{"id":36947,"date":"2020-11-16T19:40:12","date_gmt":"2020-11-16T23:40:12","guid":{"rendered":"http:\/\/stateofthenation.co\/?p=36947"},"modified":"2020-11-16T19:40:12","modified_gmt":"2020-11-16T23:40:12","slug":"ican-demands-valid-covid-19-vaccine-efficacy-endpoints-from-fda","status":"publish","type":"post","link":"http:\/\/stateofthenation.co\/?p=36947","title":{"rendered":"ICAN DEMANDS VALID COVID-19 VACCINE EFFICACY ENDPOINTS FROM FDA"},"content":{"rendered":"


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On November 6, 2020, ICAN filed a Citizen Petition and a Petition for a Stay of Action demanding that the FDA require valid endpoints for determining efficacy in the COVID-19 vaccine trials currently being run by Pfizer, Moderna, AstraZeneca, and Johnson & Johnson. \u00a0ICAN\u2019s demands include that the vaccine be shown to prevent serious cases of COVID-19 (not just mild cases) and that it can stop transmission of COVID-19.<\/b><\/div>\n
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As explained in our previous legal updates, ICAN\u2019s legal team has been hammering away at the safety requirements for the clinical trials of COVID-19 vaccines, including demanding they be placebo-controlled, long-term, and have other safeguards.\u00a0 Many of those demands were subsequently met and we are not done fighting on that front.\u00a0 But there is now another battle we are fighting.<\/div>\n
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ICAN\u2019s legal team, led by Aaron Siri, has now also focused its efforts on the basis the FDA will rely upon to determine whether any of the COVID-19 vaccine frontrunners are effective.\u00a0 Many Americans have been led to believe that the vaccines currently in trials are the answer to all pandemic-related problems.\u00a0 Many believe this is because a vaccine, when available, will prevent individuals from having a serious case of COVID-19 and will stop people from spreading it to others.\u00a0 However, the clinical trials for Pfizer, Moderna, AstraZeneca, and Johnson & Johnson\u2019s products are\u00a0not designed\u00a0<\/b>to determine either of these!<\/div>\n
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Instead, each of the four trials\u2019 primary goals for determining whether the vaccine is effective merely requires determination of whether it can reduce symptoms of mild cases of COVID-19. \u00a0\u00a0The trials will also not demonstrate whether or not a vaccine recipient can still transmit COVID-19 to others.\u00a0 This means that, under the current rules, a COVID-19 vaccine can be licensed without demonstrating it can prevent severe COVID-19, hospitalization, or deaths, nor stop the spread of COVID-19.<\/div>\n
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Also concerning is that \u201ccases\u201d of COVID-19 for trial purposes are being demonstrated by positive PCR tests.\u00a0 The scientific literature has shown that such PCR tests can be highly unreliable, frequently giving false positives.\u00a0 Consistent with this literature, we demanded that only positive PCR results meeting certain criteria be relied upon.\u00a0 ICAN also demanded that all participants be tested before and after vaccination for T-cell immunity to SARS-CoV-2, which is not currently part of the protocols. \u00a0If a person has pre-existing immunity to SARS-CoV-2 (either from being exposed to COVID-19 or otherwise) their presence in the study could affect the result by showing fewer people getting sick than would actually occur in the \u201cwild.\u201d<\/div>\n
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These alarming deficiencies in the studies were what led ICAN to direct its attorneys to file a\u00a0petition demanding that all four Phase III COVID-19 vaccine trials amend their efficacy endpoints<\/a>.\u00a0 ICAN demanded, among other things, that the trials test and determine (1) whether these vaccines will prevent severe cases of COVID-19; and (2) whether they will stop the spread of the virus.\u00a0 ICAN further demanded improvements in the PCR testing protocol and T-cell testing pre-and-post vaccination.<\/div>\n
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Recognizing the critical importance that these changes be made in a timely manner, on November 11, 2020, ICAN\u2019s attorneys filed a\u00a0Petition for a Stay of Action<\/a>\u00a0with the FDA which asks that the agency stay, or pause, any action related to the trials until the requested actions in the efficacy petition are implemented.<\/div>\n
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ICAN\u2019s attorneys separately sent a letter to Dr. Peter Marks, the Director of the Center for Biologics Evaluation and Research at the FDA, bringing these very concerns to his attention.\u00a0\u00a0You can read that letter here<\/a>.\u00a0\u00a0Dr. Marks<\/a>\u00a0has referred to himself as \u201cthe FDA point person on COVID-19 vaccines\u201d and has assured Americans that the FDA \u201cwill make sure they\u2019re safe and effective.\u201d\u00a0 ICAN will closely review any response from Dr. Marks given his promise that he and the FDA \u201cuphold globally respected standards for product quality, safety, and efficacy\u201d and\u00a0his statement<\/a>\u00a0that he would resign if \u201csomething that was unsafe or ineffective [] was being put through.\u201d<\/div>\n
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There are numerous other legal and non-legal efforts ICAN is engaged in with regard to COVID-19 vaccines that are not yet ready to be discussed here but will be featured in future updates.<\/div>\n
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<\/a>If you would like to provide the FDA a comment regarding the efficacy petition we have filed regarding COVID-19 vaccines, you can do so\u00a0here<\/a>.<\/div>\n<\/div>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-36947","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"http:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/posts\/36947","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/stateofthenation.co\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=36947"}],"version-history":[{"count":0,"href":"http:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/posts\/36947\/revisions"}],"wp:attachment":[{"href":"http:\/\/stateofthenation.co\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=36947"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/stateofthenation.co\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=36947"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/stateofthenation.co\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=36947"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}