I am a big believer in vaccines. I have taken all the vaccines suggested for my age. As I have written here recently, I took the booster of the Pfizer COVID-19 vaccine prior to the Food and Drug Administration (FDA) approving it for me. My 13-year-old grandson got his COVID-19 vaccination as soon as it was approved for his age with my blessing. So why am I saying that the answer for 5- to- 11-year-olds is not a definite “yes?”
The FDA recently released their interpretation of Pfizer/BioNTech vaccine data receiving 2-dose primary series, 10 μg mRNA/per dose, administered three weeks apart. This is 1/3 of the dose of the vaccine given to the adolescent and adult population. There were two different cohorts studied, with a total of approximately 3,100 receiving the vaccine and 1,500 the placebo. Each cohort had about the same number of subjects. Looking at immunogenicity by measuring neutralizing antibody titers, the 5- to 11-year-old group was equal to that seen in the 16- to 25-year-old age group. In participants 5 – 11 years of age without evidence of COVID-19 infection prior to dose #2, the observed efficacy against confirmed COVID-19 occurring at least seven days after dose #2 was 90.7%, with three COVID-19 cases in the active group compared to 16 in the placebo group (2:1 randomization to placebo). All cases of COVID-19 occurred in children without prior history of infection. Review of the cases showed that none met the criteria for severe infection. No doubt the efficacy looks excellent, as seen with this vaccine in the older populations.
Now about safety, which I believe is utmost in the pediatric population. One cohort had data looking at safety for two months post dose #2 and one cohort for approximately two weeks post dose #2. As expected, injection site reactions were the most common, with additional typical side effects seen in adolescents and adults such as fatigue, headache, and muscle pain. There were no serious adverse events like anaphylaxis and myocarditis or deaths. Because of the short-term data on safety, the FDA did benefit-risk assessments related to data in 12- to 15-year-olds and level of incidence of COVID-19 in the population. In the analysis with the lowest rate of COVID-19 in the community, the FDA model predicts more hospitalizations due to vaccine-related myocarditis/pericarditis compared to prevented hospitalization due to COVID-19 in males and both sexes combined. Nevertheless, the FDA states, “However, in consideration of the different clinical implications of hospitalization for COVID-19 versus hospitalization for vaccine-associated myocarditis/pericarditis, and benefits related to prevention of non-hospitalized cases of COVID-19 with significant morbidity, the overall benefits of the vaccine may still outweigh the risks under this lowest incidence scenario.”
What is my concern? With data on only 1,500 children for three months, we don’t have enough information to completely reassure parents of safety. As I was trained as a pediatrician, safety has always been my number one concern. We know that children can get severely ill with a multisystem inflammatory syndrome, be hospitalized, and die from COVID-19. Though those numbers are much, much lower than the general population, it still happens. Parents must understand the risk of COVID-19. What about preventing long-haul COVID-19? Probably, but we don’t know the true incidence in the pediatric population. What about preventing the spread of COVID-19 to others? That is definitely a concern, especially if the child has constant exposure to the elderly population, such as a grandparent being a caregiver, which should lead to getting the vaccine. Would this help prevent spread in the schools, stop quarantines, reduce need for frequent testing, and the removal of mask mandates sooner? Most definitely. It is another positive for the vaccine.
What I am saying is that we need to discuss the benefits and risks with parents and caregivers as we don’t know the long-term safety data. Yes, I believe the benefits outweigh the risks at this time, but I could definitely understand if a parent wants to delay the vaccine for their child until more safety data accumulates. We need to make a shared decision with the family that meets their values and preference on the available data.
