Pfizer, Moderna Apply for EUA for COVID Shots for Infants, FDA to Decide Quickly

Pfizer, Moderna Apply for EUA for COVID Shots for Infants, FDA to Decide Quickly

On June 1, 2022, Pfizer and BioNTech submitted an application to the U.S. Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) to distribute their messenger RNA (mRNA) BNT162b2 (also known as “Comirnaty”) COVID-19 biologic for children as young as six months to five years old. The application is for a three-dose regimen, with each dose containing three micrograms (µg) of the product.1 2

In a public statement, the FDA said:

We recognize parents are anxious to have their young children vaccinated against COVID-19 and while the FDA cannot predict how long its evaluation of the data and information will take, we will review any EUA request we receive as quickly as possible using a science-based approach.1

The data provided by Pfizer and BioNTech to the FDA for BNT162b2 use in children six months to five years old was taken from a Phase 2/3 trial involving 1,678 children. Preliminary results determined the reduced dose biologic to have an estimated efficacy of 80.3 percent at preventing COVID disease after three doses.1 2

The Pfizer/BioNTech data on the reduced dose biologic for infants and young children is “preliminary,” and it has not been peer-reviewed or published in a medical journal.2

The EUA application by Pfizer/BioNTech follows a similar EUA application made by ModernaTX, Inc. on Apr. 28 to distribute its mRNA-1273 (“Spikevax”) COVID biologic for children six months to four years of age. Unlike BNT162b2, Moderna’s product calls for two 25-µg doses.1 3 4

Moderna’s chief medical officer, Paul Burton, MD, told The Associated Press that he believes the two doses of mRNA-1273 will “safely protect” babies, toddlers and preschoolers.4 He added:

I think it is likely that over time they will need additional doses. But we’re working on that.4

FDA Decision on Pfizer and Moderna EUA Requests Expected Within Weeks

An advisory panel for the FDA, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), which consists of members appointed by the FDA Commissioner, plans to meet on June 15 to review both EUA requests. Based on comments by White House COVID response coordinator Ashish Jha, MD on June 2, it appears likely that favorable recommendations will be made by VRBPAC, followed by FDA staff approval of the EUA requests, followed by universal use recommendations by the U.S. Centers for Disease Control and Prevention (CDC).5 6

“We expect an FDA decision shortly after the [VRBPAC meeting], and we look forward to the process playing out,” Dr. Jha said. “We’ll move from planning to execution.”5

The director of the FDA’s Center for Biologics Evaluation and Research (CBER), Peter Marks, MD, said the FDA will “move quickly” to make a decision on the EUA requests “without sacrificing our standards.”4

Federal Government Ready to Move Forward With Vaccinating Young Children Against COVID

Dr. Jha noted that the Biden administration would initially make 10 millions doses of the Pfizer/BioNTech and Moderna/NIAID) COVID shots available to states, pharmacies and community health clinics and that state governments could begin placing orders on June 3, but that the doses would only begin to be delivered after approval by the FDA.5 6

Dr. Jha stressed that his intention was not to “prejudge the outcome of the process,” but that the administration was “hard at work planning all sorts of scenarios based on whatever the outcome is.”7

According to the Dr. Jha:

We’re going to ship doses out as fast as possible. We’re going to make sure that supply is always meeting demand. And we’re going to do everything we can to make it easy for providers and parents alike to get their kids vaccinated.5

Dr. Jha suggested that COVID shots for six-months-old babies to five-year-old children are expected to begin as early as June 21.5 6


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32 Responses to "Pfizer, Moderna Apply for EUA for COVID Shots for Infants, FDA to Decide Quickly"

  1. Michael   June 6, 2022 at 2:28 pm

    Jha is speaking honestly “We’ll move from planning to execution.”

    Reply
  2. Rick   June 6, 2022 at 2:39 pm

    For more good COVID info – https://anchoredinhope.com/

    Reply
  3. Chris   June 6, 2022 at 2:48 pm

    This is complete insanity and must not move forward. Please fight for your kids!!!

    Reply
  4. Julie   June 6, 2022 at 2:49 pm

    I just pray for people to wake up! That they will quit following the crazy people that want everyone to die but them!

    Reply
  5. Mary   June 6, 2022 at 2:49 pm

    So disgusting!! Leave our babies and children alone. In fact, leave all of us alone! Haven’t you killed and injured enough people with your propaganda??? All for the money. You people are so sick!!

    Reply
    • Peace   June 9, 2022 at 9:16 pm

      Agreed!!!! Your voice is loud and clear.

      Reply
  6. Donna Roeder   June 6, 2022 at 3:05 pm

    Quick, let’s hurry and kill off the next generation…..that’s what they want.
    Just nauseating.

    Reply
  7. Joe Scherzer MD   June 6, 2022 at 3:09 pm

    Omicron has mutated to such an extent that experts say it is NOT responsive to the original gene therapy shot.There is NO REASON to experiment on infants!!!!

    Reply
  8. Marie   June 6, 2022 at 3:22 pm

    Are they serious ? I can´t believe !!!

    Reply
  9. Donna   June 6, 2022 at 3:38 pm

    another crime against humanity

    Reply
  10. JLK   June 6, 2022 at 3:51 pm

    God help the ignorant parents who find out the hard way that our government is not bothered by killing any of us.

    Reply
  11. Terry Richmond   June 6, 2022 at 4:10 pm

    How much of your trial data, will you attempt to withhold fron the public? Just for your information, babies are not in any real danger from covid-19; they certainly will be from the vaccine! Those of you behind this travesty, will be brought up on charges for Crines Against Humanity; I will be expectantly awaiting the results of that “trial data”!

    Reply
  12. CATRYNA WHITE   June 6, 2022 at 4:18 pm

    This will be infanticide.

    Reply
    • Peace   June 9, 2022 at 9:14 pm

      You hit the nail on the head.

      Reply
  13. mark   June 6, 2022 at 5:08 pm

    FACT: in 2021 I met a couple at a party that worked for one of these companies. I asked is there any age too young to inject needles into. they said “no”. I asked: “The Womb?”, The did not even pause before saying “of course – why not” I yelled: “IN THE WOMB?” They said “we have to protect the mother”.

    Reply
  14. Salem zahn   June 6, 2022 at 6:16 pm

    Can the parents of the infants choose formula over vaccine? Just wondering!

    Reply
  15. Nick Quinlan   June 6, 2022 at 6:36 pm

    “We recognize parents are anxious to have their young children vaccinated against COVID-19”
    Delusional lies and propaganda from the FDA, the Fraud and Death Administration.
    There is no emergency, there never was, not for adults, teenagers, or children, and most certainly not infants.
    The govt, Pharma, and the CDC/FDA are mass murdering, genocidal, vaccine profiteers and terrorists.

    Reply
  16. VMW   June 6, 2022 at 6:42 pm

    There are plenty of physicians who are adamant about NOT giving children the experimental jab! One, it’s not necessary, snd two, it’s dangerous especially since the long term effects have yet to be determined. The push for jab is the biggest crime against humanity. The people behind this MUST be stopped. Follow the money!

    Reply
  17. Marcia   June 6, 2022 at 6:56 pm

    This puts them one step closer to their 💯 liability shield and an annual revenue stream with it on the childhood jab schedule – feels like they’re pushing fast and furious in the hopes no one is paying attention (think 2a and election fraud), and ramping it up ahead of the rest of their documentation releases that show they knew all along what the dangers were

    Reply
  18. James   June 6, 2022 at 8:33 pm

    Follow the money……follow the deaths and permanent disabilities NOT reported by the agencies.

    Reply
  19. Fowell the $   June 6, 2022 at 10:53 pm

    EAU?
    What Emergency? Children don’t die from COVID. They die with COVID because of another condition.

    Also we should never vaccinate with a more dangerous strain than the strain we want to protect from.

    How long will the protect last?
    What about long term effect?
    We’re there any children excluded from the study do to medical reasons?

    STOP.!

    18% of adults will 💉💉💉 there children.

    Reply
  20. Rebekka   June 6, 2022 at 11:31 pm

    Experimental biologics have been tested on babies all along. Y’all did it before and snubbed the parents who tried to warn you that this global horror was coming.

    Vat vir julle

    Reply
  21. Data Detective   June 7, 2022 at 5:25 am

    Biden is expected to vaccine 10 million children with a vaccine that has only been tested on 1678/2 children.
    If 1 per thousand die it would not appear in the trial. 10,000 children would die. Not enough data to show it safer than covid.

    Less than 12% of patents are willing to have their children vaccinated the first month. That would be 2 million 💉.
    What can Biden do with the other 8 million 💉.

    Reply
  22. Mark   June 7, 2022 at 5:34 am

    How did they become so evil?

    Reply
  23. Marian   June 7, 2022 at 5:52 pm

    Trials for adults have not been completed for emergency use how can you move to trials for babies… genocide.

    Reply
  24. Toby   June 7, 2022 at 10:07 pm

    COMIRNATY has never been administered to anyone in the U.S., even though it has been “approved.” All approved vaccines no longer have immunity from legal action for anything they do to a patient. The only vaccines that have been used upon all U.S. citizens are the EUA genetic experimental version which still provides legal immunity for vax providers. The only reason it was approved in the first place is because Big Pharma and U.S. Guvmint needed a boost to mandate the Vax all over the country, based upon the assumption that they are, of course, being administered the approved COMIRNITY version. Even so, it was still unconstitutional. Just another symptom of the criminal collusion involving the largest medical fraud ever perpetrated on humanity.

    Reply
  25. Toby   June 7, 2022 at 10:09 pm

    I can hardly wait to see what your moderation process does to my comment.

    Reply
  26. Deborah Arndt   June 7, 2022 at 11:58 pm

    Children are our future… now you want to kill them too! Disgusting!! Since when are children dying from covid!!! COVID IS OVER DONE … AND NEVER WAS FATAL TO THE AVERAGE PERSON … When does the plandemic stop … when people stop watching the mainstream media, thats when people will wake up!!

    Reply
  27. Michael   June 8, 2022 at 11:05 pm

    These psychopaths are now going after the kids that survived the abortion holocaust.

    Reply
  28. Data Detective   June 8, 2022 at 11:33 pm

    The Democratic that promote abortion are supporting vaccine mandate.
    They say their for free medical choice but they want to decrease population. Kill babies.

    Abortion and vaccine for all.

    Reply
  29. A. Mason   June 9, 2022 at 11:20 am

    Where are the logical scientific minds in all this insanity.? Children are born equipped with a thymus gland to protect them in childhood from infection & if fortunate are breast fed…..another level of natural immunity/protection passed along. These injections, all, have been shown, to be a bio-weapon if you look/think abt the VAERS death & horrible disabilities statistics. The shots are NOT the true definition of vaciine & they remain EXPERIMENTAL.!.. are not. ”protecting’ adults so please, even if approved DO NOT put into your children !…….Wait/watch for a year or two & see outcomes when some parents allow children to be ‘experimented’ on. You will see the wisdom of your choice….to simply ‘wait & see’.

    Reply
  30. Jeanne   June 11, 2022 at 1:43 pm

    I look on this as the childhood vaccine schedule! Autism now 1-36!!?

    Reply

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