The Essential Role of Pharmacists in Pediatric COVID-19 Vaccination

Evidence shows that pharmacists played a key role in COVID-19 vaccines for patients of all ages, including children, during the peak of the pandemic. Specifically, in the first three years of the pandemic (12/2020 – 9/2023) pharmacists provided 13 – 57% of all pediatric COVID-19 vaccines.¹ Although most children receive most of their vaccines at their doctor’s office, survey data suggests about 15% (especially teens and those in cities) obtain routine vaccines from pharmacies.² The pharmacist is the most accessible healthcare provider, with 89% of American’s living within 5 miles of a pharmacy.³ Thus, pharmacies remain an essential access point for vaccines for children.

Making Sense of COVID-19 Vaccine Recommendations for Kids

In recent months, the rules for when one can and should recommend COVID-19 vaccines to children has become confusing. The Advisory Committee on Immunization Practices has voted and Centers for Disease Control and Prevention (CDC) have changed COVID-19 vaccine for those 6 months and older to a shared clinical decision recommendation.⁴ It is important that it remains recommended at least at this level, as this will allow it to be paid for by the VFC program.

Meanwhile, the American Academy of Pediatrics (AAP) has made a stronger statement clearly recommending the COVID-19 vaccine for all infants and children 6 months through 23 months of age, as well as those 2 through 18 years old who: are unvaccinated, are at high risk of severe COVID-19 disease, live in congregate settings, have household members at high risk of severe COVID-19 disease, or whose parent/guardian wishes to provide them with additional protection.⁵

It is important to note, although confusing, these vaccine recommendations are not in conflict but rather differ in emphasis. The AAP guidance more clearly states which children are at highest risk and should be recommended to receive the vaccine while the CDC allows for individual decision-making. Notably, the CDC report shows that children < 2 years of age are at one of the highest risks of being hospitalized from COVID-19 disease, second only to those > 75 years old.⁶ As such, it is clear why this age is a routine recommendation, per the AAP. The AAP provides clear evidence for each of their recommendations in their COVID-19 specific recommendations.⁷

Which Pediatric Patients are Pharmacists Authorized to Vaccinate Against COVID-19 in 2025-26?

Which of our pediatric patients can we as pharmacists provide the COVID-19 vaccine to?  That partially depends on which state one is practicing.  The 12^th PREP Act extension allows pharmacists in every state to continue to provide COVID-19 and flu vaccines down to 3 years of age, in accordance with ACIP/CDC recommendations.⁸  Beyond this federal authorization, vaccine administration regulations revert to each state’s law.  We published an updated chart with links in a recent JPPT article to help clarify these requirements and provide you with quick access to state-specifics.⁹

References

1. El Kalach R, Jones-Jack NH, Grabenstein JD, et al. Pharmacists’ answer to the COVID-19 pandemic: Contribution of the Federal Retail Pharmacy Program to COVID-19 vaccination across sociodemographic characteristics-United States. J Am Pharm Assoc (2003). 2025;65(1):102305
2. Kang Y, Zhang F, Vogt TM. Where do children get vaccinated in the U.S.? Parental experiences, attitudes, and beliefs about place of vaccination with a focus on pharmacies and schools. 2025;62:126801
3. Berenbrok LA, Tang S, Gabriel N, et al. Access to community pharmacies: A nationwide geographic information systems cross-sectional analysis. J Am Pharm Assoc (2003). 2022;62(6):1816–1822.e2
4. Centers for Disease Control and Prevention. Child and Adolescent Immunization Schedule by Age (Addendum updated August 7, 2025). Accessed September 20, 2025https://www.cdc.gov/vaccines/hcp/imz-schedules/child-adolescent-age.html
5. American Academy of Pediatrics, Committee on Infectious Diseases. Red Book : Report of the Committee on Infectious Diseases 2024 – 2027. AAP Immunization Schedule. Accessed September 20, 2025https://publications.aap.org/redbook/resources/15585
6. Centers of Disease and Prevention. Updates to COVID-19 epidemiology. 2025. https://www.cdc.gov/acip/downloads/slides-2025-09-18-19/02-Srinivasan-covid-508.pdf
7. Committee on Infectious Diseases. Recommendations for COVID-19 Vaccines in Infants, Children, and Adolescents: Policy Statement. 2025
8. Health and Human Services Department. 12th Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19. 2024;89(238):99875–99883. https://www.federalregister.gov/documents/2024/12/11/2024-29108/12th-amendment-to-declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical#:~:text=The%20Public%20Readiness%20and%20Emergency%20Preparedness%20(PREP)%20Act%20authorizes%20the,relating%20to%2C%20or%20resulting%20from
9. Girotto JE, Warminski S, Oz T, Fly JH. Continuing as Partners in Immunization: Updates to Practice and Legislation for Pediatric Pharmacy Immunizations. J Pediatr Pharmacol Ther. 2025;30(5):691–695

 

 By Debonique Burton

Respiratory Syncytial Virus (RSV) is a very common respiratory virus that in most patients often presents with cold-like symptoms such as fever, sneezing, runny nose, cough, and/or decreased appetite.​ Unfortunately, in infants and those with risk factors for severe disease, can cause more serious illness such as bronchiolitis and pneumonia.  RSV has been the most common cause of hospital admissions among infants in the United States, leading to approximately 50,000 to 80,000 hospitalizations each year in children younger than five.​^1,2​  Data from the Respiratory Syncytial Virus (RSV) Hospitalization Surveillance Network (RSV-NET ~300 hospitals in 16 states) and the New Vaccine Surveillance Network (NVSN outpatient networks in 7 US sites), surveillance networks showed a significant reduction of RSV-related hospitalizations in children under 5 years old from 11,581 in 2018-2020 to 6,708 in 2024-2025.​³​  Specifically, this was a reduction of 28% based on NVSN data and 43% based on RSV-NET data after  the introduction of preventative RSV immunizations.​³ The authors also noted month by month reductions for those 0–7 months during the RSV immunization roll out, further evidence supporting that the change was most likely due to RSV immunizations.​³

 

Options to Protect Infants Against RSV

RSV immunizations were introduced in the fall of 2024 and included RSV vaccine RSVpreF (Abrysvo, the only RSV vaccine FDA-approved for pregnant patients) and infant monoclonal antibody nirsevimab (Beyfortus). More recently, clesrovimab (Enflonsia), another infant monoclonal antibody has become FDA approved and recommended as another option to protect infants against severe RSV lower respiratory.^4-6​

 

Impact of RSV Immunization in Infants

The 2024–2025 RSV season was the first in the U.S. with widespread use of both the maternal RSV vaccine and nirsevimab. Data from the National Immunization Survey showed that the percentage of U.S. infants aged 0–7 months protected by either approach (i.e., maternal vaccination or infant monoclonal antibody administration) rose from 30% in October 2024 to 66% by February 2025. This increase coincided with significant declines in RSV-related hospitalizations. The decrease was even more noticeable when excluding Houston, where prevention products were not widely available early in the season​.³​ The real-world drop in hospitalizations aligns with clinical trials which reported 80% efficacy of nirsevimab and about 70% efficacy of Abrysvo for preventing hospitalization among young infants.^2,7,8

Data from the phase 3 trial which included 901 infants up to 1 year of age, evaluated the safety, efficacy, and pharmacokinetics of clesrovimab in infants and children at increased risk for severe RSV disease reported that clesrovimab reduced the risk of RSV-related hospitalization for lower respiratory tract infection by about 91% compared to the control group [95%CI, 90.9 (76.2, 96.5)]​​.¹⁰  Clesrovimab was found to be well tolerated in infants considered at high risk for RSV. The most frequently reported side effects of clesrovimab included redness at the injection site (3.8%), swelling at the injection site (2.7%), and rash (2.3%)​​.^1,10

 

Recommendations for RSV Immunization

It is recommended that pregnant individuals between 32 and 36 weeks 6 days gestation, if not previously vaccinated against RSV, should receive RSVpreF vaccine September through January.^6,9  In cases when the mother did not receive the RSVpreF or receive it less than 14 days prior to delivery their infants < 8 months old are recommended to either nirsevimab or clesrovimab monoclonal antibody between October and March either at discharge from the hospital or at the first available visit in this timepoint.^4,5,9   There are also some high-risk infants and young children (i.e., those 8-19 months old) with specific risk factors for severe RSV disease including those who have chronic lung disease of prematurity (and receiving steroids, diuretics, or oxygen within the past 6 months), severe immunocompromise, cystic fibrosis or are American Indian or Alaska Native.^4,5,9 These high-risk individuals should receive nirsevimab just prior to the beginning of their second RSV season.^4,5,9​  At this time, there is not currently a preference for one method over another.

 

Summary – Infant RSV Immunization Recommendations^4-6

Immunization Product	Recommendations	Dosing
Maternal Vaccination Abrysvo (RSVpreF)	Pregnant individuals who have not yet received any RSV vaccine should receive a single dose of Abrysvo (RSVpreF) between 32 and 36 weeks, 6 days gestation, preferably from September through January in most areas of the U.S.	All: 0.5 mL IM
Infant Immunization with Monoclonal Antibody  Beyfortus (Nirsevimab) or Enflonsia (Clesrovimab)	Recommended from October through March (in most areas of the U.S.): • Infants <8 months whose mother did not receive RSVpreF ≥14 days before birth during this pregnancy should receive either nirsevimab or clesrovimab. • Children 8–19 months at higher risk for severe RSV should receive nirsevimab.	Nirsevimab: • <8 months: 50 mg or 100 mg IM (depending on weight) • 8–19 months: 200 mg IM Clesrovimab: • 105 mg IM

 

About the author: Debonique Burton is a Doctor of Pharmacy candidate at the University of Connecticut. This post was written as part of her Advanced Pharmacy Practice Experience under the guidance of her professor, Jennifer Girotto PharmD, BCPPS, BCIDP, who also reviewed and edited the piece.

 

References

1. Maternal/Pediatric Work Group of the Advisory Committee on Immunization Practices. Evidence to Recommendation Framework: Clesrovimab. Accessed July 9, 2025. Available at: https://www.cdc.gov/acip/downloads/slides-2025-06-25-26/05-MacNeil-Mat-Peds-RSV-508.pdf
2. Moline HL, Tannis A, Toepfer AP, et al. Early Estimate of Nirsevimab Effectiveness for Prevention of Respiratory Syncytial Virus-Associated Hospitalization Among Infants Entering Their First Respiratory Syncytial Virus Season – New Vaccine Surveillance Network, October 2023-February 2024. MMWR Morb Mortal Wkly Rep. 2024;73(9):209–214.
3. Patton ME, Moline HL, Whitaker M, et al. Interim Evaluation of Respiratory Syncytial Virus Hospitalization Rates Among Infants and Young Children After Introduction of Respiratory Syncytial Virus Prevention Products – United States, October 2024-February 2025. MMWR Morb Mortal Wkly Rep. 2025;74(16):273–281.
4. American Academy of Pediatrics, Committee on Infectious Diseases. Red Book: Report of the Committee on Infectious Diseases 2024 – 2027. Immunization Schedules. Accessed September 20, 2025. Available at: https://publications-aap-org.ezproxy.lib.uconn.edu/redbook/book/755/Red-Book-2024-2027-Report-of-the-Committee-on
5. Centers for Disease Control and Prevention. Child and Adolescent Immunization Schedule by Age (Addendum updated July 2, 2025). Accessed September 20, 2025. Available at: https://www.cdc.gov/vaccines/hcp/imz-schedules/child-adolescent-age.html
6. Centers for Disease Control and Prevention. Adult Immunization Schedule by Age (Addendum updated July 2, 2025). Accessed September 20, 2025. Available at: https://www.cdc.gov/vaccines/hcp/imz-schedules/adult-age.html
7. Alandijany TA, Qashqari FS. Evaluating the efficacy, safety, and immunogenicity of FDA-approved RSV vaccines: a systematic review of Arexvy, Abrysvo, and mResvia. Front Immunol. 2025;16:1624007.
8. Simões EAF, Pahud BA, Madhi SA, et al. Efficacy, Safety, and Immunogenicity of the MATISSE (Maternal Immunization Study for Safety and Efficacy) Maternal Respiratory Syncytial Virus Prefusion F Protein Vaccine Trial. Obstet Gynecol. 2025;145(2):157–167.
9. American Academy of Pediatrics, Committee on Infectious Diseases. AAP Recommendations for the Prevention of RSV Disease in Infants and Children. In: AAP Recommendations for the Prevention of RSV Disease in Infants and Children Red Book : Report of the Committee on Infectious Diseases 2024 – 2027.
10. Heather J Zar &, Louis J Bont, Paolo Manzoni M, et al. Phase 3, Randomized, Controlled Trial Evaluating Safety, Efficacy, and Pharmacokinetics (PK) of Clesrovimab in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease. 2025;Volume 12 (supplement 1).

 

By Caroline Frost, PharmD candidate

Urinary tract infections (UTIs) are a common childhood infection. About 90% of pediatric UTIs occur in females.​¹​ Uropathogenic Escherichia coli accounts for about 80% of UTIs in children, specifically 83% in females and 50% in males. Other uropathogens include Enterococcus species (5% females, 17% males), Proteus mirabilis (4% females, 11% males), and Klebsiella sp (4% females, 10% males).​² Uropathogen invasion can lead to kidney inflammation and scarring as well as impaired kidney function.​³​

Urine cultures alone cannot be used to diagnose a UTI, UTICalc is a validated calculator developed to incorporate symptoms and risk factors in those 2-23 months of age to determine if testing is needed and if so if it is best to begin empiric therapy.⁴ A UTI with fever suggests a systemic infection, potentially pyelonephritis, which could result in kidney injury.​³​ Those with febrile UTI should usually be treated right away to prevent kidney injury from occurring.​³​

The American Academy of Pediatrics (AAP) retired their last iteration of their guidelines for infant UTIs (i.e., ages 2 to 24 months) in May 2021 and there have not been national guidelines for those 2 – 12 years.​⁵​  The recommended duration of antibiotic therapy in the retired AAP guidelines suggested 7 to 14 days (with no preference between them as data comparing 7,10, and 14 days were limited), with 7 days as the minimum due to 1 to 3 day durations shown to be inferior.​⁵​ The AAP’s general infectious diseases recommendations in the 2024 Redbook recommends 5-10 days for outpatient UTI treatment, 7-10 days for inpatient UTI treatment, and for those adolescents with simple cystitis only 3-5 days duration.​⁶​

Where did these shorter durations come from? 

New data have been published on the duration of antibiotic treatment for pediatric UTIs in recent years. A retrospective cohort analysis published in January of 2020 evaluated the association of antibiotic treatment duration with recurrence of uncomplicated UTI in pediatric patients.​⁷​ This study utilized data from a claims database from 2013-2015 and included 7,698 pediatric patients 2 to 17 years old diagnosed with acute cystitis or acute pyelonephritis in an ambulatory setting that filled a prescription for either amoxicillin with or without clavulanate, ampicillin, a cephalosporin (any), trimethoprim-sulfamethoxazole, ciprofloxacin, levofloxacin, or nitrofurantoin with a 7, 10, or 14 day supply.​⁷​ Prescriptions for a 3 to 5 day supply were only included if they were for a diagnosis cystitis.​⁷​ Authors reported that no difference was seen in recurrence/reinfection rates when comparing 7 days to 10 days and comparing 7 days to 14 days were compared (compared to 7 days: 10 days, OR 1.07, 95% CI 0.85-1.33; 14 days, OR 0.89, 95% CI 0.45-1.78).​⁷​ These findings suggest a 7 day course of antibiotics is not associated with increased risk of relapse or reinfection in cases of pediatric cystitis and pyelonephritis.  It supports avoiding longer duration of antibiotic treatment in these patients 2 – 17 years old.

A meta-analysis published in December 2024 further evaluated short-course therapy compared with standard-course durations for children with UTI.​⁸​ The meta-analysis included 9 randomized controlled trials (n=1,171 pediatric patients < 18 years old) that evaluated efficacy of short-course (2-5 days) versus standard-course (6-14 days) treatment for acute UTI (including afebrile and febrile UTI) in children 2 months to 18 years of age.​⁸​ The authors reported that those randomized to short-course therapy had a 2.2% higher risk of treatment failure, but this difference was significant only for those who presented without fever (3.8% increased risk in this group).​⁸​ However, due to unexplained heterogeneity between studies and a small number of children across studies presenting with febrile UTI, the data are not clear enough to suggest short-course therapy in pediatric patients presenting with febrile UTI despite this outcome.​⁸​ This meta-analysis also reported no significant difference between treatment groups in UTI and bacteriuria 25-60 days after completing treatment.​⁸​ In summary, this study provides further evidence to support shorter durations of antibiotics for children with UTIs.  The SCOUT trial was a randomized clinical noninferiority trial published in June 2023 that included patients ages 2 months to 10 years old with symptomatic UTI.​⁹​ While this trial was included in the 2024 meta-analysis previously discussed, its focus on children 2 months to 10 years old makes it important to view the specific data in this very young but important age group.  Six hundred ninety-three children were included and randomized to either 10 or 4 days (plus 5 days placebo) therapy.​⁹​ Importantly, inclusion was determined at day 5 and only in those who showed signs of clinical improvement.​⁹​ Authors reported rates of treatment failure 0.6% 5 days vs 4.2% 10 days and recurrence within 9 days of study product discontinuation 2.7% 5 day vs 4.2% 10 day treatment groups.​⁹​ Although 5 days of therapy was statistically inferior to the standard 10 day durations, the authors noted those who were likely to fail had uncomplicated disease (e.g., UTI without fever) and unlikely to have their UTI associated with scarring ​⁹​. They calculated that the number of patients needed to treat to prevent one febrile UTI treatment failure was 67 and more importantly, quite a large number, 469 patients, exactly, would need to be treated to prevent one child from having kidney scaring.​⁹​ Looking at all of the information in context, the authors suggest that short-course antibiotics could be a reliable option for children 2 months – 10 years old with UTI with or without fever who demonstrate clinical improvement after 5 days of antibiotics.​⁹​ The evidence gathered from these three articles suggests that 5 to 7 day durations for antibiotics can be a consideration for the treatment of pediatric UTIs.

What other options can be considered?

There has also been discussion of single dose aminoglycoside therapy for UTIs. A 2018 systematic review evaluated single dose aminoglycoside therapy (i.e., netilmicin, gentamicin, amikacin) using 13 articles representing 13,804 patients, 53.8% of which were children.¹⁰​  Articles that studied pediatrics included ages 2 weeks to 16 years old (except one article that did not report age of participants).​¹⁰ Most of the pediatric specific studies included those with afebrile UTI. Microbiological cure was reported to be 84.5% +/- 4.3% with a 19.0% rate of 30 day recurrence.​¹⁰​ Only 2 studies included evaluated clinical cure, with clinical cure rates of 82.8% and 94.7%.​¹⁰​ This systematic review suggests that single dose aminoglycoside therapy may be reasonable for pediatric patients presenting with afebrile UTI.​¹⁰​ There was no recommendation for single dose aminoglycosides in the AAP 2011 guidelines at all, so this would be an extension to the guidelines if implemented. Single dose aminoglycoside therapy could be beneficial for patients who are not likely to be adherent to multiple days of outpatient oral medications. However, due to lack of robust data for pediatric patients, I think clinicians in most cases should wait for more data specific to pediatrics before implementing single dose aminoglycoside therapy for pediatric patients.

But What About WikiGuidelines?

In response to new evidence, A WikiGuidelines Group Consensus Statement was published in November 2024 and provided recommendations that included treatment of pediatric UTI.​¹¹​ Unfortunately, due to the limited amount of pediatric specific data they were unable to make a clear recommendation on duration of treatment in pediatric UTI.​¹¹​ It suggested that shorter courses, including an option for single dose aminoglycosides, may be comparable to longer courses and considered reasonable for afebrile UTI in children >2 months old with low likelihood of pyelonephritis.¹⁰ Regarding treatment of pyelonephritis, it is stated that available data is inadequate to provide any recommendation for children >2 months old, but data suggests similar clinical success with 5-9 days versus 10-14 days of treatment.​¹¹​

Summary

Overall, newer evidence suggests that shorter durations of antibiotic therapy is likely reasonable for pediatric afebrile UTI. The data for treatment duration in febrile UTI is less uncertain, the AAP Redbook recommend a range of 5 to 10 days for treatment of outpatients and 5 -10 days for treatment of inpatients, it is likely safe to lean towards the 7 days of therapy as opposed to 10 days or longer for those with fever. From the data gathered across these newer studies, 5 days of therapy is may be considered for afebrile UTI in pediatric patients that are clinically improving by day 5.

Antibiotic Durations for Pediatric UTIs: What’s Changing?

Guideline Recommendation	Recent Evidence	Potential Change
2011 AAP Guidelines (retired): (2 – 24 months) 7–14 days for cystitis and pyelonephritis   2024 Wikiguidelines: (> 2 months) limited data consider 3–5 days for cystitis; 5–9 days for pyelonephritis   2024 AAP Red Book: (not neonate) 5–10 days for outpatient UTIs; 7–10 days for inpatient UTIs; 3–5 days for simple cystitis in adolescents (longer if complicated)	2020 Retrospective cohort (ages 2–17 yrs): Duration not linked to relapse or recurrence (3–5 days for cystitis; 7 days for pyelonephritis)     2024 Meta-analysis (ages <18 yrs): Short-course (2–5 days) may be reasonable for afebrile UTIs	Consider 5 days for acute cystitis and 7 days for acute pyelonephritis in those 2 months and older.  (Additional durations may still be needed if not clinically improved or for complicated disease)

About the author: Caroline Frost is a Doctor of Pharmacy candidate at the University of Connecticut. This post was written as part of her Advanced Pharmacy Practice Experience under the guidance of her professor, Jennifer Girotto PharmD, BCPPS, BCIDP, who also reviewed and edited the piece.

References 

​​1. Sood A, Penna FJ, Eleswarapu S, et al. Incidence, admission rates, and economic burden of pediatric emergency department visits for urinary tract infection: Data from the nationwide emergency department sample, 2006 to 2011. J Pediatr Urol. 2015;11(5):246.e1–246.e8. doi: 10.1016/j.jpurol.2014.10.005.

​2. Edlin RS, Shapiro DJ, Hersh AL, Copp HL. Antibiotic resistance patterns of outpatient pediatric urinary tract infections. J Urol. 2013;190(1):222–227. doi: 10.1016/j.juro.2013.01.069.

​3. Mobley HLT, Donnenberg MS, Hagan EC. Uropathogenic escherichia coli. EcoSal Plus. 2009;3(2):10.1128/ecosalplus.8.6.1.3. doi: 10.1128/ecosalplus.8.6.1.3. 

​4. Marsh MC, Junquera GY, Stonebrook E, Spencer JD, Watson JR. Urinary tract infections in children. Pediatr Rev. 2024;45(5):260–270. doi: 10.1542/pir.2023-006017. 

​5. Subcommittee on Urinary Tract Infection, Steering Committee on Quality Improvement and Management, Roberts KB. Urinary tract infection: Clinical practice guideline for the diagnosis and management of the initial UTI in febrile infants and children 2 to 24 months. Pediatrics. 2011;128(3):595–610. doi: 10.1542/peds.2011-1330. 

​6. Systems-based treatment tableCommittee on Infectious Diseases, American Academy of Pediatrics, Kimberlin DW, Banerjee R, Barnett ED, Lynfield R, Sawyer MH, eds. Red book: 2024–2027 report of the committee on infectious diseases. American Academy of Pediatrics; 2024:0. https://doi.org/10.1542/9781610027373-TAB. Accessed 7/17/2025. 10.1542/9781610027373-TAB.

​7. Afolabi TM, Goodlet KJ, Fairman KA. Association of antibiotic treatment duration with recurrence of uncomplicated urinary tract infection in pediatric patients. Ann Pharmacother. 2020;54(8):757–766. doi: 10.1177/1060028019900650. 

​8. Mueller GD, Conway SJ, Gibeau A, Shaikh N. Short- versus standard-course antimicrobial therapy for children with urinary tract infection: A meta-analysis. Acta Paediatr. 2025;114(3):479–486. doi: 10.1111/apa.17546. 

​9. Zaoutis T, Shaikh N, Fisher BT, et al. Short-course therapy for urinary tract infections in children: The SCOUT randomized clinical trial. JAMA Pediatr. 2023;177(8):782–789. doi: 10.1001/jamapediatrics.2023.1979. 

​10. Goodlet KJ, Benhalima FZ, Nailor MD. A systematic review of single-dose aminoglycoside therapy for urinary tract infection: Is it time to resurrect an old strategy? Antimicrob Agents Chemother. 2018;63(1):e02165–18. Print 2019 Jan. doi: 10.1128/AAC.02165-18. 

​11. Nelson Z, Aslan AT, Beahm NP, et al. Guidelines for the prevention, diagnosis, and management of urinary tract infections in pediatrics and adults: A WikiGuidelines group consensus statement. JAMA Netw Open. 2024;7(11):e2444495. https://doi.org/10.1001/jamanetworkopen.2024.44495. Accessed 7/7/2025. doi: 10.1001/jamanetworkopen.2024.44495.

I have been a pharmacist that has been practicing for more than 20 years, and throughout this time, the US has alwways had an infant hepatitis B vaccine strategy in place.  But this has not always been the case.  Let’s look back in time to learn more.  The first hepatitis B vaccine was introduced into the US in 1982.  Initially, only those at high risk of hepatitis B disease were vaccinated, but cases remained high (10-13 per 100,000).  In 1991 hepatitis B vaccination was changed to universal infant immunization and high-risk adolescent to vaccine and rates finally started coming down.   This was followed in 1995 recommending routine catch-up vaccination for adolescents.  Most recently in 2022 routine adult catch-up vaccination through age 59 years. By 2023 the rate dropped to 0.7 per 100,000 population. Universal infant vaccination, not selective high risk hepatitis B vaccination is what reduced hepatitis B incidence in the US.

Why Infant Vaccination Matters

When babies and young children acquire Hepatitis B the risk of developing chronic infection is very high (90% of infants that acquire hepatitis B go on to having chronic disease). Among newborns that acquire hepatitis B about one in four will eventually die as a result of chronic liver disease.

It is estimated that about 2.4 million individuals in the US are living with hepatitis B, but only about half are aware of their status.  About 10% of children acquire hepatitis B through community or household exposures, which is known as their mother have tested negative.  This is possible because Hepatitis B is one of the most contagious and viable bloodborne pathogens. It can survive in the environment for up to 7 days, making indirect transmission possible.

For these reasons, it is critically important to protect newborns as early as possible through vaccination.

Who Should Get Vaccinated

• All infants at birth begin 3 dose hepatitis B series (95% protection)
  • Those who are born to hepatitis B infected mothers should get first hepatitis B vaccine dose and a dose of hepatitis B immune globulin within 12 hours (results in 94% protection)
• Catch-up of those who did not receive the protection through age 59 years
  • Pediatrics – 2 hepatitis B only products, primarily 3 dose series although 2 dose option is available for teens
    • Also included in multiple combination vaccines
  • Adults 3 products currently available 2 are 3 dose series, 1 is available with a 2 dose series.
    • Also included in one combination vaccine with hepatitis A

Vaccine Safety Profile

These vaccines are all inactivated, which as you know cannot cause disease. It is essential to remind our patients about that. I think it is also good to remind patients that every medication has side effects including vaccines.  The side effects expected include pain and redness at the injection site as well as minor systemic adverse effects such as fever, headache, and gastrointestinal upset.  It is possible, although rare that allergic reactions can occur.  The CDC reports additional rare adverse reactions including Guillain-Barré syndrome, chronic fatigue syndrome, neurologic disorders, rheumatoid arthritis, type 1 diabetes, and autoimmune disease have been reported, but upon investigation no causal association have been found.

 

This post was written by Dr. Jennifer Girotto, the Assistant Department Head and Clinical Professor of Pharmacy Practice at the University of Connecticut School of Pharmacy.   She specializes in pediatric infectious diseases and immunizations for all aged patients. Her goal is to provide timely, evidence-based insights that support pharmacists, other healthcare professionals, and trainees in improving patient care.