I originally wrote this piece with the hopes of pitching it to a few local news outlets. However, after a few failed attempts, I realized that it made more sense as a short pontification than an op-ed. So, here is to hoping that you, dear reader, find it interesting!
The COVID pandemic has demonstrated that the Food and Drug Administration (FDA) struggles to make timely judgments that involve weighing costs and benefits. From rapid tests to vaccines, the FDA has systematically been too hesitant and slow to approve medical tools the American people can use to mitigate the health risks. By putting vaccines for children under five in existential limbo instead of issuing an emergency use authorization, the FDA fails to entrust parents with a vital tool to manage their children's health.
The FDA has two essential criteria for approving a treatment or vaccine: safety and efficacy. Pfizer’s clinical trial saw no significant adverse reactions in children who received the vaccine. Billions of adults have gotten vaccinated worldwide, with rare examples of severe side effects. Children’s safety profiles should be broadly the same, so we have confidence the vaccine is safe.
The question of efficacy is more under scrutiny, primarily around whether the dosage tested would provide a sufficient immune response in children. While Pfizer found that the dosage tested led to a significant antibody response for ages two and below, children between 2-5 did not produce enough neutralizing antibodies to prevent infection. There are two important caveats here: first, many experts believe that the antibody level will reach a sufficient level upon giving children the third dose, something we will hopefully have data on by April. Second, with Omicron circulating, the primary function of vaccines for adults and kids is not to prevent infection but to prevent severe illness or hospitalization. Even if the vaccine does not produce sufficient antibodies in children to prevent infection, it likely still induces a significant T-cell response. This T-cell response can prevent severe illness and hospitalization, something the vaccine has done a miraculous job doing every other age group.
Thankfully, the risk of hospitalization and death to small children is small, especially compared with older age cohorts. But saying COVID is low risk for children is not the same as saying there is no risk: approximately 407 children under five have died of COVID, and 3300 kids under five have been hospitalized with COVID. To put this in context, in 2019, 81 children ages 0-4 died of the flu, and 435 were killed in car crashes. Epimeologist Katelyn Jetelina uses a concept called micromorts to estimate kids' mortality risk during Omicron:
She finds that it is about equivalent to a woman in childbirth, and childbirth receives significant medical attention.
Most parents accept the risk of seasonal flu as part of everyday life, yet 68% of children under five were vaccinated for the flu. Flu vaccines are correctly championed by public health even though flu mutates so rapidly that we cannot guarantee how precisely effective the vaccine will prove. However, for children under 5, hospitalization rates of COVID are on par or higher than the flu:
So given that we widely vaccinate for the flu (and would if we could for RSV), it would only make logical sense to let parents use the covid vaccine to minimize children’s risk?
If tomorrow a novel technology were invented that could likely reduce the risk of children in car crashes, parents would express anger if governments prevented them from voluntarily adopting it. Yet when it comes to the COVID-19 vaccine, the government is standing in the way, saying that it would somehow be unethical for parents to choose to vaccinate their kids with current data.
We are in this mess because FDA does not have a coherent cost-benefit analysis for approving drugs. Congress created the FDA’s Emergency use authorization guidelines with the following language:
“If, based on the totality of the scientific evidence available, it is reasonable to believe that the product may be effective for the specified use, FDA may authorize its emergency use.”
However, instead of following its congressional mandate, the FDA is gripped by a vague fear that deviating from its normal, extremely cautious process will hurt public trust. This notion of trust is dubious, and the cost of delayed action is significant for young families. As the parent of a two-year-old, I can attest that society has asked young children and their parents to undergo immense sacrifices to keep others safe for the duration of this pandemic. Pre-schools and childcare facilities shut down, parks and playgrounds closed. Kids celebrated birthdays and special occasions on zoom and went months without seeing their friends. Parents struggle with their little ones to comply with maks and social distancing mandates. Schools and daycares in LA seem inclined to require masking kids for the rest of the school year. My son has begun saying with great sadness, “I have to wear a Mask” whenever we tell him to do something he does not want to do.
I have noticed that Parents have reacted to this stage in the pandemic in two polar-opposite ways, leading to some highly bitter fights. Some parents are eager to resume normalcy and want to see schools and kids’ activities re-open fully, without masks or other onerous restrictions. They believe that the costs of burdens on children’s mental health and development outweigh the risks of severe illness:
However, on the flip side, another group of parents is upset that restrictions are lifted before their small kids have the chance to get vaccinated. They see a public that seems largely ignorant of their plight and want the opportunity to do everything they can to ensure their kids are safe:
I see some merit in both of these perspectives since there is no "morally right” answer to how much risk you take in life. But I also think this debate is missing the obvious solution: parental choices in vaccination. In a world where our public health agencies would expeditiously approve the vaccine for all kids under five, parents with different risk tolerances would more easily co-exist. Authorization does not force any decision on parents; it simply empowers parents with choices. Those deeply concerned for their kid's safety can get them vaccinated to mitigate the real risks kids face. Parents who are less concerned with covid risk will find that vaccines ease the anxieties of other parents. There will thus be less objection to children’s activities “resuming as normal” without the current public health restrictions. The key is that all parents are more able to do what they believe is best for their child, given all the available information. I find it endlessly puzzling that the FDA will not let parents make that decision.