uTobian | 11 May 2022
The blitzkrieg culminates with a “Future Framework” that will automatically deem all reformulated Covid-19 shots as “safe and effective” WITHOUT further clinical trials. The FDA must be stopped!
I. FDA goes full Shock & Awe in the attempt to get several toxic shots authorized in quick succession
In a little noticed article in the Washington Post, the FDA revealed that they are going to hold FIVE meetings of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) in June. FIVE! The meetings have not been officially announced on the FDA website yet but the best guess at this point is as follows:
June 7, Novavax in adults
June 8, Moderna in adolescents (delayed for a year because of myocarditis concerns)
June 21, Moderna in kids <6
June 22, Pfizer in kids <5
June 28, “Future Framework” for Covid-19 shots
This is very troubling. It means that the FDA is shifting into Shock & Awe military strategy to try to push through five authorizations in quick succession — so that the public does not have time to think and react. This is not the proper way to do science, it is an attack on democracy, and if they succeed, the FDA will kill and injure millions of American for years to come.
Let’s talk about what we know about each of these shots and then talk about what we can do to stop the FDA from destroying our country.
II. Novavax is terrible and useless
Novavax is a recombinant DNA vaccine. Fellow Substacker Robyn Chuter has done the best deep dive that I’ve seen on Novavax:
a month ago · 22 likes · 41 comments · Robyn Chuter
Robyn reviewed 3 Novavax clinical trials and the results are always terrible:
• No reductions in hospitalizations.
• No reductions in deaths.
• Tiny absolute risk reduction for a couple months (and then, after six months, the control group gets injected too so there is no long term data).
• Significant risk of adverse events in the vaccinated group.
This is not a surprise. The SARS-CoV-2 virus was never a good candidate for a vaccine (in the same way that HIV and the common cold have never had a successful vaccine in spite of decades of efforts). Recombinant DNA is not safer nor more effective than mRNA — it just fails in different ways.
III. Moderna mRNA shots in adolescents and kids are useless and terrible
A few days ago, I did a deep dive into the problems with the Moderna mRNA shot in kids. To summarize briefly:
• The Moderna application to inject adolescents has been held up since June 2021, because the Moderna shot increases the risk of myocarditis.
• Finland, Sweden, Denmark, and Norway have all suspended the use of the Moderna mRNA shot in teenagers because it leads to myocarditis. Finland and Sweden even suspended its use in men under 30 years old.
• We have no data from the Moderna clinical trial in kids younger than 12 other than selective leaks to the NY Times. But we know that even with Moderna rigging the trials, the shot made no difference on clinically significant outcomes including infection, hospitalization, ICU visits, or death.
However the Moderna shot did cause fevers in 15% to 17% of kids and fevers over 104 degrees in 0.2% of kids (which, if you multiply that by the 18 million kids they want to inject = 36,000 kids with potentially permanent neurological injury from a shot that provides no benefit).
IV. Pfizer mRNA shots in kids under 5 are useless and terrible
I’ve done several articles on the dangers of Pfizer mRNA shots in kids under 5. To summarize briefly:
• There is no Covid emergency for children under five years old. The CDC’s own research shows that 74.2% of kids 0-11 already had natural immunity. That was as of February 2022 — by now the number is probably closer to 100%.
• The Pfizer mRNA shot does not work very well in kids. The Pfizer clinical trial in kids 6 months to four years old failed in December 2021 and failed again in February 2022. A study by the NY State Department of Health shows that against the Omicron variant, after one month the Pfizer shot was only 12% effective in kids 5 to 11. After 6 weeks, vaccine effectiveness was a shocking MINUS 41% (vaccinated children were significantly more likely to catch Covid than the unvaccinated).
• The harms from the Pfizer mRNA shot in children are catastrophic. There are now 47,736 VAERS reports of adverse events in children following Covid-19 shots. These reports likely understate harms by a factor of 41 to 100. There are numerous reports of fatalities in children following Covid-19 shots (including reports that mysteriously disappear).
For those who want more details, Michael Palmer, MD; Sucharit Bhakdi, MD; and Wolfgang Wodarg, MD produced a 50 page guide, “On the use of the Pfizer and the Moderna COVID-19 mRNA vaccines in children and adolescents.”
V. The FDA’s proposed “Future Framework” for Covid-19 Vaccines is the worst idea in the history of public health
The “Future Framework” is how the FDA plans to rig the process in perpetuity. The “Future Framework” will take the” “flu strain selection process” that is used every year — and apply it to future (reformulated) Covid-19 shots.
Manufacturers love this because then all future Covid-19 shots will be deemed automatically “safe and effective” WITHOUT FURTHER CLINICAL TRIALS because they are “biologically similar” to existing Covid-19 shots.
This approach does not work with the flu shot (last year the flu shot was somewhere between 0% and 14% effective) and it will not work with Covid-19 shots either.
Moderna is already signaling that they want to manufacture a Covid-19 shot with Wuhan and Beta strains — even though neither strain is still in widespread circulation.
If the “Future Framework” is approved, there will be no future clinical trial data submitted to the FDA in connection with Covid-19 shots in perpetuity.
VI. What is to be done. Talking points.
I imagine we are all tempted to just say/write:
• No Novavax in adults.
• No Moderna in adolescents.
• No Moderna in little kids.
• No Pfizer in little kids.
• No “Future Framework”.
The problem with that approach is that negating a frame reinforces a frame. So the more we just say NO, the more we reinforce the very thing we are trying to stop.
Furthermore, we do not want to leave the bougiecrats in an existential abyss because they are incapable of original thought. So if we just say no, they will not know what to do with themselves and will become panicked and vengeful and start lashing out.
So let’s find a way to reframe and give our country a path out of this valley of misery. My proposed talking points are as follows.
1. The FDA must revoke the existing authorizations for Moderna, Pfizer, and J&J Covid-19 shots and withdraw them from the market immediately. SARS-CoV-2 was never a good candidate for a vaccine. These shots do not stop infection, transmission, hospitalization, nor death. They appear to have negative efficacy and are driving the evolution of variants that evade vaccines. The pandemic will never stop as long as the FDA and CDC are promoting shots that lack sterilizing immunity.
2. The FDA and CDC must pivot to therapeutics. This was always the answer. The CDC’s own research showed that chloroquine is safe and effective for prophylaxis and early treatment of SARS coronaviruses (hydroxychloroquine is even safer than chloroquine). The best frontline doctors have found that ivermectin is a life saver if used early. About twenty off-the-shelf treatments are more effective than vaccines. Get these safe and effective medicines to people who need them and let doctors be doctors again and treat patients based on their own best clinical judgment.
3. Vaccine safety assessments must be based on actual science. That means:
• Large (50,000+ person) double blind randomized controlled trials with inert saline placebos conducted by an independent third party.
• Safety and efficacy studies for two years prior to any application followed by 20 years of follow up (with the control group intact).
• Greater than 90% efficacy with less than 1% Grade 3 Adverse Events.
• Proper monitoring for carcinogenesis, mutagenesis, and impairment of fertility.