As the Trump administration contemplates new clinical trials for Covid boosters and moves to restrict Covid vaccines for children and others, parents whose children participated in the clinical trials expressed anger and dismay.
“It’s really devastating to see this evidence base officially ignored and discarded,” said Sophia Bessias, a parent in North Carolina whose two- and four-year-old kids were part of the Pfizer pediatric vaccine trial.
“It’s infuriating. My kids contributed literal blood and tears to help demonstrate the safety of these vaccines,” Bessias said.
“As a parent and also a pediatrician, I think it’s devastating that we might no longer have the option to protect kids against Covid,” said Katherine Matthias, a pediatrician in South Carolina and a cofounder of Protect Their Future, a children’s health organization.
Robert F Kennedy Jr, head of the US Department of Health and Human Services (HHS), has called for new trials using saline placebos for each of the routine childhood vaccines recommended by the Centers of Disease Control and Prevention (CDC), even though these vaccines have already been tested against placebos or against vaccines that were themselves tested against placebos.
Marty Makary, the head of the US Food and Drug Administration (FDA), and Vinay Prasad, the FDA’s vaccines chief, outlined a plan in a recent editorial to restrict Covid boosters for anyone under the age of 65 without certain health conditions.
For everyone else between the ages of six months and 64 years old, each updated Covid vaccine would need to undergo another randomized controlled clinical trial, Makary and Prasad said.
It’s not clear when, how or whether this plan will be implemented officially.
On Tuesday, top US health officials said on the social media site X that they would remove the recommendation for Covid vaccination from the childhood immunization schedule, and would also cease recommending it for pregnant people, who have much higher risks of illness, death and pregnancy complications with Covid.
On Friday, the CDC appeared to contradict that announcement by keeping Covid vaccines as a routine immunization for children – though the agency now says health providers “may” recommend the vaccine, instead of saying they “should” recommend it.
Changing recommendations could affect doctors’ and parents’ understanding of the safety and effectiveness of the vaccines.
Vaccines recommended by the CDC are also covered by the federal Vaccines for Children program, and health insurers are required to cover the costs of routine vaccines. It’s not clear if the wording change from “should” to “may” will affect that coverage.
If insurance no longer covers the vaccines, pediatricians are less likely to keep many of the shots in stock, Matthias said, and pharmacies are limited by different state laws on which ages they may vaccinate – which means families who want the vaccines may not be able to find them.
Matthias drove her children, then aged 15 months and 14 years old, two hours each way to a Moderna pediatric trial. They did six or seven visits, plus two visits to receive the actual vaccines after they learned they had received placebos.
Child participants spent hours on each visit and endured blood draws, Covid swabs, regular symptom and temperature monitoring, and, of course, several shots. Each shot was followed by a week of daily journaling and side-effect reporting.
Participants who got Covid, even months later, had blood draws to check their antibody responses.
“It was a pretty big commitment of our time and energy. But I did it because I wanted to be sure that my kids and all kids had access to vaccines,” Matthias said.
Laura Labarre, a parent in Oregon, said the trials involved “committing to something that felt important but larger than ourselves, because it ended up being a lot of work and a lot of logistics and a lot of effort”.
She drove her two kids, then aged one and three, an hour and a half each way to a Pfizer trial, and searched for ways to keep them occupied for hours on end.
When most people hear about new developments in pediatric medicine, such as new vaccines, they don’t often consider the hard work of volunteers, some only a few months old, who made the trials possible, Labarre said.
“I don’t think people consider the toll on the families who are the ones who bravely and nervously put their children up to be the first to try it out,” she said.
When Nick Giglia got the call asking if he still wanted to enroll his one-year-old daughter in the Pfizer pediatric vaccine trial, he immediately said yes.
For eight visits, extending over nearly a year, he would drive an hour each way to a trial in New Jersey. In all, his daughter received seven shots – three saline placebos, three vaccines and a booster.
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“It was very rigorous,” Giglia said of the study design.
Now, he said, “it’s really difficult to hear people harping on the thoughts of there not being the placebo group. Well, it’s news to me. My kid was in the placebo group,” he said.
Parents who were eager to enroll in the original trials now wonder whether families would want to endure another round of placebo-controlled trials for updated vaccines.
“Finding the number of participants that they would need would be extremely difficult,” Matthias said.
“To think that they would subject anyone, let alone children, to potentially getting the placebo in a trial where we know that the control is already so beneficial for health, just seems highly unethical and really disturbing,” Labarre said.
“A new trial today would not add anything we don’t already know,” Bessias said. “It would feel like actually participating in a project of undermining the existing evidence, rather than contributing new evidence.”
And the whole point of updating the vaccines is to counter new strains, Matthias said. Those vaccines would be out of date by the conclusion of a new study, which could take years.
“People should have the option” to get Covid vaccines, Matthias said. “The people who don’t want it don’t have to get it.”
When Matthias enrolled her kids in 2021, she felt as though they were in a limbo, and “we were all just desperate to get our kids protected”, she said. “To kind of have that feeling coming back now – we worked so hard and we advocated so much to get our kids access and now it might just be taken away – is really upsetting.”
While Covid mortality rates are highest among people over the age of 65, Covid is still the eighth leading cause of all deaths among children.
Any child dying a preventable death is a tragedy, Bessias said.
“We have to take a step back and realize that absolute numbers matter, too. And we can really avoid a lot of hospitalizations and deaths and transmission and horrible experiences for families by reaching those younger children. It’s baffling because that seems to be completely left out of these discussions.”
Labarre feels “profoundly enraged and betrayed” by the Trump administration’s actions. Limiting access to the vaccine, especially while proposing cuts to Snap and Medicaid, feels like “an additional audacious battlefront they’ve opened up in this sort of war on children”, she said.
“It is destabilizing, frustrating and enraging to feel like my daughter, who wasn’t even 18 months old, has done more for public health than some people who are now currently in charge of it,” Giglia said.
“It is very frustrating to hear that sacrifice that we volunteered to make for the country, and frankly, the world, belittled.”
At the end of the trial, Giglia’s daughter was given a stuffed teddy bear in a sweater that said “Covid-19 vaccine study hero”.
“I don’t care what anybody says. That’s what she is,” Giglia said. “I look forward to one day being able to tell my little girl all about how she helped save the world. And it’s hard to hear that many people think that we did the exact opposite.”
