Q&A: When will a COVID-19 vaccine be widely available for all children?
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On Dec. 11, the FDA issued an emergency use authorization for a COVID-19 vaccine developed by Pfizer and BioNTech, making it available for patients aged 16 years or older.
Another COVID-19 vaccine, this one developed by Moderna Inc. and the NIH, is expected to receive emergency use authorization (EUA) this week.
Based on guidance from the CDC’s Advisory Committee on Immunization Practices, health care workers and residents of long-term care facilities are being vaccinated first. Nonmedical essential workers, older patients and patients with high-risk medical conditions will be prioritized in ensuing phases.
Children have only recently been included in COVID-19 vaccine trials, and it is unclear when children aged younger than 16 years will have access to a vaccine.
“While [the EUA] is an important step forward, the work has only just begun,” AAP President Sally Goza, MD, FAAP, said in a statement. “The COVID-19 pandemic continues to take a devastating toll on children’s health, which is why it is absolutely critical that children have access to COVID-19 vaccines that are safe and effective for their use.”
As pediatric case counts continue to rise, Healio spoke with Anita Chandra-Puri, MD, a pediatrician for Northwestern Medicine and spokesperson for the AAP, about the lag in testing COVID-19 vaccines in pediatric populations.
Question: Often, children are among the last to be included in clinical trials. Do you have any concerns that enough children will be included in clinical studies for the COVID-19 vaccines so they can benefit from an authorized vaccine?
Answer: I think it's really important that children are included. Getting patients involved in clinical trials is its own stress. I think a lot of people are hesitant to have their children involved. But before a vaccine can really be licensed for use in children, we need to have enough children involved in the clinical trials to understand the safety ramifications, the effectiveness of the vaccine in children and really just to make sure we understand any side effect profiles, because this is such a new disease. We really want to be inclusive but cautious, of course.
Q: How do you think children should be prioritized to receive the vaccine?
A: It's really interesting. In my experience so far, although there are some children who have had significant complications, like multisystem inflammatory syndrome in children, overall, the vast majority of children I have seen or have taken care of have had very mild illness, similar to other respiratory illnesses. So, do I think that all children need to be in line for the vaccine right now? I think there are other groups that are probably more at risk for having complications or a significant morbidity or mortality from coronavirus. I think children at some point should be in line for this vaccine, but I don't think that they should be right at the forefront of it by any means.
Q: Following a recommendation, can we estimate when children aged younger than 16 years are going to have access to a COVID vaccine?
A: I don't know that there's any way to estimate that right now. This is all evolving. It would be lovely to have everything together before the next school year, but there's no way for me to know. I don't know that anybody can tell you that at this point, because enough children need to be involved in the studies and we need to see enough safety data. Plus, on the production end, enough of the vaccine needs to be produced to vaccinate children. But I don't know that anybody can tell you when that's going to happen.
Q: What more needs to be done in order to test the safety and efficacy of a vaccine in those aged 12 to 15 years?
A: Enough adolescents, so 12-to-15-year-old children, need to be involved in actually getting vaccinations and then there needs to be enough time after vaccination to study the efficacy and immunogenicity of the vaccine, along with duration of the protection. I think we're going to be getting a lot of information from the millions of adults who will be vaccinated as well. And so, even in the trials that have happened so far, those patients are going to be followed for a certain length of time. I think it’s going to take up to 2 years to see what's going on in terms of how long the vaccine or the immunogenicity persists in those patients. Some of that information will probably be extrapolated for younger age groups as well, but I think there just needs to be numbers of people involved in the vaccine trials in order for us to get to that point where we feel like we should be vaccinating children as well, or we could safely be vaccinating children as well.
When thinking about 16-to-17-year-old’s bodies, [their] immunogenicity is similar to that of adults. Then there are 12-to-15-year-old children, who are sort of in the pubertal phase of life, and younger children in the elementary age group, and then the youngest children. There are different age groups that are going to have to be studied, and there will definitely need to be vaccine trial participants from different age groups.
Q: Do you think the COVID-19 vaccine should be added to the routine vaccination list?
A: It's hard to say, but if we find that it's safe and effective, and we see that this viral infection continues on and on, over the years, then absolutely. I think that it would be an important thing to include in the routine vaccination list, but at this point in time, there's no way to know that.
Q: What is the importance of vaccinating children in correlation with adults? We have seen a few different study results that have shown children are silent spreaders , and if that's the case, sending kids back to school, we have to take children's safety into account, but what about if children are spreading it to teachers and staff?
A: At this point, it would be very important to go down the line of having all the adults vaccinated, because we know that there are safety data for adults. That will then at least provide a level of protection for the adults to take care of the children. If children are getting the infection, but not having a severe illness, then that's fortunate for children, but we want to protect everybody around them, and that has been the whole issue this year. It’s been that we want to make sure that even though children don't seem to be as sick, we want to protect their loved ones or their caretakers or teachers. That's why I think the rollout of having adults be vaccinated first [is correct] because we know that there are safety data for adults.
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