COVID Vaccines for Kids 5-11 Years

Becoming part of history through participation in the vaccine trial for kids

Next week (Oct 26) FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet to review and vote on Pfizer’s COVID vaccine for kids aged 5-11 years. CDC’s Advisory Committee on Immunizations Practices is planning to meet the following week (Nov 3-4) to discuss administering the vaccine to kids.

While the meetings are scheduled, Pfizer is still enrolling children aged 5-11 years into its clinical trial. These additional participants are being added at the request of the FDA as a precautionary measure to identify any rare side effects (specifically, myocarditis or pericarditis) that may be caused by the vaccine.

Yesterday I was able to enroll my 10-year-old son in the trial.

And as an epidemiologist, it is thrilling to be part of this historic trial!

Much of what I write about here on my blog is rooted in my experience and expertise as an epidemiologist. Today I am going to share my personal experience (and my son’s) as a participant in the COVID-19 vaccine trial.

To begin — let’s talk about how the trial is designed.

Participation in the study starts with informed consent. Since this is a pediatric study, my son, C, (who is 10) cannot legally consent to participate in the study. I had to provide informed consent for him to participate. He had to assent/agree to participate in the study. And I’d like to give a huge shout-out to the study coordinators — they explained the entire study to C in terms he could understand, and they answered his questions. He provided written assent into the study.

After agreeing to participate, C was tested for COVID and had a blood draw. The blood will be used to test for troponin, which is a protein found in the heart muscle. Troponin tests can help to detect a heart injury.

Following these tests, C received his shot.

Because the study is blinded, we do not know whether the shot contained the vaccine or a placebo (saline). We are guessing he received the placebo. Following the shot, we waited around for 30 minutes - watching for adverse side effects of the shot (there were none).

For the next seven days, we are required to complete a daily health survey (using a really cool app). C has to take his temperature and answer questions about side effects. As of this morning, he is showing no signs of adverse effects. His arm doesn’t even hurt!

We are scheduled to return to the clinic to receive a second shot (plus another COVID test and blood draw) on November 8th. However, if the vaccine is approved for kids before his appointment, the study will be unblinded, meaning all the kids in the trial will be told whether they received the vaccine or a placebo. If C received the placebo yesterday, he will be able to get his first dose of the vaccine on the 8th. And we will continue to monitor his temperature and report any side effects to the study coordinators.

Being part of this study has been an experience of a lifetime for me (I mean, come on… this is historic! this is the COVID vaccine trial!). And for C — he is a hero. His participation will allow for the development of a safe and effective COVID vaccine for children. It will allow children worldwide to receive a safe and effective vaccine to prevent severe disease, hospitalizations, and death caused by COVID.

While there are risks associated with receiving a new/experimental vaccine, this is how medical research is conducted. We need brave and willing participants for clinical trials. Our over-the-counter medications, the antibiotics we take for bacterial infections, cancer treatments, and all of the other medications, treatments, and medical devices that we use to alleviate pain, treat illnesses, and replace broken/ruined parts of our body are available only because willing individuals chose to participate in clinical trials.

We are proud of C and honored to be part of this historic trial.

I will provide updates in the coming weeks as the trial unfolds.