{"id":12393,"date":"2025-06-07T18:00:00","date_gmt":"2025-06-07T22:00:00","guid":{"rendered":"https:\/\/cov19longhaulfoundation.org\/?p=12393"},"modified":"2025-06-06T15:06:31","modified_gmt":"2025-06-06T19:06:31","slug":"covid-19-vaccine-reform-is-moving-slower-than-many-had-hoped","status":"publish","type":"post","link":"https:\/\/cov19longhaulfoundation.org\/?p=12393","title":{"rendered":"COVID-19 Vaccine Reform Is Moving Slower Than Many Had Hoped"},"content":{"rendered":"\n

Authored by Maryanne Demasi via The Brownstone Institute,<\/em><\/p>\n\n\n\n

Just three weeks after Dr Vinay Prasad assumed oversight of vaccines at the FDA, Moderna\u2019s latest Covid-19 vaccine,\u00a0mNEXSPIKE\u00ae<\/em>, received full\u00a0approval<\/a>.<\/a><\/p>\n\n\n\n

For those who had hoped the mRNA platform would be shelved, the decision landed like a gut punch.<\/strong><\/p>\n\n\n\n

Approved on 31 May 2025, the next-generation shot is intended for adults over 65, as well as individuals aged 12 to 64 with at least one risk factor for severe illness.<\/p>\n\n\n\n

And it came under the watch of a man who had spent years demanding greater scientific rigor from the agency.<\/p>\n\n\n\n

Prasad had been among the FDA\u2019s most outspoken critics during the pandemic,<\/strong> repeatedly condemning its reliance on surrogate endpoints\u2014such as antibody levels\u2014rather than hard clinical outcomes like reduced hospitalisation or death.<\/p>\n\n\n\n

And he didn\u2019t just say it once. He drove the point home, over and over.<\/p>\n\n\n\n

\n

\u201cShowing boosters improve neutralizing antibodies or other laboratory measures is not what we need,\u201d <\/strong>he posted<\/a> on X in July 2022.<\/em><\/p>\n\n\n\n

\u201cWe need randomized control trials powered for clinical endpoints showing boosters improve outcomes that people care about.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n

In January 2023, he co-signed a formal Citizen Petition to the FDA stating<\/a>, \u201cThis immunobridging surrogate endpoint has not been validated to predict clinical efficacy.\u201d<\/strong><\/em><\/p>\n\n\n\n

Then in March 2023, he made his position even clearer on Substack. \u201cI don\u2019t care about transient antibody titer levels,\u201d <\/em>he wrote<\/a>.<\/p>\n\n\n\n

But mNEXSPIKE\u00ae<\/em> appears to have been approved primarily using exactly those kinds of data\u2014measures of immune response, not measures of meaningful outcomes.<\/strong><\/p>\n\n\n\n

So, how do we square that?<\/p>\n\n\n\n

Technically, the approval aligns with the policy Prasad outlined in a recent New England Journal of Medicine<\/em> article. <\/p>\n\n\n\n

There, he proposed a\u00a0two-track system<\/a>\u2014no further vaccine approvals for healthy adults without RCTs showing clinical benefit\u2014but for older adults and at-risk individuals, immunobridging data could still be acceptable.<\/a><\/p>\n\n\n\n

So yes, by that standard, mNEXSPIKE\u00ae<\/em> fits the rules.<\/p>\n\n\n\n

But it doesn\u2019t erase the discomfort. Because for years, Prasad insisted those very shortcuts\u2014approving Covid vaccines based on antibody levels instead of clinical outcomes\u2014were scientifically flimsy.<\/strong><\/p>\n\n\n\n

Now, under his watch, those same shortcuts are back in play.<\/p>\n\n\n\n

When Robert F. Kennedy, Jr. was appointed HHS Secretary, reform didn\u2019t just seem likely\u2014it felt imminent.<\/strong><\/p>\n\n\n\n

Many expected the mRNA shots would be pulled from the market, or at the very least, that new approvals would be frozen until stronger evidence emerged.<\/p>\n\n\n\n

Instead, we\u2019ve seen a flood of high-production videos and polished slogans about \u201crestoring public trust.\u201d<\/p>\n\n\n\n

To many observers, it looks like transparency on the surface, but business as usual underneath.<\/strong><\/p>\n\n\n\n

Of course, no one said this would be easy.<\/p>\n\n\n\n

Having worked in government as a political adviser, I know how hard it is to shift systems that are not only slow and bureaucratic but deeply enmeshed with commercial interests. And no sector is more heavily invested in mRNA than biotech.<\/p>\n\n\n\n

This isn\u2019t just about Covid anymore. The pharmaceutical industry has poured billions into mRNA vaccines for RSV, flu, HIV, cancer, and more. Entire product pipelines are now staked on the assumption that the technology is here to stay.<\/strong><\/p>\n\n\n\n

Pulling the plug wouldn\u2019t just alter public health policy\u2014it would tank portfolios, gut R&D budgets, and unleash a political and financial firestorm from some of the most powerful corporate interests on earth.<\/p>\n\n\n\n

That\u2019s the kind of pressure Prasad is under now. That\u2019s the reality Kennedy\u2019s team has stepped into.<\/p>\n\n\n\n

This is no longer science versus ideology. It\u2019s science versus entrenched industry power.<\/p>\n\n\n\n

And many are beginning to worry we\u2019re watching the same playbook unfold\u2014just with better branding.<\/p>\n\n\n\n

That\u2019s not what MAHA supporters or vaccine-injured families were hoping for. They\u2019re not asking for tweaks. They want the shots gone. Not revised. Not updated\u2014just gone.<\/p>\n\n\n\n

But political reality rarely keeps pace with public demand. Even the most determined reformers can\u2019t move faster than the machinery they\u2019re trying to dismantle.<\/p>\n\n\n\n

So where does that leave us?<\/p>\n\n\n\n

Facing the hardest task of all\u2014staying in the fight.<\/strong><\/p>\n\n\n\n

Progress may feel glacial, but it is<\/em> underway.<\/strong><\/p>\n\n\n\n

The CDC has removed routine Covid-19 vaccine recommendations for healthy children and pregnant women.<\/p>\n\n\n\n

Prasad\u2019s new framework has halted low-risk approvals unless backed by RCTs.<\/p>\n\n\n\n

Yes, the mRNA platform is still alive – and still fiercely protected – but reform was never going to be easy. And it was never going to come all at once.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

Authored by Maryanne Demasi via The Brownstone Institute, Just three weeks after Dr Vinay Prasad assumed oversight of vaccines at the FDA, Moderna\u2019s latest Covid-19 vaccine,\u00a0mNEXSPIKE\u00ae, received full\u00a0approval. For those […]<\/p>\n","protected":false},"author":2,"featured_media":12397,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-12393","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/12393","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=12393"}],"version-history":[{"count":3,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/12393\/revisions"}],"predecessor-version":[{"id":12396,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/12393\/revisions\/12396"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/media\/12397"}],"wp:attachment":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=12393"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=12393"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=12393"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}