Should the FDA move faster on COVID-19 vaccines for young children?

Whether you are a parent, teacher, or just someone who is a bit more anxious at the sight of children, you may be asking this question:

How soon can the youngest Americans get their vaccines? Be prepared to hear the repeated mantra of pediatric medical practitioners: Children are not small adults.

In other words, don’t assume that because COVID-19 vaccines have been shown to protect adults and adolescents quite safely that the same vaccines in the same doses will work just as well for younger children.

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Children have bodies that function differently to adults. This includes their organs, muscles, bones and metabolic and immune systems. This means that children can react differently to adult medicine in adult doses.

So before COVID-19 vaccines can be cleared for the 28 million American children between the ages of 5 and 11 and the 20 million who are even younger, regulators need solid evidence that the shots are safe and that they reduce the risk of disease. This evidence will come from clinical trials, which will be reviewed by experts at Food and Drug Administration. This is often a lengthy and tedious process that can take years.

But in the midst a pandemic that has been accelerated by the Delta variant, “exacting & deliberate” is starting to sound more like “slow & bureaucratic .”

Between late June and mid-August, as the Delta variant solidified its grip on the nation, the rate at which children were hospitalized for COVID-19 surged almost fivefold. The nation’s pediatricians were becoming impatient.

“The Delta variation has presented a new and urgent risk to children, adolescents and adults across the country,” the American Academy of Pediatrics wrote Aug. 5, in a letter to FDA. Doctors exhorted FDA to “consider the effect of its regulatory decisions on further delays of vaccines for this group .”

The FDA is aware of the situation. It responded Friday with the release of an unusual public statement that acknowledged the urgency of its mission and promised to review clinical trial data “as quickly as possible, likely in a matter of weeks rather than months.”

Here’s a closer look at where we go from here.

Aren’t some COVID-19 vaccines already available to American kids?

Yes. The one made by Pfizer and BioNTech has received full approval for people 16 and older and has been authorized for emergency use in 12- to 15-year-olds.

That’s it?

So Far. Pfizer stated that it expected to submit the FDA the first results of its trial with younger children later in the month or early October. The FDA will be able to begin evaluating the data once they have received them.

A second vaccine made by Moderna has won provisional approval for adolescents 12 to18 in Canada, Europe and Japan. The company has filed to gain the FDA’s blessing for emergency use in kids in the U.S. as young as 12, saying that its clinical trial results were “consistent with a vaccine efficacy of 100%.” An advanced-stage trial in 4,000 children ages 5 to 11 has just completed enrollment.

The Johnson & Johnson vaccine is still being tested on adolescents 12 to 17.

What’s holding things up?

Anxious over the emergence of a couple of rare side effects, the FDA in midsummer went back to vaccine makers and told them to add more kids to their trials. The regulators suggested that they be tracked for longer periods of time than originally planned. Safety experts would have a greater chance to detect rare side effects and delayed reactions to vaccines.

Moderna and Pfizer increased the number of trials for children younger than five years old by about doubling their size.

The sudden shift alarmed Stanford pediatrician Dr. Yvonne Maldonado, who chairs the American Academy of Pediatrics’ Committee on Infectious Diseases and is working on one of Pfizer’s pediatric clinical trials.

” It would have extended the timeline for several months,” she stated. A statistical issue, it is likely that a trial with twice the number of children would still miss a rare side effects. She said that post-vaccine reactions most often occur within the first two months following a shot. Therefore, it was unlikely that extending the follow-up would provide any insight.

Why would regulators risk a delay?

The challenge with clinical trials is that “you are essentially trying to predict the safety of a vaccine in billions of children by looking at its safety in thousands of children,” said Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia.

Offit, who advises both the FDA and Centers for Disease Control and Prevention, stated that it is important to identify rare adverse reactions. Even if a dreadful side effect occurred in only 1 in 1 million kids, it could mean vaccine-related hospitalizations or death for as many as 120 children in the U.S. This is all.

But in a pandemic where children are being admitted to hospitals at increasing rates, it can be costly to prolong trials in the hope of catching faint safety signs. Offit stated that it was frustrating that the children were able to return to school, but that they have not been vaccinated.

Is the FDA looking for something specific?

Yes. Regulators are particularly keen to know more about a condition called myocarditis, which is swelling or inflammation of the heart muscle.

In early June, just a month after the Pfizer vaccine became available to 16- and 17-year-olds, the CDC documented a slight rise in cases of myocarditis in recently vaccinated people.

Seen mostly in boys and men younger than 30, the symptoms were generally mild and went away in a few days either on their own or with over-the-counter medication. It is not known what long-term effects a mild case may have of myocarditis.

At the same time, myocarditis is often seen in children and young adults who are hospitalized with COVID-19 — so preventing the disease with a vaccine may be a net gain. Research is ongoing, and pediatricians are unsure whether younger boys would be as prone to the side effects as their older brothers. After a June briefing, a CDC advisory panel recommended that all eligible adolescents receive the vaccine. The panel advised that anyone who develops myocarditis following a first dose of the vaccine should delay their second dose until their condition is better understood or they have recovered.

Is that it?

There’s always the possibility of an entirely unforeseen side effect, such as the blood clots that emerged in a vanishingly small number of younger women who received the J&J vaccine. Although administration of that vaccine was briefly paused while the risk was investigated, shots were quickly resumed.

In the middle of a pandemic it is best to wait until after the vaccine has been approved and large numbers of people have started getting it.

” This wait-and-see approach assumes you know what you are waiting for,” Maldonado stated. “We don’t have the luxury to wait three to five years for whatever magical endpoint might appear.”

She said that as long as children are not vaccinated, the virus will be transmitted to them and the pandemic continues.

Won’t the FDA’s extra scrutiny ensure that vaccines are safe for kids?

Medical ethicists insist on a high level of safety when administering vaccines, especially for children. Even though vaccines are given to healthy individuals, they may never be exposed to the disease-causing pathogen. That’s why there is no tolerance for vaccines that are risky in the best of times. But now, regulators face a quandary.

Public mistrust continues to suppress vaccine uptake and to drive COVID-19 hospitalizations. Will the FDA increase its efforts to detect side effects of vaccines? Will it undermine faith in vaccines and chase down problems that might be harmless?

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