Children under five, the last group of Americans still ineligible for vaccines against Covid-19, may soon receive emergency authorization for the shots, but getting all children vaccinated remains a serious challenge in the US.
Pfizer and its German pharmaceutical partner BioNTech announced on Tuesday that they were requesting emergency-use authorization of their vaccine for children aged six months to four years.
The application was submitted at the request of the US Food and Drug Administration, the companies said in a statement – an unusual move by the regulator.
The FDA’s independent advisers will meet on 15 February to discuss the application and the shots, containing just one-tenth of the dose given to adults, could be available to this population of 19 million in the US by the end of the month.
The agency’s decision could come within weeks, but that isn’t the only hurdle. The Centers for Disease Control and Prevention (CDC) also has to sign off, and many parents then have to be persuaded to get their young children vaccinated.
The Biden administration has been trying to speed the authorization of Covid-19 shots for children, contending vaccinations are critical for opening schools and daycare centers and keeping them open, and for freeing parents from childcare duties so they can go back to work.
Many parents have been pushing for an expansion of shots to toddlers and preschoolers.
While children are much less likely to be hospitalized and die from Covid than adults, children’s hospitals have seen record-high admissions during the surge of the Omicron variant, especially in children who are not yet vaccinated.
Infants under a year old are the most vulnerable of all children to severe illness.
Families, and even children themselves, say they have been eagerly awaiting this news. So do caregivers, teachers and others who work with young kids – as well as those who employ parents, who have struggled to find steady childcare.
“As a mom of two kids under five, I’m extremely excited. But as an epidemiologist and public health member, I have a ton of questions,” said Katelyn Jetelina, an infectious disease epidemiologist with UTHealth School of Public Health in Dallas.
Chief among them: “Did they move the goalposts?” She noted that researchers could change what they are examining in the trial — looking at T cell responses or cases and hospitalizations, for instance, instead of neutralizing antibodies.
If regulators are looking at real-world numbers on cases and hospitalizations among the vaccinated and unvaccinated children, she asked, “Do they have enough data?” The clinical trial wasn’t designed to examine these questions, she noted, and there might not be enough participants in the trial to understand the vaccines’ efficacy in those settings.
Parents and experts mostly remain cautiously optimistic, but many say they want to see the results of the trial first.
“Everybody is really excited about the news,” said Katherine Matthias, a pediatrician in South Carolina and the parent of two children under five. “We’re moving the needle on things, but we still need to see the data.”
The press release from the companies on Tuesday did not release any new data or updates to its study design.
In mid-December, Pfizer/BioNTech announced that two shots of a low dose created strong antibody responses in children between the ages of six months and two years.
But the doses produced disappointing results in children between the ages of two and four, prompting the addition of a third dose for all children under five in the trial. Data on the third shot is not expected until March at the earliest.
Regulators could now authorize the two-dose regimen for younger children, who saw effective responses to two shots. They might also allow slightly older children to receive the same doses in preparation for the third shot, should the data show an additional shot helps create a protective immune response.
“If two doses are authorized, parents will have the opportunity to begin a Covid-19 vaccination series for their children while awaiting potential authorization of a third dose,” Albert Bourla, chairman and CEO of Pfizer, said in the statement.
“Getting that series started now, instead of three to four months down the road after so many children inevitably contract Omicron, is a huge win,” Matthias said.
Getting kids vaccinated has been a major challenge, even for those already eligible. Vaccinations among children have lagged even as cases soared.
Shots for children aged five to 11 were authorized in October 2021. But only 22% of US children in that age group are fully vaccinated, and only three in 10 children who are eligible have received their first shot, according to the CDC.
“What we’re seeing right now is still a lot of hospitalizations and unfortunately some deaths in this age group,” said Dr Sean O’Leary of the University of Colorado, who is on the American Academy of Pediatrics’ infectious disease committee.
If the FDA clears vaccinations for these youngsters, he added, “that’s going to be really important because all of those hospitalizations and deaths essentially are preventable”.
A new report from the Kaiser Family Foundation found that 31% of parents would vaccinate their children under five right away – similar to what parents of over-fives said.
Even parents who are fully vaccinated against Covid and who usually immunize their kids have been slower to sign up for pediatric Covid shots, doctors say.
Moving too quickly on the under-five vaccines, before the science is clear, could cause even greater delays in getting this age group vaccinated.
“We just need really great communication, and then a lot of transparency with this data and this decision-making,” Jetelina said. “If we aren’t transparent in this process, it’ll continue to drive hesitancy in the United States.”
Many parents worry most about long-term effects of the vaccines.
Two-thirds say they are concerned about the Covid vaccines affecting the future fertility of their children, according to an October 2021 survey.
In response, a new campaign aims to talk about fertility fears, including a video in Spanish from pediatrician and parent Ilan Shapiro, the chief health correspondent and medical affairs officer at AltaMed Health Services.
There is “zero” evidence of the vaccines having any effect on fertility, Shapiro said. “In reality, we have not seen any decline of fertility in people that are vaccinated. There are still teenager pregnancies, there are still adult pregnancies.”
In fact, having Covid itself can temporarily affect men’s reproductive health; it’s unclear whether it has any short- or long-term effect on children.
“If you get Covid, the sperm count actually goes down. If you get Covid, you can actually have erectile dysfunction,” Shapiro said. “If you’re actually worried about fertility and protecting your kids, I would be more worried about the infection,” Shapiro said.
But he understands why some parents have been hesitant. For nearly two years, parents heard that Covid infections in children aren’t as severe as in adults.
“After the bombardment of almost 20 months of information that kids will be fine, a lot of parents were like, ‘Well, OK, you’re telling me this now?’” Shapiro said.
Kids were safer earlier in the pandemic in part because many schools were virtual or hybrid, and precautions like masks were in place, he said. Many of those precautions were subsequently lifted across the country at the same time new variants arose – including Delta, which is particularly virulent, and Omicron, which is comparatively more transmissible.
“The probability of actually getting bad outcomes from the infection is higher than before, because we’re seeing more kids ending up in hospitals and more cases and more prolonged Covid,” Shapiro said.
Authorizing the vaccines for all ages will help protect more children. But many families still have unanswered questions about the vaccine, he said – and that doesn’t make them all anti-vax.
“For our kids, you think twice,” Shapiro said. Misinformation about the vaccines can compound those worries.
“We can start that conversation and talk about how many teenagers have already had this vaccine and how many kids have had this vaccine,” he said.
In children 12 and up, vaccines reduced the risk of developing multi-system inflammatory syndrome by 91%. Vaccines also cut the chances of getting Covid at all, which means children would be less likely to develop potential complications such as type 1 diabetes, long Covid or “outcomes that we don’t know about yet from getting a Covid infection as a child”, Matthias said.
“These vaccines might not prevent all of our kids from getting infected, but they should prevent bad outcomes,” she said.
Matthias is among a group of physicians and scientists who are advocating for the FDA and the CDC to allow off-label use of the vaccine among younger children at high risk, before it’s authorized in this age group.
“This is not the answer for every kid under five, but it should at least be a conversation that we can have with parents,” she said. “This seems like an option that providers and parents should have on the table.”
Many parents are eager to see the results from this trial, and to hear the discussions with FDA and CDC independent advisers, Jetelina said.
“Once we get those answers, if the scientific committees all agree this is the right step – absolutely, I’ll be first in line.”
