Fast track: Biden FDA approves ’emergency use’ Covid-19 vaccine for kids, 5-11

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The Food and Drug Administration approved the Pfizer-BioNTech Covid-19 vaccine “for emergency use” in children aged 5 to 11.

The approval came after the FDA’s drug advisory panel recommended the approval on Tuesday. The Biden Administration says the doses of the shot will be at pediatricians’ offices, health centers, hospitals, pharmacies, and clinics, and that 15 million doses are ready for shipment.

“The authorization was based on the FDA’s thorough and transparent evaluation of the data that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group,” the FDA said in a statement that was prepared on Thursday and released on Friday.

Key points, as described by the FDA:

  • Effectiveness: Immune responses of children 5 through 11 years of age were comparable to those of individuals 16 through 25 years of age. In that study, the vaccine was 90.7% effective in preventing COVID-19 in children 5 through 11.
  • Safety: The vaccine’s safety was studied in approximately 3,100 children age 5 through 11 who received the vaccine and no serious side effects have been detected in the ongoing study.
  • The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices will meet next week to discuss further clinical recommendations.

“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” said Acting FDA Commissioner Janet Woodcock, M.D. “Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards.”

The Pfizer-BioNTech Covid-19 vaccine for children 5-11 years of age is a two-dose primary series, given 3 weeks apart, but is a lower dose (10 micrograms) than that used for individuals 12 years of age and older (30 micrograms). 

In the U.S., Covid-19 cases in children 5 through 11 years of age make up 39% of cases in individuals younger than 18 years of age, the FDA says.

According to the CDC, approximately 8,300 Covid-19 cases in children 5-11 years of age resulted in hospitalization. As of Oct. 17, 691 deaths from COVID-19 have been reported in the U.S. in individuals less than 18 years of age, with 146 deaths in the 5-11 years age group.  The agency did not report whether those children were already ill or had other complicating conditions.

“The FDA is committed to making decisions that are guided by science that the public and healthcare community can trust.  We are confident in the safety, effectiveness and manufacturing data behind this authorization. As part of our commitment to transparency around our decision-making, which included our public advisory committee meeting earlier this week, we have posted documents today supporting our decision and additional information detailing our evaluation of the data will be posted soon. We hope this information helps build confidence of parents who are deciding whether to have their children vaccinated,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

The FDA said that the Pfizer vaccine has met the criteria for emergency use authorization.

“Based on the totality of scientific evidence available, the known and potential benefits of the Pfizer-BioNTech COVID-19 vaccine in individuals down to 5 years of age outweigh the known and potential risks,” the FDA said in a statement.

49 COMMENTS

    • Yup, and the key words are “for emergency use”. These vaccines are not fully FDA approved. Why aren’t people angry at the deception from the media, television commercials and radio adds claiming otherwise?
      ***
      The FDA has “fully” approved a vaccine that has not yet been manufactured/available yet. (Comernaty).
      ***
      The argument is that Comernaty will share basic ingredients with the vaccines available now so its the same thing. So why didn’t they just fully approve the vaccine we have right now if its the same? Crickets….
      ****
      Meanwhile, ALL manufacturers of the currently available vaccines right now have total immunity from legal liability under the PREP Act if something unintentionally goes wrong with their Covid vaccines.

  1. PANEL BACKS PFIZER SHOT FOR KIDS:, “WE’RE NEVER GOING TO LEARN ABOUT HOW SAFE THIS VACCINE IS UNLESS WE START GIVING IT”

    “https://www.blacklistednews.com/article/81061/fda-panel-backs-pfizer-shot-for-kids-were-never-going-to-learn-about-how-safe-this-vaccine-is.html”

    An FDA vaccine advisory panel on Tuesday voted unanimously 17-0 in favor shooting up kids aged 5-11 with Pfizer’s experimental mRNA injection with panelist Dr Eric Rubin stating, “we’re never going to learn about how safe this vaccine is unless we start giving it.”

  2. Why would Pfizer manufacture and distribute “15 million doses are ready for shipment,” before the product was approved? Because the FDA advisory meeting was an exercise in propaganda, the decision was already made on political and financial basis.
    “Based on the totality of scientific evidence available,”
    “Available” is the key word making this statement ludicrous. Vaccines require a minimum of 10 years to identify any/all long term serious adverse effects and cumulative mortality rates from the product. Scientific evidence does not exist.
    The vaccines manufactured are designed for the original SARS-CoV-2
    strain, which no longer exists. The mass misuse of products with low efficacy rates have caused the virus to evolve into mutations prevelant currently.
    There is no medical emergency for children, there never has been.

  3. My favorite part of this is when these kids mysteriously develop cancer at the age of 30.
    Customers for life.

    It is amazing to witness the system constantly pumping out fear and how willing the masses are to line up for their magic talismans to protect them from the boogey man.

    Works every time.

    Next time there is a pandemic, I think I might invest in the vaccine companies right away!

    Scaring people to death is so damn lucrative!

    • “My favorite part of this is when these kids mysteriously develop cancer at the age of 30.”
      Talk about “pumping out fear.” You could write for “Twilight Zone.” Heheh!

      • If only you would call out the left as well when they flush fear porn into society for almost 2 years when we have had more damaging viruses before.

        • Just your opinion you can’t back up Matthew.
          Try giving a few examples of this fear porn from the left you speak of and also what does more damaging viruses have to do with this??

          • I don’t know why I respond to leftist trolls, but here goes.
            Mandates of a vaccine of any type. Fear porn. All of the big news outlets constantly talking about a virus that isn’t anywhere near as deadly as at least a dozen other viruses in the past century. Pushing dangerous gene therapies on kids that don’t need them is the epitome of sick headed. Propaganda pushing masks that do nothing. Lockdowns that do nothing. Vaccines that do nothing after a couple of months. Faucci and the idiots that repeat his lunacy.
            Look, some of the most heavily ‘vaccinated’ countries are awash in delta breakthroughs. Florida and the like are doing great.
            Useful idiots that push the party line (anti science crap) are fear porn merchants. Success stories like Florida and the absolute king that is natural immunity are largely ignored in media and policy. That is anti science and fear porn by exclusion and inclusion.
            This crap which has a low kill rate on the population in general has absolutely dominated the media and policy for almost 2 years and YOU SAY THERE IS NO FEAR PORN?!?!?!?!?!

          • I wish I could block some idiots on here and not see the lunacy that they must share.
            Sorry. I do not suffer fools well.

          • I see you are moving the goalposts here, originally mentioning damaging viruses and later switching to “deadly” ones. Which is it Matthew??
            Tough noogies to you!

          • And perhaps review what some of the world’s leading experts said on Saturday in anchorage. But those are facts. You don’t like those.

          • Liar says what?
            That symposium on Saturday was undeniably leading experts, including Dr. Robert Malone who created the mRNA technology that made these crappy ‘vaccines’ possible. Although I’m sure that he’s not as expert as YOU Steve-o, but he is pretty sharp – even if he says things that disagree with your god Faucci.

  4. Don Young Yields His Time(vaccine mandates) and DeFazio Goes Ballistic

    While it remains unclear who the comments were meant for, DeFazio uttered the words on the hot mic when Rep. Don Young (R-AK)’s time to speak was yielded to Mast to speak further on his amendment.

    “https://www.breitbart.com/politics/2021/10/29/democrat-peter-defazio-republican/”

    ‘F*cking A**hole’: Democrat Peter DeFazio Caught on Hot Mic Before Republican Congressman Spoke

    JACOB BLISS29 Oct 2021438

    Democrat Rep. Peter DeFazio (D-OR), chair of the House Committee on Transportation and Infrastructure, was caught on a hot mic blurting profanity when time was yielded to Rep. Brian Mast (R-FL) during a committee hearing Wednesday.

    Later in the hearing, the Oregon Democrat tried to recognize Young. However, the Alaska Republican yielded his time to Mast, allowing him additional time to speak about his amendment.

    After Young yielded, before Mast started speaking, DeFazio was caught saying, “Oh, you fucking asshole.”

    Rep. Beth Van Duyne (R-TX), who was also in the committee hearing, posted the exchange on social media, saying it was a “Perfect example of how Democrats approach bipartisan debate on important issues.”

    “Appalling how Dem. Chair @RepPeterDeFazio talks about Rs offering amendments. Proud to support @RepBrianMast in not allowing vaccine mandates to further damage our supply chain,” she added:

  5. a vaccine for a disease that rarely effects kids. Pointless until you remember the point is compliance, not health and safety.

    The left has been preparing for this for literal decades. Something that scares the American people so badly they agree to “temporarily” surrender their rights. Then, boom.

    By the time you come to your senses America elects a senile avatar who destroys the energy industry, throws open the borders to anybody, ravages the supply chain, arms a hostile power and does his damnedest to surrender American sovereignty.

    A few of us tried to warn you, but you got scared.

    • Just in time for Halloween, think it’s a coincidence? These people are sick!
      A child has a 99.9 % chance of surviving covid and will have a lifetime natural immunity. The jab is 50% more likely to do harm in the short term than the c19, the long-term is unknown.

      • Thanks Dr Reed.
        I took my kids to their pediatrician since birth. She recommended getting the vaccine. End of story.

        • Dump THAT one right away. Get one with some common sense that can work google and do a reasoned evaluation.

        • Wait, did you allow kids to get a dangerous experimental gene therapy for a virus that is not going to harm them?
          Oy gevalt!

        • That is simply because your pediatrician, like so many other medical professionals, is captive to both the money and the propaganda of the status-quo power structure. Medical professionals are no less susceptible to group-think and conformism than anyone else — in fact, I would argue that “professionals” of ALL stripes are much MORE susceptible to group-think and conformism, simply because in today’s society it is very difficult to rise to such a level without giving in to those factors many, many times along the way.

    • No problem, it will all be tax dollars. The convenient ‘informed consent’ releases all liability to the manufacturers. Do you think that it is coincidence that so many Pfizer employees now work for FDA approval boards, and vice versa? All they have is profit-profit-profit with no chance at liability. If kids get sick, they just make more money. Think they care about you?

  6. So according to the US Census in 2020 there are approximately 74,000,000 people in the US that are under 18 years old. Of which 691 died from Covid…..that’s a .00000946575 percent. Give me a break people!

      • Why, that must qualify those dying as 3/5 of those not dying, don’t you think? Maybe have all those kids with co-morbidities wear a yellow star to make it easier to determine your “vast majority.”
        Heheh!

        • You leftist shill with bad jokes. Implying that I am claiming that they don’t count when discussing stats on why we shouldn’t endanger other children or give them dangerous experimental gene therapies that they don’t need is pathetic.
          Punk.

  7. If one finds themself perceiving an emergency for this age group, it is highly likely that they have spent entirely to much time cowering behind a mask in an oxygen deprived atmosphere while binging on mass media inputs. Nothing good can or will come of this.

    There is NO EMERGENCY USE CASE for children in this age group. The risk from the “vaccine trial” far outweighs ANY risk from COVID19, by multiple orders of magnitude. There is no antidote. It cannot be undone. It is not really a vaccine, hence the reason that they changed the definition of vaccine a couple of months back.

    I do not know how to overcome this mass psychosis and save fools from themselves, other than a successful Appeal to Heaven. Mostly, now that we are down to the wire, its the innocent kids that I want to see saved. Heaven help us.

  8. Great move by Biden! I can already hear the Karen’s screaming and contorting their faces into Halloween masks.

  9. Children’s health WILL be compromised with this innoculation (its not a vaccine)
    Do your experiments on another planet

    • Did you expect them to start working when they got the OK. It’s like when a team wins a championship and they have the shirts and ball caps already in boxes in the locker room.

  10. In God We Trust. Then Obey him. First acknowledge God gave us our immune system. Recognize too that Big Pharma, have not been able to cure, actually cure any of the multiple terrible diseases which afflict Mankind. Now when God Gave Man the Adam Gene, He gave us the greatest gift of all, which has passed down the centuries, and is still available to us today. However, in accordance with thy Belief, Be it done unto YOU. Remember the Apostle Peter walking upon the water? Momentarily, he looked down and was overcome by fear. But Peter knew to call upon the Lord for help and so, he made the journey successfully.

    We too must exercise faith in God’s given immune system, which means we ignore the CDC/Fauci/Satan’s plan to implant fear in our hearts. In accordance to thy faith be it done unto thee. So who will you allow to control you?

  11. Domestic terrorism is intimidation and coercion of a civilian population. Forced infringements of inalienable rights are wrong and tortuous.

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