Horowitz: Deja vu: FDA committee recommends Pfizer’s RSV shot despite known risks
“Those responsible are without remorse, so there must be a reckoning. Barring that reckoning, we promise you they will make us remorseful later for not holding them accountable now.” ~“Rise of the Fourth Reich: Confronting COVID Fascism with a New Nuremberg Trial, So This Never Happens Again”
Do we have to wait for two years’ worth of death and injury reports from the incoming RSV shots before we begin warning against them? Or have we learned anything from Pfizer and Moderna’s fraudulent trials on COVID?
Last week, the CDC’s Advisory Committee on Immunization Practices met to discuss the future framework of a number of vaccines. Of course, all of them were deemed safe enough to continue, although a number of shocking nuggets of data were revealed with the understanding that the public will never discover this information. According to FDA briefing documents, two people in the Pfizer RSV trial for those over 60 years old experienced the dangerous form of neuropathy known as Guillain-Barré syndrome. The rate was 1 in 9,000, which is bad enough, but we’ve seen from COVID that GBS is a fairly common reaction, and Bell’s palsy, a similar form of neuropathy, has racked up 16,755 entries in VAERS.
This is particularly concerning because in the Phase 1/2 trial for Pfizer’s RSV shot, among a younger cohort of 18- to 49-year-olds, the trial reports one death among the 164 participants in the group getting 120 micrograms (the dose now recommended for seniors). “One participant in the 120-µg RSVpreF group died within 12 months postvaccination 1 due to toxicity to various agents (quetiapine and amlodipine) that was considered not vaccine-related,” reports Pfizer. After everything we experienced with the fraud from the COVID trials, are we really to trust that a disclosed death due to toxicity was somehow confirmed not to be related to the vaccine?
GlaxoSmithKline already had to pause its RSV trial for pregnant women due to safety concerns. According to Pharma Intelligence, one death occurred in the trial, attributed to acute disseminated encephalomyelitis 22 days after vaccination, “considered by both the study investigator and FDA to potentially be related to the vaccine.” Meanwhile, GSK’s shot for elderly people appears to be right on track, even though, as Dr. Meyrl Nass reports, ACIP participants raised questions about the fact that this shot “can overstimulate the immune system, which is why it is only used for the elderly or immunocompromised.” How in the world can anything that “overstimulates” the immune system be approved for anyone of any age after everything we’ve seen with COVID and all of the problems with neuropathies and autoimmune disorders stemming from this overstimulation?
Yet despite all these concerns, and despite just having experienced a tsunami of adverse events from rushed COVID shots, the FDA and CDC are continuing to step on the gas pedal of the “vax at all costs” cultish vehicle to make Josef Mengele great again. On Tuesday, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 7-4 to approve the Pfizer senior shot. Even if you trust the top-line data, the FDA has no specific data on how long protection lasts, how effective the shot is in the immunocompromised, or how it interacts with other common vaccines like the flu shot — or the COVID shots!
Interference with the flu shot was a particular concern to panel chair Hana El Sahly, a microbiology professor at Baylor College of Medicine. “I was left with the idea that there is interference,” she said. “And whether we like it or not, this vaccine is going to be given in the fall around the time of administration of influenza.”
Dr. Marie Griffin of Vanderbilt University Medical Center, another member of the committee who opposed the recommendation, raised concerns that all of the efficacy data was among healthy patients. This shot is likely going to be strongly pushed, if not mandated, on nursing home patients. Are we back to “test on the population first, worry about effects … never”?
Let’s not forget that Fauci recently conceded that RSV shots do not stop the virus and are really not ready for prime time. And as for clinical outcomes, how many healthy 65-year-olds die from RSV to begin with that it’s even possible to measure efficacy (claim to be 85%) on death and critical illness?
“These were very stable patients, very — selected to be healthy, that produce good immune responses but were really not the ones that have the efficacy endpoints that are so necessary for decision making,” observed Dr. Steven Pergam, another member who opposed the recommendation.
It was self-evident throughout Tuesday’s hearing that even those who voted for it remained skeptical, but the precautionary principle of new therapeutics has been thrown out the window. They essentially all agreed we don’t have enough data, there are some red flags, but we’re so excited about the prospect of an RSV vaccine that we will rely on “post-marketing” surveillance programs!
“I felt that I could vote yes at this point, with a heavy lean towards the real requirements of that post-market surveillance study,” said Dr. Adam Berger, a member of the committee who works at the NIH. Dr. Daniel Feikin said that post-marketing safety surveillance will be “critical,” but voted anyway that the shot was both safe and effective.
They are turning the Nuremberg Code on its head! They are determining a vaccine is safe not only without the data but even after the manufacturer’s own unreliable data already shows problems with a genre of vaccine that has never proven safe for over a half-century!
Moreover, it’s as if the COVID shots never happened. To this day, Pfizer has not completed a post-marketing trial on subclinical myocarditis. To this day, officials concede they do not have data on pregnant women, even though the shot is mandated on pregnant women in health care settings and recommended by nearly every gynecologist, despite glaring and blaring safety signals on reproductive health.
At the same time, they rely on post-marketing pharmacovigilance as part of the “jab first, study later” new normal, they continue to ignore VAERS and V-SAFE from the CDC that show a catastrophic level of death and injury. It is shocking how this is happening again in front of our eyes and there is no clamor from Congress to stop this.
It’s quite evident at this point that the only way to stop this dangerous experimentation is to expose the makers to all forms of liability. If Congress refuses to change the laws, it’s incumbent upon the states to bar their respective health departments from promoting or recommending a shot that is exempt from liability. And most certainly, mandates must be outlawed across the board in all settings. Additionally, all states should follow in the footsteps of Florida Governor DeSantis and create their own panel of public health experts to contest the recommendations of the CDC/FDA and potentially have their respective departments of health recommend against the shots.It’s hard to blame the American people for trusting the FDA two years ago during the peak of the pandemic to approve a new shot. Now we know better, as officials continue to engage in dangerous human experimentation before our very eyes. Fool me once, shame on you; fool me twice, shame on me.