Pfizer’s COVID-19 vaccine is now available to people as young as 12 years old. In this Q&A, Benjamin Lee, MD, a pediatric infectious disease specialist at the University of Vermont Children’s Hospital, answers questions about vaccine safety and efficacy.

Are there any health conditions that would prevent a child age 12-to-15 years old from being eligible to get vaccinated?

The only reason why somebody should not get the vaccine is if they have a known severe allergy – meaning anaphylaxis – to any of the vaccine components. Any other history of allergies, even severe allergy due to any other cause, is not a risk. Those kids can – and should – receive vaccination.

This vaccine is not a live vaccine, meaning even children who are immunocompromised are eligible to receive it. The only caution for immunocompromised children is that they might not have as strong an immune response.

What does the new availability of vaccines to children as young as 12 mean for vaccinating even younger children?

Usually vaccines are tested in adults first. And then they typically undergo what’s known as an “age de-escalation” strategy: The vaccine is tested in younger and younger cohorts until it reaches infancy. And that is the schedule that the vaccine manufacturers are on.

I’m very optimistic that these results, and that these vaccines, will be available at some point in the future for the youngest group as well.

So you think the vaccine will be approved for children younger than 12 years of age?

Absolutely. In fact, my understanding is Pfizer already believes that they should have enough data by September to file another extension for their Emergency Use Authorization (EUA) with the Food and Drug Administration (FDA) for children down to the age of two. Those trials are in progress, and all indications are that we should see promising data for the younger kids coming later this summer.  

What does Emergency Use Authorization mean?

This refers to a distinction between an authorization for emergency use versus a formal approval. Typically the formal FDA approval process is a little bit longer.

Currently all of the vaccines are approved for emergency use, meaning the data indicates clearly that they are safe and they are effective. If anything, EUA is a bureaucratic distinction rather than any concern about the performance or safety of the vaccines themselves.

Pfizer is the first to submit their vaccine for a full FDA approval; that should be coming out soon as well. Once a vaccine is approved by the FDA, the EUA is removed and it’s considered approved.

Are pediatricians ready to have conversations about vaccines with children and families?

There is tremendous value in those one-on-one interactions. Studies have shown over and over again that one of the single best predictors of whether somebody will follow any type of health recommendation is if that recommendation comes from a trusted provider.

There is a terrific program run through the University of Vermont called VCHIP, the Vermont Children’s Health Improvement Program. This network allows pediatricians to talk directly to one another. Since the beginning of the pandemic, providers can call in three times a week for information. That’s one example of how pediatricians have been getting ready for this big push coming up.

We have tremendous leadership here within our local American Academy of Pediatrics chapter as well. UVM Children’s Hospital’s Rebecca Bell, MD, our Vermont AAP president, has been a leader in this conversation. You can rest assured that our pediatrics community has a keen interest being able to provide these vaccines for our kids.

How many children participated in the vaccine trial?

The total number of kids that were included in the evaluation was about 2,200, half of which got the vaccine and half of which got placebo.

Typically what these studies would look for would be efficacy – how many kids who got vaccinated got COVID-19 compared to those who didn’t. What was astounding was that in the 12-to-15-year-old age group, not a single vaccinated child got COVID-19 during the time period of the study, compared to 18 children in the placebo group who got COVID-19.

And when we look at the reported side effects, they were very, very close to what were reported for individuals age 16 and older. Every indication is that this vaccine behaves in 12-to-15-year-olds in exactly the same way as it does for those who are over age 16.

What would you say to parents who believe the vaccines were developed too quickly?

One of the concerns that people have raised is that there were shortcuts in the process. To me that’s very unfortunate.

It is true that these vaccines were made in record time. But from my perspective as a vaccine researcher, just because these were developed in record time does not mean that shortcuts were taken. When I look at the safety data, when I look at the efficacy data, the trials were done very well and give very strong, very robust results.

From my perspective as a physician, a pediatrician, an infectious diseases specialist and a vaccine expert, I just want to reassure folks that there were no shortcuts taken. The safety data are sound. The efficacy data are strong. These were absolutely very rigorous, very well-designed, very well-executed trials. And we can trust the data.

I will say that the pace of everything having to do with COVID-19 vaccine has far exceeded my expectations. I think it’s important to reiterate what an accomplishment it is that we actually have a vaccine and are having the discussion now that we’re having. When the best minds in the scientific community around the world all pull in the same direction it’s really amazing what can be accomplished.

What would you say to parents who don’t plan to have their child get vaccinated because they say kids don’t really transmit COVID-19, there is not a lot of risk of death and they’re at really low risk for this virus?

I do acknowledge that otherwise healthy children, thus far, have been at low risk for having severe COVID-19. However, what has been generating more concern is that when a teenager gets COVID-19, it doesn’t appear that they are any less at risk for having what’s commonly known as long-haul COVID, or prolonged symptoms. Even if it’s not the same as having a child critically ill in the hospital, long-haul COVID can change a child’s quality of life, and we are seeing this happening with our children.

While younger children are less likely to transmit COVID-19, it’s become clearer that the older kids do tend to transmit it almost as well as adults. We need everybody to get vaccinated in order to slow the pandemic down as much as possible.

I think it is important to think about all the things that these kids weren’t able to do this last year, all the things that were taken away from them because there was no way to feel protected from the ongoing pandemic. For the first time now, teens can actually do something to take their lives back. And I think that we shouldn’t underestimate how much good it would do for kids to get vaccinated simply to be able to help us return to life as we knew it pre-pandemic.

The prolonged school closure, decreased access to sports and activities, these are all things that, I would argue, also pose a risk to kids, and carry a risk of long-term harm. We need to weigh all of those factors into the decisions when families are deciding whether to get their kids vaccinated or not.

Do we know if COVID-19 variants pose a risk to children?

So far all the data that we do have regarding protection from the vaccines have been very encouraging. It looks like all of the current vaccines available in the United States protect against most of these variants; I don’t see any reason why kids will be an exception to that rule.

What would you say to parents that refuse the COVID-19 vaccine for their children?

I think it’s important to remember that, as with any health intervention, we shouldn’t view it as just a one-time discussion. And I think the best thing that can be done is just making sure that families and providers have a trusting relationship that fosters ongoing discussion and communication, and that nothing is done that will erode that trust.

The best advice I could give is to say, “Let’s not give up,” when folks do raise questions or are initially hesitant to get vaccines. I think the only way that we can move forward is just by open and honest discussion, and that might not happen in a single clinic visit. Hopefully through that relationship, we can assure all families that these vaccines are, in fact, safe and effective, and that they should be given to all eligible children.

Are other COVID-19 vaccine manufacturers currently in vaccine trials for younger age groups?

Yes. Moderna has recently released data from their adolescent trials among 12-to-18-year-olds that showed very similar findings to Pfizer, so I wouldn’t be surprised if Moderna applies for an extension for their EUA in that age group fairly soon. I’m not sure yet what the timeline would be for Johnson & Johnson for the younger age cohorts. Moderna and Pfizer anticipate data being ready by the summer. Beyond that we’ll just have to wait and see.

Do you anticipate the COVID-19 vaccine becoming an annual vaccine, like the flu shot?

It’s still a little too early to say. Given what we know about other respiratory viruses, I wouldn’t be surprised if we would end up needing boosters at some point. But how frequent that would need to be remains an open question.

Despite the fact that it seems like this pandemic has been going on for forever and a day, we’ve only known about the virus for about a year and a half now. So time will tell. That’s why if we do start to see any shifts in the patterns of COVID-19, it’s going to be important to continue to be very vigilant in terms of good public health and good science to answer that question.

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