By Meaghan Lee Callaghan and Marie Rosenthal, MS
Instead of removing the COVID-19 vaccine from the childhood immunization schedule, the CDC said parents and clinicians should use shared clinical decision-making to determine whether their healthy children should receive the primary vaccine.
The new Child and Adolescent Immunization Schedule released May 29 is a change from the previous recommendations of vaccinating children 6 months of age and older with both primary and annual booster doses of vaccine, and is at odds with the announcement that same week when Health and Human Services Secretary Robert F. Kennedy Jr. said COVID-19 shots would be completely removed from the pediatric schedule.
In the May 27 video announcement posted on X, Mr. Kennedy said he “couldn’t be more pleased to announce that the COVID vaccine for healthy children and healthy pregnant women has been removed from the CDC’s recommended immunization schedule.”
However, by keeping the COVID-19 shot a recommendation, albeit with shared clinical decision-making, the CDC’s latest immunization schedule now allows parents who want their children protected to obtain the vaccine. Moreover, COVID-19 vaccines would still be covered by the Vaccines for Children’s Program (VCP)—which covers about 35 million children—as well as most insurers, explained Paul Offit, MD, the Maurice R. Hilleman Chair of Vaccinology, Division of Infectious Diseases, University of Pennsylvania, Pearlman School of Medicine, in Philadelphia, as well as an attending physician and the director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
Most insurers will only cover vaccines that are recommended by the Advisory Committee on Immunization Practices (ACIP), he told Infectious Disease Special Edition.
In the new schedule, there are notes explaining that for children 6 months of age and older who are not moderately to severely immunocompromised, clinicians and parents can come together to decide whether vaccination is right. “This provision would allow for COVID-19 vaccination in children aged 6 months and older based on shared clinical decision-making, allowing for vaccination of immunocompromised children,” the schedule notes stated.
The idea of shared clinical decision-making between a patient or parent and their physician sounds like a good idea in theory: people deciding with their doctors after a discussion. But the concept is not popular among physicians, who already have to cram a lot of patient counseling in a short office visit. Adding what can be fraught discussions about vaccines is perceived as an unwelcome, added burden—a sentiment that has been shared by physicians over and over again at ACIP meetings.
A ‘Punt’ to Pediatricians, Primary Care
While he was glad to see that compromise in the recommendation because the vaccine will still be covered by VCP and insurance, Dr. Offit called it a “punt” to the doctor. “The job of advisory bodies, the job of the CDC is to make a recommendation. Advisory committees are supposed to give advice, not just throw it back into the lap of the doctor, who doesn’t necessarily know all the data.
“I think that most doctors, if you ask, don’t know the number of children who were hospitalized and killed last year by COVID because they either didn’t watch the ACIP meeting, which most won’t, or that it wasn’t publicized because it wasn’t,” Dr. Offit said.
In his video tweet on X, Mr. Kennedy, who appeared with FDA Commissioner Martin A. Makary, MD, MPH, and Jay Bhattacharya, MD, PhD, the head of the National Institutes of Health, claimed there were no clinical data to support vaccination of healthy children. However, the CDC data that Dr. Offit pointed to, presented at an April 2024 ACIP meeting by Fiona P. Havers, MD, MHS, demonstrated that healthy children are being hospitalized with COVID-19 infection, and some are dying.
Dr. Havers, of the CDC’s Respiratory Virus Hospitalization Surveillance Network Hospitalization Surveillance Team, Surveillance and Prevention Branch, Coronavirus and Other Respiratory Viruses Division, at the National Center for Immunization and Respiratory Diseases, found there were roughly 6,600 admissions to the hospital with COVID-19 for children younger than 18 years and 152 deaths, mostly among very young children. More than 50% of those children were previously healthy, and more than 90% were unvaccinated.
“Only 5% of children younger than 5 are vaccinated, and most of those deaths were in children less than 4,” Dr. Offit said. “Why wouldn’t you recommend the [COVID-19] vaccine for healthy children knowing [they] can be hospitalized and die from this virus, and knowing that healthy children are generally unvaccinated? You want them to be vaccinated, assuming you care about whether they live or die.”
After Mr. Kennedy’s announcement, Tina Q. Tam, MD, FIDSA, FPIDS, FAAP, a pediatrician and the president of the Infectious Diseases Society of America, also took issue with Mr. Kennedy’s decision, saying the recommendation “takes away choices and will negatively impact them [Americans].”
In a statement, she reminded Mr. Kennedy that “infants and children may also develop severe disease and may suffer from prolonged symptoms due to long COVID, which can negatively impact their development.” Dr. Tam is a professor of pediatrics at the Feinberg School of Medicine at Northwestern University, Chicago; the medical director of the International Patient and Destination Services Program; the medical director of the International Adoptee Clinic; the medical co-director of the Travel Medicine Clinic at the Ann & Robert H. Lurie Children’s Hospital of Chicago; and the president of the Lurie Children’s medical dental staff.
Changing Recommendations for Pregnancy
Under the new schedule for adults, however, women did not even receive the opportunity for shared clinical decision-making. The chart is color coded, and the new schedule for adults “grayed” out the COVID-19 recommendation during pregnancy, which means it is no longer recommended during pregnancy.
The decision not to cover pregnant people doesn’t make sense, Dr. Offit emphasized, because pregnancy is an immunocompromising state and puts people at risk for hospitalization and death from COVID-19. In fact, Dr. Makary and Bhattacharya admitted as much in a commentary they wrote recently in The New England Journal of Medicine defending their change in COVID-19 vaccine policy (2025 May 20. doi:10.1056/NEJMsb2506929) (Figure).
“This change is particularly troubling because pregnancy is a well-established risk factor for severe COVID-19 complications, including preterm labor and birth, preeclampsia, heart injury, blood clots, hypertension and kidney damage,” Dr. Tan’s statement said.
Dr. Offit, who sits on the FDA’s Vaccines and Related Biological Products Advisory Committee, and was on that committee when discussing whether to authorize the COVID-19 vaccines, explained the thinking behind the recommendation during pregnancy. When the Moderna vaccine was being considered, the company presented data on the trial that included 30,000 people who received either the vaccine or a placebo vaccine, but none of the people were pregnant. In fact, the trial specifically excluded pregnant people.
Typically, in cases like this, the CDC contraindicates the vaccine, but because so many people were dying from COVID-19 at the time, the CDC’s recommendation stated, “A pregnant woman could reasonably choose to get this vaccine—that’s what they said,” Dr. Offit explained. However, if they chose to get the vaccine, the agency asked them to participate in the V-safe surveillance system, so that the CDC could follow them through their pregnancy to delivery to ensure there were no adverse events.
By April 2021, the CDC had enough data to change the recommendation from “reasonably choose” to “urgently recommended.” And the reason they did that was because COVID-19 was causing severe problems during pregnancy, including maternal deaths, preeclampsia, preterm births and stillbirths.
“Pregnancy is a relatively immune-compromised state. And so people who are pregnant are at increased risk for serious illnesses from respiratory viruses,” Dr. Offit explained. “I mean, they’re not more likely to get them. But what was shown also throughout 2020 and through early 2021, is that pregnant people were more likely to be hospitalized and more likely to die than women of the same reproductive age who weren’t pregnant. “An infected pregnant person is more likely to be hospitalized and die than is an infected nonpregnant woman of the same age,” said Dr. Offit, who wrote about the recommendations here. (https://pauloffit.substack.com/p/rfk-jrs-war-on-children)
Now, pregnant people can still be vaccinated, but because it is not recommended by the CDC, insurers probably will not pay for it, and it is an expensive vaccine without insurance coverage, according to Dr. Offit.
The IDSA urged “insurers to maintain coverage for COVID-19 vaccines so that all Americans can make the best decisions to protect themselves and their families against severe illness, hospitalization and death.”
The IDSA also urged Congress to conduct “meaningful and necessary oversight” to ensure a more transparent decision-making process at HHS. Mr. Kennedy frequently complained about the lack of transparency before he took office. Since Mr. Kennedy, Mr. Makary and Mr. Bhattacharya have been at the helm of America’s important healthcare institutions, there have been canceled public meetings, decisions made without the advice of independent advisory panels who meet in open sessions and fewer announcements to the press, who cover healthcare and report to the American people.
In a new statement released after the CDC vaccine schedules were posted, Dr. Tan said: “Despite Secretary Robert F. Kennedy Jr.’s stated efforts to promote efficiency and transparency, the Department of Health and Human Services and its affiliated agencies released multiple rounds of conflicting COVID vaccine guidelines of unclear origin last week, jeopardizing Americans’ ability to make their own choices about vaccination and causing significant confusion among medical professionals and the public.”
She reiterated the importance of vaccination and governmental guidance, which enables insurance coverage of vaccines. “Changing government recommendations about which specific and limited populations should receive COVID-19 vaccines has far-reaching consequences,” she said.
“The chaos, confusion and more limited insurance coverage for COVID vaccines that is expected to result from the latest sets of guidance will likely significantly decrease the number of people who receive COVID vaccines this fall, setting us up for increases in preventable complications, hospitalizations and deaths,” Dr. Tan said.
