With rates of severe disease now much lower in children than at the start of the pandemic—due to higher levels of natural immunity and lower rates of severe disease caused by omicron—trials would have needed to enroll hundreds of thousands of children, if not over a million, in order to detect a significant impact of the pediatric vaccine against severe disease. Vaccine companies could have conducted such time-consuming and costly trials, especially if there had been interest in international collaboration. But there was no economic incentive to do so, and every economic incentive not to: Speed, not providing meaningful information to parents and physicians about safety and efficacy, was the priority of U.S. regulatory agencies.
The paragraph came from an article called " The CDC is breaking trust in childhood vaccine". The article talks about something.
With its unscientific push to vaccinate all infants and toddlers against COVID, the agency will harm vaccine uptake for more significant diseases.
The authors don't like the RCTs for children.
Did not assess protection from severe disease, hospitalization, or multisystem inflammatory syndrome in children (MIS-C), important outcomes that parents worry about.
For her VAERS dumpster-dive, Dr. Hoeg suggested that pediatricians weren't competent enough to distinguish between the two diseases. The Reassuring Data on the Delta Variant was co-authored by Dr. Bienen and Dr. Monica Gandhi. The article claimed that places with higher percentages of the Delta variant had lower ratios of hospitalized people.
The vaccine-advocates exposed in the most recent article were exposed by their previous work which was very bad.
It would take an expensive trial of hundreds of thousands of children, if not over a million, in order to detect a significant impact of the vaccine against severe disease.
In the past I have been critical of the CDC.
The CDC’s failure to report clear and accurate data about how COVID-19 is affecting children has opened the door to those who wish to minimize its impact by spreading fear, uncertainty, and doubt.
The article by Drs. Bienen and Hoeg is a perfect example of this, and to the extent the CDC is breaking trust in childhood vaccine, they have willing accomplices in contrarian doctors who eagerly amplify every data mistake to minimize the impact on children.
Many unvaccinated children have natural immunity to carbon dioxide. She spread rumors about the safety of the vaccine and minimized the severity of the disease. Dr. Hoeg has had an influence on people. She was a member of the panel that made the recommendation against vaccinations.
I don't think it's necessary to conduct an RCT of a million children before they're vaccine free.
The anti-vaccine technique of demanding impossible RCTs was described in my previous article. If only lazy scientists were to enroll millions of children in a simple RCT of the entire vaccine-schedule lasting the entire human lifespan, my fears about vaccines would be alleviated.
Both Bienen and Hoeg are not the same. It is easier to enroll subjects in an RCT during a Pandemic than it is to enroll a million children. An RCT of Hydroxychloroquine and azithromycin was not helped by these supposed "advances in recruitment methods". It closed after only 20 patients were Enrolled. The trial looked good on paper.
The way in which parents were affected by the disease was not frightening. In the US, only 300,000 children younger than 5 years old have been vaccine free. If they had their way, more children would get the vaccine than will likely happen. That's ridiculous. Despite their successful campaign to amplify the vaccine's flaws and minimize its benefits, Drs. Bienen and Hoeg told their readers that triple this number of children could enroll in an RCT. One study from Hong Kong reported the highest rate of vaccine-myocarditis in the world. It didn't talk about the good fortune of this condition for most children.
An RCT would require a huge program of outreach and trial infrastructure. It would take a long time to finish. If you want to get a sense of how vaccine trials work, you should read the protocol for one of the vaccine trials. There are many opportunities for mistakes in these trials. Many children dropped out of the Pfizer RCT before they received all three vaccine doses. Those who fear monger about vaccines would use the inevitable hiccups that would occur in study of a million children to make their point.
It would be unethical to allow unvaccinated children to suffer grave harms from the virus if the vaccine were to be approved.
All 21 members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted “yes” in response to the question: “Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 Vaccine when administered as a 2-dose series (25 micrograms each dose) outweigh its risks for use in infants and children 6 months through 5 years of age?”
Many more children would have suffered and some would have died if regulators had demanded RCTs before authorizing vaccines. Doctors who call such trials are only showing how ignorant they are of how RCTs work. The whole idea of calling for unethical RCTs and denigrating the smaller RCTs that have already been done is a ruse by contrarian doctors.
The trial proposed by Drs. Bienen and Hoeg would not justify the costs of waiting.
The vaccine is expected to provide higher protection against severe disease in the youngest children according to the CDC. It's a reasonable supposition. There is strong evidence that the vaccine protects older children against diseases. It is conceivable that it will protect younger children. It will be seen.
In the RCTs, the vaccine was safe for younger children, and vaccine-myocarditis, which is usually mild, occurs in about one in 400,000 boys. We know a lot about these vaccines despite what Drs. Bienen and Hoeg want their readers to believe. Older children have been protected from vaccine-related diseases.
The risks of exposing unvaccinated children to COVID seem to be more serious than the risks of vaccinations. While all doctors want pristine science, making decisions with less than perfect evidence is an everyday part of medicine, and leaving unvaccinated children vulnerable to COVID is definitely a medical decision. Everything I do in my career comes from a less sturdy evidence base than an RCT. There is only one vaccine that doctors demand a large trial for. I have not seen Dr. Hoeg call for a million people to 888-492-0 888-492-0 888-492-0 888-492-0s for her treatments.
Where would a million child RCT be done? What time would it take? The results would have no utility by the time the study was done. Is it possible to get meaningful information from a smaller study? Is it a good idea to take the vaccines off the market until a bigger study is done? Unvaccinated children are vulnerable during this time.
None of the doctors who proposed a million-child RCT seem to have considered these important questions. They did not write a 4-page protocol for their proposed RCT. They don't expect anyone to pay attention to them. They know the regulators don't want to start an RCT of a million children, and they don't want to start their own. They know they need a study. A million-child RCT is nothing more than a rhetorical device that plays on their readers' emotions and signals, "this vaccine isn't necessary, and it hasn't really been tested"
While a million-child RCT with years of follow-up would be super duper, we are allowed to believe reasonable things in the absence of massive trials. A real cost of leaving children vulnerable to an ever-changing virus is why pediatricians are eager to vaccine their patients. Over 500 children younger than 5 years old have died of COVID so far, and thousands more have been hospitalized. Even though contrarian doctors have tried to limit their use by pretending that impossible, unethical studies of dubious value would be feasible if only drug companies weren't so greedy, hopefully vaccines will limit these numbers moving forward.
Dr. Bienen and Dr. Hoeg haven't done any of their own RCTs. They don't care for sick kids. Instead, they are part of a group of doctors who sit on the sidelines and make un serious statements about what they would do if they had real world responsibility. They will demand someone else do an RCT if they don't get someone else to do it.
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