The debate over the fate of a Pediatric Covid Vaccine.
(Information as of October 25, 2020)
Here’s the rub: A human trial to produce a vaccine for kids has not been started in the United States. But many experts agree: the nation cannot beat COVID-19 until children are vaccinated — and that if human pediatric trials don’t start soon, they most likely will not be ready by the start of school next fall.
Older adults may be most vulnerable to the coronavirus, but ending the pandemic will require vaccinating children, too. “A pediatric vaccine would not only help children — it will be the basis of eventually eliminating COVID-19 in our population,” says Sallie Permar, MD, PhD, an immunologist and professor at Duke University School of Medicine.
The American Association of Pediatrics (AAP) joined the cause in a letter this month to the Food and Drug Administration (FDA). “It is counter to the ethical principle of distributive justice to allow children to take on great burdens during this pandemic but not have the opportunity to benefit from a vaccine … because they have not been included in vaccine trials,” the association said.
They added: “The effects of #COVID19 on children are complex and wide-ranging – even beyond the direct effects on their physical and mental health and well-being. Children need to be able to safely return to school in person when possible. Pediatricians need to be able to provide children with the health care and services they need throughout the pandemic. And federal nutrition programs to feed families who don’t have enough to eat need to be supported. #VoteKids for policies that prioritize the health of children and families as we continue to face this global health pandemic.”
The AAP has already taken a strong position advocating for the reopening of schools
for the overall physical, intellectual, and emotional development of children of all ages. And this is supported by the data documenting an increase in adolescent depression, and domestic violence and abuse in families where the children have not been allowed to return to classrooms, sports and recreation, and peer groups for support. (Please read our blog on “Schools and Covid: A Consideration” for more on this discussion.)
“Kids don’t have anyone advocating for them and their need for a vaccine,” says Anderson, the lead author of a September article in the journal Clinical Infectious Diseases, “Warp Speed for COVID-19 Vaccines: Why are Children Stuck in Neutral?”
Vaccination Effects: Children Are Not Little Adults
The researchers highlight how long it will take to develop, test, and approve pediatric vaccines because childrens’ immunization responses are not uniform within the pediatric population, and they are not the same as those in adults. Vaccine studies in young children may be more complex because they may need different doses or, because of their typically more robust immune systems, show different reactions to the shots. Vaccinated children tend to produce stronger immune responses than adults do, and adult immune systems weaken considerably in old age. The FDA standard clinical trial process states that there must be established safety and efficacy in adults first, before trials on children should start. Typically, vaccine development and safe clinical trials take months to years. Rushing this process generates its own risks. At this point, we don’t know who is doing the risk benefit analysis (the risk of not-controlling pandemic vs. the uncertainty of a rushed vaccine release) of rushing a vaccine.
Delay in the development of a children’s vaccine not only puts kids at risk, but also continues the spread of disease to adults. While there have been more than 697,600 COVID-19 cases reported in children as of Oct. 8, the vast majority of known infections, severe illnesses, and deaths have been in adults. Children represent about 10% of COVID-19 cases documented in the U.S. And while children are far less likely than adults to get seriously ill, about 120 have died in the U.S. alone, according to a tally by the American Academy of Pediatrics. Additionally, a small number have developed a serious inflammatory condition linked to the coronavirus. But many experts say we can’t wait until adult trials are complete. Pfizer recently won FDA approval to include people as young as 12. Johnson & Johnson, Moderna, and AstraZeneca, say they plan to run trials for children in the United States at some point. Several children’s vaccine trials are underway elsewhere, including the United Kingdom and China; the FDA could approve limited use of those in the United States. Yet the CDC cautioned in a COVID-19 update on Oct. 14, “At first, COVID-19 vaccines may not be recommended for children.”
Vaccinating Children Could Have A Widespread Impact:
The nation’s 73 million children (age 18 and under) account for one-fifth of its population, according to the U.S. Census Bureau. And another 3.7 million babies are born each year, creating what Anderson calls “a continuously growing group of unvaccinated people at risk for COVID-19 disease and transmission.” Overall, Anderson says COVID-19′s impact on children is greater than some other diseases that require routine pediatric vaccinations.
Aside from their own health risks, it remains an unanswered question about how easily children can infect others. In a letter to federal health officials, the AAP cited recent evidence that those over age 10 may spread the virus just as easily as adults do.
But there is a large body of parents who reject the idea of existing vaccines, let alone a new vaccine that is against Covid. While a COVID-19 vaccine might draw more takers in the midst of the pandemic, the ongoing confusion about Covid research, treatment and epidemiology, combined with political battles over the disease have left many people mistrustful, or worse. Furthermore, a strategy to first vaccinate those at high risk (such as front-line health workers and people with certain health afflictions) would leave most of the nation’s population unprotected for the near future.
How long are we talking about?
Developing a pediatric vaccine will undoubtedly take a year or more. The normal process is to proceed by age group starting with older children to determine dosage levels and frequencies that prove to be safe and effective. The trial must monitor the vaccine effects, adjust the dosage amount and frequency in response to results, and then conduct more testing and monitoring. Last week, Pfizer Inc. received permission to test its vaccine in U.S. kids as young as 12, one of only a handful of attempts around the world to start exploring if any experimental shots being pushed for adults also can protect children.
Experts are now beginning to focus on the importance of vaccinating children, not only for their own health protection but also as a critical step in control of the pandemic. It is too soon to predict the trajectory of the vaccine, but children will continue to play a critical role not only in the future impact of Covid, but also in our world’s health.