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As a subscriber you can listen to articles at work, in the car, or while you work out. Subscribe NowIndiana officials said Wednesday that the state should be able to immediately inoculate a third of children ages 5 to 11 as preparations are made to expand Pfizer’s COVID-19 vaccine for the age group if the federal government gives it approval.
The Indiana Department of Health’s chief medical officer Dr. Lindsay Weaver said the state expects to receive 200,000 additional COVID vaccines intended for the state’s roughly 600,000 5- to 11-year-olds on Monday and Tuesday. Smaller shipments of the vaccine are expected in the following weeks, a process similar to earlier COVID vaccine rollouts, Weaver said.
The announcement came one day after an advisory committee with the U.S. Food and Drug Administration endorsed the children-size doses. The FDA is expected to authorize the shots within days, followed by the Centers for Disease Control and Prevention next week.
“We will be prepped and ready to start giving it as soon as the CDC gives its approval,” Weaver said during a news conference. “Personally, I believe this first round will definitely be enough for everybody who’s been waiting and excited to go get vaccinated.”
Dr. Kristina Box, the state health commissioner, said that state health officials will have “no problem” being able to quickly reorder more vaccines when needed.
The state has more than 1,300 vaccination sites—across Indiana’s 92 counties—that are available for children ages 5 to 11, Weaver said. The state health department also announced Wednesday that it will extend the COVID-19 vaccination and testing clinic being held outside the Indianapolis Motor Speedway until Nov. 20 in anticipation of expanded vaccines for children.
Nearly 7 million vaccine doses have so far been administered in Indiana, and about 57% of those eligible in the state are fully vaccinated, according to state data.
Roughly 300,000 COVID booster shots have been administered throughout the state, Weaver said. That number is expected to grow in the next month.
Republican Gov. Eric Holcomb and the state’s top health officials also encouraged Hoosiers to receive flu shots to prevent a “twindemic.”
Although Indiana has up to 150 deaths from the flu on average each year, the state recorded just seven flu deaths in 2020. Box said that’s attributable to COVID-19 closures and social-distancing protocols put in place a year ago.
“But I think that we’re following fewer mitigation measures now than we were last year,” Box said. “So, I’m very worried about the numbers being up, and I really want to make sure we don’t have an increased burden to our hospitals as we go forward.”
Fifty-one percent of Hoosiers–the most ever recorded–received flu vaccinations last year, Box added. She said the state is hoping to continue that trend in 2021, topping the normal yearly average of 37% to 50% of Hoosiers vaccinated.
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COVID-19 rates in children ages 5 to 11 are so low that there were ZERO cases of severe COVID-19 and ZERO cases of death from COVID in either the treatment (n= 1,518) or control group (n= 750). So any claims you see in the press about the Pfizer vaccine being “90% effective” in children are meaningless because they are referring to mild cases from which children usually recover quickly (and then have robust broad spectrum immunity). So there is literally no emergency in this population for which one could apply for Emergency Use Authorization.
The risk-benefit model created by the FDA only looks at one known harm from the Pfizer mRNA shot — myocarditis. But we know that the real world harms from the Pfizer mRNA shot go well beyond myocarditis and include anaphylaxis, Bell’s Palsy, heart attack, thrombocytopenia/ low platelet, permanent disability, shingles, and Guillain-Barré Syndrome (GBS) to name a few. Cancer, diabetes, endocrine disruption, and autoimmune disorders may show up later. But the FDA does not care about any of that because they have a vaccine to sell so they just ignore all of those factors in their model.
How on earth did the FDA claim any benefits at all from this shot? You should probably sit down for this part because it’s a doozy!
Here’s the key sentence:
Vaccine effectiveness was inferred by immunobridging SARS-CoV-2 50% neutralizing antibody titers (NT50, SARS-CoV-2 mNG microneutralization assay).
Wait, what!? I’ll explain.
There were ZERO cases of severe COVID-19 in the clinical trial of children ages 5 to 11. So Pfizer and the FDA just ignored all of the actual health outcomes (they had to, there is no emergency, so the application is moot). INSTEAD Pfizer switched to looking at antibodies in the blood. In general, antibodies are a poor predictor of immunity. And the antibodies in the blood of these 5 to 11 year old children tell us nothing because again, there were zero cases of severe COVID-19 in this study (none in the treatment group, none in the control group). So Pfizer had to get creative! What they came up with is “immuno-bridging”.
Pfizer looked at the level of antibodies in the bloodwork of another study, this one involving people 16 to 25 years old, figured out the level of antibodies that seems to be protective in that population, then figured out how many kids ages 5 to 11 had similar levels of antibodies in their blood, and then came up with a number for how many cases, hospitalizations, ICU admissions, and deaths would be prevented by this shot in the 5 to 11 population in the future, based on the antibody levels and health outcomes from the 16 to 25 year old population.
The whole ballgame comes down to Table 14 on page 34 of the FDA’s risk-benefit document. And there the red flags come fast and furious.
The FDA model only assesses the benefits of vaccine protection in a 6-month period after completion of two doses. Furthermore it assumes constant vaccine efficacy during that time period.
This is problematic on several counts.
First, reducing mild cases in children is not a desired clinical outcome. Mass vaccination turns kids into shedders of more infectious variants.
Second, we know that vaccine efficacy in the month after the first dose is negative because it suppresses the immune system and it begins to wane after 4 months so all of the FDA’s estimates of vaccine efficacy are inflated.
Third, the harms of myocarditis from these shots will likely unfold over the course of years. Robert Malone, the inventor of mRNA technology notes that the FDA is admitting that children will be injected twice a year forever (hence the six month time frame in the FDA risk-benefit model). But the risks of “adverse events such as cardiomyopathy will be cumulative.” So any model that only looks at a six month time frame is hiding the true adverse event rate.
Pfizer’s application should be dead on arrival if the FDA actually followed the science and their own rules.
Perfect. Trying to subject our children to this is shameful.
JCB, are you vaccinated?
Brent – I work in healthcare and in surgery. Personal healthcare is a private matter. If our country would get back to proper HIPAA compliance, peer reviewed prospective studies, and transparent and honest data, we’d be in a better place.
Should we ask your private health history?
Great summary JCB