Part 2 of 2. Part 1 appeared Jan. 13.
On Nov. 9, the New England Journal of Medicine published the results of the COVID-19 Pfizer vaccine trial. Participating were 2,268 children with a mean age of 8.2. Of those, 1,518 were injected with the vaccine three weeks apart. Three received one injection and 750 were injected with a placebo, three weeks apart. Before the first injection, 133 of the 1,518 tested positive for COVID-19. The corresponding number in the placebo group was 65 of 750.
Adverse effects were reported by a parent or guardian. Not unexpectedly, mild to moderate pain at the injection site was the most common, occurring in more than 70% after the first or second injection. Similarly, 30% of placebo participants experienced mild to moderate pain at the injection site, while 0.6% (10) experienced severe pain, and none of the placebo participants. Among vaccinees, redness around the injection site occurred in 15% after the first injection and 19% after the second. The percentages for swelling were 10% and 15%, respectively.
In term of efficacy, three vaccinated children without prior evidence of COVID tested positive within 126 days after the first injection. The corresponding number in the placebo group was 16. No hospitalizations due to COVID nor its complications occurred in any vaccinee or placebo subject, a result entirely expected due to their rarity.
From a scientific and statistical viewpoint, the vaccine was proven safe and efficacious within the time frame of the study. However, at issue is whether the study results are applicable to a “real world” setting. A reported 1,118 of 1,511 vaccinees experienced mild to moderate pain after the first injection; 227 of those 1,511 experienced moderate pain, defined as pain that “interferes with activity.” Given this nebulous definition, it is reasonable to assume moderate pain would interfere with ability to do schoolwork, and some unknown number of children experiencing moderate pain would be unable to attend school. Yet in the study, only three of the 227 vaccinees who experienced moderate pain did not receive a second injection, a result I would not think possible in the “real world.” What about the 10 who experienced severe pain? Who would be willing to allow their child to get a second injection? Would any of these children be barred from school for incomplete vaccination?
Other issues require explanation. Since the data does not reveal the number of participants stratified by age, it is impossible to determine how many children at each age experienced an adverse reaction, and whether it was mild, moderate, or severe. This data may influence parent’s perception of whether to have their children vaccinated at a certain age, or not at all.
A totally overlooked issue is who is financially responsible should a child experience an adverse effect from a MANDATED vaccine. Will state and/or federal agencies compensate health providers and parents who miss work to care for their sick child? If so, please don’t think of the forms and red tape involved!
Here is an anecdote. Recently, a dear friend’s 35-year-old caregiver, a mother with four children, was required to get a booster for employment. Within hours, she developed pain and swelling at the injection site, fever, generalized muscle ache, enlarged lymph nodes and a headache requiring medical intervention. She missed two days of work and recovered in seven days. Are the feds, state, her employer, or her responsible for her medical bills and lost wages?
From the evidence, I opine the COVID vaccine should NOT be mandated to schoolchildren aged 5-17 because the risk of severe illness (myocarditis and Multisystem Inflammatory Syndrome). Death in HEALTHY children is rare, while the long-term adverse effects of the vaccine, if any, are unknown. Nor do we know if boosters will need to be administered in children, and if so, how many and for how long. It is possible that the risk of an acute onset reaction at the injection site accompanied by fever and other bodily manifestations will increase as children, and adults, are administered multiple vaccinations. The only compelling reason to vaccinate children would be in those medically compromised, and only after careful consideration of benefit versus risk.
Parents should discuss COVID vaccination with their children’s physician. A decision should be made between a parent and physician knowledgeable about COVID and vaccination for it. There are obvious differences of opinion in the medical profession regarding vaccination of children. When such division exists, no one knows definitively the proper course of action. COVID-19 is a new disease, having been introduced into the United States late in 2019 or early 2020. That’s not much time to learn about a disease, especially its long-term sequelae, let alone a vaccine. In time, a clearer understanding of vaccine benefit and vaccine-associated short- and long-term adverse effects in young people will become available.
In the meantime, physicians can only make recommendations based on what is known, and parents must be the sole arbiters on whether their children undergo vaccination.
Steven H. Baron, M.D.