Vaccine Efficacy Requirements Removed for Children

Well, they've lowered vaccine requirements for children:
COVID Vaccines for Kids Under 6 Won’t Have to Meet 50% Efficacy

The FDA requirements can be found here (direct pdf download from FDA):
Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry, June 2020.
The requirement to be virologically confirmed to have covid is:

To this end, FDA recommends that either the primary endpoint or a secondary endpoint (with or without formal hypothesis testing) be defined as virologically confirmed SARS-CoV-2 infection with one or more of the following symptoms: Fever, chills, Cough, Shortness of breath, Fatigue,  Muscle or body aches, Headache, New loss of taste or smell, Sore throat, Congestion or runny nose,  Nausea or vomiting, Diarrhea

The astute reader will note that simply having a headache constitutes infection.  What a joke, but it gets worse.  To have severe covid, one must simply have any of the following:

respiratory rate ≥ 30 per minute, heart rate ≥ 125 per minute, SpO2 ≤ 93% or PaO2/FiO2 < 300 mm Hg,  Respiratory failure (defined as needing high-flow oxygen, noninvasive ventilation, mechanical ventilation or ECMO), Evidence of shock, Significant acute renal, hepatic, or neurologic dysfunction, Admission to an ICU, Death

The astute reader will note that a diagnosis of severe covid can be the result of simply wearing a mask that reduced their blood oxygen levels below 93%, or because a self-serving doctor or nurse admitted you. 
If these requirements were presented by the people, the government would deem them to be ridiculous conspiracy theories.  It is irrational to conclude that anyone has any kind of illness based on requirements as low as these.

The current requirements for vaccine efficacy:

the primary efficacy endpoint point estimate for a placebo-controlled efficacy trial should be at least 50%, and the statistical success criterion should be that the lower bound of the appropriately alpha-adjusted confidence interval around the primary efficacy endpoint point estimate is >30%...A lower bound ≤30% but >0% may be acceptable as a statistical success criterion for a secondary efficacy endpoint, provided that secondary endpoint hypothesis testing is dependent on success on the primary endpoint.

So, to be "effective", the vaccine must reduce severity in 1%-50% of recipients. That means Tylenol would pass, because it would reduce a headache in at least 1%-50% of covid sufferers. 

Vaccines for children have even lower standards.  The requirements for children were dropped from an already ludicrous standard to nothing. The 50% threshold was thrown out.  They had to though, manufacturers aren't able to meet the basement level standards:
The link in the article points out that 2, that's 2, doses failed to register any immune response at all in infants, but perhaps 3 will do it:

If three doses are successful at triggering a protective immune response, the companies expect to submit the data to regulators in the first half of next year.

Only the Brain Dead Will Do This to Their Children
So, 3 effing shots to combat an in-silico virus that does not affect their age group in any way, and the vaccine isn't required to reduce symptoms at all. 

That's proof positive that it isn't about any virus.  Its about setting up the great reset. 
And, please look up in-silico.  That's what covid is.
In my opinion, it is mindless to take a vaccine with these requirements; better off to wait it out and risk the 99.9% survival.

The vaccines are also color coded for age groups.  Makes you wonder if they are doing different things to different age groups.  After all, if they were to put carbon nanotubes in people for the Internet of Bodies, no need to do it to people they aren't planning on keeping around (eugenics).

a reply to: Wisenox

That article about the experimental third dose for children is so unsure of itself; would be funny if the subject matter and reality of the situation weren't so grave. They want to inject babies with the quackcine based on thoughts, assumptions, and expectations, after an initial failure.
When did the crazies take over?

“I think that a third dose will give a nice boost, and honestly, this is really exciting — as we know from the adult data, three doses is probably better for omicron. And I think it’ll be good to have similar data for children,” Talaat said.

This is a developing story. It will be updated.

Kawsar Talaat, one of the principal investigators of the Pfizer pediatric trial and a physician at Johns Hopkins Bloomberg School of Public Health, said that while the news may be disappointing, a third dose is expected to work well to provide protection, particularly against omicron.

Many parents and pediatricians hoped that if the results had been positive, Pfizer would be in a position to file for regulatory authorization early next year.

(this last quote is an UNREAL conditional, meaning the results have not been positive.

The companies have been testing two shots of a 3-microgram dose in children under 5, a small fraction of the adult dose. Because children’s immune systems are different from adults', smaller doses are expected to trigger equivalent immune protection. The trials were designed to test the safety and efficacy of the lower dose.

The companies reported that two doses of the pediatric vaccine failed in 2-, 3- and 4-year-olds to trigger an immune response comparable to what was generated in teens and older adults. The vaccine did generate an adequate immune response in children 6 months to 2 years old.

If three doses are successful at triggering a protective immune response, the companies expect to submit the data to regulators in the first half of next year.

“It is important to note that this adjustment is not anticipated to meaningfully change our expectations that we would file for emergency use authorization and conditional approvals in the second quarter of 2022,” said Kathrin Jansen, head of vaccine research and development for Pfizer in a call with investors.

We must follow the science!

a reply to: ColeYounger

What a liar. Even after all evidence proved the quackcine didn't prevent infection and transmission, Prez Brandon was still using shaming tactics to coerce people into unwanted medical experiments.

3 mcg dose didn't work, so let's change it to 25 mcg, which is 3x the adult dose per LB of bodyweight. Then let's waive the old efficacy requirements, do zero legitimate testing (maybe there is some old study where some rats died that we can use), then force mandate to babies where ever we can. Seems like a good formula for more profit.

a reply to: Wisenox


You wrote:

"The astute reader will note that simply having a headache constitutes infection."

Actually, the astute reader will note that you are misinterpreting what the FDA wrote. They wrote that the definition be taken as:

"virologically confirmed SARS-CoV-2 infection WITH [my emphasis] one or more of the following symptoms".

Virologically confirmed means "confirmed using the methods of virology". That means some kind of a lab test of biological samples that detects the presence of the virus either directly or indirectly. A diagnosis of infection by this definition requires BOTH detection of the virus in biological samples taken from the individual as well as detection of one or more symptoms of an infection in the individual.

You also wrote:

"The astute reader will note that a diagnosis of severe covid can be the result of simply wearing a mask that reduced their blood oxygen levels below 93%..."

I assume that a diagnosis of severe covid would also require one of the mentioned symptoms together WITH a virologically confirmed detection, but that second link that you gave from 2020 leads to a document that is no longer posted on the FDA website, so that would require further research to verify.

In any case, wearing surgical masks does not result in lowering blood oxygen levels below 93%:

"Study design and methods

With IRB approval and informed consent, we measured heart rate (HR), transcutaneous carbon dioxide (CO2) tension and oxygen levels (SpO2) at the conclusion of six 10-minute phases: sitting quietly and walking briskly without a mask, sitting quietly and walking briskly while wearing a cloth mask, and sitting quietly and walking briskly while wearing a surgical mask. Brisk walking required at least a 10bpm increase in heart rate. Occurrences of hypoxemia (decrease in SpO2 of ≥3% from baseline to a value of ≤94%) and hypercarbia (increase in CO2 tension of ≥5 mmHg from baseline to a value of ≥46 mmHg) in individual subjects were collected. Wilcoxon signed-rank was used for pairwise comparisons among values for the whole cohort (e.g. walking without a mask versus walking with a cloth mask).

Results

Among 50 adult volunteers (median age 33 years; 32% with a co-morbidity), there were no episodes of hypoxemia or hypercarbia (0%; 95% confidence interval 0–1.9%). In paired comparisons, there were no statistically significant differences in either CO2 or SpO2 between baseline measurements without a mask and those while wearing either kind of mask mask, both at rest and after walking briskly for ten minutes."

Excerpted from:

journals.plos.org.../journal.pone.0247414

a reply to: 1947boomer

You're missing the point and focusing on some low hanging fruit from the OP. The error about masks doesn't change much.

The real question is why are they lowering the standards in children's requirements when the mortality for the disease in that demographic is a fraction of 1% and the vaccines have additional known adverse effects on young people?

It's absolute insanity. Children were never at sufficient risk to approve a first of it's kind emergency vaccine. It was contrary to the law and garbage vaccines like these are the exact reason these regulations were created. How we can still be having this discussion with the new revelations from the trial docs is beyond me. These vaccines don't work. It was clearly fraud, but I'd say it's also homicide. Fauci and his comrades have been reaping millions under the table and nobody seems to care. A conflict of interests on some finance committee may be bad. A conflict of interests that financially incentivizes you to look the other while while people die is a whole different ballgame.

People are absolutely brainwashed.

THERE IS NO EMERGENCY.

THERE NEVER WAS AN EMERGENCY FOR CHILDREN WHO HAVE A STATISTICAL ZERO RISK EVEN AGAINST THE WORST VARIANT.

THE VARIANT IS LIKE A COLD VIRUS NOW.

THERE IS NO JUSTIFICATION FOR GETTING EMERGENCY USE AUTHORIZATION FOR CHILDREN.


Unless you want to increase profits and you are fighting to add it to the childhood vaccination schedule which would make the vaccine immune to lawsuits against everyone.

a reply to: v1rtu0s0

They aren't simply brainwashed, they defend their brainwashing with anger. They look at you like you're the crazy one. Its surreal.

a reply to: 1947boomer

Still in the covid cult I see.
Useless but keep pumping the poison into kids until the toxic sludge causes an immune response.
If you think this is medicine,you need your head examined.

Just remember Zos. It was the fairest election before the next one.

The next one will be even more fair!

a reply to: zosimov

Early in in this fiasco we decided as a family to keep far away from the vaccine, at minimum, until more data was available on the long term outcome. Our kids were certainly never guinea pig candidates. Watching what they did with the attempt to shoehorn this into people by exploiting employment requirements seems likely to have been a preview. I wouldn't be the least bit surprised if the next step was mandates in the public school system, just as soon as they force this approval through.

This whole thing has made clear that the best step any of us can take is to get out from under as many of these thumbs as possible as fast as possible. We are preparing to make a lump sum payment on our house to get out from under our mortgage before SHTF completely, and have pulled the kids to home school. A law recently went into effect allowing schools to expel fully remote students who do not appear for in person state testing. We were enrolled remotely with a 6 hour round trip drive to the local school to what? Provide the government numbers for their data collection sheets? This was the last straw for me, and it hit me like a ton of bricks how distasteful it is to have these people calling the shots about our lives. We are officially done with any optional involvement with the system. Their only play here is fooling people into thinking they need their "help" or support in hopes they can leverage that delusion to gain compliance.

a reply to: 1947boomer

That means some kind of a lab test of biological samples that detects the presence of the virus either directly or indirectly. 

You don't read test package inserts do you?

Test result must be evaluated in conjunction with other data available to the physician.
If the differentiation of specific SARS viruses and strains is needed, additional testing, in consultation with state or local public health departments, is required. 
Positive test results do not rule out co-infections with other pathogens.
Positive tests do not differentiate between SARS-CoV-2 and SARS-CoV.
HBV, HCV, HIV, Pneumocystis jirovecii (PJP) and Staphylococcus salivarius are not tested.

Excerpted from the SD Biosensor SARS-CoV-2 Rapid Antigen Test For in vitro diagnostics use only REF 9901-NCOV-01G.

Salivarius is normal oral flora, and they didn't bother to challenge the test with it? 
Is it your opinion that "Test result must be evaluated in conjunction with other data available to the physician" actually means "virologically confirmed"?

I assume that a diagnosis of severe covid would also require one of the mentioned symptoms together WITH a virologically confirmed detection

I assume this falls back to "there are no tests for covid".

so that would require further research to verify.

That will never happen.  Its evident that you make assumptions rather than doing any research.

In any case, wearing surgical masks does not result in lowering blood oxygen levels below 93%:

Yes it can. 

Objectives. This study was undertaken to evaluate whether the surgeons' oxygen saturation of hemoglobin was affected by the surgical mask or not during major operations.

Methods. Repeated measures, longitudinal and prospective observational study was performed on 53 surgeons using a pulse oximeter pre and postoperatively.

Results. Our study revealed a decrease in the oxygen saturation of arterial pulsations (SpO2) and a slight increase in pulse rates compared to preoperative values in all surgeon groups. The decrease was more prominent in the surgeons aged over 35.

Comes with the expected increase in heart rate.  It has to pump more to get enough oxygen circulated.

Excerpted from:
Surgical Mask Deoxygenation



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