Ask the Expert: COVID-19 vaccine for children under 12

There was big news this week for parents and caregivers of young children as progress is being made toward authorization of the Pfizer COVID-19 vaccine for kids ages of 5 to 11. Though this is welcome news for many and will help push us further toward the end of this pandemic, questions are still swirling among caregivers on the safety and efficacy of the vaccine for younger children.

We asked Dr. Aaron Carroll, pediatrician and chief health officer for Indiana University, some key questions as anticipation grows for expansion of COVID-19 vaccine eligibility.

Question: So really, how close are we to getting kids under 12 vaccinated? What's next?

Answer: Close. Reports I've seen say we could be getting younger kids vaccinated as early as the end of October. Now, there are still some steps Pfizer needs to go through before we can say with certainty what the timing will be, however.

Next, Pfizer will be submitting an Emergency Use Authorization to the FDA to use the vaccine in kids ages 5 to 11. The FDA has said it will prioritize this application and will take about a month to review a myriad of data from Pfizer.

If the FDA gives the OK, it goes to the Advisory Committee on Immunization Practices and the CDC. The ACIP reviews the safety and efficacy of vaccines, helps determine who and how people can get vaccinated, and looks at the risk-benefit analysis.

The ACIP votes on whether or not to recommend the COVID-19 vaccine for 5- to 11-year-olds. The CDC takes this recommendation and then makes the final decision on whether to allow eligibility for the Pfizer vaccine to expand to this new age group.

Q: What kind of clinical trials did Pfizer do to ensure this is safe for our kids?

A: Just like before any vaccine is authorized or approved for children (or adults, for that matter), the company developing the vaccine must go through rigorous safety measures, including the usual clinical trials. This is exactly what Pfizer has done.

In the Phase I trials, they tested the best dose for kids in the 5-to-11 age range. In the Phase II / III trials, thousands of kids received the vaccine, and scientists reviewed their immune response, collecting two months' worth of data. Good news is they found that the approved dose from Phase I worked extraordinarily well leading to a comparable immune response, and there were no serious adverse events in the data collected so far in the trial.

Q: Did the trials look at specific side effects like myocarditis or any effects on future fertility?

A: Pfizer's trials tracked myocarditis, a type of heart inflammation, and there were no cases in the clinical trials. However, because myocarditis is so rare, I'm not surprised that no cases were seen based on the number of participants.

We will continue to watch this in post-authorization monitoring, but it's likely the ACIP will determine that the benefits still outweigh the risks when it comes to myocarditis, even in this younger age group. The incidence of myocarditis with actual COVID-19 infection continues to be far greater than with the vaccine; not to mention the other negative outcomes that can occur with a COVID-19 infection.

As far as fertility concerns with the vaccine, first, the notion that the mRNA COVID-19 vaccines affect fertility in any way is a complete myth. It's false and based on misinformation about how the vaccine works. Science and research have debunked this myth and have clearly shown that the mRNA vaccines do not alter your DNA, enter your genome or create an immune response that attacks the placenta during pregnancy. Having said that, the most recent clinical trials would not assess this particular question.

Q: Will the vaccine protect kids as much as adults from severe disease and hospitalizations?

A: We have every reason to believe that the vaccine will be as effective in younger kids as it is in adults. We expect it to help with mild to severe infections and keep our kids from being hospitalized, just as we're seeing in vaccinated adults. It's also believed that the vaccine will help reduce transmission and help prevent "long COVID" in kids.

Q: Is there any news on vaccines for kids under 5?

A: Clinical trials and data collection on the Pfizer vaccine in this even younger population are still underway. It could be as early as November or December that data are available for review, however. Once those data are available, they'll have to go through the same process outlined above with the FDA, ACIP and CDC before we can get our littlest kids vaccinated.

Q: Do you have any concerns about giving kids under 12 a COVID-19 vaccine?

A: I really don't. The COVID-19 vaccines we have today are the most studied vaccines we've ever had. My kids are all over 12 and have already been vaccinated, but I'm sure if they were younger, we would be lining up to get them vaccinated as soon as they were eligible.

As I said in one of my recent articles in The Atlantic, vaccinations are arguably the greatest public-health achievement of the past century, a fact that's only become more obvious in the past year. They're a collective good, and as part of society, we should honor the social contract to protect others as we'd want to be protected ourselves.

If I was your child's pediatrician, I would absolutely recommend a COVID-19 vaccine as soon as they are eligible.