Children as young as 5 could soon be eligible for coronavirus vaccines as a panel of advisers for the Food and Drug Administration gave Pfizer's child-size COVID vaccine its endorsement Tuesday.
Full-strength Pfizer shots already are recommended for anyone 12 or older, but pediatricians and many parents are anxiously awaiting protection for younger children to stem infections from the extra-contagious delta variant and help keep kids in school.
Tuesday's vote was the first step in a review process that will still require recommendations from the FDA itself and the Centers for Disease Control and Prevention.
So what can parents expect and when? Here's what we know so far.
When could COVID vaccines for kids under 12 begin?
If the FDA authorizes the shots, the CDC will make additional recommendations on who should receive them the first week of November.
Children could begin vaccinations early next month -- with the first youngsters in line fully protected by Christmas.
Illinois Gov. J.B. Pritzker said final approval for vaccines in this age group could come in the middle of next week, clearing the way for the state to begin vaccinations.
"In just a few days time, millions of parents all across the United States should be able to breathe a sigh of relief that they've been holding in for over 18 months now," Pritzker said.
What do we know about the vaccines in kids from the trials?
Federal health regulators said late Friday that child-size doses of Pfizer’s COVID-19 vaccine appear highly effective at preventing symptomatic infections in elementary school children and caused no unexpected safety issues.
In their analysis, FDA scientists concluded that in almost every scenario the vaccine's benefit for preventing hospitalizations and death from COVID-19 would outweigh any serious potential side effects in children. But agency reviewers stopped short of calling for Pfizer's shot to be authorized.
Most of the study data was collected in the U.S. during August and September, when the delta variant had become the dominant COVID-19 strain.
The FDA review found no new or unexpected side effects. Those that did occur mostly consisted of sore arms, fever or achiness.
However, FDA scientists noted that the study wasn't large enough to detect extremely rare side effects, including myocarditis, a type of heart inflammation that occasionally occurs after the second dose.
The agency used statistical modeling to try to predict how many hospitalizations and deaths from COVID-19 the vaccine would prevent versus the number of potential heart side effects it might cause. In four scenarios of the pandemic, the vaccine clearly prevented more hospitalizations than would be expected from the heart side effect. Only when virus cases were extremely low could the vaccine cause more hospitalizations than it would prevent. But overall, regulators concluded that the vaccine's protective benefits “would clearly outweigh" its risks.
Do children need to be vaccinated from COVID?
While children run a lower risk of severe illness or death than older people, COVID-19 has killed more than 630 Americans 18 and under, according to the CDC. Nearly 6.2 million children have been infected with the coronavirus, more than 1.1 million in the last six weeks as the delta variant surged, the American Academy of Pediatrics says.
Doctors at Advocate Children's Hospital said last week that while cases in children tend to be less severe than those seen in adults, "more children are being hospitalized with severe COVID-19 infection than was seen earlier in the pandemic."
The group also warned that multiple cases of a life-threatening COVID-19-related condition called the pediatric multisystem inflammatory syndrome have been reported in the Chicago area and experts still don't know the long-term effects of COVID-19 on kids.
How will the U.S. begin vaccinations for kids?
Last week, the White House announced children ages 5 to 11 will soon be able to get a COVID-19 shot at their pediatrician's office, local pharmacy and potentially even their school, detailing plans for the expected authorization of the Pfizer shot for elementary school youngsters in a matter of weeks.
The Biden administration has purchased enough kid-size doses — in special orange-capped vials to distinguish them from adult vaccine — for the nation’s 5- to 11-year-olds. If the vaccine is cleared, millions of doses will be promptly shipped around the country, along with kid-size needles.
More than 25,000 pediatricians and primary care providers already have signed up to get the shots into little arms.
Is it only Pfizer that will be considered for shots in younger children?
Both Moderna and J&J's vaccines can only be used on people 18 and older, though Moderna also is studying its shots in elementary school-aged children.
Moderna said Monday that a low dose of its COVID-19 vaccine is safe and appears to work in 6- to 11-year-olds.
Moderna hasn't yet gotten the go-ahead to offer its vaccine to teens but is studying lower doses in younger children while it waits.
Researchers tested two shots for the 6- to 11-year-olds, given a month apart, that each contained half the dose given to adults. Preliminary results showed vaccinated children developed virus-fighting antibodies similar to levels that young adults produce after full-strength shots, Moderna said in a news release.
The study involved 4,753 children ages 6 to 11 who got either the vaccine or dummy shots. Moderna said that like adults, the vaccinated youngsters had temporary side effects including fatigue, headache, fever and injection site pain.
The study was too small to spot any extremely rare side effects, such as heart inflammation that sometimes occurs after either the Moderna or Pfizer vaccines, mostly among young men.
Pfizer and Moderna are studying vaccinations in even younger tots as well, down to 6-month-olds. Results are expected later in the year.
Is the dosage for children the same as teenagers?
Is the Pfizer vaccine that is being evaluated for younger children the exact same vaccine that teenagers and adults received?
According to Chicago Department of Public Health Commissioner Dr. Allison Arwady, the answer is no.
While the vaccine has "the exact same ingredients" and will follow the same timeframe between doses, "it is only going to be a third the dose."
"This is because younger children have a smaller body mass and in studies, they had the same level of antibodies and protection," Arwady said. "But the lower dose makes it less likely that the 5-to-11-year-olds will have side effects."
Arwady noted that the change in dosage will also require smaller needles and different vaccine vials.
"So we won't have people pulling adult and children doses out of the same vial, there is a separate process for child vaccines," she said.
What should you do if you still have questions?
Illinois health experts acknowledged that many parents will likely have questions surrounding COVID vaccinations for children.
The state's top doctor and other pediatric health officials urged parents to discuss the decision with their doctors and ensure that any other information comes from reputable websites.
"As the state's top health officials, and as a board certified pediatrician and mom, I am urging every single parent and guardian to do this for their child," Illinois Department of Public Health Director Dr. Ngozi Ezike said. "Make a plan to get them vaccinated for COVID-19."
"I also know that there are many parents out there who aren't quite ready to be the first in line to get their kids vaccinated and who might still have questions," Pritzker said. "That's OK. There are experts who can provide you with answers and I urge you to talk to your own doctor."