Pfizer has requested the U.S. Food and Drug Administration (FDA) approve its COVID-19 vaccine for use in children as young as six months old.

The pharmaceutical company’s latest request is for the FDA to approve two doses of its COVID-19 vaccine by amending its Emergency Use Authorization (EUA) “to include children 6 months through 4 years of age (6 months to <5 years of age), in response to the urgent public health need in this population.”

So far, Pfizer’s COVID-19 vaccine has been fully approved for those age 16 and older, while it is available under an EUA for those age 5-15.

However, there is still some dispute over whether Pfizer’s fully approved COVID-19 vaccine, sold under the name “Comirnaty,” is actually available to the public.

Investigative journalist Jordan Schachtel reports that even though the FDA has fully approved “Comernity,” that product “has never made its way into the United States” and that “A separate product, which remains under emergency use authorization (EUA), is the only ‘Pfizer shot’ available in the United States.”

The FDA admits as much, disclosing that “The products are legally distinct with certain differences.”

In its press release announcing the request for an EUA for those age 6 months to four years old, Pfizer acknowledged that its request was made “following a request from the U.S. Food and Drug Administration.”

In other words, the FDA asked Pfizer to request that the agency approve Pfizer’s COVID-19 vaccine for children as young as six months.

“That’s not typically the way the federal government works,” said Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia. “Usually, they wait and let the company decide when it wants to submit.”

Pfizer also noted in its press release that “more than 10.6 million children have tested positive for COVID-19 in the U.S., with children under 4 accounting for more than 1.6 million of those cases.”

According to the U.S. Centers for Disease Control and Prevention (CDC), there have been 770 deaths “involving COVID-19” in children and adolescents age 0-17. It’s unclear how many of the deaths were in children under 5.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) recently made the distinction that many children who have been hospitalized with COVID-19 may not have been hospitalized directly because of the virus.

“If you look at the children are hospitalized many of them are hospitalized with COVID as opposed to because of COVID,” Fauci asserted.

“What we mean by that is that if a child goes in the hospital they automatically get tested for COVID and they get counted as a COVID hospitalized individual, when in fact they may go in for a broken leg or appendicitis or something like that.

“So, it’s over counting the number of children who are ‘hospitalized’ with COVID as opposed to because of COVID,” he added.

And the American Academy of Pediatrics (AAP) reports that over 11 million children have tested positive for COVID-19.

But even though the virus has become widespread among children, it very rarely leads to severe illness and death.

The AAP notes that “​In states reporting, 0.00%-0.02% of all child COVID-19 cases resulted in death.”

Pfizer tweeted on February 1 that “Emergency uses of the vaccine have not been approved or licensed by US FDA but have been authorized to prevent COVID-19 in ages 5+.”

The messaging that its vaccine will “prevent” COVID-19 is seemingly at odds with Pfizer’s CEO Albert Bourla’s recent statement that two doses of Pfizer’s vaccine “offers very limited protection, if any” against contracting COVID-19.

Considering the FDA requested Pfizer ask for its approval to amend the EUA so its vaccine can be provided for children, it’s highly likely the FDA will give the go ahead in the coming weeks.

While parents weigh the potential risks and benefits of giving their young children the COVID-19 vaccine, Focus on the Family wants to help you make a wise and informed decision.

In that vein, check out our related articles and resources:

The Omicron Variant May Bring About the End of COVID-19

Doctors Talk COVID Vaccines on Friday’s Focus on the Family Broadcast

Pfizer Vaccine Approved for 12- to 15-Year-Olds. Will Your Child Get the Vaccine?

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