CDC: Healthy children can receive COVID-19 vaccine via "shared clinical decision-making" | Image Credit: © ricka_kinamoto - © ricka_kinamoto - stock.adobe.com.

Beginning in mid-May, the FDA, Health and Human Services (HHS), and the CDC outlined a new COVID-19 vaccine framework and announced on May 27 the removal of the vaccine from the CDC immunization schedule for healthy children and pregnant individuals. However, according to the CDC's Child Immunization schedule that was updated on May 29, healthy individuals aged 6 months to 17 years who are not moderately or severely immunocompromised can receive the vaccine through a "shared clinical decision-making process."^1-3

Below is a timeline recap of these changes and announcements.

May 20, 2025: FDA announces new COVID-19 policy for children

On May 20, 2025, the FDA announced a new COVID-19 vaccination regulatory framework for future seasonal vaccines and additional clinical trial requirements for approval of vaccines intended for healthy individuals. According to the framework, published in the New England Journal of Medicine (NEJM), the FDA will use an immunogenicity basis to make favorable benefit-risk findings for adults older than 65 years, and for all persons aged 6 months and older with at least 1 risk factor that increases risk for severe COVID-19 outcomes.²

The NEJM publication was authored by Martin Makary, MD, MPH, commissioner of the FDA; and Vinay Prasad, MD, MPH, director of the FDA's Center for Biologics Evaluation and Research, stated for healthy individuals aged 6 months to 64 years, with no risk factors for severe COVID-19, the FDA "anticipates the need for randomized, controlled trial data evaluating clinical outcomes," before biologics license applications for the vaccines can be approved.

Click here for more on the policy outline, as it was reported at the time of publication.

May 27, 2025: CDC pulls COVID-19 vaccine recommendation for healthy children, pregnant individuals

Just a week after the new framework was announced, on May 27, 2025, HHS Secretary Robert F. Kennedy Jr. announced that the CDC had pulled the recommendation for routine COVID-19 vaccination among healthy children and pregnant women.³

In a video posted to X, Kennedy Jr. stated the following:

"I couldn't be more pleased to announce that, as of today, the COVID vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule."

At the time of the announcement, multiple health care professionals expressed frustration and concern to Contemporary Pediatrics about the recommendation removal and frequent changes to policies by federal agencies.

"The craziness never ends, and the recent change to the CDC immunization schedule regarding the COVID-19 vaccine and use in pregnant women and healthy children is complete madness," stated Tina Tan, MD, FIDSA, FPIDS, FAAP, in an interview with Contemporary Pediatrics. Tan is editor-in-chief of Contemporary Pediatrics, president of the Infectious Diseases Society of America, an attending for Infectious Diseases at Ann & Robert H. Lurie Children's Hospital of Chicago, and a professor of Pediatrics at Northwestern University's Feinberg School of Medicine.

"COVID-19 infection can have extremely serious consequences in pregnant women, resulting in hospitalization, pre-term labor, pre-eclampsia, heart injury, blood clots, hypertension, and kidney damage," added Tan. "Not vaccinating them is sheer madness and will contribute to a significant increase in possible morbidity and mortality. Also, not vaccinating healthy children is completely inappropriate, given that some healthy children can have severe COVID infections with long-lasting consequences. This will make it much more difficult for practitioners as they will have to determine which of their patients are eligible for the COVID vaccine to determine how much vaccine to order and to determine if insurance will cover vaccine cost."

Click here for more reactions to the removal of the vaccine recommendation, as it was reported on May 27, 2025.

May 29, 2025: Updated CDC child immunization schedule

As of May 29, it appears the CDC has again changed course on routine COVID-19 vaccination, stating that children aged 6 months to 17 years who are not moderately or severely immunocompromised may receive the vaccine in situations where the parent wishes their child to get the vaccine, along with clinical judgement provided by a health care professional on a case-by-case basis.¹

For clarity, the "Shared clinical decision-making" section listed by the CDC states the following:

"Ages 6 months–17 years who are NOT moderately or severely immunocompromised"

"Shared clinical decision-making vaccinations are individually based and informed by a decision process between the health care provider and the patient or parent/guardian. Where the parent presents with a desire for their child to be vaccinated, children 6 months and older may receive COVID-19 vaccination, informed by the clinical judgment of a healthcare provider and personal preference and circumstances."

Following this statement, the childhood vaccine schedule continues, with recommendations for vaccination by various age groups.

Change in previous behavior

"[The clinical trials could] be a major factor in delaying whether or not individuals are going to be able to receive the vaccine, and that that is not how this should be done, because we know these vaccines work," said Tan. "The vaccines are being reformulated every year to take into account the circulating subserotypes. We know the vaccines work, we know the vaccines are safe. To do [this is] really going to delay availability."²

William Schaffner, MD, professor of Medicine in the Division of Infectious Diseases at the Vanderbilt University School of Medicine, agreed with this sentiment, telling our sister publication Contagion, "So, the [FDA] regarding COVID vaccines has become very assertive in indicating which populations ought to be vaccinated going forward this fall," said Schaffner.⁴

"That, to the minds of many of us, has the FDA getting into the CDC territory. The FDA looks at the effectiveness of the vaccine and its safety and then licenses it, and traditionally, then that vaccine has been left to the CDC advisory committee to make recommendations as to which populations ought to receive the vaccine. But here, just recently, the FDA seems to be, if you will, poaching on CDC territory. The mechanism that I've described, first the FDA and then the CDC, has stood in good stead for over 60 years. In the minds of many people, it ain't broke. Why do we have to fix it?"

As far as implementations and actual vaccination outcomes in the fall, Schaffner said it could be a waiting game.

"[These policies are] a little bit different than in the past, and changes always raise questions. There's that old saying, the devil is in the details. And so as these new policies come forward and are implemented, everybody will be looking at them very, very carefully."

References:

1. Child immunization schedule notes. CDC. Updated May 29, 2025. Accessed June 2, 2025. https://www.cdc.gov/vaccines/hcp/imz-schedules/child-adolescent-notes.html#note-covid-19

2. Tan T, Fitch J. Tina Tan, MD, discusses impact of FDA's stricter COVID-19 vaccine policy for children. Contemporary Pediatrics. May 23, 2025. https://www.contemporarypediatrics.com/view/tina-tan-md-discusses-impact-of-fda-s-stricter-covid-19-vaccine-policy-for-children

3. Fitch J. CDC pulls COVID-19 vaccine recommendation for healthy children, pregnant individuals. Contemporary Pediatrics. May 27, 2025. Accessed June 2, 2025. https://www.contemporarypediatrics.com/view/cdc-pulls-covid-19-vaccine-recommendation-for-healthy-children-pregnant-individuals

4. Parkinson J, Schaffner W. Federal government changes course again on COVID-19 vaccine policy. Contagion. June 2, 2025. Accessed June 2, 2025. https://www.contemporarypediatrics.com/view/cdc-pulls-covid-19-vaccine-recommendation-for-healthy-children-pregnant-individuals