{"id":1123221,"date":"2023-01-29T06:11:37","date_gmt":"2023-01-29T11:11:37","guid":{"rendered":"https:\/\/bugaluu.com\/news\/fda-quietly-changes-end-date-for-study-of-heart-inflammation-after-pfizer-covid-vaccination\/1123221\/"},"modified":"2023-01-29T06:11:37","modified_gmt":"2023-01-29T11:11:37","slug":"fda-quietly-changes-end-date-for-study-of-heart-inflammation-after-pfizer-covid-vaccination","status":"publish","type":"post","link":"https:\/\/bugaluu.com\/news\/fda-quietly-changes-end-date-for-study-of-heart-inflammation-after-pfizer-covid-vaccination\/1123221\/","title":{"rendered":"FDA Quietly Changes End Date For Study Of Heart Inflammation After Pfizer COVID Vaccination"},"content":{"rendered":"
\"\"<\/a><\/div>\n

FDA Quietly Changes End Date For Study Of Heart Inflammation After Pfizer COVID Vaccination<\/span><\/p>\n

\n

Authored by Zachary Stieber via The Epoch Times<\/a> (emphasis ours),<\/em><\/p>\n

The U.S. Food and Drug Administration (FDA) has changed the end date for a key study on post-vaccination heart inflammation without notifying the public.<\/p>\n

Pfizer was supposed to<\/a> complete a study on the occurrence of subclinical myocarditis, or heart inflammation, after receipt of its COVID-19 vaccine.<\/strong> The completion date was listed by the FDA in 2021 as June 20, 2022. Pfizer was also supposed to submit the results of the study to the FDA by the end of 2022<\/a> as part of a list of requirements the FDA imposed as a condition of approving Pfizer\u2019s jab.<\/p>\n

But after the deadline passed, the FDA quietly changed the date.<\/p>\n

Under a list of postmarketing requirements for the Pfizer-BioNTech vaccine, the FDA now says the same study has an \u201coriginal projected completion date\u201d of June 30, 2023.<\/p>\n

The current status of the study is listed as \u201cpending.\u201d<\/p>\n

The FDA and Pfizer did not respond to requests for comment.<\/p>\n

Jessica Adams, a former regulatory review officer at the FDA, said the wording amounts to misinformation.<\/p>\n

\u201cBy definition, \u2018original\u2019 dates can\u2019t change,\u201d she wrote on Twitter, tagging the agency. \u201cPlease correct this \u2018misinformation.’\u201d<\/strong><\/p>\n

Dr. Vinay Prasad, who has increasingly criticized the FDA over its decisions during the pandemic, said the new timeline \u201cis so slow it will be entirely moot.\u201d<\/p>\n

\u201cAnother FDA failure<\/strong>,\u201d he said on Twitter.<\/p>\n

Study<\/h2>\n

The study is one of nine Pfizer was to complete to examine post-vaccination adverse events.<\/p>\n

The study is designed\u00a0to \u201cprospectively assess the incidence of subclinical myocarditis\u201d after receipt of a third dose<\/strong>, or a booster, in people aged 16 to 30.<\/p>\n

Pfizer submitted a timetable to the FDA stating the company would submit a final protocol by Nov. 30, 2021, and complete the study by June 30, 2022, according to the FDA\u2019s approval letter for the company\u2019s vaccine. The final report was due to the FDA by the end of 2022.<\/p>\n

The study was one of several examining myocarditis and pericarditis, a related condition. Both are caused by the Pfizer and Moderna vaccines, according to U.S. officials and other experts.<\/p>\n

Some of the vaccine-caused myocarditis cases have led to death.<\/p>\n

FDA officials expressed concern about the post-vaccination heart inflammation when considering whether to approve Pfizer\u2019s vaccine.<\/p>\n

Signal for Myocarditis After New Booster<\/h2>\n

The bivalent Pfizer vaccine triggered a safety signal for adults aged 18 to 35, Richard Forshee, an FDA official, told the agency\u2019s\u00a0vaccine advisory committee on Jan. 26.<\/p>\n

Regulators cleared that bivalent and one from Moderna in the fall of 2022 despite there being no clinical data for either shot.<\/p>\n

The adverse event happened at a concerning rate after a Pfizer bivalent in recent months, according to analyses of data from the FDA\u2019s Biologics Effectiveness and Safety initiative, which pulls from systems such as one managed by CVS Health.<\/p>\n

\u201cThe only signal we have detected so far is for myocarditis\/pericarditis following the Pfizer bivalent vaccine among adults 18 to 35 years old<\/strong>,\u201d Forshee told the panel.<\/p>\n

Safety signals indicate a vaccine may cause events but don\u2019t establish causality. But officials have stressed that the bivalents are similar to the original vaccines in defending the authorization without clinical data, and have acknowledged a causal link between the original messenger RNA vaccines and the heart inflammation.<\/p>\n

Most of the meeting presentations that went over adverse events focused on ischemic stroke, which triggered the threshold for a safety signal following Pfizer\u2019s bivalent booster<\/a> in the elderly and following receipt the original Pfizer and Moderna vaccines<\/a>\u00a0in all adults.<\/p>\n

Officials said that the stroke has happened in many people who received a flu vaccine<\/a> on the same day as a COVID-19 vaccine. They\u2019re studying whether there\u2019s a connection, though they noted there was no signal for the stroke after a flu shot alone.<\/p>\n

Dr. Nicola Klein, a Kaiser Permanente researcher who helps the CDC monitor vaccine safety, said that the signal for stroke wasn\u2019t as strong as that for myocarditis.<\/p>\n

\u201cThis is a cluster but \u2026 it doesn\u2019t stand out as extremely striking, unlike some other signals which we have seen,\u201d Klein said. \u201cFor example, myocarditis, it\u2019s an extremely strong signal that you can see without doing statistics.\u201d<\/p>\n

Panel Notified of CDC Analyses<\/h2>\n

During the public comment portion of the meeting, any panel members watching were notified that the CDC\u2019s analyses of reports to a different surveillance system concluded hundreds of adverse events met the safety signal threshold, including approximately 500 with a signal larger than that for myocarditis.<\/p>\n

Read more here…<\/strong><\/a><\/em><\/p>\n<\/div>\n

Tyler Durden<\/a><\/span>
\nSun, 01\/29\/2023 – 08:10<\/span><\/p>\n

From:Zerohedge<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

FDA Quietly Changes End Date For Study Of Heart Inflammation After Pfizer COVID Vaccination Authored by Zachary Stieber via The Epoch Times (emphasis ours), The…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_post_was_ever_published":false},"categories":[1],"tags":[],"class_list":["post-1123221","post","type-post","status-publish","format-standard","hentry","category-news","wpcat-1-id"],"jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/pbimBl-4Ict","jetpack_featured_media_url":"","_links":{"self":[{"href":"https:\/\/bugaluu.com\/news\/wp-json\/wp\/v2\/posts\/1123221","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/bugaluu.com\/news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/bugaluu.com\/news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/bugaluu.com\/news\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/bugaluu.com\/news\/wp-json\/wp\/v2\/comments?post=1123221"}],"version-history":[{"count":0,"href":"https:\/\/bugaluu.com\/news\/wp-json\/wp\/v2\/posts\/1123221\/revisions"}],"wp:attachment":[{"href":"https:\/\/bugaluu.com\/news\/wp-json\/wp\/v2\/media?parent=1123221"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/bugaluu.com\/news\/wp-json\/wp\/v2\/categories?post=1123221"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bugaluu.com\/news\/wp-json\/wp\/v2\/tags?post=1123221"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}