In-Depth: Why some FDA advisers voiced reluctance during vaccine vote for kids 5-11

Posted at 6:24 PM, Oct 26, 2021
and last updated 2021-10-26 22:19:56-04

SAN DIEGO (KGTV) -- Pfizer cleared a critical vote Tuesday in its bid to vaccinate children as young as 5 against COVID-19, keeping the child-sized shots on track to roll out as early as next week.

A panel of medical advisers to the Food and Drug Administration voted 17-0 to recommend emergency authorization of the shot for children aged 5 through 11. One adviser abstained.

An advisory group to the Centers for Disease Control and Prevention is scheduled to cast a similar vote early next week.

Pfizer’s clinical trials on roughly 4,600 children in the 5-11 age group demonstrated vaccine effectiveness of 90.7 percent while the delta variant was circulating. Side effects were typically milder than those seen in older children. There were no serious adverse events linked to vaccination.

Still, some members of the FDA’s Vaccines and Related Biological Products Advisory Committee expressed a note of reluctance during Tuesday’s vote because of the rare risk of vaccinated-related heart inflammation seen in older children.

At the same time, they noted children aged 5 to 11 have a lower risk of hospitalization than adults, lowering the ceiling for the vaccine’s potential benefits.

“It just seems to me, in some ways, we’re vaccinating children to protect the adults. And it should be the other way around,” said VRBPAC member Dr. James Hildreth.

In children 12 to 17, there have been about 60 to 70 cases of myocarditis per every one million vaccinations. There are indications that younger children might experience fewer cases of myocarditis than their peers, FDA staff said. Still, the agency conservatively projected about 100 cases of myocarditis per million doses. Most cases have occurred in boys.

Nearly two million kids aged 5 to 11 have been infected with COVID, leading to more than 8,300 hospitalizations. About one-third of those hospitalizations involved children without underlying health conditions, highlighting the virus’ unpredictable risk.

“Kids are dying of COVID and getting put in the intensive care unit with COVID, and we’ve seen that here in San Diego,” said VRBPAC member Dr. Mark Sawyer, a pediatrician at Rady Children’s Hospital. “We’ve had over 75 kids in our Intensive Care Unit with COVID.”

The FDA produced several models to analyze the benefits and risks of vaccination in the age group. In one scenario, vaccinating one million boys aged 5 to 11 prevented 203 COVID hospitalizations of these children but caused 156 hospitalizations from vaccine-related myocarditis.

However, those numbers can be misleading, Sawyer said.

“We’ve actually seen some of these myocarditis cases after the vaccine and they’re all very mild,” he said. “Even though it is a recognized side effect, it’s not that serious compared to what COVID can do.”

A few committee members said they think the vaccine should be targeted to high-risk children only, such as those with obesity and underlying conditions, not all 28 million kids in the age category.

That decision will be up to the CDC, which has its own advisory meeting on Nov. 2 and 3.

The CDC and the FDA typically follow the advice of their expert panels, but the advisory groups’ votes are not binding. If approved by the agencies, shots for kids 5-11 could begin rolling out as early as next week.