Rotavirus Vaccines Are Safe and Effective: So Why Aren’t All Children Protected?

The American Academy of Pediatrics (AAP) recommends routine rotavirus vaccination for all infants, yet rotavirus vaccination rates have lagged behind public health goals. In this issue of Pediatrics, Moran et al1 describe rotavirus vaccine coverage and barriers to vaccination idenfied using data from the New Vaccines Surveillance Network (NVSN). They examined vaccination coverage and demographic factors, including prematurity, health insurance, and birth year, among children enrolled in NVSN from 2014 to 2024. Children born in 2007 or later were studied to limit the sample to those born after the Advisory Committee on Immunization Practices recommended adding rotavirus vaccination to the routine childhood immunization schedule in 2006.2 This study identified later diphtheria, tetanus, and pertussis (DTaP) vaccine initiation (aged ≥15 weeks); extremely preterm birth; birth closer to the time of rotavirus vaccine introduction (2007–2009); and lack of health insurance as risk factors for failure to initiate, late initiation of, or failure to complete rotavirus vaccination. The authors call for reconsidering guidelines around rotavirus vaccination in the neonatal intensive care unit (NICU) as one way to increase the number of infants who can benefit from rotavirus vaccination.Moran et al’s work confirms prior findings and highlights barriers to rotavirus vaccination at a time when the need to improve infant vaccine coverage is particularly salient. Only 75% of US children born in 2020–2021, the last years for which Centers for Disease Control and Prevention (CDC) data are available, received rotavirus vaccine by the age of 8 months.3 This continued a pre–COVID pandemic trend of rotavirus vaccination rates lagging behind other routine infant immunizations and failing to meet public health goals. It is notable that rotavirus initiation and completion rates were higher (closer to 90%) during the mid– and late/post–COVID-19 pandemic periods in the cohort studied by Moran et al, which included children with rotavirus-negative acute gastroenteritis as well as healthy controls.Similar to Moran et al’s findings, a systematic review conducted in 20184 summarized several studies that found lower rotavirus series completion for children who were uninsured or covered by Medicaid and children who did not receive or complete DTaP vaccination. A 2019 survey of US pediatricians5 found that respondents with a higher percentage of Medicaid-insured children were more likely to report difficulty initiating rotavirus vaccination on time. The same survey identified parental safety concerns and parents wanting to defer vaccination as barriers to rotavirus vaccination. Medicaid coverage as a negative predictor of rotavirus vaccination suggests that challenges accessing well child care negatively impact rotavirus vaccination, perhaps moreso than other vaccinations because of age restrictions on timing of the first dose of rotavirus vaccine. Failure to receive DTaP vaccination as a predictor of nonreceipt of rotavirus vaccination may reflect access barriers or parental vaccine hesitancy.Restrictions around vaccine administration in NICU settings are another barrier to rotavirus vaccination for preterm infants. Among extremely preterm infants who received DTaP, Moran et al1 found that more than half remained in the NICU at the age of 15 weeks, and 80% of these infants did not receive rotavirus vaccination, even though most did receive DTaP vaccination in the NICU. Pediatricians also identify hospitals not giving rotavirus vaccine as a barrier to timely rotavirus vaccination.5 Recent CDC guidance stated that the benefits outweigh the risks of rotavirus vaccination for preterm infants, and vaccination was recommended at time of or after discharge from NICU.6 The 2024–27 Red Book7 states, “Individual institutions may consider administering rotavirus vaccine at the recommended chronologic age to otherwise eligible infants during hospitalization, including in the neonatal intensive care unit.” Prior studies have highlighted low prevalence of rotavirus vaccination in NICUs, including one that noted receiving 2-month vaccines in the NICU was associated with lower rates of rotavirus vaccination and higher risk of infection with rotavirus later in childhood.8 A 2020 review of 31 publications found that viral shedding was common in the week after the first dose of rotavirus vaccination, but transmission was rare and only described in household settings.9 Studies from several countries have demonstrated the safety of rotavirus vaccination in NICUs,10–13 including a recent large study from the Children’s Hospital of Philadelphia that found less than 1% of stool samples from patients who were unvaccinated tested positive for vaccine-strain rotavirus.14 Among unvaccinated infants who tested positive in that study, none had gastrointestinal symptoms. This finding is supported by earlier work showing that although rotavirus detection by polymerase chain reaction was common in the 2 weeks after vaccination, positivity by cell culture (and thus transmissiability) was much less common.15 All of these studies support Moran et al’s suggestion that guidance around rotavirus vaccination in NICUs may be overly restrictive.Despite suboptimal vaccination coverage, the progress that has been made in rotavirus vaccination has led to dramatic decreases in rotavirus hospitalizations in the United States. Prior to widespread use of rotavirus vaccines, 55 000 to 70 000 infants were hospitalized annually, with 50 to 100 deaths. In recent years, thanks to widespread vaccination, hospitalizations due to rotavirus have dropped by roughly 80%, and deaths are exceedingly rare.16 Population-level benefits have also been noted, and costs from rotavirus hospitalization have greatly decreased.Given these benefits, the recent move by the US Department of Health and Human Services (HHS) to remove a routine recommendation for rotavirus vaccination is incredibly misguided. As of this writing, in response to a federal lawsuit by AAP and other medical organizations, a judge has ruled that the changes made by the HHS cannot be implemented for now as the case makes its way through the courts. Regardless of the ultimate outcome, though, significant damage has been done to trust in vaccinations by the antivaccine agenda of current HHS leadership, with resultant dramatic increases in vaccine-preventable diseases, such as measles and pertussis. Rotavirus may not be far behind.Meanwhile, important public health data are being suppressed, including information about vaccine-preventable diseases such as influenza, COVID-19, and respiratory syncytial virus, seemingly as part of a strategy to downplay the impact of infectious diseases.17 Furthermore, the HHS has signaled that they will not fund research that seeks to study how to increase vaccination uptake. These actions have led to concerns about the future of networks such as the NVSN. The NVSN has been a vital surveillance system in the United States for more than 20 years, designed to measure the burden of disease and real-world impact of newly introduced vaccines, with dozens of studies published in high-impact journals.18 Led by staff at the CDC, the consortium of 7 US pediatric health systems has made invaluable contributions to our understanding the burden of respiratory and gastrointestinal pathogens in US children and the impact vaccines have had on reducing those burdens. The United States must continue to fund the NVSN. Its existence is vital to understanding the impact of vaccines after licensure, informing national immunization policy and strenghthening public trust in vaccines through transparent, evidence-based surveillance and preparedness for future infectious disease threats.This study by Moran et al once again demonstrates the value of the NVSN and also helps us better understand barriers to rotavirus vaccination that can inform policy. Regardless of what the federal government does with rotavirus vaccine recommendations, the AAP will continue to recommend rotavirus vaccination for all eligible infants. NICUs should examine their policies regarding rotavirus vaccine, and pediatricians should continue to offer a strong recommendation for this very safe, highly effective vaccine to all infants.