By Dorit Reiss
COVID-19 vaccines are extremely safe, and serious harms are rare. But rare does not mean the risk is zero; thus, we need a way to determine which people have plausible claims of harm from the vaccines, and we must then compensate them quickly and generously. However, the regular torts system is not a good option for adjudicating these claims. Fortunately, we already have a better system — no-fault compensation — available to address the problem.
By Victoria Kalumbi
Despite pediatric COVID-19 vaccine availability, many youth remain unvaccinated, and are thus at higher risk of life-altering outcomes as a result of contracting COVID-19.[1]
Some children may be unvaccinated by no choice of their own, but instead because of decisions made by parents, guardians, or state or local government officials.
In this post, I argue that young people should have the opportunity to consent to vaccines. I focus on the specific case of children in foster care and the juvenile justice system, as they are particularly vulnerable amid the ongoing pandemic. However, the legal and political avenues explored in this piece to ensure that young people have a stake in their health and vaccine status are broadly generalizable to all children.
By Carmel Shachar
As trials stall and the omicron variant surges, the U.S. Centers for Disease Control and Prevention (CDC) is failing parents by preventing off-label use of our existing COVID-19 vaccines in the under-five set.
The cries of frustration, anger, and fear from parents of small children have reached a new pitch amidst the ruckus of 2022. Parents of children under five years old need to navigate omicron-fueled rising pediatric hospitalization rates while their kids remain entirely unvaccinated. They must also juggle childcare and work responsibilities amid unpredictable, lengthy daycare and schooling closures. Give us the vaccine to help protect our kids, shorten quarantines, and keep children in care they all clamor.
But where are the vaccines for the pediatric set — the same vaccines that have been proven safe, both in adult populations and in older children? So far the story has focused on disappointing efficacy results and delays in studies from Pfizer and Moderna. But that is not the entire explanation for why parents of small children are blocked from vaccinating their offspring.
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As children are experiencing the highest rates of COVID-19 in many states, can efforts to universally preclude vaccination of those under 12 until the U.S. Food and Drug Administration (FDA) specifically authorizes use in that age group be justified?
In a case commentary published today in Pediatrics, we argue that the answer is no.
This view diverges from the positions of the American Association of Pediatrics, FDA, and the U.S. Centers for Disease Control and Prevention (CDC). In fact, the CDC, which controls the nation’s supply of COVID-19 vaccines, has taken steps to currently ban the practice of vaccinating youth under the age of 12.
We acknowledge that recommendations to widely vaccinate 5-11 year olds should await FDA and CDC guidance (which is expected soon, given upcoming advisory committee meetings). But, especially at the lower dose offered in pediatric clinical trials, we think that off-label pediatric administration of approved COVID-19 vaccines, like Pfizer’s Comirnaty mRNA vaccine, should be treated like other off-label uses and left to the individual risk-benefit judgments of doctors and patients (or here, parents).
By Dorit Rubinstein Reiss
If COVID-19 vaccines lead to any serious harms, society should compensate those victims generously and quickly.
Currently, under the Public Readiness and Emergency Preparedness (PREP) Act, COVID-19 vaccine manufacturers and providers are immune from liability.
Anyone seeking compensation for a severe side effect from a COVID-19 vaccine needs to go through a government program that is extremely narrow and hard to win; the Countermeasures Injury Compensation Program (CICP). The program requires “compelling, reliable, valid, medical and scientific evidence” to be compensated — a very high bar. It has compensated only a very small percentage of claims submitted over the years.
But we have an alternative. The Vaccine Injury Compensation Program (VICP) provides compensation under a much more generous standard. It has been used for years for childhood vaccines, and has served us well. While not perfect, it offers a decent path forward.