The New England Journal of Medicine just published a study Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age that reports phase 1 and 2 data about the vaccine in children.
During the phase 1 study, a total of 48 children 5 to 11 years of age received 10 μg, 20 μg, or 30 μg of the BNT162b2 vaccine (16 children at each dose level). On the basis of reactogenicity and immunogenicity, a dose level of 10 μg was selected for further study. In the phase 2–3 trial, a total of 2268 children were randomly assigned to receive the BNT162b2 vaccine (1517 children) or placebo (751 children). At data cutoff, the median follow-up was 2.3 months. In the 5-to-11-year-olds, as in other age groups, the BNT162b2 vaccine had a favorable safety profile. No vaccine-related serious adverse events were noted.
The investigators conclude: A Covid-19 vaccination regimen consisting of two 10-μg doses of BNT162b2 administered 21 days apart was found to be safe, immunogenic, and efficacious in children 5 to 11 years of age.
Are these data sufficient to recommend routine vaccination against COVID in children? Note that the total number of children receiving the vaccine was 1565 and the follow-up was just 2.3 months. These numbers are ridiculously small to make any conclusion about the vaccine’s safety when administered to millions of subjects. They state that an effective vaccine is urgently needed for school age children and cite some data about the incidence of the disease in children.
Here are the latest data from the American Academy of Pediatrics:
Cumulative Number of Child COVID-19 Cases
- 6,503,629 total child COVID-19 cases reported, and children represented 16.7% (6,503,629/38,944,914) of all cases
- Overall rate: 8,641 cases per 100,000 children in the population
Change in Child COVID-19 Cases
- 107,350 child COVID-19 cases were reported the past week from 10/28/21-11/4/21 (6,396,278 to 6,503,629) and children represented 24.0% (107,350/448,210) of the weekly reported cases
- Over two weeks, 10/21/21-11/4/21, there was a 3% increase in the cumulated number of child COVID-19 cases since the beginning of the pandemic (207,981 cases added (6,295,648 to 6,503,629))
Testing (11 states reported)
- Among states reporting, children made up between 11.6%-22.5% of total cumulated state tests, and between 5.0%-13.5% of children tested were tested positive
Hospitalizations (24 states and NYC reported)
- Among states reporting, children ranged from 1.7%-4.2% of their total cumulated hospitalizations, and 0.1%-2.0% of all their child COVID-19 cases resulted in hospitalization
Mortality (45 states, NYC, PR and GU reported)
- Among states reporting, children were 0.00%-0.26% of all COVID-19 deaths, and 7 states reported zero child deaths
- In states reporting, 0.00%-0.03% of all child COVID-19 cases resulted in death
Cases means those with a positive test. Of these 0.1 to 2% were hospitalized. The death rate from the disease was 0.00 to 0.03%. This places a heavy burden on any vaccine prescribed to grade school age children. Even a death rate from the vaccine of one in a million might be too high. Given the minute number of children observed following vaccination, I would not be able to recommend it to the parents of healthy children who likely are at greater risk from automobile accidents than from the virus – according to the CDC 608 children 12 or under died in automobile accidents in 2019. The the risk-benefit ratio of the vaccine will be apparent only after millions of doses are administered. Thus, the initial cohort of children treated will be test subjects. I cannot see a good reason for routine vaccination of healthy children. There is no reason for governments or school to mandate such treatment.