FDA Approves U.S. Babies and Young Children to Get Omicron COVID Booster Shots

FDA Approves U.S. Babies and Young Children to Get Omicron COVID Booster Shots

In early December 2022, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for the Pfizer/BioNTech and Moderna/NIAID mRNA COVID-19 shots to include administration  of the Omicron COVID booster shots to children as young as six months old. The action allows everyone over the age of six months to get the newest booster shot.1

The FDA made the decision to authorize the vaccination of infants and very young children just three days after Pfizer submitted an application to the regulatory agency for the Omicron BA.4/BA.5-Adapted Bivalent COVID vaccine.2

The bivalent COVID booster, which contains the original strain of the SARS-COV-2 virus along with spike proteins from the BA.4 and BA.5 variants of the Omicron strain, was approved for children five years of age and older on Oct. 12, 2022.3 FDA commissioner Robert Califf, MD said:

More children now have the opportunity to update their protection against COVID-19 with a bivalent COVID-19 vaccine, and we encourage parents and caregivers of those eligible to consider doing so–especially as we head into the holidays and winter months where more time will be spent indoors.4>

COVID Vaccination Uptake Has Been Slow Among Babies and Young Children

Omicron COVID booster shot uptake is limited because it is only available to infants and children who have received both doses of the original COVID shots developed by Pfizer and Moderna. Children who have already received three doses of the original Pfizer COVID shot are not eligible for the booster.

U.S. Centers for Disease Control and Prevention (CDC) officials have reported that less than five percent of children aged two to four and only three percent of children and babies under the age of two have received the original COVID shots.5 Therefore, there is not much demand for the Omicron booster shots among very young children. Meanwhile, 32 percent of children aged five to 11 years are fully vaccinated against COVID.6

Yale School of Medicine pediatrician Leslie Sude, MD said:

While a significant proportion of the population was not eligible for vaccination, there was still the opportunity for widespread circulation of COVID among children, who could then keep transmitting it to older people. And as long as the virus spreads from person to person, the virus can keep changing and evolving into new variants.7

However, Dr. Sude’s comment conflicts with CDC director Rochelle Walensky’s acknowledgement that the getting a COVID shot does not prevent infection with and transmission of the SARS-CoV-2 virus to others. Dr. Walensky stated:

 Our vaccines are working exceptionally well … but what they can’t do anymore is prevent transmission.8

Covid Shot Study Data Not Peer Reviewed or Published

The FDA and a committee of independent vaccine experts relied on data provided by the vaccine manufacturers when extending the EUA for the bivalent Omicron COVID booster shot to infants and very young children. The data presented by vaccine manufacturers has not been peer reviewed or published.9

When extending the EUA status of the Moderna COVID booster shot to babies and young children, the FDA relied on a clinical study looking at the immune response of adults to the Moderna product.  The FDA also compared a clinical study looking at the immune response of 56 children aged 17 months through five years after getting the full dose series of the original COVID shots plus the booster dose to a study examining the immune response of 300 young adult participants, who received the two-dose original Moderna COVID shot. The FDA concluded that the immune response of the infants and very young children was comparable to the immune response in young adults.10

The FDA also looked at a clinical study examining the safety of a single dose Moderna COVID booster shot in 145 children aged six months through five years old. The study showed the common side effects in babies 17 through 36 months old was irritability/crying, sleepiness and loss of appetite. Previous clinical trials showed the common side effects in this age group to also include fatigue, muscle pain, headache, joint pain, nausea/vomiting and chills.11

The third dose of the monovalent Pfizer COVID shot will no longer be used in very young children and will, instead, be replaced with the booster dose. The FDA relied on efficacy data previously submitted by the drug manufacture in individuals aged six months through four years old, 16 years and older and adults aged 55 years and up who received the original two dose series of shots, the monovalent booster as well as the bivalent booster dose.12

The safety of the Pfizer COVID booster shot for children aged six months through five years old was determined by looking at safety data from a clinical study of the bivalent booster shot in participants aged 55 years and older; clinical trials looking at the safety of the primary vaccine series in children six months and older with the monovalent booster, as well as safety data from clinical trials and post marketing safety data of the booster shot in participants five years and older.

Even though the safety data presented did not include the bivalent COVID booster shot, the FDA concluded the previous trials and studies on the monovalent booster were relevant to the approval process of the bivalent Omicron version due to the fact the same manufacturing process was used to make both versions of the shot.13

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6 Responses to "FDA Approves U.S. Babies and Young Children to Get Omicron COVID Booster Shots"

  1. Candace A. Peterson   January 11, 2023 at 4:43 pm

    Israel has a heartbreaking account of an infant receiving the mRNA vaccine. I believe it was this site that published the horrific experience.
    Oregon approved this abuse last Summer. I would like to charge every parent with child abuse that sacrifices their child to mRNA poisoning. (What to do with the doctors)?

  2. John   January 11, 2023 at 5:02 pm

    Babies having heart attacks? This is insane. They are jeopardizing the future of mankind.

  3. Tom   January 11, 2023 at 9:12 pm

    Completely a death sentence for young children.

  4. Fowell the $   January 13, 2023 at 12:22 am

    We need to look at the bigger picture.
    CDC didn’t recommended the new ☣️💉 to all children, just the ones that had Moderna, or were stupid enough to get Pfizer 💉💉 , but smart enough not to get 💉💉💉. That isn’t enough children for a pediatric MD to mix a batch of 20 💉 that can only be used in 12 hours.
    a pediatric MD won’t loose their license but could get fired for giving bad advice to their customers.

    So what is the point?
    What is next?

  5. Peace   January 14, 2023 at 3:01 pm

    It’s very sickening to vaccinate as young as 6 months old. Very cruel and inhumane. What kind of medicine are they practicing? Bad medicine. FDA is reckless. CDC doesn’t give a rip, only profit in my eyes. We have no immunity, so don’t take the poison(Covid shots).

  6. Boxerdog   January 23, 2023 at 11:42 am

    The whole “vaccine” program is insane. Sounds like Hitler and the destruction of the Jews all over again….oh wait, it is. Considering Klaus Schwab has resurrected the III Reich and turned it into the IV Reich now. Only now it’s not just the Jews they are going after. They now want to destroy 99% of the population on earth, because, you know, 500 million or less are easier to control and make into slaves. All that talk about utopia, you will own nothing and you will like it, it’s all BS, it’s evil and demonic, and if it happens, it’s because people won’t have the courage to say no.


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