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Tuesday, January 31, 2023

What If Getting a Kids’ Vaccine Approved Is the Easy Part?

This morning, Pfizer/BioNTech submitted data to the Food and Drug Administration from its clinical trial of a Covid vaccine for children, launching a process that could deliver doses to kids between 5 and 11 within the next month or two.

With child cases rising—last week, those under age 18 made up almost 27 percent of newly reported cases, according to the American Academy of Pediatrics, although they only represent 22 percent of the US population—there’s a lot of pressure to move through regulation quickly. But parents who have been waiting tensely for this moment may find more hurdles in their way than they expect. As complex as it has been, getting the vaccine authorized was just part of the challenge of protecting kids. Getting it distributed and administered will be complex too.

For one thing, the new shots will arrive in a system that’s already overwhelmed. “Immunization programs haven't had a second to think about this group yet, because they have been dealing with adult vaccination, and additional doses for the immunocompromised, and influenza vaccination season, which can't be postponed,” says Kelly Moore, a physician and president and CEO of the nonprofit Immunization Action Coalition. “They haven't been able to catch their breath, which is a problem, because it’s coming up fast.”

But those shots also will be delivered to kids in different locations, likely by different personnel, than the adult vaccines released last winter. They are arriving in a national landscape that is even more politicized than it was before. And it’s not even clear how many Americans welcome them: A Gallup poll released just this morning finds that 45 percent of parents do not plan to vaccinate their young kids.

A recap of where we are on shots and kids: Let’s stipulate, first, that all these plans address just Pfizer/BioNTech, the only manufacturer whose trials have moved far enough ahead to allow for child vaccination. Their vaccine has had full FDA new drug approval since August, but only for ages 16 and up; for kids 12 to 15, the vaccine remains under emergency use, and kids younger than 12 have not been able to receive it at all.

Pfizer has been pursuing clinical trials aimed at clearing the vaccine for younger kids since March. The approximately 4,500 children in those trials are split into three cohorts: 6 months to 23 months, 2 years to just under 5, and 5 to 11. In each group, the vaccine being tested is some fraction of the adult dose, from one-third down to one-tenth. Last week, the company made its first comment on its pediatric trial results, saying that two rounds of those one-third doses achieved the same antibody levels in 5- to 11-year-olds as two full-sized doses did in 16- to 25-year-olds. It is those results, with a lot more data, that the company brought to the FDA today. Data for the under-5s is supposed to follow.

(The other manufacturers haven’t gotten as far in their trials. Moderna’s vaccine has an emergency use authorization for ages 18 and over, and is awaiting full approval for adults and authorization for younger teens. The company began studies in children younger than 12 in August. J&J, the single-dose vaccine, is behind the other two companies in its research; it still has only an emergency authorization that just covers adults.)

Since last summer, Pfizer, regulators, and business analysts have all been saying that they hope the first authorization would arrive in late October or November. That estimate still looks solid, if optimistic. The timeline is wiggly, because no one outside the FDA knows how rapidly the agency will review what are likely to be complex data sets covering efficacy, safety, and side effects. Two independent committees, advisers to the FDA and the Centers for Disease Control and Prevention, must weigh in afterward, and no one outside their ranks can say how thoughtfully they will scrutinize that data. (Those are the two committees that met in the past two weeks to discuss and ultimately approve booster shots for a wide swath of Americans.)

But you only have to remember last spring’s first frantic searches for vaccine appointments to realize that authorization doesn’t guarantee delivery. And it’s delivery that planners are fretting about now.

It's important to remember that the Covid vaccine is unlike almost all the others we receive. It’s not sold on the open market; it was prepurchased by the US government, and it is distributed under government supervision to state health departments, who funnel it to health care systems and pharmacies. Those state programs are under strain. “Over 50 percent of program managers are new since the pandemic began,” Moore says. “I'm concerned about the experience needed to be able to roll this out. These logistical decisions are not things that can be made at a very high level; they require local knowledge and expertise.”

Local knowledge is crucial, not just because every state has conducted distribution slightly differently, but because who delivers the vaccine can vary by county or town. In the spring, the preferred method for getting lots of shots into lots of adults’ arms was mass vaccination clinics that served hundreds or thousands of people in a day. But planners are skeptical that mass clinics will work this time. They expect that parents will want to take children to a health care provider they already know.

“We anticipate that a parent is going to be, not hesitant or unwilling, but just having a few more questions, being a little more cautious, and wanting to go where they have established a relationship,” says Marcus Plescia, a physician who is chief medical officer of the Association of State and Territorial Health Officials.

There’s nothing wrong with wanting a child to receive their vaccine at a doctor’s office or community health center. (The pressure that pediatricians are already feeling to administer shots to kids in advance of authorization suggests that plenty of parents are already making the request.) But a parent seeking that shot might find their pediatrician’s office hasn’t signed up to make it available.

First, there’s that vaccine ownership issue. To give those government-purchased shots, a vaccinator has to sign a CDC-crafted agreement that sets forth a slew of rules. Even providers who are already enrolled in other federal arrangements—such as the Vaccines for Children program, which pays for routine childhood vaccinations when uninsured or underinsured families can’t afford them—aren’t grandfathered in; they need to apply separately.

And second, there’s a logistics issue, created by the vaccine’s storage requirements and shipping constraints. Storage is a little easier now than when the Pfizer vaccine was first rolled out last spring. At that time it had to be kept at ultracold laboratory freezer temperatures throughout its journey. Today it’s shipped ultracold but then can be held at home freezer temperatures for two weeks, plus thawed at fridge temperatures for a month beyond that. But it is still shipped in lots of 450 to 1,175 doses, which takes more fridge space—and vaccine recipients—than a pediatric practice is likely to have.

Given the paperwork burden, the storage space needed, and the possibility that doses could go unused and be wasted, pediatric practices have not universally signed up to deliver the new vaccine. “We continue to try to recruit them in some states,” Plescia says.

Yet vaccination planners say there’s one kind of venue that can handle all the challenges posed by Covid shots for kids. That would be school-based clinics, which are hosted by a district and held at a school building, but operated by a local health department or a medical subcontractor. Those clinics are routinely popped up at the start of the academic year, to catch kids up on required shots and protect them against flu season.

“We are experts in doing mass vaccination clinics in schools, and we've done them for many, many years,” says Kate King, a doctor of nursing who is president-elect of the National Association of School Nurses and a school nurse at World Language Middle School in Columbus, Ohio. “Parents trust schools. They trust that their kids get good care at schools. And schools, especially ones with gymnasiums and many entrances, are set up to handle volumes of kids.”

That would be logistically ideal. But it may not be politically feasible. King’s district, Columbus City Schools, comprises 50,000 kids in 111 schools; it already held clinics this year to vaccinate older and then younger teens against Covid, and it is planning for vaccinating younger kids once FDA authorization arrives. But across the US, schools and school boards have been a battleground for anti-mask, anti-vaccine forces. Last week, an Idaho school board meeting was canceled after protesters swarmed its building. On Monday, classes were canceled in Knox County, Tennessee, after protestors threatened to blockade campus entrances with cars.

Nurses worry that, as much as some parents may want their children vaccinated, others may see a school-based clinic as a focus for their rage. “Nurses are dealing with a lot of hostility and anger from parents, when we call to isolate kids or quarantine them,” King says. “There are parents who are just wonderful about it too, but there is a lot more anger than we’re used to. We, of course, would only immunize students who had parental consent, and it would be voluntary. So I hope we would not have that contention.”

Given the political polarization of vaccines, it’s possible that when child vaccinations are authorized, there won’t be a rush to claim them. Experts admit they are a bit disquieted that rates for teen vaccination haven’t been higher; as of last week, 55 percent of 12- to 17-year-olds had received at least one shot, and 45 percent had received both, according to the American Academy of Pediatrics. (According to the CDC, those are each about 20 percentage points less than vaccination rates in adults.) Of more concern, the pace of vaccination has slowed. The 587,000 shots given to teens in the most recent week recorded marked the smallest figure since the vaccine was authorized for them.

And the most worrisome detail is deep in the data: In 21 states, fewer than half of eligible teenagers have received one dose. Put that finding together with that new Gallup poll that finds 45 percent of parents don’t plan for their children to receive the vaccine. Together those data suggest there will be an ongoing, politically fueled pandemic of the unvaccinated—and the victims who could have been protected, but were not, will include young kids.

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