LANSING, Mich. (Michigan News Source) – In a significant shift of policy, the Food and Drug Administration (FDA) has announced it will no longer recommend COVID-19 boosters for healthy individuals under the age of 65, citing a lack of evidence to support continued use.

After years of aggressively promoting boosters, the agency now concedes that data supporting their effectiveness in otherwise healthy adults simply isn’t strong enough to justify the ongoing campaign. Instead, there will be a streamlined approach to make them available to seniors, young adults and children with at least one high-risk health problem.

FDA to big pharma: show real results, not just antibodies.

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In a New England Journal of Medicine article, FDA Commissioner Martin Makary, along with vaccine regulator Vinay Prasad, say that drugmakers must now submit clinical trial data proving boosters actually improve overall health outcomes – not just boost antibody counts – before they can be approved. Under the new regulatory framework, the FDA now expects randomized, controlled trial data showing actual clinical outcomes for individuals ages 6 months to 64.

Prasad says, “For many Americans we simply do not know the answer as to whether or not they should be getting the seventh or eighth or ninth or tenth COVID-19 booster.”

Michigan still following CDC’s one-size-fits-all vaccine guidance.

However, the Michigan Department of Health and Human Services (MDHHS), run under Democratic Governor Gretchen Whitmer, still aligns with the Centers for Disease Control and Prevention (CDC) recommendations for COVID-19 vaccinations.

According to the most recent information available on the CDC website, they continue to recommend that “everyone ages 6 months and older should get a 2024-2025 COVID-19 vaccine” to protect from severe illness, hospitalization and death.

Senate committee turns up heat on federal health agencies over Covid-era decisions.

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In another move reflecting growing scrutiny of federal pandemic policies, the Senate’s Health, Education, Labor, and Pensions (HELP) Committee publicly confronted top officials from the CDC, FDA, and NIH over alleged COVID-era cover-ups, including questions about vaccine efficacy and censorship of dissenting views. The hearing occurred on Wednesday, May 21st amid the FDA’s recent decision to stop recommending COVID boosters for healthy Americans under 65, signaling a broader reckoning with how federal health agencies handled the pandemic and communicated with the public.

Chaired by Senator Ron Johnson (R-WI), the Senate session scrutinized the actions of federal health agencies during the COVID-19 pandemic, particularly concerning the communication of vaccine- related risks. Key allegations and findings presented at the hearing included delayed public warnings about the risks of myocarditis and pericarditis associated with mRNA COVID-19 vaccines; suppression of medical dissent and transparency issues with the Biden administration including issuing talking points guiding health officials with misleading claims. Coinciding with the hearing, the FDA announced expanded warnings on the labels of Pfizer and Moderna COVID-19 vaccines.