
- August/September 2026
- Volume 42
- Issue 03
The unharmonious 2026 child and adolescent immunization schedule
Court fight over CDC 2026 childhood vaccine schedule shifts shots to shared decision-making; experts warn lower uptake for Hep A, B, flu, COVID.
*Editor’s Note: Since the print publication of this article, there have been several updates to this article. Please click here for the addendum.
For several decades, the Centers for Disease Control and Prevention (CDC) and the American Academy of Pediatrics (AAP) have jointly issued annual harmonized immunization schedules for children and adolescents. This practice was born of the confusion caused by discordant recommendations in the late 1980s and early 1990s—most notably, disagreements over the timing of the second dose of the measles, mumps, and rubella vaccine. The Advisory Committee on Immunization Practices (ACIP), which consists of up to 19 independent experts in infectious diseases, epidemiology, and public health, with representatives from federal agencies and organizations such as the AAP, makes formal vaccine recommendations to the CDC director, who typically adopts them.
In June 2025, all sitting ACIP members were dismissed and replaced with newly appointed individuals, many of whom lacked technical expertise in vaccine-related fields and had previously expressed concerns about vaccine safety and the number of vaccines administered in the US relative to other developed nations, such as Denmark and Japan. In January 2026, the CDC acting director issued a revised immunization schedule that incorporated several significant changes. This was accompanied by a policy assessment (Congressional Research Service, R48982, June 11, 2026) that compared US childhood vaccine recommendations with those of peer developed nations, distinguishing "consensus" vaccines (which protect against 11 diseases) from "nonconsensus" vaccines. The 2026 CDC schedule retained consensus vaccine recommendations but moved nonconsensus vaccines to risk-based or shared clinical decision-making categories. The assessment raised concerns about declining public trust in vaccines, argued that manufacturers lack adequate incentives to study adverse effects, characterized postmarket surveillance as limited, and called for more rigorous safety research—including double-blind trials and large population-based studies—to better understand vaccine safety and potential links to chronic disease.
The AAP rejected these changes and endorsed the harmonized schedule issued in 2025. Legal challenges followed: In American Academy of Pediatrics v Kennedy, the US District Court for the District of Massachusetts suspended the 2026 schedule and reinstated the May 2025 version as the operative guidance. The federal government has appealed this ruling, but no appellate decision has been issued as of this writing.
This paper reviews the differences between the 2 schedules. Vaccines for which CDC recommendations were unchanged are not discussed (Table 1). Pediatricians and other health care personnel administering vaccines to children and adolescents should follow the evidence-based 2025 harmonized schedule endorsed by the AAP, American Academy of Family Physicians, and the American College of Obstetricians and Gynecologists. The most current information is available at
Childhood vaccines for which CDC recommends shared clinical decision-making (SCDM)
What is SCDM?
The CDC defines SCDM vaccination as an approach that is "individually based and informed by a decision process between the health care provider and the patient or parent/guardian." Originally introduced in 2019 for select adult vaccines, SCDM has now been extended to several childhood vaccines under the 2026 schedule, including those for rotavirus, COVID-19, influenza, hepatitis A, hepatitis B, and meningococcal vaccines.
The stated rationale is to present individualized information about vaccine benefits, risks, and infection burden to parents through open-ended discussion—ostensibly to restore trust in public health vaccine recommendations. In practice, however, this approach raises serious operational and public health concerns. Busy pediatric practices are ill-equipped to accommodate the time demands of individualized discussions for each vaccine at well-child visits. Some physicians may simply choose not to promote these vaccines due to time constraints, and parents who are not proactively informed may never know to ask. The predictable consequence is a reduction in childhood vaccine uptake and a resurgence of vaccine-preventable diseases. It is worth noting that federal law already requires pediatricians to provide CDC-issued vaccine information statements to parents prior to vaccine administration—a mechanism that has long served the purpose of informed consent.
Public understanding of SCDM is strikingly poor. Two surveys conducted by the Annenberg Public Policy Center of the University of Pennsylvania (August 2025, N = 1699; December 2025, N = 1637) found that only a small minority of US adults correctly understood the concept. Approximately 22% believed SCDM meant a vaccine "may not be a good idea for everyone but would benefit some." Approximately 40% incorrectly interpreted it to mean that individuals could decide on their own whether to consult a health care provider at all. Another 23% understood it to mean they should discuss the decision with their family rather than their physician, and 13% were simply unsure of its meaning.1 These findings underscore the risk that SCDM, as currently framed, will be widely misunderstood in ways that discourage vaccination rather than facilitate genuinely informed decision-making.
Hepatitis A
Hepatitis A virus (HAV) remains a leading cause of acute viral hepatitis worldwide.2 Disease burden falls predominantly on adolescents and adults; children under 6 years are typically asymptomatic.3 Clinical presentation is nonspecific—fever, jaundice, nausea, and anorexia—and generally self-limited, though acute fulminant liver failure is a rare but recognized complication modulated by age and immune status. Transmission is fecal-oral; contaminated food and water drive major outbreaks, whereas in developed countries, men who have sex with men, intravenous drug use, and international travel to endemic regions have become increasingly prominent drivers.4
Before the HAV vaccine was introduced in the mid-1990s, approximately 36,000 HAV cases with 100 deaths from liver failure occurred annually in the US. Vaccine implementation reduced cases by 95.5%.3 Despite this documented effectiveness and established safety profile, the CDC has reclassified HAV vaccination from a universal recommendation to SCDM, a shift occurring precisely as global HAV incidence is rising.3,4 Increased adult susceptibility in developed countries—attributable to improved sanitation reducing natural immunity and to foodborne trade expansion—underscores why vaccination remains indispensable. SCDM materially diminishes the probability of eradicating a disease that is, in principle, entirely vaccine-preventable.
Hepatitis B
Mother-to-child transmission is globally the most common cause of chronic hepatitis B virus (HBV) infection. In 1991, the CDC mandated universal hepatitis B surface antigen (HBsAg) screening of all pregnant women at their first prenatal visit (replacing selective high-risk screening) and recommended universal HBV vaccination of all medically stable infants, preferably at birth. These policies reflected critical epidemiologic realities: Most pregnant women with HBV infection lacked identifiable risk factors; perinatally acquired infection progresses to chronic carriage in 80% to 90% of infants vs only 5% of adults; chronic infection confers a high lifetime risk of cirrhosis and hepatocellular carcinoma; an estimated 16,000 annual HBV infections occurred annually in US children 10 years or younger, with documented racial disparities; and approximately 50% of adults with chronic HBV infection are unaware of their status. Despite decades of guidance, approximately 15% of US pregnant women still do not receive HBsAg screening.5-7
The impact of vaccination has been striking. Birth-dose administration rose from 21% in 2002 to approximately 83% in early 2023, then declined to 73% by summer 2025.8 Globally, the World Health Organization (WHO) estimated birth-dose coverage at 45% in 2024, though the full 3-dose infant series was completed in 84% of children.7 In the US, acute HBV infections among children fell by 99% between 1990 and 2019,9 and new perinatal HBV infections have dropped to approximately 20 cases per year.6 Immune protection from the completed infant series is durable, maintained even when hepatitis B surface antibodies (anti-HBs) become undetectable, owing to immunologic memory sustained by B cells and virus-specific CD4+ T cells.
The HBV vaccine has a well-established safety record. Adverse effects are limited to mild to moderate injection site reactions and transient low-grade fever. Rare deaths temporally associated with vaccination were thoroughly investigated and found to be unrelated to the vaccine. Thimerosal-containing HBV vaccines were discontinued in 1999 and have been absent from routine childhood vaccines since 2001. Multiple rigorous studies have failed to support any association between thimerosal and autism—with autism rates continuing to rise following thimerosal removal, further refuting a causal link.
Notwithstanding this record, the ACIP voted 8 to 3 on December 5, 2025, to recommend SCDM for infants born to HBsAg-negative mothers, with the first vaccine dose deferred to no earlier than 2 months if parents decline the birth dose. Recommendations for infants born to mothers who are HBsAg positive or whose status is unknown remain unchanged. The stated rationale was "restoring the balance of informed consent to parents whose newborns face little risk of contracting hepatitis B." However, it warrants noting that parents have always retained the right to refuse the birth dose. A second proposed ACIP recommendation would use anti-HBs antibody levels to guide subsequent dose decisions.
The consequences of delay are quantifiable. Deferring the birth dose in HBsAg-negative births is estimated to produce an average of 90 acute HBV infections, 76 chronic HBV infections, 29 HBV-related deaths, and $16.4 million in added costs annually under ideal conditions,10 with independent analyses yielding similar projections.11 Real-world conditions are invariably less than ideal, and outcomes are likely to be worse. The proposed serologic testing strategy is additionally problematic: Venipuncture is invasive and unnecessary in healthy infants, and protective anti-HBs antibodies develop in only 25% after 1 dose, 63% after 2 doses, and 95% after the completed 3-dose series. Whether an incomplete series confers durable immune memory remains unknown.6 New guidance will likely accelerate the already-declining birth-dose rate, compounded by parental hesitancy, social media misinformation linking the vaccine to autism and autoimmune disease, and the broader erosion of vaccine confidence following the COVID-19 pandemic.
Rotavirus
Rotavirus (RV) is the leading global cause of severe diarrhea and dehydration in children younger than 5 years.12 Transmission is predominantly fecal-oral. RV causes acute gastroenteritis with rapid-onset diarrhea, vomiting, abdominal pain, and fever; severe dehydration and electrolyte disturbances frequently lead to shock, hospitalization, and death if inadequately managed. RV infection has been implicated in neurological complications, autoimmune disease, and biliary atresia, though mechanistic elucidation is incomplete.12
Prior to vaccine introduction, RV caused approximately 500,000 child deaths annually worldwide, including 50 to 100 in the US. The FDA has approved 2 oral live-attenuated vaccines for use in the US beginning in early infancy: RotaTeq (3-dose series) and Rotarix (2-dose series), administered concurrently with the diphtheria, tetanus, and pertussis vaccine. Efficacy in high-income countries ranges from 98% to 100% for RotaTeq and 85% to 96% for Rotarix; RV-related hospitalizations have been reduced by 80%, with deaths now nearly eliminated.13
Despite this efficacy, coverage remains lower than for comparable childhood vaccines: only 75% among children born in 2020-2021, with postpandemic recovery lagging. Key barriers include nonvaccination of preterm infants, lack of health insurance, and, paradoxically, greater difficulty initiating the series among Medicaid-covered children.14 SCDM threatens to erode further coverage of a demonstrably safe and highly effective vaccine, compounding existing disparities and undermining progress in eliminating RV-related morbidity and mortality.
Influenza
Influenza vaccine coverage among US children remains insufficient. During the 2024-2025 season, coverage among children aged 6 months to 17 years was 50.2%. Coverage was highest among children aged 6 months to 4 years, at 57.5% (Figure)—far below the 75.3% peak that group reached in 2019—and ranged geographically from 31.7% in Mississippi to 69.3% in the District of Columbia.
Influenza complications in children include pneumonia, encephalitis, seizures, otitis media, sinusitis, asthma exacerbations, and death. Most hospitalized children have chronic health problems (Table 2). During the 2024-2025 season, 280 children died (median age, 7 years); influenza A accounted for 86% of fatalities. Of those who died, 89% were not fully vaccinated, and 56% had an underlying chronic condition.15 Among laboratory-confirmed influenza deaths in children aged 6 months to 17 years from August 2016 through July 2025, only 23% of those with chronic conditions and 13% of those without had received that season's vaccine.16 As of August 1, 2026, 191 pediatric deaths have been recorded for the 2025-2026 season, with data still accumulating.
The influenza vaccine has a well-established safety record. Vaccine Adverse Event Reporting System data for children 6 months to 17 years from July 2018 through June 2023 identified 7815 reports; the most common adverse effects were injection site erythema (11.2%), fever (8.8%), and syncope (8.5%). Febrile seizures, anaphylaxis, and Guillain-Barré syndrome (GBS) were described in 3%, 0.3%, and 0.1% of reports, respectively.17 Population-based GBS risk following influenza vaccination is estimated at 1 to 2 cases per million doses—up to 20-fold lower than following natural infection. Febrile seizures after influenza vaccination are mostly associated with coadministration of other vaccines. Approximately 31% of US children have an influenza vaccine-hesitant parent.18 The CDC and AAP strongly recommend influenza vaccination, recognizing that a provider recommendation is among the strongest predictors of uptake (Table 3).19
COVID-19
The COVID-19 pandemic inflicted profound harm on US public health: more than 1.3 million deaths, prolonged lockdowns, economic losses, rapid introduction of unfamiliar messenger RNA (mRNA) vaccine technology, and an unprecedented erosion of vaccine confidence fueled by social media misinformation.20 COVID-19 vaccine uptake in children was limited at the height of the pandemic and has continued to decline; as of May 9, 2026, only 9.7% of children aged 6 months to 17 years were current on the vaccine, and coverage among pregnant women stood at 11.1%.
In the SCDM context, clinicians should communicate that SARS-CoV-2 can cause severe disease with currently circulating strains; that because SARS-CoV-2 is an RNA virus, the potential for emergence of more virulent variants persists; that hospitalization rates are second highest in infants younger than 6 months, surpassed only by adults aged 75 years or older, and that 75% of these infants have no underlying high-risk conditions; and that 41% of hospitalized children aged 6 months to 17 years lack recognized high-risk conditions. Primary benefits of current COVID-19 vaccination in children include reduced risk of emergency department visits, hospitalizations, and long COVID.21 Children should receive the updated 2026-2027 formulation (JN.1-lineage XFG subvariant), with regimens varying by age, risk status, and prior vaccination history.
Most reported serious adverse events have been found to be unrelated to vaccination. Myocarditis/pericarditis, although widely discussed, carries an overall risk of approximately 8 per million doses, with higher rates in men aged 12 to 24 years; myocarditis following natural SARS-CoV-2 infection is several-fold more common and more severe. Vaccine-associated cardiac inflammation is generally mild and transient, though MRI findings may persist for several months with unclear long-term implications. Risk is reduced by spacing subsequent doses more than 30 days apart.22-24
Meningococcal vaccines
Meningococcal disease, caused primarily by Neisseria meningitidis serogroups A, B, C, W, X, and Y, progresses rapidly to meningitis and sepsis. Mortality is up to 15% even with prompt treatment, and survivors often have substantial long-term morbidity.25 High-risk groups include adolescents, college students, military personnel, and immunocompromised or asplenic individuals.26 Quadrivalent conjugate vaccines (meningococcal ACWY) are currently administered at ages 11 to 12 years and 16 years but can be started as early as 2 months of age in infants and children at high risk (eg, asplenia, sickle cell disease, complement deficiency). The vaccines have resulted in a 90% reduction in the number of covered serogroups in the US. Two effective meningococcal B vaccines—Bexsero and Trumenba—are recommended for high-risk individuals and those aged 16 to 23 years. Prior to 2025, the ACIP recommended the quadrivalent vaccine as a routine adolescent immunization; this has since been reclassified as SCDM. Given inadequate vaccination coverage in at-risk and college-aged populations, SCDM carries a meaningful risk of unnecessarily reducing uptake of a vaccine that prevents a rapidly fatal and debilitating disease.
Vaccine schedule modifications not requiring SCDM
Respiratory syncytial virus (RSV)
Prior to universal RSV immunization, the virus caused 58,000 to 80,000 US hospitalizations annually in children younger than 5 years, and 75% of these occurred in term infants without high-risk conditions. Long-acting monoclonal antibodies nirsevimab (2023) and clesrovimab (2025) have reduced RSV hospitalizations by 80% to 85%. The maternal RSV prefusion F (RSVpreF) vaccine, administered as a single dose at 32 0/7 to 36 6/7 weeks’ gestation during RSV season, reduces infant lower respiratory tract disease by 69% through 90 days of age and severe disease by 72% through 6 months of age, but uptake is only 42%.27,28 Benefits for premature infants (< 37 weeks’ gestation) are comparable in terms of RSV-related hospitalizations and intensive care unit admissions. Infant RSV vaccine coverage (maternal and/or monoclonal antibody) was approximately 75% for the 2024-2025 RSV season.
Beyond the acute episode, RSV lower respiratory tract disease in infancy confers a 4- to 6-fold increased risk of asthma, disproportionately affecting children of low socioeconomic status. Emerging evidence links nirsevimab immunization with a 36% reduction in invasive pneumococcal disease during the first 6 months of life.29 The current calendar-based RSV schedule presents logistical challenges, particularly as RSV seasonality has shifted toward year-round activity in some states and globally.30,31
HPV vaccine
A large Costa Rican trial of more than 20,000 girls aged 12 to 16 years demonstrated that single-dose 2-valent and 9-valent HPV vaccines were noninferior to 2-dose regimens, with at least 97% efficacy against carcinogenic persistent HPV types 16 and 18 over 60 months.32 In 2022, approximately 464,000 deaths from all HPV-related cancers occurred worldwide.33 As of 2024, 93 of 166 countries with HPV vaccines in national schedules use a single-dose WHO-recommended schedule. In the US, more than 60% of adolescents aged 13 to 17 years are up to date on their 2- or 3-dose vaccine series, with substantial geographic variation ranging from 40% to 50% in states such as Mississippi to 70% to 80% in states such as New York. Approximately 78% of US teens had received at least 1 HPV vaccine dose in 2024. The new CDC recommendation for a 1-dose HPV schedule, currently on hold pending judicial review, would raise calculated coverage rates, because some adolescents start but do not complete the AAP-recommended series. Vaccine hesitancy persists, driven by perceptions that the vaccine is unnecessary, safety concerns, and social media misinformation.34
What’s ahead for pediatric vaccines
Active pediatric vaccine development continues across various platforms. Examples include the following:
- Pneumococcal conjugate vaccines: A 25-valent vaccine covering 90% of invasive pneumococcal serotypes is in late-stage testing; 24-valent and 31-valent vaccines are being evaluated in children; and a 35-valent vaccine is in early-stage development for adults.
- Influenza: An egg-free recombinant influenza vaccine, currently approved for ages 9 years and older, is under evaluation in younger children; an mRNA influenza vaccine is in development, as is a combined RSV, influenza, and COVID-19 mRNA vaccine.
- HPV: Trials of 11-valent and 14-valent vaccines are underway, with results anticipated in 2028.
- RSV: Live-attenuated intranasal, mRNA, and RSVpreF candidates are in clinical development.
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