FILE PHOTO: Pfizer/BioNTech’s new pediatric COVID-19 vaccine vials are seen in this undated handout photo. (Pfizer/Handout via REUTERS)
By Shiv Sudhakar | Fox News
‘I don’t see a difference in a child four years and five years, except for the age – the immune system works the same’.
After the federal Food and Drug Administration (FDA) delayed authorization of the Pfizer-BioNTech COVID-19 vaccine last week for children under the age of five in the United States, parents are making a passionate plea for its off-label use, according to a recent Guardian report.
“The dose may be different for younger ages. The AAP recommends against giving the vaccine to children under 12 [years] until authorized by the FDA.”
The Moderna vaccine is approved for adults aged 18 and older while the Pfizer-BioNTech vaccine is approved for those ages 16 and older, but vaccines for younger patients are still under emergency use authorization, per the report.
And when health care providers sign an agreement to administer the vaccines, they agree not to provide the vaccine for non-authorized indications, such as off-label use, the report said.
“If providers were to give it to these children, they could lose their status as a vaccine provider,” Dr. Sean O’Leary, pediatric infectious diseases specialist and vice-chair of the AAP’s committee on infectious diseases, recently told the Guardian.
The 10-microgram vaccine authorized for kids five to 11 has not been studied in younger children, who receive a 3-microgram dose in the Pfizer-BioNTech pediatric trial, so it’s possible children younger than five can have more side effects if they receive the higher dose, according to the Guardian.
But the paper noted some parents and physicians argue the clinical trials have already demonstrated the 3-microgram dose is safe in young children.
“I don’t see a difference in a child four years and five years, except for the age – the immune system works the same,” said Dr, Wolfgang von Meissner, a family doctor in Germany.
But after Pfizer-BioNTech discovered the omicron variant led to a higher rate of infection than previously documented in younger patients in their clinical trial, they requested a delay to authorize it because of the variant’s ability to evade the immunity provided by the two-dose series of the vaccine, according to the New York Times.