COVID-19 vaccine shots for kids under 12 may be available in November: 6 things to know

Pfizer has submitted for FDA vaccine authorization for kids ages 5 to 11.

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 six 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 FDA approved the Pfizer vaccine for people ages 16 and older in August. It is currently authorized for emergency use in children ages 12 to 15.

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The clinical trial results, which have not yet been peer-reviewed, showed the antibody response in children at that dose was at least as strong as the full adult does in patients ages 16 to 25.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. FDA authorization is not expected to be rushed.

The FDA has signaled it will be extremely thorough in its review of COVID-19 vaccines for younger kids, so a quick authorization is not expected for the Pfizer BioNTech vaccine.

For reference, Pfizer announced the results of its clinical trials for the COVID-19 vaccine in children ages 12 to 15 in March. The FDA authorized the vaccine for emergency use in that age group around two months later, in May.

4. The vaccine 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.

5. The vaccine will be distributed to kids through pediatricians, pharmacies, health clinics and more.

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.

The doses will be sent to thousands of sites, including pediatricians, family doctors, hospitals, health clinics and pharmacies enrolled in a federal program that guarantees the shots are provided for free.

Initial distribution of the Pfizer vaccine for children ages 5 to 11 years old will be based on a state’s population of eligible children, according to a planning document sent to state officials in advance of the vaccine being authorized by the FDA.

The pediatric vaccine will be shipped in 100-dose packs, each with 10 vials, the document said.

A person familiar with the planned rollout told ABC News that while the government purchased 65 million doses total, the initial shipment may be closer to the 10 million to 20 million range.

After an initial distribution, a "weekly supply will be made available to help sustain the network," according to the document.

6. 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, Katherine Faulders and Anne Flaherty contributed to this report.

Top Stories

Top Stories

Top Stories

Top Stories

ABC News Live

ABC News Live

24/7 coverage of breaking news and live events