Q&A: COVID-19 vaccine makers ramp up testing in children
Although the Biden administration has said that enough COVID-19 vaccine doses will be available in the U.S. to vaccinate 300 million people by the end of July, it is still unclear when vaccines will be widely available to children.
Currently, the only COVID-19 vaccine available in the U.S. for any pediatric population is the Pfizer-BioNTech vaccine, which is authorized for use in people aged 16 years or older. However, both the Pfizer-BioNTech and Moderna messenger RNA (mRNA) vaccines are now being tested in children as young as age 12 years, and other manufacturers are eying similar efforts.
Oxford and AstraZeneca announced that they have begun enrolling children aged between 6 and 17 years in a trial for their vaccine candidate, and an executive for Johnson & Johnson told Bloomberg last month that the company expected to begin enrolling children in trials 4 to 6 weeks after receiving phase 3 data from its adult trials.
Healio spoke with Infectious Diseases in Children Editorial Board Member C. Buddy Creech, MD, MPH, an associate professor of pediatrics and director of the Vanderbilt Vaccine Research Program at Vanderbilt University Medical Center, about the timeline for pediatric vaccine trials and what it means for opening schools.
Healio: Do you think a vaccine will be available for children in time for next school year?
Creech: I think the same model that we have had for other companies and other products is what we'll see with these newer vaccines, too. What they basically do is establish that the vaccine is safe and effective in adults, and then once they can establish that, since that's where the burden of this pandemic lies, we can then turn our attention to younger children. There may be slightly different approaches moving forward, given that we now have some effective vaccines in adults. But by and large, this has been an adult pandemic, and that's where the focus has been.
Pfizer has moved down to 12 years, Moderna also has moved down to 12 years and all of the companies have pediatric plans that have a variety of approaches. But I think it will probably be the fall school year before we see our teenagers potentially being vaccinated, particularly those with underlying medical conditions. It would be further into the winter or early spring when I think we would see our youngest kids vaccinated, because it may be that we don't have to vaccinate all of them, because vaccination of everyone else may move us past this pandemic.
Healio: Do you think it’s important that children are vaccinated for schools to be open?
Creech: No, but I'll also say that different scenarios require different answers. My kids have been in school, in-person, all year, and so, we have a clear sense of what it looks like to do it safely and well. I don't think vaccination of students should be a prerequisite for school openings, primarily because their burden of disease is so much less than it is among adults. That being said, one of the best ways that we can ensure that schools can stay open is if we have our teachers and children vaccinated, particularly those with underlying medical conditions.
Healio: How important is it for teachers and staff to be vaccinated?
Creech: I think they should be prioritized, and in fact, they are. Teachers are widely recognized as belonging to the early vaccine phases, and I think in most areas, they are currently being vaccinated. That's certainly the case here in Tennessee. My wife is an elementary school teacher and is on the schedule to be vaccinated quite soon. I also think that we are seeing really good impact of risk mitigation strategies, which means that it's an important part of returning to school, but it's not a requisite part.
Healio: What about teachers and staff who might be hesitant about vaccines?
Creech: Well, I’d want to dive in, and I’d want to understand the basis for that hesitancy. If that hesitancy is from thinking that the vaccines were created by the government, I would say that almost all of our vaccines have been developed, at some stage in their development, through government funding. If their hesitancy is because they think that it happened too quickly, I would point to two decades of research on the spike protein of coronavirus and to two decades of research on mRNA vaccines and adenovirus vectors. I think it’s an unfortunate misunderstanding to say that these vaccines are a year in the making. In reality, it’s been the better part of 20 years.
If it's because of fears of infertility or of microchips being implanted, I would point to the fact that misinformation abounds, and people are trying to create chaos by creating false statements about vaccines. Finally, if it's because they have specific medical reasons that put them at risk for a specific vaccine adverse event, then I'd want to understand that and be able to make a more personalized recommendation. But many of the reasons that we're hearing people say that they're hesitant do not have a biologic basis and can be addressed with a straightforward conversation.
Healio: Is there anything else that we have not discussed?
Creech: One of the things that I would stress is that it is really important that we do these studies in children, so that if vaccination of adults and older adults is insufficient to rid us of this pandemic, then we need to know how to roll out this vaccine in kids. Do they have more fever? Do they have more arm pain? We also need to make sure we've got the right dose, and we need to make sure there aren't any other unusual responses to vaccine that would give us pause. When kids have been affected by coronavirus, they can uncommonly develop inflammation that looks a lot like Kawasaki disease. The development of multisystem inflammatory syndrome is going to be one of the things in the pediatric development programs that we're going to be watching for very carefully. At the end of the day, we all need to be reminded that kids aren't just little adults, therefore we need to evaluate them differently.