Pfizer & BioNTech will soon seek approval for COVID-19 vaccine in young children

Vials of Pfizer-BioNTech COVID-19 vaccine lined up.

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Pfizer and BioNTech will likely apply for approval of their vaccine for children as young as 5 years of age within the next couple of weeks, according to recent news reports. The news comes as schools have reopened across the U.S., amid a sharp rise in children hospitalizations due to the dominance of the highly-transmissible delta variant. 

“In the coming weeks we will present the results of our study on the 5 to 11 year olds worldwide to the authorities and apply for approval of the vaccine for this age group, including here in Europe,” Dr. Özlem Türeci, chief physician and co-founder of BioNTech, told German news site Der Spiegel. “We’re already preparing for production.”

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The vaccine is the same as that given to adults, but will be given as a lower dose for children, she added.

Currently, only children ages 12 years and up are authorized to receive the Pfizer-BioNTech vaccine in the U.S. The other two vaccines being administered in the U.S., Moderna’s and Johnson and Johnson’s, have not yet been approved for those younger than 18 years of age. 

The Food and Drug Administration (FDA) released a statement on Friday (Sept. 10) saying they will “follow the science” on COVID-19 vaccine approvals for children. 

“Just like every vaccine decision we’ve made during this pandemic, our evaluation of data on the use of COVID-19 vaccines in children will not cut any corners,” Dr. Janet Woodcock, FDA commissioner and Dr. Peter Marks, director of the FDA’s center for biologics research and evaluation wrote in the statement. 

“Until we authorize or approve a vaccine for this younger population, it’s especially important that parents and others who interact closely with children under 12 years of age get vaccinated, wear masks, and follow other recommended precautions so that we can protect those who cannot yet protect themselves through vaccination,” they wrote.

Türeci, and her husband and co-founder of BioNTech Uğur Şahin said everything possible must be done to convince people who are eligible but currently undecided to vaccinate in the next few weeks, according to Der Spiegel.

“As a society, we still have around 60 days to avoid a harsh winter,” Şahin said. “We should do what we can to mobilize as many people as possible in these two months.”

Vaccine data on children and infants as young as six months of age will likely be available by the end of the year, according to Der Spiegel.

Since the start of the pandemic, children have been largely spared of the worst effects of COVID-19, having much fewer hospitalizations and deaths than adults. But the delta variant has increased the risk that children are infected and child COVID-19 hospitalizations are at an all-time high.

Since the start of the pandemic, more than 5 million children have tested positive for COVID-19, according to The American Academy of Pediatrics (AAP). In the week between Aug. 26 and Sept. 2, more than 250,000 new COVID-19 cases (26.8% of new cases) were reported in children. That’s the largest number of reported weekly pediatric cases since the start of the pandemic. 

As of Tuesday (Sept. 7), 2,396 children were hospitalized in the U.S. with COVID-19, a record-high, CNN reported.

 Originally published on Live Science.

Yasemin Saplakoglu

Yasemin is a staff writer at Live Science, covering health, neuroscience and biology. Her work has appeared in Scientific American, Science and the San Jose Mercury News. She has a bachelor’s degree in biomedical engineering from the University of Connecticut and a graduate certificate in science communication from the University of California, Santa Cruz.

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