A Revolution in Vaccine Regulation and Approval

Finally!  And easily the Best vax-related News of 2025

Source: https://www.malone.news/p/a-revolution-in-vaccine-regulation

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Dr Robert MALONE is vice-chair of the CDC's ACIP committee and a member of the relevant working group committee (whose proceedings are confidential).  

And on his substack he shared the internal letter that Dr. Prasad, MD, sent out last Friday to FDA staff. 

Dr. Pasad is director of the CBER, the center within the FDA that regulates biological products like blood, vaccines, and gene therapies to protect public health.

 

Dr Malone does not exaggerate when he writes: 

"I am stunned, gobsmacked.

The significance and importance of this letter in the context of US and global vaccine policy cannot be overestimated.

This is a revolution, the likes of which I never expected to see in my lifetime." 

Besides a mea-culpa from the FDA the letter announces a radical and immediate U-turn policy in how the FDA will deal with vaccine regulation and approval.  

It addresses specifically respiratory vaccines, like the Covid-shots and the flu-jabs, but will also profoundly impact all other vaccines.  

 

Do read the letter as it heralds a radical turn-around in vaccine regulations/approval and even a summary of the policy changes would be too lengthy to address in a single post.  

> https://www.malone.news/p/a-revolution-in-vaccine-regulation

 

 

FOR INFO > The full letter by dr Prasad to FDA vaccine staff, is rendered in dr Malone's article posted higher. 

But you can also access the letter directly via this link: 

> https://www.washingtonpost.com/documents/3042d15c-676b-48ac-8148-1a2204ef420e.pdf

It is very good news. The empire of lies and corruption colloquially referred to as vaccinology is on the brink of collapse.

I read the letter 3 times and did not understand the point Dr Prasad, MD CBER Director was making.

 

Is a layman's  version english translation available?

46 minutes ago, Mark Nothing said:

I read the letter 3 times and did not understand the point Dr Prasad, MD CBER Director was making.

 

Is a layman's  version english translation available?

A summary of what Vinay Prasad wrote. The purported CBER Director at the FDA, he reports that agency staff have identified at least 10 child deaths causally linked to COVID-19 vaccines, based on an analysis of VAERS reports from 2021-2024. He argues this number is an underestimate due to underreporting and biases, highlighting broader implications for U.S. public health policy, including coercive mandates that may have harmed more children than they helped. Prasad criticizes past FDA and CDC failures, such as delaying acknowledgment of myocarditis risks in young males, ignoring mitigation strategies, and prioritizing authorizations over safety. He also addresses common objections, like claims that COVID-19 causes more myocarditis than vaccines, dismissing them as flawed due to improper denominators, demographics, and the reality of breakthrough infections.

Looking forward, Prasad calls for reforms in CBER’s vaccine regulation, emphasizing evidence-based medicine with demands for randomized trials on clinical endpoints rather than surrogates, reappraising annual flu vaccines, and treating vaccines like other medical products without special incentives. He condemns staff leaks to media as unethical and inaccurate, invites internal debate while urging resignations from dissenting staff, and commits to elevating vaccine science through humility, introspection, and stricter post-market oversight to prevent future oversights.

14 minutes ago, novacova said:

A summary of what Vinay Prasad wrote. The purported CBER Director at the FDA, he reports that agency staff have identified at least 10 child deaths causally linked to COVID-19 vaccines, based on an analysis of VAERS reports from 2021-2024. He argues this number is an underestimate due to underreporting and biases, highlighting broader implications for U.S. public health policy, including coercive mandates that may have harmed more children than they helped. Prasad criticizes past FDA and CDC failures, such as delaying acknowledgment of myocarditis risks in young males, ignoring mitigation strategies, and prioritizing authorizations over safety. He also addresses common objections, like claims that COVID-19 causes more myocarditis than vaccines, dismissing them as flawed due to improper denominators, demographics, and the reality of breakthrough infections.

Looking forward, Prasad calls for reforms in CBER’s vaccine regulation, emphasizing evidence-based medicine with demands for randomized trials on clinical endpoints rather than surrogates, reappraising annual flu vaccines, and treating vaccines like other medical products without special incentives. He condemns staff leaks to media as unethical and inaccurate, invites internal debate while urging resignations from dissenting staff, and commits to elevating vaccine science through humility, introspection, and stricter post-market oversight to prevent future oversights.

Thanks for the summary. 

Two of the points in that summary deserve some extra emphesis: 

• The 10 children deaths where it was as good as certain that the mRNA vaccine was the cause of death, came from a sample of 96 children's deaths.  Prasad indicated that there is almost certainly a large underestimate of the actual jab-provoked deaths. 
• He also made it clear that from now on vax manufacturers instead of a) only having to show that their product results in an 'immune reaction', would b) have to provide evidence of actual efficacy of their product in c) a randomized control trial (i.e. comparing the effects of their product with a non-vaccinated control group, instead of comparing it with the results of earlier versions of their vaccine). 

> That last 3-pronged point is common sense and will put an end to the current wax-nose requirements that allowed vax manufacturers to market products that were actually approved without proper insight in their actual safety and effectiveness.  Needless to say that the vax manufacturers will do anything in their power to torpedo it.