Question: We just enrolled our 2.5 year old in a COVID 19 vaccine trial. It’s a 2 year study which entails two shots, a few blood draws, physicals, etc. She’ll get her first shot (and a blood draw) in a couple of weeks, followed by a second shot a few weeks later. There’s a 50/50 chance she’ll actually get the vaccine (10X less potent than the adult version) vs. placebo. After 6 months, if she received the placebo, she’ll automatically get the vaccine, or if EUA for her age group arrives before the 6 month mark, she’ll be first in line to receive the vaccine. I’m a little nervous about the blood draws and long office visits, but overall, I see this as a great opportunity for our family and to help advance science in a small way. What are your thoughts?
Answer: How exciting! It sounds like you’re doing something that is both selfish (your daughter gets to be first in line!) and selfless (your daughter is contributing to research for the good of all!)– it’s a win-win!
I encourage you to talk with the study team to make sure that they’ve transparently discussed the risks and benefits for you to make the best decision for your family. Be sure to ask about the frequency of blood draws and how the research team minimizes discomfort. I also encourage you to talk with your daughter about her participation in the trial so that she understands (as best she can). You two can also talk about things that will motivate her before/during/after long doctor’s office visits. Along these lines, a small study published in 2018, Parent’s perceived obstacles to pediatric clinical trial participation, found that “Establishing trust, appropriate timing, a transparent discussion of risks and benefits oriented to the layperson, and providing motivation for children to participate were key factors that impacted parents’ decisions.” Interestingly, The Hastings Center (nonpartisan, bioethics research institute) published an essay examining the ethical dilemmas parents face answering this very question, Should We Enroll Our Child in a Covid-19 Vaccine Trial? Since it was written in May, some of the information is dated, but you may find the author’s thoughts helpful nonetheless. Finally, you can take heart knowing that the vaccine has proven safe in older ages (in higher doses to boot). In the recent phase 2/3 Pfizer clinical trial among children ages 5-11 no severe adverse events related to the vaccine were reported. And as CDC’s ACIP concluded yesterday for a slightly older age group, “Balance of benefits and risks favorable for vaccination of all children.” Though it’s only partially relevant to your question, I’ve copied a couple of ACIP’s slides below that discuss the risks/benefits since the committee just met yesterday (Figure 1).
Figure 1. Benefits/Risks of Pfizer vaccination in children ages 5-11 (from CDC’s ACIP)