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Horowitz: CDC committee shockingly approves yet another RSV shot that had more fatalities in trial group than placebo
The FDA/CDC lack of concern re safety and efficacy we saw with COVID has not gone away and now pervades all new products. Unacceptable for everyone.
The RSV vaccine was the original poster child for negative efficacy of failed vaccines in the 1960s. Now officials want to take your newborn and, on top of the existing list of vaccines plunged into his body, administer a brand-new RSV shot that openly has safety concerns. Josef Mengele is smiling in hell.
What sort of government would rush RSV shots on newborn babies with numerous questions about the clinical trial data, especially after experiencing so much carnage from the rushed COVID shots? A country that values the biomedical security state and pharma grift more than the lives of children.
State of play with RSV shots
Despite Fauci himself warning that RSV shots were not ready for prime time, and despite no rationale to rush an RSV shot at pandemic speed, the FDA has already approved three versions. Officials have approved Pfizer’s shot both for seniors and for pregnant women and have approved GSK’s version for seniors. GSK’s shot for pregnant women was suspended because of safety concerns, but Pfizer’s was approved even though it has the same problems and is very similar.
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. Also, in the Phase 1/2 trial for Pfizer’s RSV shot, among a younger cohort of 18- to 49-year-olds (which has not been approved yet), the trial reports one death among the 164 participants in the group getting 120 micrograms. As for GSK’s senior shot, members of the CDC’s advisory committee raised concerns that it “can overstimulate the immune system, which is why it is only used for the elderly or immunocompromised.” Gee, where have we seen that before? Autoimmune problems from a rushed vaccine?
Committee members also raised concerns about the efficacy and rationale because very few seniors get seriously ill from RSV, and as Dr. Steven Pergam observed, “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.”
So the entire rationale for and safety profile of Pfizer’s and GSK’s RSV senior shots are built on a fallacy.
What about the pregnancy shot? GSK’s shot was pulled from the market after one woman died from acute disseminated encephalomyelitis 22 days after vaccination, which GSK conceded was likely from the shot. Testing also found a 6.8% rate of preterm births in the trial group compared to 4.9% in the placebo group. The rate of neonatal deaths was also double.
But Pfizer, which has more clout in the U.S. than British-based GSK, had its shot for pregnant women approved, even though it is a very similar formulation. As researchers in the British Medical Journal observed, Pfizer reported three out of 116 (2.6%) premature births in the placebo group and six out of 114 (5.3%) in the group that received the vaccine that was chosen as Pfizer’s final product.
Finally, within a few months, the FDA will likely approve Moderna’s mRNA version for seniors, which openly shows 200 adverse events and 10 serious ones per mild case avoided.
Monoclonal 'vaccine' for newborn babies
Which leads us to AstraZeneca and Senofi’s new monoclonal antibody shot, nirsevimab, for newborn babies. Without any understanding of the effect on babies from pregnant mothers already getting Pfizer’s dangerous RSV shot designed for the mother to convey immunity to the babies, the CDC just approved the antibody injection for newborns!
Although monoclonal antibodies have been given to treat an illness after it sets in, this is the first time they are proposed to be administered en masse as a preventive – and to newborns of all people! There have already been documented cases of antibody-resistant mutations forming within the RSV-F protein after prophylactic administration of nirsevimab, something observed in a previous attempt at RSV monoclonal treatments in 2010. Mass vaccination for a respiratory virus has always been associated with creating resistant mutations, as we painfully learned (or didn’t) with COVID.
But why are we even doing this in the first place? As Dr. Meryl Nass points out, although the rationale for fearing RSV in babies is not as unfounded as with seniors, there are about 25 babies who die on average every year from the virus. It is very treatable with a nebulizer. So it would be criminal to rush such a novel antibody, produced in hamster ovary cells, even if there were no problems with the trial.
But right off the bat, the company’s own trial shows more all-cause deaths during a 12-month observational period in the trial group than in the placebo group: 12 babies died in the trial group compared to four in the placebo! According to the FDA, the number of deaths in all the trials put together "exceeds what one would expect with the 2:1 randomization in Trials 03, 04, and 05." Relative to the size of each arm, there was roughly a 50% higher death rate in the trial arm.
Yet the manufacturer and government officials automatically are assuming that every one of them died of natural causes.
Four died from cardiac disease, two died from gastroenteritis, two died from unknown causes but were likely cases of sudden infant death syndrome, one died from a tumor, one died from COVID, one died from a skull fracture, and one died of pneumonia.
Gee, pneumonia, COVID, heart problems, “sudden infant death syndrome,” and “unknown causes,” yet we can conclude without autopsies that none of this is from a respiratory viral vaccine that has been known since the 1960s to result in negative efficacy? Sure, we can rule out the one who died from a skull fracture, but what about the others?
We are now living through a time when the government can continue producing vaccines long after they are conclusively unsafe. This is not even human experimentation. We already know these vaccines are extremely problematic.
Moreover, why is a monoclonal antibody, which is a therapeutic, being treated as a vaccine, even though it cannot stop infection? Well, of course, the companies treat it like a vaccine so they can place it on the child immunization schedule and enjoy the liability shield from all harm! At the same time, they are treating it like a drug in the sense that it will not be on VAERS reporting!
They are also planning to bomb all seniors and pregnant women with a triple whammy this fall – COVID, RSV, and flu shots – with no understanding of how all those pro-inflammatory antibodies interact with each other.
Also, remember that all respiratory viral vaccines are leaky and include waning antibodies. The CDC is sucking people into these dangerous shots on a promise of reduced severity of illness when few people get severely ill. However, even if one believes the manufacturer’s efficacy data, the partial protection likely only lasts for a few months and then, like the COVID shots, makes it more likely you will get the virus – something indicated by the Moderna and Pfizer COVID vaccine trial data for children. So, this will become a regular booster campaign every season.
The reckoning we need
At a minimum, Republicans must push to end the liability shield at least for all vaccines approved in recent years under this warp speed paradigm. Moreover, we must make approval of any of these shots contingent on the following:
No shot can be marketed as a vaccine in any way if it is not proven to stop infection.
No shot can be approved without a full placebo group that is kept permanently to study long-term differences with the trial group.
No shot can be approved unless it shows an all-cause mortality benefit over time and most certainly cannot show more deaths in the trial group.
Warp Speed was not an anomaly. It is a new framework that requires bold new leadership to reset the great reset on bodily autonomy and informed consent. What the RSV vaccine blitz shows us is that a candidate’s position on Warp Speed should be a make-or-break point in earning our support.