience any of the above symptoms, they likely have nothing to worry about. &#8220;If several weeks have passed since you have received your Johnson &#038; Johnson vaccine,&#8221; said Dr. Schaffner, &#8220;you&#8217;re in the clear.&#8221;\n<\/p>\n<p id=\"mntl-sc-block_1-0-49\" class=\"comp mntl-sc-block mntl-sc-block-html\">\n<em>The information in this story is accurate as of press time. However, as the situation surrounding COVID-19 continues to evolve, it&#8217;s possible that some data have changed since publication. While Health is trying to keep our stories as up-to-date as possible, we also encourage readers to stay informed on news and recommendations for their own communities by using the <\/em><a href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/index.html\" data-component=\"link\" data-source=\"inlineLink\" data-type=\"externalLink\" data-ordinal=\"1\" rel=\"noopener\"><em>CDC<\/em><\/a><em>, <\/em><a href=\"https:\/\/www.who.int\/health-topics\/coronavirus\" data-component=\"link\" data-source=\"inlineLink\" data-type=\"externalLink\" data-ordinal=\"2\" rel=\"noopener\"><em>WHO<\/em><\/a><em>, and their local public health department as resources.<\/em>\n<\/p>\n<p id=\"mntl-sc-block_1-0-51\" class=\"comp mntl-sc-block mntl-sc-block-html\">\n<strong><em>To get our top stories delivered to your inbox, sign up for the <\/em><\/strong><a href=\"https:\/\/pages.email.health.com\/newsletters\/\" data-component=\"link\" data-source=\"inlineLink\" data-type=\"internalLink\" data-ordinal=\"1\"><strong><em>Healthy Living<\/em><\/strong><\/a><strong><em> newsletter<\/em><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Fact checked on May 6, 2022 by Rich Scherr, a journalist and fact-checker with more than three decades of experience.  Johnson &#038; Johnson&#8217;s COVID-19 vaccine is now<\/p>\n","protected":false},"author":505,"featured_media":2315279,"comment_status":"open","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_mo_disable_npp":"","fifu_image_url":"","fifu_image_alt":"","footnotes":""},"categories":[],"tags":[],"class_list":["post-1471186","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\/1471186","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\/505"}],"replies":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/comments?post=1471186"}],"version-history":[{"count":0,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/1471186\/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=1471186"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/categories?post=1471186"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/tags?post=1471186"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}