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FDA Panel Approves Pfizer’s COVID-19 Vaccine for Children Age 5-11

FDA Panel Approves Pfizer’s COVID-19 Vaccine for Children Age 5-11

Centers for Disease Control and Prevention panel will meet next week to discuss official recommendation.

https://www.youtube.com/watch?v=Hbg2Vi4xNwE

Food and Drug Administration (FDA) officials have approved Pfizer’s COVID-19 vaccine for children ages 5 to 11.

The Vaccines and Related Biological Products Advisory Committee convened Tuesday morning to hear presentations for several hours before it held the vote. The FDA will consider the recommendation before deciding whether to grant emergency authorization for smaller doses vaccine for children in the younger age range.

Last week, the pharma company said that the doses were better than 90% effective in children 5-11.

To date, fewer than 100 children between 5 and 11 have died from COVID-19 and 8,300 have been hospitalized, said Dr. Peter Marks, who heads the FDA vaccines division, according to The New York Times.

The next phase in this approval process comes next week. The Centers for Disease Control and Prevention (CDC) will then decide whether to recommend the shots and which youngsters should get them.

While children are at lower risk of severe COVID-19 than older people, 5- to 11-year-olds still have faced substantial illness — including over 8,300 hospitalizations reported, about a third requiring intensive care, and nearly 100 deaths.

The dose for young children is just one-third of the Pfizer shot already recommended for everyone 12 and older. Moderna also is studying its vaccine for young children.

One big concern related to the vaccine in children are reports of myocarditis (inflammation of heart tissue) in young men. The panelist indicated the smaller dose would mean such an occurrence would be unlikely.

“We’ve identified a lower dose which we expect is going to decrease the frequency of the rare side effect of myocarditos,” said Dr. Arnold Monto, chairman of the committee an a professor of epidemiology at the University of Michigan.

“I am just worried that if we say yes, then the states are going to mandate administration of this vaccine for children to go to school and I do not agree with that,” said Dr. Cody Meissner, a professor of pediatrics at Tufts University School of Medicine. “I think that would be an error at this time.”

But Dr. Peter Marks, who heads the FDA’s vaccine arm, the Center for Biologics Evaluation and Research, said that was unlikely.

Just to reassure the committee, because we are taking an emergency use authorization rather than an approval, in general, although it’s possible that mandates could be put in place, I suppose, in general people have not done mandates with emergency use authorizations and there are certain governors who have already announced that they would not do a mandate until there was an approval as opposed to an emergency use authorization,” Marks said after the vote.

It must be noted that studies in the already-vaccinated show the Pfizer vaccine efficacy decline substantially over time.

A study published on Monday in The Lancet medical journal found that the efficacy of the Pfizer-BioNTech COVID-19 vaccine fell below 50 percent after about six months after the second dose.

The Pfizer-funded study found that Pfizer’s vaccine was 88 percent effective in the first month after full vaccination but dropped to 47 percent effectiveness at about six months. The vaccine was also found to be highly effective against the delta variant, which was found to be over 90 percent effective in the first months before dropping to 53 percent effectiveness after four months.

I suspect the same would be true for the kids’ shots as well.

I sure hope, for the sake of the children, the vaccine is as safe as our “experts” are claiming.

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Comments

Hmmm

Did they ‘approve’ it, or did they issue another EUA?

I am sick and tired of the deception games.

    MattMusson in reply to Exiliado. | October 27, 2021 at 7:58 am

    Remember that Pharma companies asked for Emergency Authorization only so they have no legal liability.

      20keto20 in reply to MattMusson. | October 27, 2021 at 2:22 pm

      Which means how can any president, governor or school board REQUIRE an experimental drug? These people have lost what little sanity they every had!!
      Any adverse reaction should result in an immediate lawsuit. The proof would come in the continuation of the lawsuit or the dismissal on the grounds of limited government liability for an EMERGENCY USE AUTHORIZATION and thus have no legal grounds to require anyone to take it!
      Notice, Joe isn’t mandating it himself. He is deflecting to OSHA, who has not taken any action, and pressuring employers to be the BAD GUY in all of this. The truly egregious part of the entire fiasco is MANDATING young children to take an experimental, genetic altering, potentially cancer-causing drug with no hope of ever being paid for medical treatment, serious injury or death. The devil truly does live at 1600 Penn Ave now! And that pervert needs to give up saying God protect our troops unless he is begging God to protect the troops from an idiot in the White House!!

    Lucifer Morningstar in reply to Exiliado. | October 27, 2021 at 8:17 am

    .

    The FDA will consider the recommendation before deciding whether to grant emergency authorization for smaller doses vaccine for children in the younger age range.

    Statement from the UPI article. So I”m going to assume they are simply going to add another use statement to the EUA authorizing its use in young children and not issue an actual approval for the use.

    https://www.upi.com/Top_News/US/2021/10/26/fda-pfizer-covid-vaccine-children-5-11/2201635256166/

    CommoChief in reply to Exiliado. | October 27, 2021 at 10:53 am

    Exactly! The framing of the decision by MSM is deceptive.
    None of the vaccines available in the US are approved. All of them are authorized under emergency use authorization.

    Pharma has a liability protection but no one else does. Not employers and not cheerleaders who interchange authorized and approved as if they are not legally distinct.

      20keto20 in reply to CommoChief. | October 27, 2021 at 2:25 pm

      Every thing this administration does is based on word salad. Garland today never had a straight answer for a single question. Garland is to Biden what Holder was to Obama. Holder killed American citizens. Is Garland planning on the same?
      Speaking of Holder, isn’t he the one who set the precedent for ignoring Congressional subpoenas?

Ghouls.

2smartforlibs | October 27, 2021 at 7:34 am

Yesterday everyone was worried about beagles. This WWII stuff.

Meanwhile – cases of Covid19 among children 5-11 years of age are plummeting. Even though schools have reopened.

Sure, let’s force kids to be injected with an experimental ‘vaccine’ based on a technology never before used in humans, with unknown and possibly serious long term side effects, for a virus for which they naturally have a 99.99+% survival rate. For a virus less deadly to kids than the seasonal flu. A ‘vaccine’ whose effectiveness rapidly diminishes over a six month period, requiring continual ‘boosters’.

What could go wrong?

Let’s do this to kids so that obese overpaid unionized government employed school teachers can feel ‘safe’.

And Big Pharma can make tens of billions a year.

America has gone mad.

And so have parents who unnecessarily submit their kids to be lab rats for government and Big Pharma run experiments in new ‘vaccine’ technology.

Let’s Go Brandon!

    20keto20 in reply to JHogan. | October 27, 2021 at 2:34 pm

    Granted, I’m not in the classroom now but I was for years. I rarely caught the flu ( just about the only times I did come down with the flu were the years that I was tricked into taking a flu shot–against the advice of my doctor, due to a myriad of drug and other allergies) and I always attributed that to being exposed to different viruses and allowing my body to take over and develop my own natural immunity. I was a different age. I was never a whiny, spoiled teacher who expected everything to be done for me and I believed that you got out of an education pretty much what you put into it. I didn’t give grades for showing up. I didn’t have a no-fail policy and railed against systems/principals who believed and ordered it. Ironically, the students who struggled the most to learn but understood that I would work with them any way possible if they were willing to LEARN are the ones who came back repeatedly to thank me and to keep me appraised of their educational status!
    If you are scared to be around kids, you’re in the wrong field. Besides, almost every state has a virtual learning certification and a free K=12 virtual school available. Do that instead of coming into the classroom on a regular basis. You may have more students, more papers to grade, more contacts to make, but you can do it from the safety of your home. Heck, you won’t need to leave home for anything!! Get your groceries delivered, medicine delivered, door dash can deliver. You won’t need to buy gas or drive out of your driveway. You’ll see kids on the screen regularly so you won’t miss human contact. If you need to get out, most areas have garbage pickup once a week so that can be your big outing!!

The vaccine risk for kids outweighs any beneficent, by a country mile.
I feel sorry for parents who have been brainwashed. They are putting their kids in danger, with the sincere belief it is right thing to do. The price they pay for this will be horrific. Lesko Brandon.

    #FJB ... Disco Stu_ ... #ExGOP in reply to amwick. | October 27, 2021 at 7:38 pm

    And who knows how these experimental chemical compounds might react with the dynamic puberty hormones arriving someday for these younger children?

    No one – that’s who knows.

    randian in reply to amwick. | October 28, 2021 at 1:02 am

    How can their belief be sincere, when there is no safety data whatsoever?

Of the kids who have become seriously ill or died from Covid, how many of them had a co-morbidity, or more than one? One in particular being overweight for their age? Instead of giving young kids shots, maybe we should instead bring back physical education classes, active recess, and encouraging kids to get outside to kick around a ball on a Saturday afternoon instead of sitting in front of the XBox.

    20keto20 in reply to p. | October 27, 2021 at 2:36 pm

    The lockdown caused a massive increase in obesity across all age groups in every country that locked down their populations. The exceptions–those who worked! Nurses, doctors, truckers, grocers, etc. Gee, wonder if there’s a pattern there?????

Why would anyone believe anything the FDA or this current “Administration” say? They’ve been proven again and again to be feckless liars.

Fortunately, sanity is the order of the day with my family. My Daughter and Son in Law absolutely WILL NOT allow my Granddaughter to be given the covid shot.

She’s also homeschooled, so no worries on the possible mandate front either.

So far most states have been sane about not mandating for kids 12-18.

I hope this is true for this version as well. Seattle school districts have been begging the state to mandate it, and they usually have their way with Inslee. Fingers crossed they don’t.

We will pull our kid and homeschool if they mandate it. This is the line that will not be cross in our world.

Why would anyone rely on “hope” that the vaccine doesn’t have serious side-affects? for a disease with 99.99+ recovery for this age group.. and NO long term testing of the “vaccine”????

“the pharma company said that the doses were better than 90% effective in children 5-11”

Easy to be effective when your patients have basically 100% effective natural immune systems.

What really enrages me is they will be doing safety studies after millions of children get jabbed. They’re using our children as guinea pigs and the FDA is allowing it. Disgusting.

    Ben Kent in reply to randian. | October 28, 2021 at 4:19 pm

    “PROVEN 90% EFFECTIVE”

    Against a virus that 99.9% of the kids easily recover.

    QUESTION – Does FDA need a lesson in MATH ?
    Maybe they’re the one’s who should be in school.

barbiegirl ny | October 28, 2021 at 5:52 pm

Ya know, maybe they’re right about us being dead in ten years, but it won’t be from climate change.

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