(CNN) — As parents shop for backpacks, No. 2 pencils and sneakers in preparation for the new school year, making sure children are up to date on their vaccinations is on many families’ back-to-class checklists.
This year, many health experts are worried that decisions about vaccination — how many shots to get and when to get them – may be unnecessarily complicated because of an executive order signed by President Donald Trump on Monday that seeks to pare down the number of routine immunizations given to American kids and, in some cases, reformulate them and space them out.
“The president wants to maximize parental choice choices over vaccinations for their children,” a White House official said Monday.
Doctors said the a la carte approach to vaccination spelled out in Trump’s executive order would harm families, rather than help.
“The only thing that I can see is going to happen as a result of the announcement from today is an injection of greater amounts of uncertainty and fear and confusion, where there doesn’t need to be any of that,” Dr. Andrew Racine, president of the American Academy of Pediatrics, said Monday.
Types of vaccines, insurance coverage won’t change soon
The first thing to know is that there aren’t likely to be any changes to the types of shots available to families – or to the US Centers for Disease Control and Prevention’s recommended vaccine schedule – for months or years, if they happen at all.
Insurance coverage also is not likely to be affected since childhood vaccines remain on the CDC’s schedule as recommended, even if they have been moved to a category called “shared clinical decision-making,” which means patients need sign-off from their healthcare provider before they get them.
Two major insurers, Blue Cross Blue Shield and CVS, said Monday that they were reviewing the president’s order but planned to continue to cover CDC-recommended pediatric vaccines without co-pays, at least for the time being.
The White House said that free vaccines provided through the Vaccines for Children program would also not be affected by the new executive order because, by law, that program relies on guidance from the CDC’s vaccine advisory committee.
Trump’s vaccine order likely to face challenges
Next, the order is likely to be challenged. Executive orders aren’t the legal mechanism though which vaccine recommendations are made in the US, said Dr. Dorit Reiss, a professor at the University of California at San Francisco who specializes in vaccine law. Congress has laid out a different process, she said.
“Several Congressional laws put the power to make these recommendations on the [CDC’s] Advisory Committee on Immunization Practices, with approval or rejection by CDC director. The President can direct CDC to convene ACIP and consider these changes, but an Executive Order is not a substitute to that process,” Reiss said in an email.
This isn’t the Trump administration’s first attempt to overhaul US vaccine policy. US Health and Human Services Secretary Robert F. Kennedy Jr. tried to have the CDC change the childhood vaccine schedule in January, and his group of handpicked advisers had been meeting to debate the safety of vaccine ingredients before a judge’s order stopped those changes in March. That litigation is still ongoing.
The White House said the order complies fully with the existing court orders and injunctions.
“What this particular executive order does is, on behalf of the president, recognizes the gold standard science for the United States government. This is separate from any other committee processes,” a White House official said.
Evidence for vaccines hasn’t changed
Something else to be aware of is that the changes called for in the executive order aren’t being driven by new science or evidence, said Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
The executive order draws its recommendations from a January review that compared the childhood vaccine schedule in the US with those of other developed countries.
The review was criticized at the time for comparing the United States to Denmark, a much smaller county that provides universal health care to its citizens.
“What’s good for the children in Denmark is probably good for the children in Denmark, and what’s good for the children in Japan is probably good for the children in Japan,” Racine said.
“But the recommendations for immunization here in this country and the schedule that we’ve developed has been developed over generations with thousands and thousands of studies, and it’s really based on what the conditions that the children in the United States are facing, which is what it should be,” he added.
The executive order, titled “Delivering Gold-Standard Vaccine Recommendations for Americans,” bears the fingerprints of Kennedy, who has weakened vaccine recommendations and has questioned both the safety of routine childhood immunizations and the schedule that parents and doctors rely on to deliver them.
Challenges of splitting up vaccines
The new order calls for splitting up combination vaccines, like the one that protects against measles, mumps and rubella, which would be given as three shots instead of one, at three separate office visits.
This currently isn’t possible even if parents wanted to do it, said Dr. Katherine Matthias, a pediatrician who practices near Greenville, South Carolina.
“That doesn’t exist in the United States, so I don’t know where he’s getting that from,” Matthias said. “As a pediatric office, you cannot order a measles shot, a mumps shot and rubella shot. It comes as an MMR, or it comes as an MMR-varicella, which we give combined at age 4.” The varicella vaccine protects against chickenpox.
On Monday, White House officials acknowledged that single vaccines for measles, mumps and rubella are not currently available in the US.
“This specific recommendation will be followed up by work at HHS and to work with the private sector and others on making that option commercially available,” an official said.
Even if the shots were available separately, giving them that way doesn’t make much practical sense, Matthias said.
At the 4-year-old well child visit, doctors typically give kids two shots: MMRV, which protects against measles, mumps, rubella and chickenpox; and a shot that protects against diphtheria, tetanus, whooping cough and polio. If those came separately, parents would be giving kids five to nine shots instead of two, and they’d be coming back to the doctor every two weeks to get another dose.
“A lot of my patients have transportation issues,” Matthias said. “They’re not going to come in every couple weeks to get the shots all separated out.”
That also means kids on an extended vaccination schedule are less safe because they’re more likely not to finish the full series of shots they need.
What’s more, Matthias said, kids are exposed to hundreds of things every day that stimulate their immune systems. Combining vaccines is still only giving them only a fraction the number of things they are already being exposed to.
Eyes on vaccine timing, ingredients
The executive order would pare down the number of vaccines that are recommended for all children from 18 to 11; the rest would be available based on a recommendation from a healthcare provider.
It also calls for more study of the timing of the vaccine schedule as well as scrutiny of vaccine ingredients such as aluminum, or alum, which is used in small amounts in some shots as a booster, or adjuvant, to help them work better.
The amount of aluminum in vaccines is much smaller than what kids already take in through eating, drinking and breathing, said Racine, of the American Academy of Pediatrics.
“Right now, there are no equivalently effective alternative adjuvants that could be put into a vaccine tomorrow that would that would do what aluminum does,” Racine said. “There’s no evidence at all that aluminum has any safety concerns for children when it’s given in the context of an adjuvant in a vaccine.”
What’s more, changing vaccine ingredients would require new studies, which would be costly and take years. It’s unlikely that pharmaceutical manufacturers would be willing to do that, since the vaccines we have now are already safe and effective.
“To do a trial for its new vaccine, it would cost tens and possibly hundreds of millions of dollars to do that kind of work. To what end?” Offit said. “It’s not going to make it safer. All it’s going to do is make it less available and less affordable.”
Targeting school vaccination requirements
The executive order also threatens states and counties with legal action if they don’t allow religious or personal-belief exemptions to vaccination, and it suggests that the federal government could withhold funding to states that don’t adopt its recommendations.
Vaccines are required for public school attendance in all 50 states, though that standard has been weakened in many states in recent years by a slate of new laws allowing personal-belief exemptions, which allow parents to opt out of routine vaccines for their kids without a documented medical reason.
Four states don’t allow families to opt out of vaccines required for school through religious or personal-belief exemptions: California, Connecticut, Maine and New York. In West Virginia, legal challenges threaten the state’s longstanding policy of not allowing religious exemptions to vaccination.
States without personal-belief exemptions consistently have higher vaccination rates – and are less likely to see outbreaks of vaccine-preventable diseases – than states that do allow them.
‘Already seeing the fallout’
Doctors say that the only predictable result of Trump’s executive order is confusion and fear, which is likely to cause falling vaccination rates in the United States to drop even further.
“We’ve already seeing the fallout of it,” said Matthias, who is also co-founder of the nonprofit Protect Their Future, a group of parents who advocate for access to pediatric vaccines.
Matthias said her practice is near Spartanburg, South Carolina, which dealt with a large measles outbreak this year. She saw many parents bring in babies to be vaccinated on an accelerated schedule because they were worried they’d get sick before they could get their first MMR dose.
“There’s going to be more people hesitant to get their vaccines on time, and there’s going to be more outbreaks of vaccine-preventable diseases,” Matthias said. In the past year, her practice has seen more cases of whooping cough, or pertussis, and chickenpox than she can remember.
Experts urge parents to listen to pediatricians, who have the best interests of their kids at heart.
“I see this as a ploy to further erode public confidence in vaccines and ensure vaccination rates continue to decline and bring the diseases back, which has already started to happen,” said Dr. Peter Hotez, a senior fellow in disease and humanity at the Baker Institute at Rice University.
“These vaccines are incredibly safe, very effective, and have historically led to the elimination of the diseases they’re designed to prevent,” Hotez said.
CNN’s Elise Haulund contributed to this report.
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