Why Vaccinating Kids Is an Emergency

This week the FDA’s Vaccines and Related Biological Products Advisory Committee will meet twice to consider COVID-19 emergency use authorizations for children.  On Tuesday, June 14 the committee will consider Moderna’s request to vaccinate children aged 6 through 17, and on Wednesday, June 15, the committee will consider requests from Pfizer and Moderna to vaccinate all children and infants down to six months of age.  Infants and children have the lowest death rate from COVID and the highest risk for adverse health consequences, so why is vaccinating children an emergency?

Kids die from COVID-19, but the death rate is astonishingly low, especially when compared to other childhood risks.  According to the American Academy of Pediatrics, between 0.00% and 0.02% of all COVID-19 cases in U.S. children result in death.  As of June 2, 2022, there have been 1,049 childhood deaths from COVID-19, total.  By comparison, in 2019 nearly 2,400 teenagers died in car accidents, and 1,250 infants died of SIDS.  Yet, any childhood death is tragic.  If vaccination reduces death from COVID-19, why not vaccinate our children to reduce even this tiny risk?

An honest risk-benefit analysis requires examination of both sides of the equation, so we must first look at the risks of vaccine in children.

Many of these risks are still unknown.  The kids who have been vaccinated have not grown up, entered the workforce, or had children.  Nevertheless, sobering data is emerging.  Vaccinated males between 16 and 19 years old have a 13.6 increase incidence of myocarditis compared to historical norms.  So far, there have been 52 deaths reported to VAERS after COVID-19 vaccine in children aged 6 months to 17 years.  Reports of blood clots in vaccinated children are beginning to surface, unsurprising since thrombotic vaccine risks in adults are well established.  According to data released by Pfizer, vaccination is associated with increased miscarriages.  Perhaps most compelling, the study funded by Pfizer and published in the New England Journal of Medicine to support vaccine administration in children shows no improvement in all-cause mortality (see table S2).

And we still have those risks of the unknown.  Read again how a seemingly harmless hormone caused cancer in the daughters of women injected with it.  

If it is hard to reconcile the risk-benefit in favor of vaccinating kids, there must be another reason for the push to do so.  Perhaps it is not a health emergency for children but a liability emergency for vaccine manufacturers.  Vaccine liability protection will evaporate once the COVID-19 emergency is lifted, but childhood vaccines enjoy special liability protection.  

Emergency Use Authorization makes unapproved products—vaccines, tests, treatments, and so on—available during a public health emergency when there is nothing approved that works.  Manufacturers do not want to be liable for unintended consequences of unapproved products. Although an EUA does not by itself provide product liability protection, there is a loophole.  The Secretary of HHS can issue a PREP Act Declaration which absolves manufactures from all liability except willful misconduct for claims “resulting from administration or use of countermeasures to diseases, threats and conditions.”

The HHS Secretary issued a PREP Act Declaration for COVID-19 that includes vaccines, granting liability protection for as long as the emergency lasts.  It has been extended 10 times.  But the emergency cannot go on forever.  The end game is permanent liability protection.  

In 1986, congress passed the National Childhood Vaccine Injury Act (NCVIA) which created the National Vaccine Injury Compensation Program, “a no-fault alternative to the traditional legal system for resolving vaccine injury petitions.”  If you can prove vaccine injury, you can ask for financial compensation from the fund rather than file lawsuit against the manufacturer.  This system is open to “any individual, of any age, who received a covered vaccine,” but there is a catch:

For a vaccine to be covered, the Centers for Disease Control and Prevention (CDC) must recommend the category of vaccine for routine administration to children or pregnant women…

Heath Services and Resources Administration definition of Covered Vaccines.

Currently, COVID-19 vaccine manufacturers have liability protection because they are selling unlicensed products under emergency use authorization.  But once these products are recommended for routine administration to children or pregnant women, then vaccine liability protection will continue under the NCVIA, even when the emergency declaration is lifted.

Now we know why vaccinating children is an emergency.  At the same time, we have stumbled on the answer to a question I asked a few weeks ago.  Why does CDC recommend COVID-19 vaccines to pregnant women, despite the explicit Fact Sheet statements (see page 44) warning of the lack of safety data? 

The answer to both questions is the same.  Like vaccinating pregnant women, vaccinating children gives manufacturers a pathway to permanent liability protection.