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Reviews |  The intolerable wait for a children’s vaccine

Julie Swann, an engineer who studies health systems and models infectious diseases at North Carolina State University, leads a team of researchers that recently attempted to simulate how the Delta variant of the coronavirus might move around schools in various scenarios. The results, published by the Washington Post over the weekend, were alarming.

Without masking and testing, according to the study, more than 75 percent of susceptible students would be infected within three months. Same with masking and testing, the simulation revealed, children in low-immunity environments – which include virtually all elementary school classrooms – had a 22% chance of contracting Covid within 107 days.

As a parent of two elementary school students, I found these numbers poignant. It already felt like a punch when, last week, Dr Francis Collins, director of the National Institutes of Health, said he didn’t expect a pediatric Covid vaccine to be approved until after the end of the year.

I live in New York City, where school staff must be vaccinated, and mask warrants are relatively uncontroversial. But Swann’s team calculations made it seem like my family’s chance to get through this fall without any of our children falling with Covid was almost a draw.

After talking to Swann, I realize it’s not that simple. His team did not take into account the effect of quarantining students who tested positive and assumed imperfect use of the mask. For many schools, she expects the number of infections to be lower than what the model has shown. However, this is unlikely to be of much comfort to parents who take Covid seriously but are surrounded by people who do not. With the start of the school year and pediatric hospitalizations already higher than ever, they find themselves in a particularly intolerable situation.

That’s why we need the Food and Drug Administration to act quickly. “I can almost certainly tell you that there will be data available in September to present to Pfizer,” said Dr Yvonne Maldonado, professor of pediatric infectious diseases at Stanford and principal investigator at the Stanford site of the Pfizer-BioNTech pediatric vaccine trial. . She believes Pfizer will be able to apply for an emergency use authorization in October.

So why is Collins saying the end of the year? It’s unclear. One question, which even well-connected people struggle to answer, is whether the FDA is going to require additional data for the children’s vaccine. In July, the agency asked Pfizer-BioNTech and Moderna to double the number of children in their clinical trials to have a better chance of detecting rare side effects. The FDA also said it wants four to six months of follow-up safety data, compared to two for adults.

Most experts don’t think this data is necessary for the FDA to authorize the vaccine on an emergency basis. But we don’t know if the FDA will insist on waiting for it. “This is probably one of the decision points that affects the different predictions,” said Dr. Lee Savio Beers, president of the American Academy of Pediatrics.

Two weeks ago, 108 members of Congress, worried about how long it would take to approve a pediatric vaccine, wrote to the FDA asking for some visibility on its timeline. On Monday, the FDA responded, but without giving details. “We understand that it is essential that the public have complete confidence in the FDA review process, complete confidence in all products we approve or authorize, and confidence in the FDA and our commitment to protect. public health, ”the agency said.

Personally, I lose that confidence. I’m afraid the FDA will know it will be blamed if something goes wrong with the vaccine, but not necessarily if children get horribly ill from lack of the vaccine.

Even with Delta, children are much less likely to die than adults. But it’s hard to take comfort as children’s hospital beds fill up. In a letter to President Biden, the Executive Director of the Children’s Hospital Association recently wrote: “With pediatric volumes at or near capacity and the next school season expected to increase demand, there may not be. enough beds or expert staff to care for the children. and families in need.

Many parents, convinced that Covid is more dangerous for their children than the vaccine, go to great lengths to try to get their children vaccinated. Some, the youngest of whom may pass for 12-year-olds, simply lie about their age.

I am among those who have tried unsuccessfully to get my pediatrician to give my children an off-label inoculation, which is technically legal now that the Pfizer-BioNTech vaccine has been fully approved by the FDA (The American Academy of Pediatrics advises against this, in part on the grounds that physicians should not calculate dosages and dosing schedules on their own.)

In addition to modeling illnesses for a living, Swann has a 10-year-old returning to school. She told me that if her pediatrician agreed to vaccinate her off-label child, she would. “Parents desperately need it,” she said.

The FDA can minimize the risk to itself by taking its time. Families don’t have that luxury.

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