{"id":12155,"date":"2025-05-24T12:00:00","date_gmt":"2025-05-24T16:00:00","guid":{"rendered":"https:\/\/cov19longhaulfoundation.org\/?p=12155"},"modified":"2025-05-24T09:51:34","modified_gmt":"2025-05-24T13:51:34","slug":"no-trial-data-no-vax-fda-demands-gold-standard-testing-for-any-new-covid-19-vaccines","status":"publish","type":"post","link":"https:\/\/cov19longhaulfoundation.org\/?p=12155","title":{"rendered":"No Trial Data, No Vax: FDA Demands Gold Standard Testing For Any New COVID-19 Vaccines"},"content":{"rendered":"\n

Authored by Zachary Stieber via The Epoch Times\u00a0,<\/em><\/p>\n\n\n\n

The Food and Drug Administration (FDA) will not approve COVID-19 vaccines for many Americans absent trial data showing that the benefits outweigh the risks<\/strong>, top agency officials said on May 20.<\/a><\/p>\n\n\n\n

\u201cMoving forward, the FDA will adopt the following Covid-19 vaccination regulatory framework: On the basis of immunogenicity\u2014proof that a vaccine can generate antibody titers in people<\/strong>\u2014the FDA anticipates that it will be able to make favorable benefit\u2013risk findings for adults over the age of 65 years and for all persons above the age of 6 months with one or more risk factors that put them at high risk for severe Covid-19 outcomes,\u201d such as asthma or cancer, FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, head of the FDA\u2019s Center for Biologics Evaluation and Research, wrote<\/a> in a New England Journal of Medicine article.<\/p>\n\n\n\n

\u201cFor all healthy persons\u2014those with no risk factors for severe Covid-19\u2014between the ages of 6 months and 64 years, the FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications can be granted.<\/strong>\u201d<\/p>\n\n\n\n

Pfizer, Moderna, and Novavax, which have received licenses for their COVID-19 vaccines, did not immediately respond to requests for comment.<\/p>\n\n\n\n

Several medical groups that have commented on FDA steps concerning COVID-19 vaccines, such as the American Academy of Family Physicians, did not return inquiries.<\/p>\n\n\n\n

The FDA in 2024, in its most recent action concerning the Pfizer and Moderna vaccines, approved<\/a> updated versions for most Americans and extended emergency authorization for others, despite there being no trial data available for those formulations.<\/p>\n\n\n\n

The regulatory agency on May 16 approved<\/a> Novavax\u2019s COVID-19 vaccine for the first time<\/strong>. The approval was for adults aged 65 and up. The agency said that people aged 12 to 64 could receive a Novavax shot, but only if they have one of the conditions that puts them at higher risk for severe COVID-19 outcomes.<\/p>\n\n\n\n

An earlier version of Novavax\u2019s shot was tested in a randomized, controlled trial in 2021.<\/p>\n\n\n\n

The Centers for Disease Control and Prevention currently recommends that people aged 6 months and older receive one of the latest COVID-19 vaccines, but just 13 percent of children and 23 percent of adults have followed that recommendation.<\/p>\n\n\n\n

Makary and Prasad noted that a number of other countries, such as Australia and Germany, only recommend COVID-19 vaccines to certain populations.<\/strong><\/p>\n\n\n\n

\u201cWhile all other high-income nations confine vaccine recommendations to older adults (typically those older than 65 years of age), or those at high risk for severe Covid-19, the United States has adopted a one-size-fits-all regulatory framework and has granted broad marketing authorization to all Americans over the age of 6 months,\u201d they wrote on Tuesday. \u201cThe U.S. policy has sometimes been justified by arguing that the American people are not sophisticated enough to understand age- and risk-based recommendations. We reject this view.\u201d<\/p>\n\n\n\n

The officials said that while the quick development of COVID-19 vaccines was a scientific and medical achievement, the benefit of repeated dosing\u2014some people have received at least six doses\u2014is unclear.<\/strong><\/p>\n\n\n\n

The trials of the vaccines should measure prevention of symptomatic COVID-19, with secondary endpoints including severe COVID-19, hospitalization, and death, according to Makary and Prasad, who said that the trials should include participants who contracted COVID-19 within the past year, and they should follow participants for at least six months \u201cto ensure that early booster gains persist.\u201d The control group could receive a saline placebo, the officials said.<\/p>\n\n\n\n

\u201cUltimately, these studies alone can provide reassurance that the American repeat-boosters in-perpetuity strategy is evidence-based<\/strong>,\u201d they wrote.<\/p>\n\n\n\n

Health Secretary Robert F. Kennedy Jr. recently pledged<\/a> to require placebo-controlled trials for new vaccines.<\/p>\n\n\n\n

Makary and Prasad planned to talk about the policy update at 1 p.m.<\/a> on Tuesday.<\/p>\n","protected":false},"excerpt":{"rendered":"

Authored by Zachary Stieber via The Epoch Times\u00a0, The Food and Drug Administration (FDA) will not approve COVID-19 vaccines for many Americans absent trial data showing that the benefits outweigh […]<\/p>\n","protected":false},"author":2,"featured_media":12158,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[761,849,877,914,445,592,974,608],"tags":[],"class_list":["post-12155","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-concerns","category-jj-vaccine","category-moderna-vaccine","category-pfizer-vaccine","category-policies-politics","category-treatments","category-vaccine-long-term-safety","category-vaccine-safety"],"_links":{"self":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/12155","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=12155"}],"version-history":[{"count":1,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/12155\/revisions"}],"predecessor-version":[{"id":12157,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/12155\/revisions\/12157"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/media\/12158"}],"wp:attachment":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=12155"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=12155"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=12155"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}