Are 3 doses of Pfizer COVID-19 vaccine safe for babies?

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The CDC just recommended 3 doses of the Pfizer COVID-19 vaccine for babies 6 months and older – is that safe? Here is what you need to know…

 

Are 3 doses of Pfizer COVID-19 vaccine safe for babies?

The Children’s Health Defense, which is chaired by Robert F. Kennedy Jr., just posted an article (archive) which claims or suggests that it might not be safe for babies to receive 3 doses of the Pfizer COVID-19 vaccine because it’s unlicensed for children under 12.

There Are No Licensed COVID Vaccines for Kids Under 12 — But CDC Wants Babies to Get 3 Pfizer Shots by Age 9 Months

It has since been shared and promoted as evidence that the Pfizer COVID-19 vaccine is dangerous for babies.

Robert F. Kennedy Jr. : The CDC recommends THREE Pfizer Covid shots for babies by age 9 months. These shots are unsafe and ineffective, especially over the long term. And babies are at near-zero risk from Covid. So whose benefit is the CDC serving here?

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Are 3 doses of Pfizer COVID-19 vaccine safe for babies?

 

CDC : 3 doses of Pfizer COVID-19 vaccine are safe + effective for babies

In this article, I will go through some of their points, and show you what the facts really are!

Fact #1 : FDA authorised Pfizer COVID-19 vaccines for babies

First, let’s start by pointing out that the US FDA just authorised the latest, updated Pfizer COVID-19 vaccine, including for babies 6 months or older:

Unvaccinated individuals 6 months through 4 years of age are eligible to receive three doses of the updated, authorized Pfizer-BioNTech COVID-19 Vaccine or two doses of the updated, authorized Moderna COVID-19 Vaccine.

Individuals 6 months through 4 years of age who have previously been vaccinated against COVID-19 are eligible to receive one or two doses of the updated, authorized Moderna or Pfizer-BioNTech COVID-19 vaccines (timing and number of doses to administer depends on the previous COVID-19 vaccine received).

In other words – there is nothing wrong with the CDC’s recommendation that the babies as young as 6 months old should receive 3 doses of the Pfizer COVID-19 vaccine.

Fact #2 : FDA authorised two COVID-19 vaccines for babies

In fact, the US FDA actually authorised two COVID-19 vaccines for babies 6 months and older (archive):

  • Moderna COVID-19 Vaccine (2024-2025 Formula) for individuals 6 months through 11 years of age
  • Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) for individuals 6 months through 11 years of age

So why is Children’s Health Defense article focusing only on the Pfizer COVID-19 vaccine? After all, the Moderna COVID-19 vaccine is also based on a similar mRNA platform.

Does this mean that Children’s Health Defense believes only the Pfizer COVID-19 vaccine is dangerous for babies, but not the Moderna COVID-19 vaccine? Why only Pfizer, but not Moderna – they didn’t say.

In that case, well, just go ahead and opt for the Moderna COVID-19 vaccine! Problem solved for people who are hesitant about the Pfizer COVID-19 vaccine for babies.

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Pfizer COVID-19 vaccine 2024-2025 formula

Fact #3 : EUA undergoes same approval process

In case you are wondering – the Pfizer COVID-19 vaccine has full FDA approval for children and adults who are 12 years and older, and is authorised for emergency use in children between 6 months and 11 years of age.

This does not mean that the Pfizer COVID-19 vaccine is dangerous or ineffective in children. After all, both EUA and full FDA approval undergo the same approval process, with this major difference in post-study follow-up:

  • EUA : At least half of the participants in the studies must be followed for at least two months after vaccination.
  • Full FDA Approval : All of the participants in the studies must be followed for at least six months.

In addition, full FDA approval requires more details on manufacturing plans and processes, as well as extra time for FDA to conduct oversight and inspections of manufacturing facilities.

You can read more about the differences between full FDA approval, and Emergency Use Authorisation (EUA) here.

Fact #4 : Pfizer COVID-19 vaccine was proven safe + effective for babies

As the Mayo Clinic points out, both the Pfizer and Moderna COVID-19 vaccines were tested to confirm their safety and effectiveness in children aged 6 months and older:

To find out the effectiveness of the Pfizer-BioNTech vaccine for children ages 6 months through 4 and the Moderna COVID-19 vaccine for children ages 6 months through 17 years old, the FDA looked at the immune responses of children in these age groups after they were fully vaccinated.

The FDA compared those responses to the immune responses of young adults who’d been given higher doses of the same mRNA vaccine.

As with the other vaccines, side effects were recorded. Some of the children were monitored for safety for at least two months after being fully vaccinated.

So it would be false to suggest that the Pfizer or Moderna COVID-19 vaccine was never tested in babies as young as 6 months old.

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Fact #5 : VAERS reports are unverified

The Children’s Health Defense article said that there were “37,814 deaths following COVID-19 vaccination had been reported to VAERS, the Vaccine Adverse Event Reporting System, run by the FDA and CDC.

As I pointed out many times before, VAERS data is unverified, and notoriously susceptible to abuse, and false reporting. That’s because it’s an open system that anyone – not just doctors, can report anything they want.

In addition, the reports may be duplicated and have not been verified to be related to the vaccine or drug in question. That’s why VAERS specifically warns against using its reports to reach any conclusion about the risks or safety of vaccines / drugs in question.

But that is probably why anti-vaccination activists love using VAERS data – it’s unverified, and very susceptible to abuse and false reporting.

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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.

He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.

 

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