COVID shots for youngest are almost here. What you need to know

Combined ShapeCaption
Pfizer's COVID vaccine for kids under 5 , moves closer to FDA approval .Pfizer announced June 1 that its application to the Food and Drug Administration for the vaccine was complete.Pfizer announced June 1 that its application to the Food and Drug Administration for the vaccine was complete.The three-dose vaccine is for children between the ages of 6 months and 5 years.Pfizer released a statement detailing the application.Pfizer and BioNTech completed a rolling application to the U.S. Food and Drug Administration for emergency use authorization (EUA)... , Pfizer statement, via ABC News.... of the 3-µg (microgram) dose of the Pfizer-BioNTech COVID-19 Vaccine.., Pfizer statement, via ABC News.... for children 6 months through 4 years of age (also referred to as 6 months to under 5 years of age) on June 1, 2022, Pfizer statement, via ABC News.Pfizer reported an 80% effectiveness rate in children in May

The FDA’s independent experts are scheduled to meet Wednesday to review COVID vaccine data

More than two years into the COVID-19 pandemic, Georgia parents can expect to finally be able to vaccinate their youngest children as soon as June 21.

The Food and Drug Administration’s independent experts are scheduled to meet Wednesday to review COVID vaccine data and make a recommendation on whether Pfizer and Moderna’s vaccines for the country’s youngest kids should receive emergency authorization. The federal agency finished staff evaluations days ahead of the meeting, saying both appear safe and effective for young children. Pfizer is already authorized for children 5 to 11.

Moderna’s vaccine has been cleared for only adults, but they will be looking to get the authorization next week for kids 6 through 17 years of age, as well as kids under 6 years of age.

It’s been a long wait for parents who have been anxious to vaccinate their children under 5, and have watched adults, teenagers and older children get their shots and even a booster or two. The timetable was delayed in February when the results of a two-dose series of the Pfizer vaccine didn’t provide a sufficient level of protection. The company decided to amend the trial to add a third dose.

ExploreUpdate: US opens COVID vaccine to little kids
Combined ShapeCaption
In this file photo, From left, Jim Zvikas, R.N., Riley Erickson, site manager with CORE, and Douglas Ruano, with CORE, eat their lunch as they wait for the last scheduled client showing up at North Springs United Methodist Church in Sandy Springs. (Hyosub Shin / Hyosub.Shin@ajc.com)

Credit: HYOSUB SHIN / AJC

In this file photo, From left, Jim Zvikas, R.N., Riley Erickson, site manager with CORE, and Douglas Ruano, with CORE, eat their lunch as they wait for the last scheduled client showing up at North Springs United Methodist Church in Sandy Springs. (Hyosub Shin / Hyosub.Shin@ajc.com)

Credit: HYOSUB SHIN / AJC

Combined ShapeCaption
In this file photo, From left, Jim Zvikas, R.N., Riley Erickson, site manager with CORE, and Douglas Ruano, with CORE, eat their lunch as they wait for the last scheduled client showing up at North Springs United Methodist Church in Sandy Springs. (Hyosub Shin / Hyosub.Shin@ajc.com)

Credit: HYOSUB SHIN / AJC

Credit: HYOSUB SHIN / AJC

Once authorized, many parents will likely rush to get their children vaccinated. But they could be in the minority. A Kaiser Family Foundation survey conducted in April found that just 18 percent of parents with children under 5 said they would get them vaccinated right away, while 38 percent said they would wait and see.

Most parents especially in Georgia have not vaccinated their children between the ages of 5 to 11, which likely doesn’t bode well for vaccination uptake for the state’s youngest children. Among children 5 to 11 in Georgia, 173,627 — 18% of the children in that age group — have received one dose as of earlier this month, according to DPH. Only 147,803 children or 15% in this age bracket have been fully vaccinated. Vaccination uptake is higher among older kids: 47% of kids 12 to 17 in Georgia have received one dose, and 43% are fully vaccinated.

Here’s the latest on COVID vaccines for young children based on information from the Centers for Disease Control and Prevention and other sources.

Combined ShapeCaption
This combination of 2022 and 2020 file photos shows logos for the U.S. Centers for Disease Control and Prevention and the Food and Drug Administration. (AP Photo/Ron Harris, Manuel Balce Ceneta, File)

Credit: Ron Harris

This combination of 2022 and 2020 file  photos shows logos for the U.S. Centers for Disease Control and Prevention and the Food and Drug Administration. (AP Photo/Ron Harris, Manuel Balce Ceneta, File)

Credit: Ron Harris

Combined ShapeCaption
This combination of 2022 and 2020 file photos shows logos for the U.S. Centers for Disease Control and Prevention and the Food and Drug Administration. (AP Photo/Ron Harris, Manuel Balce Ceneta, File)

Credit: Ron Harris

Credit: Ron Harris

Q. How long it would it take for my child to get a COVID vaccine after authorization?

A: The process will start with the FDA’s independent experts scheduled meeting Wednesday to review the data on Pfizer and Moderna’s COVID vaccines for younger children. The FDA is not obligated to follow the committee’s recommendation, though it usually does. Advisors to the CDC must also weigh in and CDC Director Dr. Rochelle Walensky would have to give the green light before vaccinations in this youngest age group could start.

If this all happens as expected, the first doses could start arriving at pediatrician’s offices, children’s hospitals, and other locations in Georgia on Monday, June, 20 and vaccines could start as early as June 21.

Combined ShapeCaption
Dr. Ashish Jha, the White House COVID-19 response coordinator, makes remarks during a news briefing at the White House in Washington on Thursday, June 2, 2022. Jha said that the first COVID-19 shots for children under age five could become available as early as June 21, and that states can begin ordering them from the Biden administration beginning on Friday. (Doug Mills/The New York Times)

Dr. Ashish Jha, the White House COVID-19 response coordinator, makes remarks during a news briefing at the White House in Washington on Thursday, June 2, 2022. Jha said that the first COVID-19 shots for children under age five could become available as early as June 21, and that states can begin ordering them from the Biden administration beginning on Friday. (Doug Mills/The New York Times)

Combined ShapeCaption
Dr. Ashish Jha, the White House COVID-19 response coordinator, makes remarks during a news briefing at the White House in Washington on Thursday, June 2, 2022. Jha said that the first COVID-19 shots for children under age five could become available as early as June 21, and that states can begin ordering them from the Biden administration beginning on Friday. (Doug Mills/The New York Times)

Q: Will the vaccine be widely available right away?

A: Probably not. Only about 10% of retail pharmacies across the country plan to participate in vaccinating children in this youngest age group. Officials say that they expect pediatricians and family doctors to administer most of the shots.

The first orders placed for Georgia, and contingent on the vaccines being authorized include 27,000 doses of Pfizer and 9,400 doses of Moderna vaccine, according to DPH.

The first orders were placed by about 150 providers, which include 89 pediatricians and several family practice doctors and health departments.

Dr. Ashish Jha, the White House COVID-19 response coordinator, said recently, “Our expectation is that within weeks, every parent who wants their child to get vaccinated will be able to get an appointment.

To find a provider offering the vaccine for younger children, go to https://www.vaccines.gov/

Q: What do we know from the studies so far about the vaccines for younger children?

A: Pfizer said preliminary findings in clinical trials of its three-dose vaccine for children under 5 and as young as 6 months old was 80% effective at preventing symptomatic COVID-19. The data was collected during a time when omicron was the main circulating variant.

Moderna said its two-dose vaccine was about 51% effective against symptomatic infection in children 6 months through 2 years of age, and about 37% effective among those 2 through 5. This data was also collected when omicron was circulating widely. The company said it anticipates a third dose will be necessary as a booster dose.

Both companies said the child-size doses were well tolerated and no safety signals were identified.

Both companies have also submitted detailed data for regulatory review by the FDA.

Q: What is the proposed dosing vaccine for younger children?

A: The Pfizer vaccine for children ages 6 months through 4 years of age is one-tenth of the dose for adults. Moderna’s two-dose vaccine for children 6 months through 5 is one-quarter of the strength for adults.

Combined ShapeCaption
Parents concerned as latest COVID-19 variant is showing up in more and more children

Parents concerned as latest COVID-19 variant is showing up in more and more children

Combined ShapeCaption
Parents concerned as latest COVID-19 variant is showing up in more and more children

Q: How important is COVID vaccination for young children?

A: COVID generally causes less severe disease among children compared to adults, with significantly lower mortality.

Even though children are far less likely than adults to be hospitalized or to die from COVID, it is not a benign disease in young ages, according to the American Academy of Pediatrics. Vaccination can help prevent serious complications like multisystem inflammatory syndrome in children (MIS-C). MIS-C is a condition where different body parts become inflamed, including the heart, lungs, kidneys, brain, skin, eyes, or gastrointestinal organs. There have been about 8,000 cases in the U.S. of MIS-C, and vaccination reduces the chances of MIS-C by 91%, according to the CDC.

The number of children hospitalized rose during the omicron surge. While children with chronic health conditions are at increased risk for severe illness from COVID, almost half of the children hospitalized with COVID had no underlying conditions, according to the CDC.

And as omicron swept the country over the winter, it also infected large numbers of people especially children. The CDC estimates about 75% of children had been infected with the coronavirus by February, according to a study. While children seem to be mostly spared from the worst effects of COVID, pediatric hospitalizations rose during the omicron surge, and some experts worry about long term-consequences even for children who have mild symptoms.

Omicron not only sent more children to the hospital in the ICU than in previous waves, but children who were unvaccinated were twice as likely to be hospitalized than those children who were vaccinated, according to the American Medical Association Director of Science, Medicine and Public Health Dr. Andrea Garcia.

Q: Does a child need to get vaccinated if they have already had COVID?

A: If your child has had COVID, they may be protected for some time from another infection. But right now, there is no test to reliably check how much or how long a person is protected by a prior infection. What is clear is those who have recovered from a COVID infection can still get infected again. Breakthrough infections have also become more common.

Growing evidence indicates people get added protection by getting vaccinated after having been infected by COVID, according to the CDC.


Upcoming scheduled FDA meetings

Tuesday: Moderna’s EUA (emergency use authorization) request for COVID vaccine for children ages 6 -17.

Wednesday: Moderna’s EUA request for COVID vaccine for 6 months through 5 years of age and Pfizer-BioNTech’s EUA request for its COVID vaccine for 6 months through 4 years of age.

June 28: Discussion on proposals to update existing COVID-19 vaccines for all ages so they work better against coronavirus variants.