The FDA has updated its guidance on vaccination this month in May 2025. As your care team, we want to help you understand what these new recommendations mean and how we’ll continue working with you to make informed, personalized decisions.
What’s New in 2025?
The Department of Health and Human Services made a change to recommend annual COVID-19 vaccination for:
- Adults 65 years and older
- Individuals 6 months and older with one or more specific high-risk conditions
- The recommendation has been removed for healthy individuals between 6 months to 65 years old, including healthy children and pregnant women
Why The Change?
In a framework published on May 20, 2025, in the New England Journal of Medicine, health agency officials Dr. Vinay Prasad and Dr. Marty Mackery described the points that influenced some of these recommendations:
- Most people now have some form of immunity — either from prior infection, vaccination, or both.
- Hospitalization and death are now more rare in healthy individuals under 65, especially those without underlying medical conditions.
- Booster uptake has declined, and there’s a desire to ensure that ongoing recommendations for specific populations are driven by clear, evidence-based benefit.
What Does That Mean for Earlier Recommendations?
We believe the initial rollout of COVID-19 vaccines in 2020-2021, during the most dangerous wave of the pandemic, was justified even in younger healthy adults. The broader recommendation was grounded in:
- Large randomized clinical trials that included healthy younger adults and showed high efficacy in preventing symptomatic illness.
- A broader public health aim — during a time when no one had prior immunity — to stop community spread, reduce hospitalizations, and save lives.
- Real-world studies that confirmed effectiveness and safety across age groups, including in young, healthy populations.
As time went on and as many individuals have had COVID-19 infection and a few doses of the vaccine, the added benefit of additional boosters in the young and low-risk subgroup, especially in children, became less clear. Dr. Paul Offitt, a pediatrician at Children’s Hospital of Philadelphia and internationally-recognized expert in the fields of virology and immunology, called into question the recommendation to reimmunize all young, healthy kids beyond the initial 2-3 doses. He felt repeated boosters in healthy children was not the best use of resources and that it exposed rare but unnecessary risk.
Concerns and Criticisms
The CDC’s Advisory Committee on Immunization Practices (ACIP) was already preparing to review and potentially update Covid-19 vaccination guidelines for healthy children in a couple months. However, before ACIP could convene to discuss these changes, U.S. Secretary of Health and Human Services, Robert F. Kennedy Jr., announced that the CDC would no longer recommend COVID-19 vaccinations for healthy children and pregnant women.
This decision was made unilaterally, bypassing the traditional advisory process involving ACIP. ACIP is the independent advisory group that reviews data, clinical trials, and risk-benefit analyses before updating vaccine guidelines. Its members include epidemiologists, doctors, immunologists, and ethicists. This means the decision circumvented the normal review process, which is designed to ensure scientific transparency and rigor.
While one could make an argument that healthy children who have had a few doses of the vaccine may not need repeated boosters, it is very difficult to justify the removal of the recommendation for pregnant women. Pregnancy is a state of immunocompromise, and neonates under 6 months of age are most at risk of Covid complications. Babies are protected in those first few months of life when their mothers are vaccinated and boosted. The American College of Obstetrics and Gynecology (ACOG) denounced this change. Additionally, the American Academy of Pediatrics criticized the lack of due process and stated this position would increase risk for pregnant women and children.
Unvaccinated pregnant women with a COVID-19 diagnosis have a greater risk of morbidity and mortality, while severe COVID-19 symptoms increases the risk of severe maternal complications, perinatal complications, intensive care unit admission, and death. COVID-19–associated hospitalization rates among infants less than 6 months of age remain higher than those among any other age group except adults aged ≥75 years. Babies of booster-vaccinated mothers had less than half the risk of being diagnosed with COVID-19 when compared with those of unvaccinated mothers. They also had the lowest rates of preterm birth, medically indicated preterm birth, respiratory distress syndrome, and number of days in the neonatal intensive care unit. Newborns of unvaccinated mothers had double the risk for neonatal death.
Furthermore, concerns remain about how this new framework may be interpreted or implemented:
- The shift may undermine confidence in past vaccine decisions, further eroding trust in public health recommendations.
- The new policy overlooks benefits like reduced risk of long COVID, which studies suggest may be lowered by 25–60% with vaccination, even in younger people.
- It is unclear if insurers will continue to cover boosters for low-risk individuals, and whether access will become more difficult as pharmacies and providers carry less vaccine and begin gatekeeping based on strict definitions.
- Finally, the guidelines don’t fully account for nuanced situations—like those living with immunocompromised family members or working in high-exposure settings.
What This Means For You
If you’re 65 or older, or under 65 with a qualifying medical condition, you can continue to receive an annual COVID-19 booster to help protect against serious illness.
For those under 65 without high-risk conditions, the recommendation may be less straightforward, but that doesn’t mean a booster isn’t right for you — it simply means the decision may be more individualized. Factors like your personal health history, pregnancy, previous COVID-19 infections and vaccinations, travel plans, household risk, and personal preferences may still make a booster a reasonable choice.
As your care team, we don’t believe in a one-size-fits-all approach. If you’re uncertain about whether a booster is right for you this year, we’re here to talk it through. Together, we’ll help you make a decision that aligns with your health goals and values.
Dr.Judy Kim
