In this post, SciMoms asked mom and ICU nurse, Renee Chavez, about her experience in the Pfizer kids COVID vaccine trials for kids under 12. Renee has been an ICU (intensive care unit) nurse for 12 years. She worked for 6 years in the adult ICU and 6 years in the pediatric CVICU (Cardiovascular Intensive Care Unit). She has 2 kids (ages 9 and 6) who both participated in the Pfizer kids COVID vaccine trial.
Pfizer recently announced the results of their kids COVID vaccine trials in kids age 5-11 (via press release) and submitted a request to the FDA for Emergency Use Authorization (EUA) for this age group on October 7. In anticipation of this request, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will review this data on October 26. At this meeting, experts will review the data on the safety and efficacy of the vaccines in kids under 12. They will also vote on whether to recommend that the FDA grant EUA for the Pfizer COVID vaccine (Brand name: COMIRNATY) for kids aged 5-11. Assuming that vote is favorable, it would then go to the FDA to grant EUA. For previous EUAs for COVID vaccines, FDA granted EUAs the day after the VRBPAC vote.
For previous EUAs, the CDC’s Advisory Committee on Immunization Practices (ACIP) met a few days after the FDA granted EUA. This committee makes specific recommendations about approved and authorized vaccines to the CDC about who specifically should get the vaccine and when. They base their recommendations on a wide range of issues from disease epidemiology to economics. For kids age 12 and up, vaccines were available in some states immediately after EUA was granted. Other states waited to administer vaccines until ACIP met and voted. (For more on the role of ACIP, see our post on the vaccine schedule.)
How did you learn about the kids COVID vaccine clinical trial?
I had been keeping a close eye on the Pfizer and Moderna websites for trial sites in our area. I received an email from work regarding Stanford’s participation, so I went to the website and signed the kids up that day.
Why did you decide to enroll your children?
As an ICU nurse, I’ve seen what COVID can do. I have cared for patients who are on the same modalities used to keep COVID patients alive: intubated, proned, and on ECMO because they are unable to be kept alive any other way. I knew I had to find a way to get my kids vaccinated as soon as possible. It was extremely important to us that our whole family be vaccinated, for us, for our loved ones, and for our community.
SciMoms note: “Proned” refers to put patients in respiratory distress on their stomachs to help them breathe. ECMO stands for extracorporeal membrane oxygenation. As explained by the Mayo Clinic: “in ECMO, blood is pumped outside of your body to a heart-lung machine that removes carbon dioxide and sends oxygen-filled blood back to tissues in the body. Blood flows from the right side of the heart to the membrane oxygenator in the heart-lung machine, and then is rewarmed and sent back to the body. This method allows the blood to “bypass” the heart and lungs, allowing these organs to rest and heal.”
Were you concerned about safety of the kids COVID vaccine?
Prior to nursing school, I was a clinical research coordinator. One of the studies I worked on was the pediatric HPV vaccine study. I know the ins and outs of clinical research trials, as well as the various phases. I also know how much focus is placed on the safety of all trial participants. It’s a ton! Furthermore, the vaccine had already been given to literally millions of adults and teenagers over the age of 12. I believe in science, I believe in research. We also spoke to our pediatrician prior to enrolling them. We trust her. She agreed that we should enroll them both.
What information did you receive before starting the trial?
Before agreeing to participate, we received the study consent form. It contained detailed information on the study process, COVID, and the known side effects of the vaccine from the adult trials. The kids were given an assent form, containing everything we were told, presented in a way that was easily understood by both kids. We went through the entire thing with the kids and made sure they were comfortable moving forward. There was also a Zoom meeting with the study coordinator, providing even more information, prior to enrollment. The study site has been extremely transparent throughout the entire process and staff are always available for any questions. We were enrolled in the Phase 2/3 study.
SciMoms note: Informed consent is a cornerstone of clinical trials. However, children cannot legally provide consent until they are 18. So for pediatric clinical trials, children provide assent. This article on Children’s Assent from the National Cancer Institute explains this process.
A Phase 2/3 clinical trial refers to clinical trials where Phase 2 and 3 are conducted at the same time. This allows studies to be completed more quickly and with fewer patients. For more on what types of questions are addressed in each phase of clinical trials, read here. In these Phase 2/3 trials for kids COVID vaccines, doses were based on the results of Phase I trials that were conducted in late spring 2021. Children ages 5 to 11 years received two doses of 10 micrograms (µg) each. Children under age 5 received two doses of 3 µg each. These doses for kids are lower than the dose for adults (30 µg). These Phase 2/3 trials are placebo-controlled with ⅔ of kids receiving vaccines and ⅓ receiving placebo.
What happens if your kids were in the placebo group? Can they get vaccinated earlier or do you have to wait until the vaccine has been authorized?
We were told that once the vaccine is granted EUA, we would find out which group they were in. If they were in the placebo arm, we would be scheduled to return to the study site to have them receive the vaccine.
Did you receive compensation for participating?
For each in-person visit, we were compensated for gas and time. Each kid received $100 per study visit.
SciMoms note: Reimbursement for expenses and compensation in clinical trials is standard. The FDA has guidance on what is appropriate, non-coercive, and ethical. When Institutional Review Boards review clinical trials, they review the reimbursement and compensation practices as part of the review.
Did your kids have any side effects? How did you report this? How often do your kids see a doctor during the trial?
Both of the kids had sore arms, a fever, and chills after both injections. We were stoked to see an immune response!
We have an e-diary that we filled out every day for 7 days after each injection, and then we fill it out weekly for 2 years. If there is a concern, we see the study physician in the clinic, as well as follow up with our pediatrician.
Do you worry about long term side-effects?
I have always felt comfortable giving my kids vaccines. I feel comfortable that the scientists and physicians who developed these vaccines understand mRNA, immunology, and virology. I trust the science behind it. I felt comfortable because of how many people around the world received the vaccine prior to our kids receiving it. To my knowledge, there have never been this many people receiving a vaccine at once. I could be wrong about that, but the fact that millions of people had received it already made me feel much more comfortable. What I AM worried about are the long-term side effects of COVID.
SciMoms note: Serious vaccine side effects are exceedingly rare. When they do occur, they occur within hours or days of vaccination. Historically, long-term effects that showed up later have only occurred very rarely with vaccines that use live viruses (like oral polio and varicella/chickenpox vaccines). The COVID vaccines do not contain ANY viruses, live or deactivated.
Based on what we know about the technology used to deliver the vaccines, the immune system, and the response to vaccines in general, there is no reason to expect that these vaccines will have long-term effects. At this point, we have been administering these vaccines for nearly a year with post-approval monitoring in place to catch any potential safety concerns. We discussed details of these post approval processes in our FAQ: Will vaccines continue to be monitored after a vaccine is approved? We also recommend this post from Dear Pandemic: Should I be worried about potential long-term side effects of COVID-19 vaccines?
How can you trust a company like Pfizer with your childrens’ health?
I trust Pfizer with my childrens’ health the way I trust other drug companies who research and manufacture Tylenol, Motrin, amoxicillin, other vaccines, and all the other medications that have all been given to my kids. The fact that the data from the previous trials in adults and teens were reviewed prior to EUA by CDC and FDA definitely made me feel comfortable enrolling my kids in the study.
SciMoms note: For more info on how CDC and FDA review vaccine trial data, see our previous FAQ: How will we know a COVID vaccine is safe?