Guest Post by Alex Berenson
This question is not rhetorical. A new treatment to lower harm from a minor respiratory virus in infants instead is associated with MORE baby deaths, clinical trials show. Yet no one seems to care.
Two years after Covid jabs turned into the world’s best-selling pharmaceutical product, Big Pharma is chasing billions from new products for another airborne illness: respiratory syncytial virus, or RSV.
Two European drug companies, AstraZeneca and Sanofi, want the Food and Drug Administration to approve a costly new treatment called nirsevimab for RSV for kids under age 1.
The FDA looks ready to go along. There’s just one catch.
The companies’ own trials show far more deaths in infants who received nirsevimab than those who got either placebo or a competing older treatment.
In the most important trial, of healthy near-full-term and full-term infants, three out of 994 infants given nirsevimab died within a year. None of the 496 infants who received a placebo shot died.
In all, 12 infants treated with nirsevimab died in the trials, compared to four who were treated with an older antibody or a placebo. Even accounting for the fact that more infants received nirsevimab than placebo or the older antibody, infants given nirsevimab had a nearly 50 percent higher risk of death.
But the deaths did not bother an FDA’s advisory committee on antimicrobial drugs, which unanimously supported the nirsevimab application earlier this month.
The FDA reviewers who examined the companies’ application also downplayed the deaths. They noted that eight of the 12 deaths “were clearly unrelated to study drug” and related the death rate to the global infant mortality rate.
That comparison is so irrelevant as to be misleading. The point of clinical trials is to provide two balanced arms for comparison so that scientists don’t need to guess what reasonable background rates might be.
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(Previously healthy, found dead in crib)
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The imbalance in deaths is particularly troubling because the safety standards for nirsevimab’s approval should be even higher than for most drugs, and not just because it will be given to infants.
Like the mRNA Covid jabs, nirsevimab falls in the grey area between a vaccine and a traditional drug – and its corporate developers hope it will be given to “all infants,” including healthy children, like a vaccine.
Nirsevimab consists of antibodies that attack RSV in much the same way that the body’s natural immune defenses do, preventing the virus from latching to cells.
But the antibodies aren’t given after an infant has been infected, as anti-viral drugs usually are. Instead they are injected in the fall, for protection through the winter, when most RSV cases occur.
Thus, like a vaccine, nirsevimab is offered before infection, in advance of illness. But unlike traditional vaccines, nirsevimab is not meant to stop (nearly) all infections. Instead – like the mRNA Covid shots – the antibodies are supposed to lessen RSV’s severity, saving infants from needing a doctor’s visit or hospitalization.
Sanofi refers nirsevimab as an immunization. But in reality might best be called a “preventative therapeutic” – an awkward name for an awkward category of drug.
Further, RSV is generally mild illness for most healthy infants. In the pivotal clinical trial of healthy infants, only two infants required intensive care for RSV – including one who had received nirsevimab. Most infants who required medical care were treated as outpatients.
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For infants with chronic conditions, RSV can be more dangerous. But an antibody treatment for those kids already exists. And when AstraZeneca and Sanofi tested nirsevimab against that older treatment in a separate trial for infants at high risk from RSV, the results were even more concerning.
Five of 614 infants given nirsevimab died. Just one out of 304 who got an older treatment did. And nirsevimab’s overall side effect profile looked even worse compared to the older treatment after a second year of dosing. Almost 10 percent of infants who received two years of nirsevimab suffered a serious side effect in the second year – none of the infants who received the older drug did.
In other words, for the kids most at risk, nirsevimab appears less safe than the older drug.
And the companies will likely charge a high price for the treatment, maybe as much as $500-600 per child in the United States, or in the range of $2 billion annually if they succeed in their quest to give nirsevimab to “all infants.”
Even assuming that nirsevimab prevents some hospitalizations, its widespread use would “add marginal effectiveness at very high cost in the general population,” a Michigan professor warned the Centers for Disease Control last week.
But even putting cost aside, anyone looking at the data has to wonder why regulators appear so eager to approve a drug that has at best marginal benefit in the face of serious red flags. Deaths are the ultimate yardstick for whether a drug aimed at healthy people – much less healthy infants – is working as promised.
By that yardstick nirsevimab has failed. That fact alone suggests that regulators should take a very cautious attitude toward its approval – possibly by insisting on another large trial that would focus primarily on safety.
But once again, they seem to have forgotten that their first duty is to protect the public, not Big Pharma’s ability to sell new medicines.
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Profit and depop.
Duh.
‘Unconscionable’: Pfizer, Moderna to Rake in Combined $93 Billion in 2022 COVID Vaccine Sales
A report by health data analytics group, Airfinity, projects “unprecedented” sales and profits for Pfizer and Moderna in 2022. According to the People’s Vaccine Alliance, the companies are pricing their vaccines by as much as $41 billion above the estimated cost of production.
MORE:
https://www.lewrockwell.com/?s=pharma+93+billion
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At this point the topic of drugwhy has become one of the standard stories of our time. It used to be Man Vrs Man and Man vrs Nature and Man vrs Himself but now we have another topic to add.
Man vrs Logic.
Like the term ” you can not fight the math ” Man vrs Logic embraces the math. You have a itchy skin rash? Here take this shit. The math says .02% percent of those who take this pill will die a painfull lingering death. How many do you want today?
Like I and many others have said time and time again. The fact that pharma can even advertise these concoctions with horible effects on the body shows a growing disconnect between what you know is good for you and what you want. People can now be trusted to make choices about technology that are not reversable? I thought we could not be trusted with guns but now I can buy a drug that can geneticly alter the DNA of myself and all my decendants?
What could go wrong………
The biggest casualty of all, in my opinion, is the loss of trust in institutions, and in the people that we thought we could trust. It is not possible for the individual to double check in every single instance as they live their lives whether guidelines or rules are followed, which we thought were established and upheld to maintain a life in which we are relatively safe from harm or homicide. If you want to fly, you have to trust that the engines have been serviced and maintained to a minimum standard. You cannot walk around and double check that, personally.
Now, we here already know that that was not happening, but many people have not understood that and fail to put 2 and 2 together, to this day. Physicians, who are the last line of defense against those that want to harm us medically (pharmaceuticals etc.) and the medical boards that certify physicians let us down, collectively and individually. We must now stop to fly, because we don’t know if the plane is safe. We must now stop to see most physicians, certainly those employed at hospitals, because we don’t know if the hospital is a safe place or of the physician is “in on it” or one of the protectors of health. For at least a few years from now, we are on our own. I believe that some day there will be a better system built, but the old one has to be fully dismantled first. It will take decades to rebuild, and probably yet more decades to rebuild trust.
Where will this lead? I don’t know, but I do know that there will be a time that a critical number of people will realize these truths and will take their collective heads ouf of the sand. It will not be subtle when that happens, but rather a tsunami of some sort will be unleashed. I don’t know if it will be channeled to build a new system peacefully or if it will be a tsunami of anger.
The matter was not trivial. If the QA of the chair you just bought was sloppy and as a result one of its legs broke off, that’s one thing. If the QA of the airplane landing gear was sloppy, you might get lucky and have a semi crash landing at CLT without casualties. You could also end up with a catastrophic outcome. In this case, the QA of the entire healthcare system was sloppy (as Ed Dowd says, a combination of regulatory fraud, pharmaceutical fraud, media fraud and healthcare fraud), the results are just about as catastrophic as they can be, with numbers that stagger the mind. People don’t lose their mind over a broken chair. They do lose it over a loss of a granddaughter or the turbo cancer of their spouse of 53 years or the infertility of their son.
But first, we have to wait. Wait for a painfully long amount of time for people to face what’s in front of them.
Yes. But,
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After 50+ years of watching people do mental gymnastics to lie to themselves about just about everything, I have my doubts. Strong ones.
One problem is that few women are as logic-based as you, and they always vote for “safety” – in the form of institutional power – however illusory that may be. Institutions are amplifiers for the ambitious sociopaths among humanity; sheeps’ clothing for wolves.
Man or woman, I see little difference now.
I would suggest there are very few actual men or women now, just lots of boys and girls in adult bodies. Infantilized and willfully ignorant.
Yes, now . . . largely as a result of what I wrote above you. Time was when the sex roles were well-defined. One that was interrupted by feminism and progressivism, we got what we have.
If I’m reading this right, it appears that someone murdered three innocent babies just to satisfy their own greed and curiosity.
I’m certain I know exactly how to feel about THAT.
Anything to keep the depopulation juggernaut chugging along.
Vote Kennedy
Abolish the state.
Giant Meteor 2024
Lets just end it already.
Relax, the neocons are working on it.
I noticed many years ago when my oldest had just started school that the more vaccines other families took the more sickly their children were. I’d hear the moms talking about taking the entire family for flu shots but in the coming winter their kids would be the ones with constantly runny noses or out with bronchitis.
We have always avoided the medical-industrial complex as much as possible very rarely even have colds. My kids never get the optional vaccines no matter how great they make them sound.
From the Rappoport series on aborted infant anaesthesia-free vivsection for medical research:
https://blog.nomorefakenews.com/tag/medical-infanticide/
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Referenced in the above article:
More from the above author, AnnaMaria Cardinalli:
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. . . and testimony from those who have left it.
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Big pHARMa is unmitigated evil.
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MORE:
https://blog.nomorefakenews.com/tag/medical-infanticide/
That just means it’s working! I have no more sympathy for morons.
If the doctors don’t give these dangerous drugs to US … then there’s no worry … and they will wither and die on the corporate vine.
IF …
As long as it doesn’t adversely affect profits, any excess Nirsevimab infant deaths would NOT a problem
It truly astonishes me that anyone would put their infant in these clinical trials. For what? Some extra cash? Just don’t fucking get it.
The point is the behavior addiction of those approved for the mark.
https://www.drrobertyoung.com/post/there-is-no-evidence-of-the-existence-for-any-virus-isolated-by-anyone-anywhere-in-the-world-1?
https://www.drrobertyoung.com/post/there-is-no-evidence-of-the-existence-for-any-virus-isolated-by-anyone-anywhere-in-the-world-1?