{"id":69717,"date":"2021-07-13T18:25:05","date_gmt":"2021-07-13T23:25:05","guid":{"rendered":"https:\/\/milesfortis.com\/?p=69717"},"modified":"2021-07-13T18:25:05","modified_gmt":"2021-07-13T23:25:05","slug":"69717","status":"publish","type":"post","link":"https:\/\/milesfortis.com\/?p=69717","title":{"rendered":""},"content":{"rendered":"

FDA adds warning to J&J COVID-19 vaccine over links to rare autoimmune disorder.<\/a><\/p>\n

July 13 (UPI) —<\/span>\u00a0The U.S.\u00a0Food and Drug Administration<\/a>\u00a0announced a new warning for the Johnson & Johnson\u00a0COVID-19<\/a>\u00a0vaccine over its association with an increased risk of Guillain-Barre syndrome, a rare autoimmune disorder where the immune system damages the nerve cells.<\/p>\n

The FDA announced the update to the one-shot jab on Monday in\u00a0a letter<\/a>\u00a0to the company as well as in amendments to its\u00a0fact<\/a>\u00a0sheets<\/a>\u00a0on the vaccine in response to new data showing cases of people displaying symptoms of the syndrome within 42 days of receiving the shot.<\/p>\n

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The warning states: “Reports of adverse events following use of Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of Guillain-Barre syndrome during the 42 days following vaccination.”<\/div>\n<\/div>\n

Janssen is a subsidiary of Johnson & Johnson.<\/p>\n

The FDA said in its fact sheet for recipients and caregivers that “[t]he chance of having this occur is very low.”<\/p>\n

Between 3,000 and 6,000 people develop Guillain-Barre syndrome each year in the United States with only about 100 people of the 12.8 million Johnson & Johnson dose recipients having shown symptoms, the FDA\u00a0said<\/a>. Of those who exhibited symptoms, 95 were hospitalized and there was one death.<\/p>\n

The agency said that while there is enough evidence to suggest an association between the vaccine and the syndrome “it is insufficient to establish a casual relationship.”<\/p>\n

The Centers for Disease Control and Prevention said on\u00a0its website<\/a>\u00a0Guillain-Barre syndrome is a rare disorder of the immune system attacking nerve cells, causing muscle weakness and sometimes paralysis and often follows infection of a virus or bacteria.<\/p>\n

The CDC said men older than 50 were at greater risk of contracting the syndrome after receiving the shot.<\/p>\n

Johnson & Johnson released\u00a0a statement<\/a>\u00a0Monday stating it has updated its COVID-19 vaccine factsheet to include the new warning while reiterating that evidence continues to prove its vaccine protects against the coronavirus.<\/p>\n

“Evidence has demonstrated that Johnson & Johnson’s single-shot COVID-19 vaccine offers protection against COVID-19 disease and prevents hospitalization and death, including in countries where viral variants are highly prevalent,” it said.<\/p>\n

The FDA gave the Johnson & Johnson jab emergency use approval in late February.<\/p>\n

In April, CDC issued a warning for the vaccine concerning its association with a rare blood clotting disease, ending\u00a0a federal government temporary halt<\/a>\u00a0to the drug’s distribution.<\/p>\n","protected":false},"excerpt":{"rendered":"

FDA adds warning to J&J COVID-19 vaccine over links to rare autoimmune disorder. July 13 (UPI) —\u00a0The U.S.\u00a0Food and Drug Administration\u00a0announced a new warning for the Johnson & Johnson\u00a0COVID-19\u00a0vaccine over its association with an increased risk of Guillain-Barre syndrome, a rare autoimmune disorder where the immune system damages the nerve cells. The FDA announced the … Continue reading “”<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[41,29],"tags":[],"class_list":["post-69717","post","type-post","status-publish","format-standard","hentry","category-health-medicine","category-safety"],"_links":{"self":[{"href":"https:\/\/milesfortis.com\/index.php?rest_route=\/wp\/v2\/posts\/69717","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/milesfortis.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/milesfortis.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/milesfortis.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/milesfortis.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=69717"}],"version-history":[{"count":1,"href":"https:\/\/milesfortis.com\/index.php?rest_route=\/wp\/v2\/posts\/69717\/revisions"}],"predecessor-version":[{"id":69718,"href":"https:\/\/milesfortis.com\/index.php?rest_route=\/wp\/v2\/posts\/69717\/revisions\/69718"}],"wp:attachment":[{"href":"https:\/\/milesfortis.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=69717"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/milesfortis.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=69717"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/milesfortis.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=69717"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}