New COVID-19 Vaccine Recommendations Cause Confusion Among Public, Health Care Providers
The conflicting information and abrupt changes are likely to contribute to a lack of trust and confidence in health care, Lauren Angelo, PharmD, MBA, said.
Within the past few weeks, there has been a lot of information coming out about the COVID-19 vaccine and the upcoming 2025-2026 respiratory season. Recommendations, which were once aligned, have now become conflicting—the Department of Health and Human Services (HHS) has one set and the CDC website has another.
The conflicting information and abrupt changes are likely to contribute to a lack of trust and confidence in health care, Lauren Angelo, PharmD, MBA, said. | Image Credit: Production Perig - stock.adobe.com
“The latest recommendations over the past couple weeks have created confusion, and we have seen individuals, as opposed to advisory groups or committees, independently changing vaccine policy. This, coupled with the lack of transparency, is unprecedented and concerning,” said Lauren Angelo, PharmD, MBA, associate dean of academic affairs at Rosalind Franklin University of Medicine and Science.1
On May 27, Secretary of Health and Human Services Robert F. Kennedy, FDA Commissioner Marty Makary, MD, MPH, and the National Institutes of Health (NIH) Director Jay Bhattacharya, MD, PhD, released a video on X stating the recommendation for the COVID-19 vaccine for healthy children and healthy pregnant women has been removed from the CDC’s recommended immunization schedule. Kennedy stated, “Last year, the Biden administration urged healthy children to get yet another COVID shot despite the lack of any clinical data to support the repeat booster strategy in children.”2
At the time of the recommendation switch, the CDC website for pregnant women had not been updated, which caused confusion among the media, health care community, and general public. When it was updated on May 29, it differed from the video that announced the change.3,4
“The pregnancy category of recommendation was removed from the adult schedule, and it now states that there is no guidance and it's not applicable, which is consistent with the initial change,” Angelo said.1 “However, the adult schedule still includes vaccination for healthy adults younger than 65 [years], and the childhood schedule group has children who are not moderately or severely immunocompromised, in other words, healthy, into the shared clinical decision-making category.”
In a Sounding Board published by the New England Journal of Medicine, Vinay Prasad, MD, MPH, and Makary stated that the country’s “one-size-fits-all regulatory framework” is more aggressive compared to all European nations. They echoed the recommendations by the HSS, NIH, and FDA, and they are encouraging manufacturers to conduct randomized controlled trials in healthy adults. The piece calls for more evidence and testing on COVID-19 vaccination.5
Angelo mentioned 2 issues that could arise from the new recommendations. When the recommendations are updated, it takes time to roll them out into routine clinical practice, which can be challenging. For vaccines specifically, she stated that it is easier to have universal and age-based recommendations instead of recommendations for specific groups or for shared clinical decision-making. The other issue is increased liability for health care providers, especially pharmacists who rely on recommendations from the CDC. This could pose an issue if the changes are not communicated in a timely or transparent manner.1
Although healthy children infected with COVID-19 have had less of an impact on the health care system, shared decision-making will allow the opportunity to vaccinate children if it is what is best for them.
“This particular change for pregnant individuals is the most perplexing and confusing. We know that pregnant and non-pregnant women who are healthy have the same risk for getting an infection,” Angelo said.1 “However, should a pregnant person get infected with the SARS-CoV-2 virus, there's a much higher risk for severe infection and hospitalization when compared to nonpregnant individuals who got COVID had higher rates of ICU [intensive care unit] admission, requiring a ventilator, and death.”
Another issue could be an increased risk of preterm birth, so preventing infection for pregnant patients is extremely important, Angelo said. Further, infants are too young to vaccinate, so passive immunity—immunity passed via antibodies from vaccinated mothers—can protect the infant in the early months.1
According to the CDC website, Medicare Part B covers COVID-19, hepatitis B, influenza, and pneumococcal vaccines. However, Medicare Part D covers all recommendations by the Advisory Committee on Immunization Practice, except for those covered by Part B. With the conflicting information and changes in schedules without warning, it will be difficult for both public and private insurances to keep up, and it could prevent pregnant patients from getting vaccinated.6,7
“This is especially true when individuals in the media are communicating a specific message and the immunization schedule is different from that. We currently see this with the case of healthy adults,” Angelo said.7 “One group says don't vaccinate, but the adult schedule still recommends vaccination.”
The conflicting information and abrupt changes are likely to contribute to a lack of trust and confidence in health care, Angelo said. She said that it might contribute to an uptick in vaccine hesitancy, and health care providers have an increased responsibility to keep up with all the changes. The next meeting for ACIP will be June 25 to June 27, 2025, and COVID-19 vaccination and recommendations are likely to be discussed at the meeting.7
"Prior to these changes announced over the past couple of weeks, we've had a fairly good system, complete with checks and balances for vaccine recommendations in the United States. Recommendations have been evidence based with a great deal of focus on safety and cost effectiveness,” Angelo said. “The recent COVID-19 vaccine recommendations made by a few appointed individuals were a complete deviation from the science-based approach. I am concerned that a potentially unsafe and irresponsible precedent may have been set.”
READ MORE: COVID-19 Resource Center
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