{"id":3993,"date":"2025-05-21T23:02:23","date_gmt":"2025-05-21T23:02:23","guid":{"rendered":"https:\/\/mailitics.com\/index.php\/2025\/05\/21\/fda-covid-vaccine-guidelines-analysis-questions-raised-on-access-trials-transparency\/"},"modified":"2025-05-21T23:02:23","modified_gmt":"2025-05-21T23:02:23","slug":"fda-covid-vaccine-guidelines-analysis-questions-raised-on-access-trials-transparency","status":"publish","type":"post","link":"https:\/\/mailitics.com\/index.php\/2025\/05\/21\/fda-covid-vaccine-guidelines-analysis-questions-raised-on-access-trials-transparency\/","title":{"rendered":"STAT+: Five burning questions on the FDA\u2019s new Covid-19 vaccine framework"},"content":{"rendered":"<p>    STAT+: Five burning questions on the FDA\u2019s new Covid-19 vaccine framework<br \/>\n \t<BR><br \/>\n<BR><\/BR><br \/>\n    <!-- no image --><br \/>\n \t<BR><br \/>\n<BR><\/BR><\/p>\n<div>\n<p>WASHINGTON \u2014\u00a0Food and Drug Administration Commissioner Marty Makary promised stakeholders last week that the agency\u2019s new Covid-19 vaccine framework would answer all of their questions.\u00a0<\/p>\n<p>But the framework has perhaps created as much confusion as clarity. Broadly, the FDA said <a href=\"https:\/\/www.statnews.com\/2025\/05\/20\/fda-vaccine-framework-new-covid-shot-recommendations-vinay-prasad-marty-makary\/\">it will limit approval of Covid-19 vaccines<\/a> to people 65 and older and to those at risk for severe Covid outcomes, and will require vaccine makers to conduct clinical trials investigating whether the shots benefit healthy adults and children.\u00a0<\/p>\n<p>At a public webinar on Tuesday, top vaccine regulator Vinay Prasad described the approach as a \u201ccompromise\u201d allowing Covid-19 vaccine access for millions of Americans while still generating evidence. He answered some questions, asked by Makary, about his rationale.\u00a0<\/p>\n<p><a href=\"https:\/\/www.statnews.com\/2025\/05\/21\/fda-covid-vaccine-guidelines-analysis-questions-raised-on-access-trials-transparency\/?utm_campaign=rss\">Continue to STAT+ to read the full story\u2026<\/a><\/p>\n<\/div>\n<p> \t<BR><br \/>\n <BR><\/BR><br \/>\n    Lizzy Lawrence and Helen Branswell<br \/>\n \t<BR><br \/>\n<BR><\/BR><br \/>\n<a href=\"https:\/\/www.statnews.com\/2025\/05\/21\/fda-covid-vaccine-guidelines-analysis-questions-raised-on-access-trials-transparency\/?utm_campaign=rss\">Go to statnews<\/a><br \/>\n \t<BR><br \/>\n <BR><\/BR><\/p>\n","protected":false},"excerpt":{"rendered":"<p>STAT+: Five burning questions on the FDA\u2019s new Covid-19 vaccine framework WASHINGTON \u2014\u00a0Food and Drug Administration Commissioner Marty Makary promised stakeholders last week that the agency\u2019s new Covid-19 vaccine framework would answer all of their questions.\u00a0 But the framework has perhaps created as much confusion as clarity. Broadly, the FDA said it will limit approval [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2194,2154,2469,2208,2146,1428,2179,2176,2155,2151,2144,2180,2152,2195],"tags":[2150],"class_list":["post-3993","post","type-post","status-publish","format-standard","hentry","category-biotech","category-biotechnology","category-coronavirus","category-drug-development","category-fda","category-health","category-infectious-disease","category-pharma","category-pharmaceuticals","category-policy","category-politics","category-public-health","category-stat","category-vaccines","tag-statnews"],"_links":{"self":[{"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/posts\/3993"}],"collection":[{"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/comments?post=3993"}],"version-history":[{"count":0,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/posts\/3993\/revisions"}],"wp:attachment":[{"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/media?parent=3993"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/categories?post=3993"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/tags?post=3993"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}