COVID-19 vaccine shots for kids ages 5 to 11 may be available as soon as November after Pfizer and BioNTech submitted on Thursday an emergency use authorization to the Food and Drug Administration (FDA).
The FDA has scheduled a public hearing on Oct. 26th to examine the request.
The companies' authorization request comes just weeks after they announced new clinical trial data showing the vaccine was "safe, well-tolerated and showed robust neutralizing antibody responses" in kids ages 5 to 11.
It also comes as the U.S. faces a surge of COVID-19 cases, including among children who are both back in school and not yet old enough to be vaccinated.
Here are five things parents should know about COVID-19 vaccines and kids under the age of 12.
1. Kids ages 5 to 11 are still not eligible for a COVID-19 vaccine.
While the FDA authorization request from Pfizer and BioNTech is an encouraging next step, it does not mean that children under age 12 are now eligible to get a COVID-19 vaccine.
The FDA will still need to review the data and decide whether or not to grant emergency use authorization.
If the FDA does ultimately grant authorization for the Pfizer vaccine in kids ages 5 to 11, the vaccine would be able to be administered fairly quickly
Then the FDA will continue to review data to decide whether to grant full FDA approval for the vaccine in kids ages 5 to 11.
The two other vaccines currently available in the U.S., Moderna and Johnson & Johnson, are currently available only for people 18 years and older.
2. The Pfizer dose is different for kids under age 12.
In Pfizer and BioNTech's clinical trial of more than 2,200 children, the COVID-19 vaccine was administered in two doses, but the doses were one-third the amount given to adults.
The clinical trial results, which have not yet been peer-reviewed, showed the antibody response in children at that dose was at least as strong as the full adult does in patients ages 16 to 25.
Pfizer and BioNTech say the vaccine produced minimal side effects in children ages 5 to 11, and the side effects were similar to those experienced by adults and older children.
For 12- to 15-year-olds, the FDA has authorized the same dosing as adults with the Pfizer two-dose vaccine.
3. The vaccine's focus is on kids' immune systems.
Children have different immune systems than adults, so it should be reassuring for parents that the Pfizer BioNTech vaccine has been shown to be safe in kids.
Differing immune systems among people of different ages also help explain why the cutoffs for vaccine eligibility rest on age and not body size.
In addition to the COVID-19 vaccine, other immunizations are also scheduled and administered based on age and not weight. This is partially due to the fact that the body’s immune responses to vaccinations and infection are thought to be different based on age.
4. The vaccine will be distributed to kids through pediatricians, pharmacies, health clinics and more.
Once greenlighted, the pediatric doses of the vaccine will be sent to thousands of sites across the country, including more than 25,000 pediatricians’ offices, more than 100 children’s hospitals, tens of thousands of pharmacies, and hundreds of school and community- based clinics, the White House announced Oct. 20th.
Within days, more than 15 millions of doses are set to begin distribution across the country.
Though the White House has purchased 65 million Pfizer pediatric vaccine doses -- more than enough to fully vaccine all children ages 5-11 in America -- the first launch will dole doses out in waves based on states’ eligible population of kids. Shipments can recalibrate based on shifting demand.
The distribution plan will also include a national public education campaign to "reach parents and guardians with accurate and culturally-responsive information about the vaccine and the risks that COVID-19 poses to children," according to the White House.
White House officials told the nation's governors on Oct. 12th that it has enough pediatric doses on hand for the 28 million children ages 5 through 11 expected to become eligible once the FDA gives the green light.
To troubleshoot any confusion in distribution, federal health officials are outlining a new color-coded cap system for each formulation of the vaccine, though still "preliminary." Purple-capped vials will contain doses for adult and older adolescents, a chart offered to states said; orange-capped vials will contain doses for kids aged 5-11.
5. Families need to remain vigilant against COVID-19.
While there is a light at the end of the tunnel with younger kids having access to a COVID-19 vaccine, families need to stay vigilant against the virus as they wait for FDA authorization.
Unvaccinated children can not only become ill from COVID-19 themselves, but they can also spread the virus to more vulnerable family members and other adults with whom they interact.
Both the Centers for Disease Control and Prevention and the American Academy of Pediatrics recommend universal mask wearing in schools to help slow the spread of COVID-19.
Experts say that in addition to unvaccinated children wearing face masks, parents and siblings who are vaccinated should also continue to wear face masks indoors because of the rates of breakthrough infections in the U.S.
Families should also continue to follow other safety guidelines shared throughout the pandemic, including social distancing and hand washing.
ABC News' Sasha Pezenik and Anne Flaherty contributed to this report.