Opinion | Did Faulty Assumptions Dash Parents’ Hope for an Under-5 Vaccine?

Dr. Michael Z. Lin, a professor of neurobiology at Stanford, told me that clear observation and sensible rules were important but only if they made sense when considering the science behind them. “If we only relied on empirical observations and never developed theories to act on,” Lin said, “we’d still be in the Middle Ages trying to turn lead into gold.”

More than two years into the pandemic, the FDA can rely more on markers besides symptomatic infection, such as how well a vaccine gets the immune system to form antibodies and protects other age groups, especially from severe outcomes. Based on the totality of such data, the agency could have authorized a two-dose regimen of the Pfizer vaccine for children under age 5 during the Omicron wave. It could then have waited for the data to decide whether to recommend a third dose — adults got their third dose added later, too. It could also have explained the available data to parents and let them know that the vaccine provided a great benefit to their children even if it provided lesser protection against lesser symptoms.

As Deepta Bhattacharya, an immunologist at the University of Arizona, explained to me, a singular measure doesn’t capture all the benefits of vaccination. Vaccines train the immune system to recognize and more quickly respond to a virus, giving it a head start that he notes can “reduce severity and reduce the period of time that you are contagious.”

Marion Pepper, a professor of immunology at the University of Washington, told me that vaccines additionally reduced rates of a dangerous inflammatory disease seen in children, MIS-C. Marc Veldhoen, a professor of immunology at the University of Lisbon, pointed out to me that vaccines help reduce the incidence of long-term complications that can occur even from mild SARS-CoV-2 infections.

We want to be sure, of course, that vaccines are safe, and thus far, the trials for under-5 vaccines have not raised any safety concerns. Plus, children who are 5 years and a month old aren’t a different species than those who are 4 years and 10 months old — and we have plenty of data points on the safety and the benefits of these vaccines since they were authorized for children over 5 just about six months ago.

So what should the FDA do?

First, it should stop all the five-dimensional chess games that predict blowback due to perverse behavioral outcomes, and often do so without a sound social science basis. It’s good that the officials consider vaccine confidence as a key issue as they try to navigate such a challenging time. However, those concerns should be based on a realistic understanding of how people are likely to actually behave, and the officials should prioritize empowering and informing people, rather than trying to guide behavior by withholding tools. There should especially be no room for pop psychology. Transparency is great, proper communication is essential, and, above all, providing tools that help protect children as soon as possible is crucial.

According to the CDC, through the end of February, record numbers of children were infected during the Omicron wave, and, between Dec. 19 and Jan. 31, 572 children under 5 were hospitalized. Similar trends likely continued into March. Vaccination might have helped protect these children and, crucially, prevented many of these hospitalizations.

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