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FDA grants EUA for COVID vaccine in 5- to 11-year-olds; AAP experts answer questions ahead of roll-out

October 29, 2021

Editor’s note: For the latest news on COVID-19, visit

The Food and Drug Administration on Friday authorized emergency use of Pfizer-BioNTech’s COVID-19 vaccine for children ages 5-11 years, after data showed it is safe and effective in this age group.

Before the vaccine rolls out, the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) will recommend who should get the shot, and the CDC director then must approve the recommendations. ACIP is scheduled to meet on Nov. 2 to discuss recommendations.

Experts at an AAP virtual town hall on Thursday talked about how pediatricians can prepare to administer the vaccine and instill confidence in parents.

AAP Chief Population Health Officer Anne R. Edwards, M.D., FAAP, set the stage by reviewing the most recent statistics on COVID-19 cases and hospitalizations in children as well as vaccine uptake in youths ages 12 and older. Nearly 50% of youths ages 12-17 are fully vaccinated, according to an AAP report. Yet vaccination rates vary by state, and there has been a downward trend in those getting their first dose.

Joining Dr. Edwards were Shaquita L. Bell, M.D., FAAP, immediate past chair of the AAP Committee on Native American Child Health; Lisa M. Costello, M.D., M.P.H., FAAP, a member of the AAP Committee on State Government Affairs and president of the West Virginia Chapter; and James D. Campbell, M.D., M.S., FAAP, a member of the AAP Committee on Infectious Diseases.

Following are some questions the experts addressed.

Q: Why will younger children get a 10 microgram dose rather than the 30 microgram dose given to those ages 12 and older?

A: Dr. Campbell explained that the first trials compared 10, 20 and 30 microgram doses in children. The first few children who received 30 micrograms developed fevers and red, sore arms. So the trial continued with only 10 and 20 microgram doses. Results showed the same immune response in those who received 10 micrograms vs. those who got 20 micrograms, and minor side effects were lower in the 10 microgram group.

“So if you have same immune responses but fewer side effects, then you go with that dose,” Dr. Campbell said.

Q: What if a child is 11 years old when she gets the first dose but turns 12 before the second dose?

A: The child should get 10 micrograms for each dose.

Q: What dose should children ages 11 and under get if their weight is comparable to a teen’s or adult’s?

A: They should get 10 micrograms. The dose is not weight based. It’s based on immune maturity, Dr. Campbell said.

Q: Should children get the vaccine if they already had COVID?

A: Yes. “You do get protection from being infected, but you get better protection if you're infected and then vaccinated,” Dr. Campbell said.

Q: How should the vaccine be stored?

A: It can stored in an ultra-cold freezer for up to six months or in a refrigerator at 2-8 degrees Celsius for up to 10 weeks, Dr. Costello said. “The storage is a little bit friendlier, which I think is music to everyone's ears.”

However, once the vial is punctured, it needs to be used within six hours, she added.

Q: Are there any other differences between the vaccine for 5- to 11-year-olds and the one for those ages 12 and older?

A: The vaccine for the younger group has an orange cap rather than a purple cap. The injection volume, fill volume and amount of diluent used also are different. The vial also contains 10 doses compared to six doses in a vial of adult/adolescent vaccine.

Dr. Campbell noted that the typical pediatric vaccine injection volume is 0.5 milliliters (mL), but the COVID vaccine is 0.2 mL. “So you really have to be careful with this to mix it correctly and to give the right dose.”

Conversations with parents

The panelists also offered advice on how to talk with parents who have questions or are hesitant to give the vaccine to their children.

Dr. Bell said she often hears parents say they are going to wait to see what happens to other children. She also continues to hear concerns about how the vaccine will affect fertility and fears about other long-term effects.

“It's just meeting people as a human and really being open and sharing and saying, ‘You know how much I care about the health of our community and your children and I would never advise you to do something that I think is dangerous. I think COVID vaccines are safe, they're effective and they are what is best for our community,” she said.

Dr. Campbell noted that questions about long-term effects have been raised about every vaccine.

“So the way that I just discuss it is we've never had a vaccine that has ever had a long-term side effect that we didn't discover early on. Could these be the first vaccines where there would be something? It's possible, but it's really unlikely.”

He called the link to fertility problems “a social media hoax.” It started when someone looked at the amino acid sequences of virus’ spike, found one sequence that was the same as a placental protein and hypothesized that the vaccine could cause infertility.

“And boom, that's all it took to turn this into ‘the vaccine causes infertility,’” Dr. Campbell said.

He responds by saying, “If that were true, then you would want to get vaccinated because if you get COVID, the amount of spike that you're going to have … is multiple 1000s of orders of magnitude above what you get by getting the vaccine.”

Town hall participants ended on a hopeful note.

“I think for each of you out there, whether you're giving vaccines in your clinic or you're planning to or you're talking to families, how many hugs have you helped make happen?” Dr. Costello asked. “And I think that we have many hugs in those moments in the future, and the work that we do as pediatricians is incredibly important.”

The next COVID-19 Town Hall will be held at 5 p.m. CT on Nov. 4. To register, visit




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