{"id":5411,"date":"2022-09-12T06:00:00","date_gmt":"2022-09-12T06:00:00","guid":{"rendered":"http:\/\/wp.cov19longhaulfoundation.org\/?p=5411"},"modified":"2022-09-12T06:00:00","modified_gmt":"2022-09-12T06:00:00","slug":"fda-restricts-jjs-covid-19-vaccine-due-to-blood-clot-risk","status":"publish","type":"post","link":"https:\/\/cov19longhaulfoundation.org\/?p=5411","title":{"rendered":"FDA restricts J&amp;J\u2019s COVID-19 vaccine due to blood clot risk"},"content":{"rendered":"\n<p>Authrsors: Associated Press<\/p>\n\n\n\n<p>WASHINGTON (AP) \u2014 U.S. regulators on Thursday strictly limited who can receive&nbsp;<a href=\"https:\/\/nypost.com\/2022\/04\/19\/johnson-johnson-suspends-covid-19-vaccine-sales-forecast\/\">Johnson &amp; Johnson\u2019s COVID-19 vaccine<\/a>&nbsp;due to the ongoing risk of&nbsp;<a href=\"https:\/\/nypost.com\/2021\/12\/15\/health-officials-to-weigh-limits-on-jj-vaccine-due-to-blood-clots\/\">rare but serious blood clots.<\/a><\/p>\n\n\n\n<p>The Food and Drug Administration said the shot should only be given to adults who cannot receive a different vaccine or specifically request J&amp;J\u2019s vaccine. U.S. authorities for months have recommended that Americans starting their COVID-19 vaccinations use the Pfizer or Moderna shots instead.<\/p>\n\n\n\n<p>FDA officials said in a statement that they decided to restrict J&amp;J\u2019s vaccine after taking another look at data on the risk of life-threatening blood clots within two weeks of vaccination.<\/p>\n\n\n\n<p>J&amp;J\u2019s vaccine was initially considered an important tool in fighting the pandemic because it required only one shot. But the single-dose option proved less effective than two doses of the Pfizer and Moderna vaccines.<\/p>\n\n\n\n<p>Under the new FDA instructions, J&amp;J\u2019s vaccine could still be given to people who had a severe allergic reaction to one of the other vaccines and can\u2019t receive an additional dose. J&amp;J\u2019s shot could also be an option for people who refuse to receive the mRNA vaccines from Pfizer and Moderna, and therefore would otherwise remain unvaccinated, the agency said.<\/p>\n\n\n\n<p>A J&amp;J spokesman said in an emailed statement: \u201cData continue to support a favorable benefit-risk profile for the Johnson &amp; Johnson COVID-19 vaccine in adults, when compared with no vaccine.\u201d<\/p>\n\n\n\n<p>Despite the restriction, FDA\u2019s vaccine chief Dr. Peter Marks said J&amp;J\u2019s vaccine \u201cstill has a role in the current pandemic response in the United States and across the global community.\u201d<\/p>\n\n\n\n<p>The FDA based its decision on \u201cour safety surveillance systems and our commitment to ensuring that science and data guide our decisions<\/p>\n\n\n\n<p><a href=\"https:\/\/nypost.com\/2022\/05\/05\/nearly-15-million-deaths-associated-with-covid-19-who-says\/\"><\/a><a href=\"https:\/\/nypost.com\/2022\/05\/05\/nearly-15-million-deaths-associated-with-covid-19-who-says\/\">Nearly 15 million deaths associated with COVID-19, WHO says<\/a><\/p>\n\n\n\n<p>The clotting problems first came up last spring, with the J&amp;J shot in the U.S. and with a similar vaccine made by AstraZeneca that is used in other countries. At that time, U.S. regulators decided the benefits of J&amp;J\u2019s one-and-done vaccine outweighed what was considered a very rare risk \u2014 as long as recipients were warned.<\/p>\n\n\n\n<p>COVID-19 causes deadly blood clots, too. But the vaccine-linked kind is different, believed to form because of a rogue immune reaction to the J&amp;J and AstraZeneca vaccines because of how they\u2019re made. It forms in unusual places, such as veins that drain blood from the brain, and in patients who also develop abnormally low levels of the platelets that form clots. Symptoms of the unusual clots include severe headaches a week or two after the J&amp;J vaccination \u2014 not right away \u2014 as well as abdominal pain and nausea.<\/p>\n\n\n\n<p>The New Brunswick, New Jersey-based company announced last month that it didn\u2019t expect a profit from the vaccine this year and was suspending sales projections.<\/p>\n\n\n\n<p>The rollout of the company\u2019s vaccine was hurt by a series of troubles, including manufacturing problems at a Baltimore factory that forced J&amp;J to import millions of doses from overseas.<\/p>\n\n\n\n<p>Additionally, regulators added warnings about the blood clots and a rare neurological reaction called Guillain-Barr\u00e9 syndrome.<\/p>\n\n\n\n<p>Pfizer and Moderna have provided the vast majority of COVID-19 vaccines in the U.S. More than 200 million Americans have been fully vaccinated with the companies\u2019 two-dose shots while less than 17 million Americans got the J&amp;J shot.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Authrsors: Associated Press WASHINGTON (AP) \u2014 U.S. regulators on Thursday strictly limited who can receive&nbsp;Johnson &amp; Johnson\u2019s COVID-19 vaccine&nbsp;due to the ongoing risk of&nbsp;rare but serious blood clots. The Food [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":5447,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[90,761,849,973,607,608],"tags":[],"class_list":["post-5411","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-clots-bleeds","category-concerns","category-jj-vaccine","category-vaccine-failure","category-vaccine-news","category-vaccine-safety"],"_links":{"self":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/5411","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=5411"}],"version-history":[{"count":0,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/5411\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/media\/5447"}],"wp:attachment":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=5411"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=5411"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=5411"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}