The vaccine made by Pfizer and its German partner BioNTech already is available for anyone 12 and older. Though with kids now back in school and the extra-contagious delta variant making a huge jump in pediatric infections, many parents are anxiously anticipating vaccinations for their younger children.
"Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine. We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children," announced Pfizer CEO Albert Bourla.
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For elementary school-aged kids, Pfizer examined a much lower dose -- a third of the amount that’s in each shot delivered now. Yet after their second dose, children ages 5 to 11 developed coronavirus-fighting antibody levels just as strong as teenagers and young adults, Dr. Bill Gruber, a Pfizer senior vice president, told The Associated Press.
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"The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose," stated Dr. Ugur Sahin, CEO and co-founder of BioNTech.
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While kids are at lower risk of severe illness or death than older people, over 5 million children in the U.S. have tested positive for COVID-19 since the pandemic started and no less than 460 have died, according to the American Academy of Pediatrics. Cases in children have risen dramatically as the delta variant swept through the nation.
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Pfizer announced it studied the lower dose in 2,268 kindergartners and elementary school-aged kids. The FDA required what is called an immune "bridging" study: proof that the younger children developed antibody levels already proven to be protective in teens and adults. That's what Pfizer reported Monday in a press release, not a scientific publication. The study still is continuing, and there haven't yet been enough COVID-19 cases to compare rates between the vaccinated and those provided a placebo — something that might offer further evidence.
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The study isn’t large enough to detect any greatly rare side effects, like the heart inflammation that sometimes happens after the second dose, mostly in young men. The FDA’s Marks announced that the pediatric studies should be large enough to rule out any higher risk to young children. Pfizer’s Gruber stated once the vaccine is authorized for younger children, they’ll be carefully monitored for rare risks just like everyone else.
A second U.S. vaccine maker, Moderna, further is studying its shots in elementary school-aged children. Pfizer and Moderna are studying even younger tots as well, down to 6-month-olds. Results are expected later in the year.
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