Pfizer Vaccine For Children: When Will It Be Approved In IL?

ILLINOIS — The drug company Pfizer on Thursday asked federal regulators to approve its COVID-19 vaccine for use in children as young as 5. The U.S. Food and Drug Administration has promised to come to a decision quickly. If it approves the shot, as many as 28 million young Americans could be one step closer to life as they knew it before the pandemic.

Pfizer and its German partner BioNTech said they have submitted data showing the vaccine is safe and effective in children aged 5-11. The mRNA shot was "well tolerated and showed [a] robust neutralizing antibody response," according to a news release from the company.

The FDA is scheduled to discuss Pfizer's data at a meeting on Oct. 26, and a shot for kids could be approved for emergency use by Halloween.

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“Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine," Pfizer CEO Albert Bourla said in a statement. "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."

RELATED:Overcrowded Pediatric ERs: Seek Care Only If 'Seriously Ill'

Children do not usually get as sick, as often, as adults who catch the coronavirus, but hundreds of children have died from COVID-19, and thousands have been hospitalized.

Across Illinois, pediatric emergency rooms have seen a "serious increase" of children with COVID-19 and other respiratory viruses. Officials warned of overcrowded emergency departments ill-equipped for a surge of infections, even cautioning parents to "seek care at an emergency department [only] if their child is seriously ill."

Dr. Ngozi Ezike, Illinois' top public health official, urged parents to get their children vaccinated as soon as they are eligible.

"And I'm not letting the adults off the hook either," she continued. "We know that the more adults get vaccinated, that also provides that protective cocoon to our young people, especially those that are too young to be vaccinated."

Pfizer said the safety profile of the vaccine, which it administered to children at a lower dose than adults, was comparable to the adult version. Potential side effects include soreness at the injection site, fatigue, fever, chills and headache.

Allergic reactions are very rare, and easily treatable if they do occur.

Like its adult data, the full data from Pfizer's clinical trial for children will be available for peer review, the company said.

The company expects to release data and seek emergency use authorization for children as young as 6 months old later this year, according to a news release.

"With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19," Pfizer tweeted Thursday.

RELATED: COVID-19 Booster Shots: Illinois Adopts CDC Recommendations

Last month, the FDA approved — and the U.S. Centers for Disease Control and Prevention formally recommended — a Pfizer booster shot for millions of eligible Americans.

The Illinois Department of Public Health followed suit a few days later.

"While the vaccines continue to be highly effective at preventing severe illnesses, hospitalization, death, as we learn more about COVID-19 and the science evolves, so too must our recommendations," Ezike said. "Scientists and medical experts continue to monitor vaccines for waning immunity and how well the vaccines protect against new variants, and across which age groups and risk factors. The information reviewed by the FDA shows that there is clear evidence of the benefit of booster doses at this time."

Both Johnson & Johnson and Moderna have asked the FDA to allow booster shots of their own COVID-19 vaccines. J&J said a second shot will provide a "rapid and robust increase" in protective antibodies, while Moderna said its data suggests a booster will significantly reduce breakthrough infections.

Federal regulators are increasingly in favor of booster shots of all available vaccines, according to the New York Times. The FDA is set to discuss data from J&J and Moderna next week.