Children have to get vaccinated for less urgent threats—and it works. So why not with Covid?
By Riley Griffin and Suzi Ring
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 co-principal investigator at one of the sites that’s been testing the Pfizer-BioNTech 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 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.
Vaccination by Age Group, U.S.
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 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.
Four and a half miles down the road from the Duke trial site, past a Biscuitville, a church, and a cemetery, three dozen teens stand in a line snaking around the exterior of Hillside High School. Dressed in varsity jackets, graphic tees, and surgical masks, they’re joined by their parents, all beading with sweat in the 80-degree heat. The kids will, like Cam O’Hara, be among the first in the U.S. to be immunized against Covid.
A little after 10 a.m., 14-year-old John Osorio Vasquez and his 12-year-old brother, Diego, inch forward. Their mother, Maria, soon joins them inside, filling out consent forms with a toddler in tow. A speaker thumps with the heavy bass of Drake and Ariana Grande songs. The coronavirus, John and Diego say, is scarier than the shot.
They know from experience. Last summer, Covid tore through Durham’s sizable Latino community. The population accounted for 77% of cases in the county, and Maria, who’s originally from El Salvador, and John were among those who got sick. This summer will be different, John says after receiving the shot, an “I Got Vaccinated” button affixed to his shirt. He has a job washing dishes at a local restaurant. He hopes being vaccinated will mean he won’t have to wear a mask.
Covid has been rebounding in the U.S., driven by delta, with weekly average cases roughly tripling since late May, and the surge has hit unvaccinated pockets of the South particularly hard. Less than half of North Carolina is fully vaccinated, and the figure for 12- to 17-year-olds is barely over a quarter. Durham has been something of a bright spot. It’s a politically progressive enclave in the Research Triangle, a hub of three major medical schools (Duke, the University of North Carolina at Chapel Hill, and North Carolina State University in Raleigh) that have attracted biotech companies, and 56% of the county is fully immunized. According to the local public-health director, Rod Jenkins, families in Durham have been generally receptive to counter-Covid measures.
“My health director colleagues throughout the state have not fared as well,” Jenkins says. “Some got spat on, some got hate mail. They were driven out of their jobs or into retirement.” He’s worried that Durham is at risk because of its proximity to undervaccinated counties, particularly with the delta variant surging. The proportion of Covid patients who are younger than 18 recently hit a new peak.
On that hot May morning at Hillside High School, only half the expected number of kids turns up to get their shot, a trend that’s playing out across the South. It’s a worrying sign for the pediatric campaign, whose success or failure is being decided at the country’s more than 100,000 public and private schools. A CDC survey published in July found that parents of adolescents living in the Midwest or South are the least likely to plan for their child to receive the vaccine. At the same time, 13% of parents who reported being unwilling to get their kids immunized (and almost double the share of hesitant adolescents) suggested they could be swayed if their school system required it. As a result, educators have a debate on their hands: whether to implement mandates requiring Covid vaccinations, as they routinely do for measles, polio, and other diseases, or punt because of politics and let parents decide.
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Vaccine mandates, and fights over vaccine mandates, have been around for a long time. In 1855, Massachusetts became the first state to pass a law ordering schoolchildren to get the smallpox shot. Similar measures were put in place around the U.S. over the following years, in and out of classrooms. In a landmark 1905 case, the U.S. Supreme Court ruled that states have the authority to require vaccinations as necessary measures to protect public health and that individual freedoms weren’t “absolute.” The court also reaffirmed the right of states to exclude unvaccinated children from public schools.
Today all 50 states and the District of Columbia require children to be immunized against chickenpox, measles, polio, and whooping cough to attend school, though some allow exemptions for religious or other reasons. These mandates persist even though they’ve been so successful that the risk of contracting some of the illnesses they cover is now almost nonexistent: The last known U.S. case of polio dates to 1979, and measles was effectively eradicated in 2000. Measles has resurfaced somewhat in recent years, however, as antivaccine sentiment has gained ground.
With vaccine skepticism and misinformation spreading, the CDC has continued to stress the scientifically settled principle that school mandates are a critical public-health tool. With Covid, though, the Biden administration has left that to others to debate. “These are local decisions for schools and communities to make,” says Sonya Bernstein, a senior policy adviser for the administration’s Covid response team. No states have yet ventured to put such a policy in place.
Biden’s overseas counterparts initially moved more slowly on vaccinating kids. The U.K., for example, has been limiting its rollout of the Pfizer shot for children to only the most vulnerable 12- to 17-year-olds and those living with at-risk adults. But more than half of EU nations have started to vaccinate healthy children, and debates about mandates have begun. China has taken an aggressive approach, with its regulator granting emergency authorization for Sinovac Biotech Ltd. and Sinopharm Group Co. shots to be used in children as young as 3, even though trials are ongoing. Some Chinese provinces are vaccinating older kids this summer.
For most countries, the decision about whether to offer vaccines to kids is being driven by supply, especially in places where shots are still badly needed for adults. But the risk of new waves of infection driven by young people also matters. “The longer that other countries delay vaccinating children,” says Paul Offit, an infectious disease specialist at the Children’s Hospital of Philadelphia and an adviser to the FDA, “the longer it will take to significantly slow the spread of this virus.” He notes that waiting gives the virus time to mutate into variants that can potentially evade existing vaccines.
School mandates could diminish the risk, but in the U.S. the most vehement opponents are already rallying. On Facebook, parent groups are circulating petitions, touting dubious or altogether false research and airing concerns that mRNA technology will harm their children. Some plead for more robust safety data, and others are convinced the vaccines cause autoimmune diseases or contain Russian microchips. These parents are mobilizing offline, too, joining town halls, press briefings, and even U.S. health agency panels to criticize the pediatric rollout. “If parents don’t have a say, if they’re pushed into a corner, they’re going to pull kids out of school,” says Jason Rego, a father in Florida who runs a Facebook group for parents opposing Covid vaccines.
The reluctance of states and school boards to implement a mandate traces in part to the emergency use authorizations. “We’re in a bit of a legal vacuum,” says Sharon Masling, a partner in Washington, D.C., for the law firm Morgan Lewis, which is advising employers and administrators on the legal issues surrounding mandates. Without full licensure in place, Masling says, many are reluctant to test the waters on their own.
One of the few to suggest he’d require the shot was Austin Beutner, who, as superintendent of the Los Angeles Unified School District, said in January that vaccination would be necessary to return to the classroom. In an interview in May, he qualified his position. “We expect it will be required of children on campus in time,” said Beutner, who stepped down the following month. “Let’s not rush. Let’s let people get comfortable, build a coalition of the willing, and I think by the time fall rolls around, there will be more information.”
As the school year nears, public support for a mandate is growing. Researchers at Northeastern, Harvard, and other universities found that 61% of American adults are in favor of one, up from 54% in the winter. But a stark partisan gap remains, with Democrats’ support for a mandate doubling that of Republicans.
The U.S. campaign for kids 12 and up will provide new information about the vaccines’ safety profile. That nearly 9 million 12- to 17-year-olds have completed their regimen has, for many, demonstrated the Pfizer shot’s safety. But some possible issues have surfaced that weren’t evident in the much smaller trial. In June, U.S. health advisers met to discuss a link between mRNA vaccines and myocarditis and pericarditis—inflammation of the heart muscle and its surrounding membrane, respectively. The CDC had noticed a spike in cases, particularly among male teenagers, with more than 1,200 counted at the time of the meeting. Its data showed there was only a 0.00126% chance that those 12 to 39 years old would develop either heart condition within 21 days of being administered their second dose, and most who develop the condition quickly recover after treatment and rest. The agency’s advisers noted that Covid-caused conditions such as MIS-C pose a greater threat. And with the delta variant “more readily impacting younger people,” as the CDC, the American Academy of Pediatrics, and other organizations said in a joint statement, that small risk shouldn’t deter families from heading to the clinic. In the U.K., by contrast, the heart risks informed its decision not to give the shot to healthy children yet.
The discussion will be even trickier when it comes to younger children. Pfizer is expected to report its trial data on those age 5 to 11 as soon as September, and on those age 2 to 4 shortly thereafter, potentially clearing the way for an EUA before the end of the year. Gruber, the Pfizer executive, estimates that data for the 6- to 24-month-old group will be ready as soon as October. The new trial results—which will be based on a dose one-third the size of that for adults for children age 5 to 11 and one-tenth for children under 5—will look different from previous ones. Because there are now fewer Covid cases in the U.S. than last winter, Pfizer likely won’t report efficacy data that compares cases among vaccinated participants against those in a placebo group. Instead it will assess the immune response the shot prompts.https://a55e7bb6eb89f1d9eb4dcff25d9222ac.safeframe.googlesyndication.com/safeframe/1-0-38/html/container.html
This method is often used to validate pediatric vaccines, but the absence of clear efficacy numbers along the lines the public has grown accustomed to for Covid vaccine trials will be one more new variable for parents to consider. Despite the long-term risks to younger children who get the disease, it hasn’t been seen in them in numbers suggesting as urgent a need to vaccinate them for their own health, for reasons that still aren’t properly understood. (Hypotheses include that the cells controlling blood-clotting are healthier and therefore less susceptible to infection; that they have fewer of the receptor cells that allow the virus to gain entry; and that their immune systems are innately stronger.) It’s also not known at what age children might become more vulnerable.
“I don’t think that we know the accurate balance of benefit and harm from these vaccines in young children,” says H. Cody Meissner, a pediatric infectious disease expert at Tufts University School of Medicine and an FDA adviser. It’s important to compare the potential for adverse effects against the potential for Covid hospitalizations, he adds. “If it’s higher, then we’re causing more harm than we’re preventing.”
The more the argument for vaccinating younger children rests on getting to herd immunity, the more officials and scientists will have to consider the ethics involved. The question becomes, “Is it fair to vaccinate somebody and expose them to the very small risk of the vaccine if the benefit is predominantly for the population?” says Nigel Curtis, a pediatric infectious diseases physician and researcher at the University of Melbourne and Murdoch Children’s Research Institute. “I’m just amazed by how people are so certain about what the right thing to do is.”
To quell concerns about safety, Meissner suggests the FDA first grant a full biologics license for the shot in younger kids, rather than an EUA, before expanding the rollout. Pfizer is likely to get full approval for those 16 and up as soon as this fall, but it will take longer to get it for those who are younger, as the FDA requires six months of safety data. Waiting could fundamentally change the rollout, however, helping sway parents worried about legitimate side effects and dispelling concerns, unfounded though they may be, about unapproved technology. It could also give officials cover to mandate vaccines in schools without quite so much fear of retribution.
Marks, the FDA director responsible for vaccines, says, “As we get down below age 12, we’re going to be looking even more critically at the safety data, so that we make sure that there we’re very convinced that the children are getting as much direct benefit as they possibly can.” To that end, U.S. regulators have asked Pfizer and Moderna to at least triple the size of the under-12 trials.
“The other worry,” Marks says, “is that it’s been a little while since we had a new Greek letter.”
“We don’t want to have a situation where kids have to vacate the classrooms”
With mandates not in place, U.S. middle and high schools continue to rely on local officials, health providers, and grassroots organizations to win over parents. They’ve focused on identifying families most at risk of the disease, who are often people of color. In South Los Angeles, Kedren Health is busing children to vaccine sites at schools and hosting clinics one organizer describes as a “High School Musical vax-style event” with celebrities. New Jersey’s Essex County held a free vaccine event at Turtle Back Zoo. Across the South, providers are following the lead of Fair Count, the organization Stacey Abrams founded in Georgia, which has been using canvassers typically focused on voter turnout to spread vaccine information.
Community organizers do sometimes encounter hesitancy. Diane Latiker, founder of Kids Off the Block, an outreach program for low-income children in Chicago, says she often hears Black families cite the infamous experiment in Tuskegee, Ala., in which Black men with syphilis were denied treatment without their knowledge for four decades. “They know about all the wrongdoing that their parents and grandparents have been through,” she says. “So when it comes down to the vaccine, they’re not trusting.” In considering the shot, people felt better when the outreach came from those “who not only look like them, but people who actually live in their community.”
Jenkins and his team in Durham have done meticulous geomapping, cross-referencing neighborhoods with the highest rates of social vulnerability and lowest vaccination rates to determine where to place pop-up clinics for teens. Then they make sure community organizers are running the show. Hillside, a historically Black high school, was chosen as a site through this model, along with a fun park that has a go-kart track and a roller rink. The aim is to bring in not only kids but their parents, too. “How awkward would it be to see your kids vaccinated, with their TikToks and their school’s town halls, and you yourself not be, as a caretaker?” Jenkins asks.
If the vaccination campaign is a marathon, we’re at Mile 20, he says solemnly. It’s the toughest part of the race, especially with Covid cases and hospitalizations rising once more. Jenkins has a final sprint planned for the four days before kids return to the classroom: a back-to-school immunization event at Durham County Memorial Stadium. “I’m really weary,” he says. “We don’t want to have a situation where kids have to vacate the classrooms.”
For John Osorio Vasquez, the patchwork rollout means he won’t likely be able to forgo his mask in the classroom, as he’d hoped to at his summer job. Durham Public Schools currently require face coverings for students and staff, regardless of whether they’ve been vaccinated—an approach the CDC backed in late July. “Many of our families, teachers, and staff feel more secure with universal masking,” says DPS spokesman Chip Sudderth. No vaccine mandate is in the offing, at least for now, which means carrying on with the painstaking process of persuading everyone to get their shots.
But where adults are weary and wary, kids remain hopeful. John’s brother, Diego, already feels freer. His father has long promised to take him to El Salvador. John has been a handful of times, and it’s finally Diego’s turn. The country has recently faced a surge in cases, but with a shield of protection, Diego thinks his odds have improved. He grins. “It’s a good time to get my vaccine.”
This article was originally published on Website: www.bloomberg.com
Author is: Riley Griffin and Suzi Ring