Kids and Vaccines: After FDA’s Emergency Authorization, a Look at the Evidence

11 months ago 125

News Analysis

To work the headlines, you’d deliberation the verdict was in.

On Oct. 26, the Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee recommended the support of Pfizer-BioNTech’s RNA COVID-19 vaccine for children 5-11, nether an Emergency Use Authorization (EUA).

On Oct. 29, the FDA issued an exigency authorization based connected the committee’s recommendation.

Still, a fewer tiny steps stay earlier vaccines scope a kindergarten adjacent you.

A Centers for Disease Control and Prevention (CDC) advisory sheet needs to transportation retired their ain ballot connected giving kids the vaccine for COVID-19, the illness caused by the Chinese Communist Party (CCP) virus.

CDC Director Rochelle Walensky volition past connection her ain proposal aft evaluating that panel’s finding.

Assuming these decisions spell Pfizer’s way, the way would beryllium wide for the wide vaccination of young children passim the United States.

The Biden medication seems assured that the pharmaceutical elephantine volition triumph: connected Oct. 20, they released their Fact Sheet connected their prospective rollout of the drug, stating that “the Administration has procured capable vaccine to enactment vaccination for the country’s 28 cardinal children ages 5-11 years old.”

On Oct. 28, Pfizer announced that it had sold 50 cardinal doses of its pediatric vaccine, deliverable by April 2022, to the U.S. government.

“Our readying efforts mean that we volition beryllium acceptable to statesman getting shots successful arms successful the days pursuing a last CDC recommendation,” the Biden administration’s Fact Sheet stated.

The FDA advisory committee’s proposal was, we were assured, wholly scientific—after debating the evidence, including immoderate results from an ongoing objective trial of the Pfizer-BioNTech vaccine, panelists voted 17-0, with 1 abstention, to corroborate that the benefits of two-course vaccination outweigh the risks successful children 5 done 11.

Yet a fewer memorable sour notes marred that day’s presentations.

In 1 wide circulated comment, panelist Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine, said information information are inactive lacking—but “that’s conscionable the mode it goes.”

“We’re ne'er going to larn astir however harmless the vaccine is unless we commencement giving it,” said Rubin earlier adding that cognition astir uncommon vaccine complications was acquired the aforesaid mode successful the past.

In an email to The Epoch Times, Rubin defended his comments, writing, “The objective proceedings of the Pfizer-BioNTech COVID-19 vaccine successful children showed nary adverse events. All information to day bespeak that it is safe. It volition forestall the hospitalization of children with terrible disease, arsenic it does with adults. The vaccine works, and saves lives.”

Concerns with semipermanent information information partially motivated the panel’s one abstention, from Dr. Michael Kurilla of the National Institutes of Health.

Let’s chopped done the noise: what precisely is the lawsuit for vaccinating young children—and what’s the lawsuit against it?

Risks From COVID-19 for Young Children

The risks of decease and superior unwellness from COVID-19 among young children are 1 cardinal constituent of contention.

The FDA’s ain briefing modeled scenarios for comparative risks of superior unwellness oregon decease from COVID-19 and superior unwellness oregon decease from conscionable 1 imaginable risk—namely, bosom inflammation.

Relying connected real-world information from individuals 20 years of property oregon older during the Delta wave, they assumed that the vaccine was 70 percent effectual against COVID-19 and 80 percent effectual against hospitalization.

In its briefing to the FDA, Pfizer stated that COVID-19 was among the apical 10 causes of decease successful children aged 5 to 14 betwixt January and May 2021, referencing an analysis from the Kaiser Family Foundation.

The CDC has noted that implicit 94 percent of COVID-19 deaths included different comorbidities, with an mean of “4 further conditions oregon causes per death.”

Citing a Research Letter that analyzed CDC data, Pfizer’s FDA briefing counted 1.8 cardinal cases and 143 deaths related to COVID-19 done Oct. 14, 2021, and  8,622 hospitalizations done Sept. 18, 2021, successful children ages 5 done 11—reflecting a vanishingly debased hazard of superior unwellness oregon decease successful that population.

Notably, portion the briefing did not specify however galore of the children who died had superior comorbidities, astir two-thirds of those hospitalized had 1 oregon much underlying comorbidity.

Researchers person consistently recovered that the dangers of COVID-19 to young children are precise low.

A Nature survey estimating the COVID-19 corruption fatality complaint (IFR), oregon the proportionality of those who dice from infection, recovered an IFR of conscionable 0.001 percent successful children aged 5 to 9—less than 1 successful 100,000.

Risks From the Vaccine

While Rubin told The Epoch Times the objective proceedings information did not place immoderate adverse events successful children ages 5-11, the FDA’s own briefing document from Pfizer elaborate a few, including 13 cases of lymphadenopathy, oregon lymph node swelling.

Notably, the proceedings did not observe immoderate bosom inflammation, a concern for young radical receiving the vaccine.

However, Pfizer’s FDA briefing papers stated that “the fig of participants successful the existent objective improvement programme is excessively tiny to observe immoderate imaginable risks of myocarditis [heart inflammation] associated with vaccination.”

Some physicians person spoken successful favour of administering the vaccines, adjacent to their ain young children.

“I americium a committee certified immunologist. My woman is simply a pediatric ER physician. I’ve followed #COVID vaccine information successful teens & adults, work Pfizer safety/efficacy information successful 5-11 twelvemonth olds & listened to FDA discussion. We volition vaccinate our 8 & 11 twelvemonth aged children w assurance & gratitude,” wrote Dr. David Stukus, a prof of Clinical Pediatrics astatine Nationwide Children’s Hospital connected Twitter.

Dr. Leana Wen, a CNN aesculapian expert and erstwhile president of Planned Parenthood, argued successful The Washington Post that young children “need vaccines.”

Others person expressed misgivings, based successful ample portion connected what they spot arsenic insufficient information data.

“I don’t deliberation children should beryllium vaccinated for COVID. I’m a immense instrumentality of vaccinating children for measles, for mumps, for polio, for rotavirus, and galore different diseases, that’s critical. But COVID is not a immense menace to children,” said Dr. Martin Kulldorff, a Harvard University Professor of Medicine, successful an interview with Jan Jekielek connected EpochTV’s “American Thought Leaders” program.

“It’s not astatine each wide that the benefits outweigh the risks for children,” Kulldorff aboriginal added.

Rep. Andy Harris (R-Md.), a aesculapian doc who erstwhile served arsenic main of obstetric anesthesiology astatine the Johns Hopkins Hospital, voiced akin concerns to NTD astir vaccine mandates

“Well, we surely don’t cognize what the semipermanent consequences of the vaccine are, due to the fact that it’s lone been a substance of months since children person gotten this vaccine, due to the fact that of course, the aboriginal studies done present astir a twelvemonth and a fractional ago, were done lone successful adults,” Harris said. “We bash cognize that astir children who are not peculiarly precocious risk, that the hazard of COVID is really not that high.”

Slowing the Spread?

Given the debased rates of superior unwellness and decease among children, a peculiarly cardinal justification for vaccinating them is reducing the complaint of assemblage transmission.

Children, Pfizer’s FDA briefing claimed, are “important reservoirs of SARS-CoV-2 transmission and whitethorn go a superior operator of the pandemic successful the adjacent future.”

Yet researchers person mostly not identified children—particularly young children—as cardinal sources of assemblage transmission.

One observational study successful the Journal of the American Medical Association suggests that children up to the property of 9 attending schoolhouse were not large contributors to COVID-19 spread, though the study’s findings connected teenagers were much equivocal.

A 2020 meta-analysis, oregon investigation of aggregate studies, connected COVID-19 susceptibility among young children and adolescents concluded that susceptibility was little successful those groups than successful adults and offered “weak evidence” that they play a lesser relation successful population-level transmission.

More recently, a 2021 meta-analysis connected COVID-19 transmission clusters concluded that children infected successful schoolhouse “are improbable to dispersed SARS-CoV-2 [COVID-19] to their cohabiting household members.”

The FDA seems to concede that preadolescent children are not super-spreaders successful its briefing, noting that successful schools, “transmission betwixt schoolhouse unit members whitethorn beryllium much communal than transmission involving students” and that “there is grounds that SARS-CoV-2 transmission is greater successful secondary and precocious schools than simple schools.”

What’s more, successful the weeks since U.S. schools resumed in-person instruction, galore for the archetypal clip since the pandemic began, hospitalizations of children with COVID-19 person not risen, arsenic 1 mightiness expect if children are large drivers of transmission.

In actuality, hospitalizations person rapidly fallen according to Department of Health and Human Services data, and arsenic reported by Bloomberg.

Should it continue, this inclination would marque it adjacent harder to warrant vaccination of children 5-11 according to the FDA’s ain risk-benefit assessments, astir of which are predicated connected the COVID-19 incidence and hospitalization rates successful aboriginal September astatine oregon adjacent the highest of the Delta variant surge.

Additionally, new research suggests that vaccinated individuals person the aforesaid likelihood of spreading the COVID-19 Delta variant wrong their households arsenic unvaccinated individuals, raising further questions astir the effectiveness of vaccinating children if slowing the dispersed is simply a cardinal aim.

With these facts successful mind, it seems hard to authorities conclusively that vaccinating young children would marque overmuch of a quality astatine each erstwhile it comes to COVID-19 transmission.

So Why Vaccinate Kids?

The existent propulsion for wide vaccination of our children seems to person multiple, often overlapping motivations—some much understandable than others.

For many, genuine interest astir illness, hospitalization, and decease successful young COVID-19 patients is nary uncertainty the predominant factor—particularly aft months of media sum connected the dangers of coronavirus, starring viewers of outlets specified arsenic CNN and MSNBC to person a less close understanding of the COVID-19 decease complaint than viewers of much blimpish outlets specified arsenic Fox News and OANN, according to a canvass by Rasmussen. And galore precise good informed individuals, specified arsenic the doctors quoted above, mean connected vaccinating their children.

At the aforesaid time, it’s hard to disregard Big Pharma’s large wealth and influence.

As mentioned above, the Biden medication has already purchased 50 cardinal of Pfizer’s pediatric doses, which are 1 3rd the size of the company’s big dose.

According to Endpoints, “the outgo of these 50 cardinal doses was not initially made available, though the outgo of the Pfizer vaccines has steadily risen for the US,” hitting $24 a dose successful July 2021 versus astir $19.50 per dose successful July 2020.

Open Secrets reports that Pfizer unsocial was the 25th largest lobbyist successful the United States successful 2020, spending implicit $10.8 cardinal that twelvemonth alone. (That’s successful summation to the $381,930 Pfizer-affiliated individuals donated to Joe Biden’s statesmanlike campaign, the $119,768 specified individuals donated to Donald Trump’s campaign, and the $47,869 specified individuals donated to Bernie Sanders’ campaign, among galore different governmental donations.)

Yet Pfizer’s lobbying inactive falls abbreviated of the Big Pharma commercialized radical Pharmaceutical Research & Manufacturers of America. That enactment was the 3rd largest lobbying radical successful the United States successful 2020, spending $25,946,000 according to Open Secrets.

Patrick Howley of National File has reported that galore voters connected the FDA’s advisory committee person nonstop Pfizer ties. Gregg Sylvester, for example, was antecedently the vice president for Pfizer vaccines.

Other motivations look to spell beyond the purely aesculapian and financial.

For the globe-trotting, technocratic people James Burnham identified arsenic the “managerial elite,” power whitethorn beryllium an extremity successful itself, with compliance a indispensable means to that end.

Thus, successful New York City and galore different jurisdictions, the vaccine passports that radical property 12 and older (though soon, perhaps, 5 and up) request to entree indoor restaurants, gyms, and different spaces bash not admit earthy immunity arsenic an alternative to vaccination—a argumentation astatine likelihood with however the CDC, the Army, and different entities person approached immunity successful the past.

In Israel, meanwhile, individuals who person received “green passes” done vaccination are losing them six months aft their vaccine’s 2nd dose, necessitating a booster changeable to clasp entree to galore indoor venues. While this argumentation whitethorn originate partially retired of doubts astir the effectiveness of the vaccine, the thrust for compliance doesn’t halt there. Those who person recovered from COVID-19, and tin truthful beryllium expected to person earthy immunity, are now being required to person 1 dose of vaccine to support their greenish passes.

Authorities determination person not yet stated whether radical volition request much boosters successful the aboriginal to clasp state of movement.

Enthusiasts for globalism talk of the request to “build backmost better,” which means, successful part, moving toward a satellite without borders, whether betwixt nations oregon betwixt our bodies and a corporatist state. Perhaps this tone informed Central Bank President Christine Lagarde successful saying that “the full world” needs to beryllium vaccinated, lest COVID-19 “come backmost to haunt us.”

In this world, small children whitethorn not beryllium exempt.

Nathan Worcester

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Nathan Worcester is an biology newsman astatine The Epoch Times.

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