{"id":12384,"date":"2025-06-05T16:00:00","date_gmt":"2025-06-05T20:00:00","guid":{"rendered":"https:\/\/cov19longhaulfoundation.org\/?p=12384"},"modified":"2025-06-05T14:10:26","modified_gmt":"2025-06-05T18:10:26","slug":"fda-not-recommending-newly-approved-covid-19-vaccine-official","status":"publish","type":"post","link":"https:\/\/cov19longhaulfoundation.org\/?p=12384","title":{"rendered":"FDA Not Recommending Newly Approved COVID-19 Vaccine: Official"},"content":{"rendered":"\n

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

The Food and Drug Administration (FDA) approved a new COVID-19 vaccine but is not recommending people receive it, the agency\u2019s top vaccine officials said on June 4.<\/p>\n\n\n\n

\n

\u201cThere\u2019s another misconception I want to clarify, which is, people have said, \u2018You at FDA are recommending the shots to high risk people and older people.\u2019 I want to be very clear, the FDA is not your doctor. We are not, we don\u2019t recommend shots to people,<\/strong>\u201d Dr. Vinay Prasad, head of the FDA\u2019s Center for Biologics Evaluation and Research, said in a video<\/a> released by the agency.<\/em><\/p>\n\n\n\n

<\/a><\/em><\/p>\n\n\n\n

\u201cWhat we do is we make them available for patients to have a conversation with their doctor.<\/strong> But I can understand a 66-year-old who goes to see their doctor and they may decide to do it or not do it, that\u2019s their medical decision. FDA is granting a marketing authorization for that, but we are not in the business of making recommendations.\u201d<\/em><\/p>\n\n\n\n

Dr. Marty Makary, the FDA commissioner, said<\/a> on the social media platform X that the FDA\u2019s job \u201cis to review data and decide whether products are safe and effective.\u201d<\/strong><\/p>\n<\/blockquote>\n\n\n\n

Officials with the Center for Biologics Evaluation and Research on May 31 approved<\/a> a new COVID-19 vaccine from Moderna.<\/p>\n\n\n\n

The FDA cleared the shot for two groups who have previously received a COVID-19 vaccine: people 65 and older, and those 12 to 64 with at least one condition the Centers for Disease Control and Prevention says<\/a> increases their risk of severe COVID-19.<\/p>\n\n\n\n

The CDC recently stopped<\/a> recommending COVID-19 vaccines for healthy children and pregnant women.<\/strong><\/p>\n\n\n\n

The FDA typically authorizes and approves vaccines, while the CDC issues vaccine recommendations.<\/p>\n\n\n\n

Prasad\u2019s predecessor<\/a> at the FDA, Dr. Peter Marks, who resigned earlier this year, repeatedly recommended COVID-19 vaccination during the COVID-19 pandemic.<\/strong><\/p>\n\n\n\n

\n

\u201cYou should get a COVID-19 booster,\u201d Marks said<\/a> in one video, published on Dec. 21, 2021.<\/em><\/p>\n\n\n\n

He said that a booster, or an additional shot on top of a previous vaccination, \u201cwill increase the level of your immunity and will provide strong protection from the serious complications of COVID-19, including hospitalization and death.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n

The COVID-19 vaccines were originally marketed as one- or two-dose regimens, with no mention of potential boosting. When evidence emerged showing the effects of the vaccines waned over time, the FDA cleared boosters.<\/p>\n\n\n\n

The agency later authorized or approved updated formulations of the vaccines in a bid to better target newer variants. They relied primarily on animal and immunogenicity data.<\/p>\n\n\n\n

Prasad and Makary announced<\/a> in May that the FDA would not approve COVID-19 vaccines for Americans who are neither elderly nor have one of the risk conditions, such as obesity, as defined by the CDC, unless manufacturers produced trial data showing the vaccines were effective against clinical endpoints such as symptomatic COVID-19 among the healthy.<\/strong><\/p>\n\n\n\n

\n

\u201cThe FDA can only approve products if it concludes, based on scientific evidence, the benefit-to-harm balance is favorable. And we simply need more data to have that confidence for younger individuals at low-risk of severe disease,\u201d Prasad said at the time.<\/em><\/p>\n<\/blockquote>\n\n\n\n

The FDA\u2019s approval of Moderna\u2019s new COVID-19 vaccine was based on data from a trial in which participants received either the new vaccine or Moderna\u2019s already-available COVID-19 shot. The trial showed the new vaccine triggered non-inferior immune responses, according to data Moderna provided to the FDA.<\/p>\n\n\n\n

\n

\u201cWe at FDA felt that that was sufficient to allow this product to be available to the vulnerable people, older people and high-risk people,\u201d Prasad said<\/a> on Wednesday, or that the benefits of the vaccine outweigh the risks for those populations.<\/em><\/p>\n<\/blockquote>\n\n\n\n

Moderna has committed to running a placebo-controlled trial of the new shot among healthy people aged 50 to 64. The FDA \u201cwill scrutinize every aspect of the trial,\u201d<\/strong> Health Secretary Robert F. Kennedy Jr. said<\/a> this week.<\/p>\n\n\n\n

\u201cThey\u2019re not going to go up against another Moderna product in this study. It\u2019s Moderna vaccine against a saline placebo,\u201d Prasad said. \u201cWe\u2019re going to see all the adverse events in this study. We\u2019re going to see whether or not it helps people, and what it does, and whether or not it\u2019s working like we think it might be in 2025.\u201d<\/strong><\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

Authored by Zachary Stieber via The Epoch Times, The Food and Drug Administration (FDA) approved a new COVID-19 vaccine but is not recommending people receive it, the agency\u2019s top vaccine […]<\/p>\n","protected":false},"author":2,"featured_media":12386,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[761,101,877,445,1,607,608],"tags":[],"class_list":["post-12384","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-concerns","category-covid-19","category-moderna-vaccine","category-policies-politics","category-uncategorized","category-vaccine-news","category-vaccine-safety"],"_links":{"self":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/12384","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=12384"}],"version-history":[{"count":1,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/12384\/revisions"}],"predecessor-version":[{"id":12385,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/12384\/revisions\/12385"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/media\/12386"}],"wp:attachment":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=12384"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=12384"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=12384"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}