Thread by @sasha_latypova

Zero-Evidence-Based: FDA's new covid shot policy is deliberately harmful. Thread🧵👇
A new article by the FDA chief Marty Makary and new CBER Director Vinay Prasad published in the New England Journal of Medicine announced the adoption of an “evidence-based approach” to covid shot recommendations. The policy mirrors the approval parameters just granted to Novavax.

Read the full FDA policy in the NEJM article: nej.md/3F6EIhV

Quoting from the published FDA policy:

"Moving forward, the FDA will adopt the following Covid-19 vaccination regulatory framework: On the basis of immunogenicity — proof that a vaccine can generate antibody titers in people — the FDA anticipates that it will be able to make favorable benefit–risk findings for adults over the age of 65 years and for all persons above the age of 6 months with one or more risk factors that put them at high risk for severe Covid-19 outcomes, as described by the CDC (Figure 2). For all healthy persons — those with no risk factors for severe Covid-19 — between the ages of 6 months and 64 years, the FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications can be granted. Insofar as possible, when approving a Covid-19 vaccine for high-risk groups, the FDA will encourage manufacturers to conduct randomized, controlled trials in the population of healthy adults as part of their postmarketing commitment."

Moderna stock rose 10% on this news, which should tell you something. What it should tell you is that the Wall Street is not stupid, and they can do the math very quickly. The FDA is working hard to expand the fledging covid vax market and this policy signals the commitment from the USG to purchase at least 100M doses of the poison that nobody needs.

Here are the details about this genius policy move:

Makary and Prasad wrote that the FDA “anticipates that it will be able to make favorable benefit-risk findings” on immunogenicity studies for these populations moving forward.

Let’s pause here for a minute to take in the sheer awesomeness of the gold standard science emanating from this profound statement. First, notice that the FDA does not expect to make non-favorable decisions on immunogenicity studies. This language about immunogenicity studies simply means “regulation-free EUA Countermeasures” by another name. Immunogenicity studies are short-term testing of antibodies elicited by the shots.
Antibodies DO NOT represent immunity to anything, that’s been known for a long time even in the establishment science. The antibodies also drive so-called vaccine enhanced disease (VED) which was explicitly recognized as a possibility in the DOD contracts awarded to Moderna and in preclinical testing studies by all manufacturers.
Remember that all mRNA and DNA shots pushed by the deadly Operation Warp Speed produced positive antibody titers, and thus would have easily sailed through under this “new” FDA policy.
They subsequently killed millions of people (including thousands of children) and caused hundreds of millions of injuries and induced repetitive bouts of more severe and deadly covid illness. This is because the antibodies being tested for are computer models designed to fight other computer models of “new viral strains” predicted (ahem, fabricated) by CDC.

The well-known fact that covid shots increased incidence of covid despite fulfilling the immunogenicity test criteria does not stop our brave MAHA warriors, Makary and Prasad from planning to approve future vaccines on antibody titers alone.

Thus, the FDA will not be requiring any new clinical trials prior to the [fake] approval of new versions of already [fake] approved covid injections for 65+ and what they deem “vulnerable” population of younger age. Let’s see whom they consider “vulnerable”. Gosh! Who could have predicted this? Pregnant women are the prime target for these injections! If you are a couch potato, you too are a target:

It is unclear what gold standard science was used by the FDA to identify these categories of the “vulnerable”. While obesity have been shown to put people at risk from a severe illness from whatever was used to simulate “covid”, there is no data showing that this was the case for the rest of the categories listed. In fact smoking turned out to be protective from it. Needless to say that no data exists demonstrating that covid vaccines benefited any of the above listed categories of people.

Today, the uptake of the covid shots hovers around 20%. Approximately 75% of the US population has at least 1 “risk factor” from the above list. It is not difficult to see who Makary and Prasad really work for…

If you are still unsure about that question, the fact that they included pregnant women into the “vulnerable” target group should drive this home for you. Let’s recall that clinical trials of safety or efficacy of the original mRNA/DNA “platforms” for covid shots in pregnancy HAVE NEVER BEEN CONDUCTED. They were included in the original post-marketing commitments by the FDA and have never been completed. This commitment was simply dropped. The labels for all covid shots to date state that there is no data to determine the safety of these shots in pregnancy. There is however a lot of clear “real-world” data on the harms of these shots for pregnancy and reproductive function for both women and men:

The “mRNA platform” shots cause >80% miscarriage rates and triple (!!!) stillbirth rates: sashalatypova.substack.com/p/re-publishin…

The “mRNA platform” shots cause skeletal malformations and maternal toxicity, and mRNA transfers through placenta and lactation to the baby:

From Moderna regulatory file. The FDA concealed this information from the public: sashalatypova.substack.com/p/my-affidavit…

The “mRNA platform” destroys approx 60% of non-renewable female eggs (and will do that to a female fetus, too):

The “mRNA platform” destroys male reproductive potential (presentation by late Dr. Arne Burkhardt).

https://x.com/RefugeOfSinner5/status/1627215969385848832

Both Prasad and Makary discussed their NEJM editorial at a town hall meeting on Tuesday (yesterday). That meeting had the comments turned off, obviously, because it was a radically transparent meeting by the new administration dedicated to taking public feedback very seriously.

In that radically transparent and open meeting where nobody could comment, Vinay Prasad was positively thrilled about conducting medical experiments on babies and children (clip by Sense Receptor). This is apparently his idea of what constitutes the gold standard vaccine science. If babies and children die or get injured as a result of this experimentation, don’t worry, Prasad will make fun of them and their bereaved families on a live stream with ZDogg or another internet moron, like he did before he was catapulted into the head of CBER at the FDA to be in charge of “gold standard vaccine science”.
x.com/SenseReceptor/…

Now that we are clear about 65+ and “vulnerable” being marked for extermination based on testing “antibodies” to a computer model in 8 mice (wait, scratch that, we don’t want to put the mice in danger! sashalatypova.substack.com/p/you-didnt-wa…) be happy, ungrateful peasants - randomized, placebo-controlled postmarketing studies will be recommended in healthy adults. That has to be a MAHA win! Let’s look more closely:

"Those studies should include people who have previously had Covid-19, and the preferred endpoint will be symptomatic disease “with special attention paid to several secondary endpoints: severe Covid-19, hospitalization, and death.” Sample sizes should demonstrate a reduction in the incidence of the primary endpoint “with a lower confidence interval bound that is ideally above 30%,” meaning the range of likely vaccine efficacy shown in the trial should be no lower than 30%. Manufacturers are also instructed to use a saline placebo."

Need I mention that “vaccine efficacy” of 30% is NO efficacy at all? It is remarkable that the FDA policy does not specify whether the vaccine efficacy will be measured in absolute or relative terms, nor whether the efficacy assessments will include prevention of transmission. Recall that in relative terms Pfizer’s claimed 95% efficacy translated to an absolute risk reduction of less than 1%, largely because covid is not dangerous to anyone. Pfizer also famously claimed that they did not test for prevention of transmission because they were “moving at the speed of science”. It appears that the new FDA, just like the old FDA does not intend to limit that speed.

To summarize this new FDA policy = it is the same as the old one but in red instead of blue:

-The chemical substances amply demonstrated to be harmful and known to promote the illness which they are claimed to prevent are going to be pushed onto duped consumers without any meaningful testing.

-The randomized placebo controlled studies will be only “recommended” in 50-64 yo, and “sponsor-initiated” in other populations. This means they will not be done, period. Nobody in pharma spends money on studying safety, especially in vaccines, without gun to the head. Makary and Prasad will not enforce any of this gold standard science and their paper is very clear about this.

-Covid “vaccines” are still EUA Countermeasures sashalatypova.substack.com/p/memo-re-eua-…, still under the current PREP Act declaration, making them regulation-free and liability-free poison. sashalatypova.substack.com/p/prep-act-bri… The “new” MAHA-FDA policy aims to mask these facts.

People familiar with medical research ethics are asking reasonable questions, such as - how can you do a “post-marketing” study on the population that is NOT eligible for the vaccine which was “approved” based on testing imaginary antibodies to a computer model?

That one is a head scratcher…

Neither Makary nor Prasad, nor anyone at the FDA are burdened by minor issues like recommending KNOWN, DEMONSTRATED harmful, miscarriage, stillbirth and sterility causing substances for pregnant women or conducting medical experiments on children that ONLY carry risk to the subjects while offering no possible benefit. Functioning moral compasses have no place in the Brave New MAHA-FDA that caters to pandemic threats and rapid countermeasures! What we have learned from these past 5 years is that this stance has always been the “public health” policy in the United States. It has been a covert policy, very carefully hidden for decades. However, since 2020 it became visible and now, with this “new” iteration - completely overt.

I hope this reveal from the FDA disabuses all of you from the idea that the ongoing democide via faked pandemics and military response is going to stop under the new administration. MAHA policy includes continued roll out of new versions of the military weapons onto government’s main targets - the elderly, pregnant women and people (and children) that can be labeled “vulnerable”. Please protect yourself and your family and friends by sharing and discussing this information, and defying these policies at every step. Do not cheer for MAHA, do not support them financially, remove your trust completely from these lying monsters. Do not comply.