Clinical Advisory  Pediatric Hepatitis B Vaccine Shortage Advisory October 1, 2018

Date:	10/01/2018
Organization:	Bureau of Infectious Disease and Laboratory Sciences
Referenced Sources:	Bureau of Infectious Disease and Laboratory Sciences

There is an ongoing national shortage of pediatric single-component hepatitis B (HepB) vaccine.  Effective October 1, 2018, the MDPH Immunization Program will need to reduce all orders (except those from birth facilities) of single-component hepatitis B vaccine by 25%.  Practices will need to make some adjustments, as described below.

Key Points During the Shortage

• Prioritize the birth dose of hepatitis B (HepB) vaccine.
• Prioritize vaccination of infants born to hepatitis B surface antigen (HBsAg)-positive mothers, or whose status is unknown. These recommendations are unchanged.
• For providers using Pentacel (DTaP-IPV/Hib) and/or single-component vaccines, there are several options for your practice. You will need to choose the one that works best in your setting:
  • Defer administration of the 3rd dose of single-component HepB vaccine until later within the recommended range of 6-18 months of age for healthy infants born to HBsAg-negative mothers.*
  • Transition to an all Pediarix (DTaP-IPV-HepB) schedule for all 3 doses in the DTaP primary series at 2, 4, and 6 months.
  • Substitute 1 or 2 doses of Pediarix for Pentacel in the DTaP primary series, as a temporary measure during the shortage.
• Providers using Pediarix (DTaP-IPV-HepB) can continue the infant schedule with no change.
• Regardless of vaccine formulation(s) used, all providers should prioritize the birth dose and completion of the infant series over catch-up vaccination of older children and adolescents.

* In populations with high rates of childhood HBV infection (e.g., Alaska Natives, Pacific Islanders, and immigrant families from Asia, Africa, and countries with intermediate or high endemic rates of infection), the first dose of vaccine should be administered at birth and the final dose at age 6–12 months.

Hepatitis B Clinical Guidance

• See the Centers for Disease Control and Prevention’s (CDC) Pediatric Hepatitis B Vaccination Guidance during the Supply Shortage for their current clinical recommendations.
• For detailed guidance for the vaccination and management of infants born to HBsAg-positive mothers, or whose status is unknown, see pages 12 and 15-16 in the Advisory Committee on Immunization Practice’s (ACIP) recommendations for hepatitis B vaccination. Remember, the final dose of HepB for these infants is at age 6 months of age.

General Immunization Schedule Guidance

• See the Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger, United States, 2018.
• Take advantage of the places in the schedule where there is a range of ages for administration of that antigen.
• While the ACIP prefers a vaccine series be completed with the same brand when feasible, providers should complete a vaccine series with the available formulation.
• A vaccine series begun with single-component vaccines can be completed using combination vaccines. A series begun with combination vaccines can be completed with single-component vaccines.
• When using combination vaccines, ensure the minimum intervals between doses and the minimum age have been met for each of the components. See CDC’s Recommended Minimum Ages and Interval Table (PDF).

Ordering Vaccine

The MDPH Vaccine Management Unit staff will reduce pediatric single-component Hep B vaccine orders by 25% starting October 1, 2018 for all provider sites except birth facilities. The Vaccine Unit will continue to closely review vaccine orders to meet provider needs and work within the allocations allowed by the CDC.

It is important that you decide as a practice which temporary schedule to implement in your office as this will affect your vaccine ordering patterns during the shortage period. Some providers will need to plan on increasing their orders of some single-component vaccines and/or Pediarix.

If you choose to switch from Pentacel to an all Pediarix schedule for routine use in your office or if you choose to substitute 1 or 2 doses of Pediarix for Pentacel in the DTaP series on a temporary basis during the shortage, please call the Vaccine Unit to assist you with your orders and be sure to update your monthly order quantities of single-component vaccines (Hep B, DTaP, Hib, IPV). Keep in mind that MDPH does not encourage frequent switching of vaccine formulations, so be sure to have a plan to use all remaining supplies of Pentacel to avoid vaccine wastage.

Providers must track their inventory closely during this shortage to maximize the number of available doses for all practices and clinics. Please use all doses ordered so that vaccine does not go unused or be allowed to expire, which will result in vaccine restitution.

The pediatric single-component HepB vaccine shortage is an evolving situation and may change over the coming months. MDPH will be monitoring the national vaccine supply and will communicate with providers, by email and on the MDPH website at https://www.mass.gov/immunization-program.

Questions

For questions about immunization schedules, please call the Immunization Program at [phone] and ask to speak to an immunization epidemiologist or nurse.

For questions about vaccine availability and ordering, please contact the Vaccine Management Unit at [phone].

Thank you again for your understanding and flexibility during this challenging period. We appreciate your efforts to protect our children against vaccine preventable diseases!

Resources

CDC Current Vaccine Shortages and Delays

CDC’s Pediatric Hepatitis B Vaccination Guidance During the 2019 Supply Shortage

ACIP’s Prevention of Hepatitis B Virus Infection in the U.S. Recommendations for Vaccination

ACIP’s General Best Practice Guidelines for Immunization

ACIP Vaccine Recommendation Website

Immunization Action Coalition, Ask the Experts –Combination Vaccines