One afternoon in May, Michael Joseph Smith, a pediatric infectious disease specialist, strides in baseball patterned socks through a Duke University facility in Durham, N.C., to welcome Cameron O’Hara, a 14-year-old vaccine trial subject. Smith has been acting as a co-principal investigator at one of the sites that have been testing the PfizerBioNTech vaccine in kids since last winter. O’Hara and his mother have come to the office following the “unblinding” process—in which he’d learned, to his disappointment, that he’s been getting a placebo—to get his first dose of the real thing. He crosses his sneakers and grips his mom’s hand as the needle goes into his arm.
O’Hara is eager to return to the classroom this fall as a high school freshman. He’s planning to celebrate his second dose with a road trip to the Adirondacks to see his grandparents. “The first thing I’m going to do is give them a hug,” he says, bringing his mother to tears. O’Hara’s parents, both pharmacists, encouraged his enrollment in the trial. He’s more enthusiastic about vaccination than many of his friends, some of whom fear needles, some of whom carry youthful delusions of immortality.
Smith worries that laissez-faire attitudes about vaccinating adolescents could slow the U.S. pediatric immunization campaign and even cost lives. Although Covid-19 has taken its greatest toll on older adults, over the past year he’s seen infected children develop fatigue, brain fog, and chest pain— all symptoms of “long Covid.” And his hospital has treated dozens of cases of the multisystem inflammatory syndrome, or MIS-C, a sometimes deadly pediatric condition associated with Covid. His concern has increased as the more transmissible delta variant has become the nation’s dominant strain. “A lot of people think this is going way too fast,” he says of the clinical trial process. “It’s not. We’ve just removed the bureaucratic red tape.”
Although pediatric studies moved quickly, the rollout of shots to millions of kids age 12 to 17, who account for 7.5% of the U.S. population, has lagged. Only 43% have received their first dose. That’s led the White House to call upon schools, community organizers, and even the Gen Z pop star Olivia Rodrigo to double down on pitching the vaccine’s benefits before the school year starts.
More than 4 million children in the U.S. have tested positive for Covid, but the true number of infections is likely much higher because kids are often asymptomatic and they’re less likely to be tested. In recent months, as a growing number of adults have been vaccinated, children have at times accounted for more than a third of confirmed weekly cases. At least 44,000 kids, from newborns to 17-year-olds, have been hospitalized since August, and about 350 have died, according to the U.S. Centers for Disease Control and Prevention.
Peter Marks, the director of the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration, says 350 deaths from Covid might not sound like many, but “when you think about childhood illnesses that are vaccine-preventable, that is a lot.” And as with adults, Covid has taken a disproportionate toll on those from racial and ethnic minorities and those with underlying health conditions such as asthma, diabetes, and obesity.
Guliz Erdem, a pediatric infectious diseases physician at Nationwide Children’s Hospital in Columbus, Ohio, is frustrated by what’s seemed, at times, to be widespread dismissal of the risk Covid poses to kids. She’s tended to MIS-C patients as young as 2 months old, who appear in the emergency room with swollen hands, bloodshot eyes, and blue lips. She describes the syndrome as a bomb that explodes in the body and fragments the immune system. “At first we didn’t really believe this condition was real,” she says. It was months before the CDC started counting cases, but from May 2020 to July 2021, the agency received more than 4,100 reports of MIS-C, including 37 deaths, with most cases occurring in Black and Hispanic kids and those younger than 14.
The other major impetus behind vaccinating children, beyond their own health, is the contribution it could make to ending the pandemic. Kids make up more than 25% of the global population, which many scientists say makes them the key to reaching the goal of herd immunity, estimated at protection for at least 70% of the population. (That number could be higher as variants continue to emerge.)
The U.S. government campaign to immunize children before the school year began in May when an emergency use authorization (EUA) was granted for the shot produced by Pfizer Inc. and its development partner, BioNTech SE. The companies ran their pediatric trial soon after the adult one, finding that their vaccine was 100% effective at preventing symptomatic Covid in 2,260 kids age 12 to 15 and that the subjects produced antibodies exceeding levels seen in vaccinated young adults, without exhibiting new or worrisome side effects. Moderna applied for U.S. clearance, after also seeing 100% efficacy in its trials for 12- to 17-year-olds, and has already received a green light from European regulators. Novavax Inc. and Johnson & Johnson are currently testing their vaccines in adolescents. Early U.K. trials for the shot from AstraZeneca Plc have been delayed in the wake of rare blood clots found in adults who’d had the vaccine.
Pfizer has shifted to study even younger children, enlisting as many as 4,500 6-month- to 11-year-olds to get lower-dose shots in the U.S. and Europe, with initial data expected as early as September. At a White House briefing in May, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said that by the first quarter of 2022, “we will have enough information regarding safety and immunogenicity to be able to vaccinate children of any age.” To prepare for that moment, a Biden administration official told Bloomberg News, the U.S. government has purchased 65 million doses tailored to the under-12 cohort.
Ensuring that vaccines are ready for all children by yearend is “our best hedge against preventing a nasty variant of the future,” says William Gruber, Pfizer’s senior vice president for vaccine clinical research and development. “There will be a risk-benefit assessment as we see where the pandemic is at that particular time.”
The risk-benefit discussion promises to become even more pointed when Covid immunization expands to younger kids— and if schools begin to implement mandatory vaccination, as they already do for any number of diseases. Already, the rates for children are falling along red and blue lines, much as they have for adults. To help end the pandemic in the U.S., the Biden administration will have to keep trying to build confidence among hesitant parents, continue vaccinating older children, and speedily deploy shots for younger ones. If the rollout succeeds, it could redefine the global approach to the fight against Covid.
A vaccination event at Wheels Fun Park in Durham
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