FDA panel meets on COVID-19 vaccine shots for kids under 12: Five things to know

October 26, 2021

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(NEW YORK) — COVID-19 vaccine shots for kids ages 5 to 11 may be available as soon as November, depending on the outcome of a Food and Drug Administration (FDA) advisory panel hearing happening Tuesday.

At the hearing, the FDA’s independent advisory committee is expected to have a public discussion and hold a non-binding vote on whether to authorize the Pfizer/BioNTech vaccine for the approximately 28 million children in the United States ages 5 to 11.

Once the FDA decides to authorize the vaccine, the issue goes before the Centers for Disease Control and Prevention’s vaccine advisory group.

That group, the Advisory Committee on Immunization Practices, is set to meet on Nov. 2 and 3, and from there, the CDC director must sign off on the recommendation.

Dr. Francis Collins, director of the National Institutes of Health (NIH), said on “Good Morning America” Tuesday that getting more kids vaccinated will be key to ending the pandemic.

“If we can create a situation where more of these kids are not getting infected, we should be able to drive this pandemic down which is what we really hope to do, even as we face the cold other and other concerns about whether we might see another surge,” said Collins. “We don’t want that, and this would be one significant step forward in getting our country really in a better place.”

As the countdown begins, 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 yet eligible for a COVID-19 vaccine.

Tuesday’s public hearing does not mean that children under age 12 will immediately be eligible to get a COVID-19 vaccine.

The final vote on whether the vaccine is authorized for use in kids ages 5 to 11 will happen in early November, and will come from the CDC director.

Once that decision is made, the vaccine would be able to be administered relatively quickly to children across the country.

At the same time, 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.

Moderna said Monday it plans to submit data to the FDA soon showing its vaccine for children ages 6 to 11 produces a strong immune response and appears safe.

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 known 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 million 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 CDC and the American Academy of Pediatrics recommend universal mask-wearing in schools to help slow the spread of COVID-19.

Experts said 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.