BMC Leading COVID-19 Vaccine Trial for Children

In the year since the COVID-19 pandemic took hold of the world, significant strides have been made to research and develop treatments and vaccines for the novel virus. Boston Medical Center has played an active and prominent role on both fronts, which included being one of 130 Phase III clinical trial sites testing Pfizer and BioNTech’s promising SARS-CoV-2 vaccine in adults. That vaccine is now among those with Emergency Use Authorization by the Food and Drug Administration—a pivotal step toward slowing the spread of a virus that has claimed more than 562,000 lives in the United States so far.

Now, Boston Medical Center is part of an exciting new chapter in protecting the public: studying Pfizer and BioNTech’s vaccine in younger age groups. Elizabeth Barnett, MD, pediatric infectious diseases specialist, and her study team have been selected to serve as the principal investigators for a two-phased pediatric vaccine study. In a Q&A with BMC’s Development Office, Barnett discusses BMC’s role in the trial and its importance for both the BMC community and beyond.

Boston Medical Center (BMC): First and foremost, can you tell us about this study overall?

Elizabeth Barnett, MD (EB): This is the continuation of a study looking at one of the vaccines that’s available for preventing COVID-19. It’s the extension of [Pfizer’s] adult study into younger age groups. We are very excited to offer participation in this study to our community. We are grateful Pfizer has provided the opportunity to Boston Medical Center to host this study.

BMC: Why is it important to include the pediatric population in vaccination efforts? How will this study contribute to that?

EB: We think of COVID as a disease of older adults or people with underlying medical problems.  Although we don’t think of it as a disease that disproportionately affects children and young people, we do see that younger individuals may have a role in the spread of COVID. Therefore, protecting younger individuals from getting sick and infecting others may have a role in reopening society. We are still learning about the role of young children in the spread of COVID, but it’s important to at least provide the opportunity to have a vaccine available for children so that we can move forward and understand how it can be best used in that age group.

BMC: Right now, you and your study team are leading the Phase I trial, and then will move into Phase II/III this the summer. What are the aims of the phases?

EB: Phase I is where you look at different doses of the vaccine in a specific age group. The goal of the Phase I study is to determine the best dose of the vaccine for that age group of children. In the Phase I study, there are three different age groups that are being investigated [and those are participants ≥5 to <12 years, ≥2 to <5 years, and ≥6 months to <2 years of age]. BMC will enroll five to 11 year olds; the other sites are enrolling children under five years of age. At the end of the Phase I study, Pfizer will look at both how children reacted to the vaccine in terms of their side effects and the antibody response they had to vaccine (an antibody response is when the immune system produces a protein, known as an antibody, to fight off a foreign substance in the body—in this case, the COVID-19 virus). They will combine the data they have about both of those, and then pick the correct dose for each age group. That’s the goal of the Phase I study.

When the Phase II/III study begins, the dose will have been chosen. At that point, children will be randomized, as was done in the adult study, into a specific study arm [to receive the vaccine or a placebo]. The pediatric study is slightly different from the adult study in that for every two children who are given the vaccine, one will get placebo. The study will involve two doses of vaccine given 21 days apart, three blood tests, and nasal swabs. With the help of their parents, children will record in a diary the symptoms they have in the week after they get their vaccine doses. Children will be in the study for two years.

There will be about 100 study sites but only a few will be participating in the Phase I trial. We’re pleased to have been included [in Phase I].

BMC: Vaccines are not new to pediatric populations, of course, but the COVID vaccine is new and novel for all of us. Are you encountering, or do you anticipate to encounter, hesitancy when it comes to participation? How is your study team addressing it?

EB: We have had an overwhelming interest in the study. We are focused on making sure there’s opportunity for our patients and our community to enroll in the study. We are also focused on ensuring our community is aware that this study is taking place and if they wish to have their children take part, they can.

BMC: Running a study site is a huge effort involving several teams and departments. What does that look like at BMC?

[The commitment to a trial like this] comes from hospital leadership on down. We have support from hospital leadership, the clinical trials office, the investigational review board, the General Clinical Trials Unit and the Investigational Pharmacy—all of these groups paved the way for the success of the adult study and are doing so for the pediatric study. We also have an experienced and committed team in Pediatric Infectious Diseases—the members of this team are central and critical to the success of both studies.

Conducting research during the “COVID era” has taught us a lot about what it takes to be successful in doing research at Boston Medical Center—what worked, what was challenging, what didn’t work, what lessons we learned. I hope we can take what we’ve learned to continue to build an infrastructure that enhances our ability to provide even more opportunities for our patient population to participate in research that has the potential to benefit them.

BMC: What makes BMC an important study site? What does BMC’s participation mean for our patients and surrounding communities?

EB: There is a preconceived notion that certain groups are not as inclined to engage in research, but we should not allow that idea to limit opportunities provided to everyone in our community. So, we are making sure everyone has the chance to participate in the study and make the decision for themselves about whether or not they want to participate. The right approach is to say, “We have an opportunity here. We’re going to make it available to everybody. And to do that, we’re going to make special efforts to reach groups that may not be as easy to reach as others.”

BMC: Lastly, what is the significance of BMC’s involvement in this study and contributions to research about the COVID vaccine in pediatric populations?

EB: Our involvement allows those who work or who are patients at BMC, many of whom come from communities most affected by COVID, to have access to a study of a vaccine that could help to end this pandemic.