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Biotech / Medical : Coronavirus / COVID-19 Pandemic

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From: Sam6/6/2025 10:45:37 AM
   of 22867
 
Rewriting of Covid vaccine recommendations has doctors and other experts worried
Moves led by HHS secretary will likely diminish use of shots by vulnerable populations, they say
By Helen Branswell
June 5, 2025
Senior Writer, Infectious Diseases

Delivering Covid vaccinations has never been an easy job. But health secretary Robert F. Kennedy Jr.’s rewriting of government recommendations will make the effort to get vaccine doses into arms exponentially more difficult, experts say.

The changes will complicate discussions between pediatricians and parents, obstetricians and pregnant patients, and both groups and their insurers, these experts say. They will also likely result in Covid shots being harder to access, with fewer doctors choosing to stock them and fewer pharmacies willing to administer them, for both economic and liability reasons, the experts said.

“I think it’s going to create confusion for doctors and for patients,” said Linda Eckert, a professor of obstetrics, gynecology, and global health at University of Washington in Seattle, and a member of the immunization work group of the American College of Obstetricians and Gynecologists.

Kennedy’s new policy — announced last week in a 58-second video on the social media platform X — drops a recommendation that all healthy children and healthy pregnant people be vaccinated. Citing no scientific evidence, he and other senior U.S. health officials argued that the vaccines do not deliver sufficient benefits for healthy children. They noted other countries, including in Europe, have dropped recommendations that kids be vaccinated. The officials also argued that there is not enough safety data on the use of the vaccines in pregnant people.

Health experts largely dispute those conclusions. They say the revised policy is a formula for further erosion of uptake of Covid vaccines by people who would benefit from them: pregnant people, the infants they give birth to, and other very young children. These are groups for whom good evidence exists that Covid infection still poses a significant risk, they said.

“I’m afraid that the more shade that’s thrown in this direction, the more confusion, the more ambiguity on the part of the federal public health establishment, that we will start to see harm that is otherwise preventable actually being realized. I’m deeply worried about that,” said Ruth Faden, a professor of biomedical ethics and founder of the Johns Hopkins Berman Institute of Bioethics.

“The last thing that health care professionals who are advocates for the health of women and their babies need is an undermining or mixed message from the federal government,” she said.

When the new policy worked its way into the vaccine schedules posted on the Centers for Disease Control and Prevention’s website late last week, vaccine advocates were dismayed. The wording of the recommendation for children was converted from saying they “should” get vaccinated to they “ may” be vaccinated, after consultation with a doctor. That process is known as shared decision-making. For pregnant people, the CDC now offers no advice — a situation that horrifies people who work in this field.

“I find it heartbreaking, frankly,” said Eckert, who said that hospitals in the University of Washington network will nevertheless instruct its OB-GYNs that they should urge their pregnant patients to get a Covid booster. “I’ve seen pregnant women contract Covid. I’ve seen what it does to them. We’ve had several deaths in our institution.”

Other authorities are stepping in to fill the recommendation void. On Wednesday, Wisconsin’s Department of Health Services issued a statement saying that it continues to recommend Covid vaccination in pregnancy and all children, with Secretary Kristen Johnson saying the vaccines remain “an important tool in preventing severe illness and death.”

Eckert noted that a pregnant person’s risk of ending up in intensive care in a hospital when infected with Covid is three times that of a similarly aged person who isn’t pregnant. “It’s very clear that the Covid vaccine in pregnancy offers distinct advantages to pregnant individuals should they contract Covid and to their infants.”

A study from the CDC found that children younger than 6 months — infants who are too young to be vaccinated — were the second-most likely group to need hospitalization for Covid infection, after adults 65 and older. The vast majority of babies hospitalized for Covid were born to mothers who had not been vaccinated during pregnancy. Antibodies triggered by vaccination in pregnancy transfer to the fetus and protect infants during their first weeks and months of life.

Recommendations on who should receive specific vaccines are normally the responsibility of the CDC, on advice from an expert outside panel known as the Advisory Committee on Immunization Practices. The CDC rarely disagrees with the ACIP.

The ACIP has been planning to vote on revisions to the existing Covid vaccine recommendations at its scheduled meeting in late June. The committee is expected to be asked to move from a universal recommendation (everyone 6 months of age and older) to one that recommends vaccines for people at high risk from infection because of age — the very young and adults 65 and older — or medical conditions, while healthy adults and some children would be listed as being eligible to get boosters if they want them, after consultation with a health care provider. There has been no suggestion the committee was considering omitting pregnant people, given that demographic’s risk.

The ACIP effectively has three options when it considers how a vaccine ought to be used after it has been licensed by the Food and Drug Administration, said Sean O’Leary, a pediatric infectious diseases specialist at Children’s Hospital Colorado and the American Academy of Pediatrics’ liaison to the ACIP. The group can recommend use of the vaccine; it can choose not to recommend use of the vaccine: or it can opt for a middle ground, the “may” recommendation that requires shared decision-making.

Under the Affordable Care Act, health insurers are supposed to cover the cost of vaccines that carry a “should” or a “may” recommendation, and they are available to children from lower-income homes through the Vaccines for Children Program.

The ACIP infrequently uses “may” recommendations, O’Leary said.

“And the times that they have done that in general over the last several years have been where it really didn’t make sense from a public health standpoint to make a recommendation for the entire population, very often because of cost, because it would be such an expensive proposition to recommend the vaccine, but they wanted to have the vaccine available for those who wanted it,” he said, noting the decision not to recommend that all 27- to 45-year-olds get the human papillomavirus, or HPV, vaccine is one such example.

Because “may” recommendations are covered by the ACA, a shared decision-making recommendation is — at least in theory — better than no recommendation at all. But pediatricians do not like them, O’Leary said.

“We’ve seen that in surveys. And anecdotally, what I’ve heard over and over again is basically, ‘You guys are the experts. If you can’t tell us what the right thing to do is, how are we supposed to figure that out in a 10- or 15-minute office visit with a family?’” he said.

Doctors use a joint decision-making approach often with patients in discussions unrelated to vaccines, when they face a choice for which there isn’t a clear best answer, O’Leary said.

“Routine vaccines are not a place for … shared decision-making because there is a clear right answer,” he said.

Aaron Milstone, a pediatric infectious disease physician at Johns Hopkins Children’s Center in Baltimore, said the new recommendation will add complexity to these deliberations. “I think that discussion is harder now because now pediatricians can’t say, well, there’s a recommendation that this is a safe and effective vaccine.”

The new recommendation for kids and the way it was arrived at — secretarial edict, with no involvement of the ACIP or the CDC — injects politics into a process in which it shouldn’t factor, Milstone said. “Shared decision-making should be focused around the doctor-patient relationship. It shouldn’t come from a political slant.”

Uzma Hasan, division chief of pediatric infectious diseases at Cooperman Barnabas Medical Center, in West Orange, N.J., worried the controversy could upstage the scientific evidence in these discussions.

“Once you plant the grain of doubt about anything, whether it be with data that is not substantiated, has no meaning, has no proof, then the ripple effects of that are very, very difficult to control,” she said.

Politics aside, the lack of a firm recommendation from the CDC for any children will complicate the discussions pediatricians and their staff have with parents, Hasan said. “??This conversation may now need to be more detailed and it may require, for example, perhaps more than one visit to address concerns, which may become challenging with tight schedules and timelines for vaccinations.”

Pediatricians who take part in the Vaccines for Children program — most primary care pediatricians and many family medicine physicians do —must stock vaccines that the CDC says children should get, but they don’t have to stock vaccines that are the subject of shared decision-making recommendations, O’Leary noted. Given the high cost of stocking vaccines in general and pricey Covid vaccines in particular, and the low uptake of the vaccines among children, some practices may conclude they don’t want to bother anymore.

“We already know that access is an issue for these vaccines and kids. These are sometimes hard vaccines for families to get, and I think this move is only going to make that harder because I think fewer practices will probably stock it after this,’’ he said.

For pregnant people, the lack of a recommendation from the CDC may also restrict where they can be vaccinated against Covid. Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against Covid–19 — better known as the PREP Act — pharmacy workers do not have liability protection for administering Covid shots, if there is no recommendation for their use in the person seeking vaccine. Under those circumstances, experts suggested, pharmacies are unlikely to be willing to administer the shots. (Doctors are still protected, said Dorit Reiss, a law professor at UC Law San Francisco who focuses on vaccination policy.)

ACOG, the group that represents obstetricians and gynecologists, continues to strongly recommend that pregnant people get vaccinated against Covid during each pregnancy. Other groups — the Infectious Diseases Society of America and the American Academy of Family Physicians — have been critical of the lack of a transparent process or a scientific rationale by U.S. health officials for making these new recommendations.

They and others fear that having no clear guidance for pregnant people could lead insurers to stop covering the cost of Covid shots for this group.

Even with strong support of ACOG, the lack of a CDC recommendation for pregnant people is “not a good state of affairs,” said Faden. She noted that pregnant people face multiple difficult decisions as they try to do their utmost to shield their fetuses from conditions and exposures that might affect their development.

When Kennedy announced his new policy, he suggested the U.S. was an anomaly among peer countries, which don’t routinely vaccinate all children against Covid at this point. But on the issue of recommending vaccination of pregnant people, a lack of guidance puts this country out of step with most of those same countries. Canada and the World Health Organization recommend Covid shots for pregnant people; the United Kingdom’s vaccination plans for the coming season suggest pregnant people can be vaccinated, because pregnancy is listed as a condition that increases the risk of severe illness. Australia doesn’t routinely urge pregnant people who have already been vaccinated against Covid get another shot with each pregnancy, but acknowledges they may choose to do so, because they have health conditions that increase their risk or because of personal preference.

statnews.com
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