In a major change in vaccine policy, the Trump administration recently dropped recommendations that all kids get six immunizations long considered routine. Instead, they're now in a category called "shared clinical decision-making."
That's when the patient (or the parents if the patient's a child) has a conversation with a health care provider to decide if a treatment is appropriate, says Wendy Parmet, who studies health care policy at Northeastern University in Boston.
"In theory, shared clinical decision-making sounds great," she says. But the approach is usually reserved for complicated medical decisions where the answer is often muddy, not for routine vaccines that have been clearly shown to be safe and effective.
Some examples include: Should someone get surgery or physical therapy for back pain? Which men need regular PSA prostate cancer testing?
But many doctors say there's no ambiguity when it comes to these vaccines, which protect against hepatitis A, hepatitis B, the flu, meningitis, respiratory syncytial virus (RSV), and rotavirus, a dangerous gastrointestinal infection.
"These vaccines have clear evidence of benefit for all children," says Jake Scott, an infectious disease researcher at Stanford University. "So moving them to shared decision-making doesn't reflect the scientific uncertainty that the category exists for. It manufactures this sort of uncertainty where no uncertainty really exists."
The problem with shared decision making in this context, is "you're suggesting that both options are equally valid," says Dr. Lainie Friedman Ross, a pediatrician and bioethicist at the University of Rochester School of Medicine. "And the fact is: Not getting vaccinated puts your own child at risk, puts you at risk and puts your community at risk. So it is not an equal decision."
Vaccine critics argue there's enough nuance about these immunizations to warrant moving them to the shared clinical decision-making category. And administration officials say the change is designed to restore trust in vaccines.
But Ross and others argue that dropping these vaccines to a lower spot in the new CDC vaccine hierarchy sows dangerous confusion and doubt, especially at a time when vaccine hesitancy is already on the rise and vaccination rates are already falling.
"It's a huge embarrassment for U.S. public health and a disaster for public trust, and most of all for children," says Dr. Douglas Opel, a professor of pediatrics at the Washington School of Medicine.
They also point out that doctors already routinely answer any questions parents may have, in addition to providing detailed handouts about each vaccine.
New hurdles to vaccine access
And there are many practical implications that could become hurdles to kids getting the shots, even if their parents do want them, Scott says. That includes deleting automatic electronic medical record alerts when shots are due and canceling standing orders for nurses and pharmacists to vaccinate kids without getting a doctor involved.
"Moving it from routinely recommended to shared clinical decision-making has a dramatic effect on the practical delivery of vaccination," Scott says.
And while the administration says the decision shouldn't affect whether government programs or private insurance pay for the immunizations, some legal experts say that may not be guaranteed.
"The administration says that there's not going to be insurance implications. But there are a number of problems there," says Dorit Reiss, who studies vaccine policies at UC Law San Francisco. "First of all they can change their interpretation later. Second, if a private insurer wanted to challenge this and say, 'This vaccine is no longer recommended. I don't have to cover it,' they probably have some good arguments."
Even with insurance, parents may now get hit with co-pays for those extra conversations with swamped pediatricians, according to Dr. Molly O'Shea, a Detroit-area pediatrician who serves as a spokesperson for the American Academy of Pediatrics.
"Before, if it was a vaccination that we didn't have to have a conversation about, we could feel safe allowing families to schedule a vaccine-only appointment," O'Shea says. "Because shared-decision making is required now, that takes time and that now is going to be billed for."
New liability concerns for drugmakers
Another big question is: Does this make vaccine makers and doctors vulnerable to getting sued? Many lawyers don't think so.
"On a legal standpoint, nothing has changed," says David Carney, a Philadelphia lawyer who's the president of the Vaccine Injured Petitioners Bar Association.
But some lawyers argue that the change does open the door to more litigation over vaccine injuries.
"The immunity under the National Childhood Vaccine Injury Act of 1986 (the 1986 Act), which shields pharma and physicians from liability when vaccines cause serious harms and deaths, only applies to vaccines that are recommended for routine administration to children and/or pregnant women," Aaron Siri, managing partner at Siri & Glimstad, wrote in an email to NPR.
Siri is a close ally of Health Secretary Robert F. Kennedy Jr. and has been extensively involved in litigation against federal agencies and vaccine manufacturers.
Some legal experts say that this uncertainty is alarming. Without liability protection, vaccines could become unavailable, says Parmet.
"We don't quite really know whether shared clinical decision-making will be considered as sufficient enough of a recommendation to provide the liability protection," Parmet says. "And if it doesn't do that, then there are real concerns about whether the manufacturers will continue to make vaccines."
A chilling effect on prescribers
Even if the change doesn't lead to an increase in successful lawsuits involving vaccines, just the possibility of lawsuits could be enough to intimidate doctors, some say.
"They're worried about stepping on a landmine if one thing goes wrong," Parmet says. "One kid gets sick. The next day — even if it has nothing to do with the vaccine — are they going to be the ones held responsible? And someone's going to say, 'You had the nurse do it without talking to the doctor?'"
That could make doctors hesitant to recommend these immunizations, which means imposing shared clinical decision-making could leave more kids more vulnerable to dangerous infections.
"I do think many physicians will be chilled in their behavior around recommending vaccination," says Michelle Mello, a professor of health policy and law at Stanford. "We've got this change now that plunges us into a situation of chaotic uncertainty."
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