Technically Speaking — Vaxelis: What You Should Know

Vaxelis^™ is a hexavalent vaccine that protects against diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b, and hepatitis B. It is now available for use in children between 6 weeks and 4 years of age, regardless of whether they have private insurance or are covered by the Vaccines For Children (VFC) program. The vaccine, which was developed by the MCM Vaccine Co., a joint venture between Merck and Sanofi Pasteur, combines previously FDA-licensed versions of other commonly used vaccines:

• The same DTaP components as Pentacel^®, Sanofi Pasteur
• The same inactivated poliovirus vaccine components as IPOL^®, Sanofi Pasteur
• The same Haemophilus influenzae type b (Hib) vaccine component as PedvaxHIB^®, Merck, but in a lower quantity
• The same hepatitis B vaccine component as Recombivax HB^®, Merck

While two pentavalent vaccines, Pentacel^® and Pediarix^®, have been common options for reducing the number of shots in the infant vaccination series, Vaxelis represents the first six-component version.

Key dates

• December 2018 — Licensure by the Food and Drug Administration (FDA)
• June 2019 — Resolution to add Vaxelis to the Vaccines for Children (VFC) Program, recognizing that supplies would not be available immediately
• 2021 — Vaccine availability in the U.S.

Scheduling

• Indication: 3-dose series for infants at 2, 4, and 6 months of age or for children who fell behind and need to be brought up to date prior to their fifth birthday
• Minimum age:
  • Minimum age for any dose is 6 weeks
  • Minimum age for dose 3 is 24 weeks
    If dose 3 is given before 24 weeks of age, an additional dose of hepatitis B vaccine should be given at 24 weeks of age or older to complete the series.
• Maximum age for any dose:  4 years and 364 days (i.e., before the fifth birthday)
• Minimum intervals:
  • Minimum interval between doses 1 and 2 — 4 weeks
  • Minimum interval between doses 2 and 3 — 4 weeks

Interchangeability

As with other combination vaccines, the CDC’s general recommendation is that subsequent doses of vaccine be of the same brand whenever possible, but providers can deviate, if necessary, in order to complete a series. Related information can be found in the “General Best Practice Guidelines for Immunization” on the CDC’s website.

Who should not get Vaxelis

Do not give Vaxelis to anyone with a history of:

• Severe allergic reaction to a previous dose of Vaxelis, any ingredient of Vaxelis, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or Hib vaccine. Note that the vial stopper, syringe plunger stopper, and syringe tip cap do not contain natural rubber latex.
• Encephalopathy within 7 days of a pertussis-containing vaccine with no other identifiable cause.
• Progressive neurologic disorder until a treatment regimen has been established and the condition has stabilized.

Coding and billing

The following codes have been assigned to Vaxelis:

• CVX code 146
• MVX code PMC

• CPT codes:

• Vaccine product code: 90697
• Vaccine administration codes:
  • With qualified healthcare professional counseling: 90460 for the administration of the first component (diphtheria) +90461 for each of the other five components (tetanus, pertussis, inactivated polio, Hib and HepB)
  • Without counseling (administration only): 90471 (first component) +90472 (for each of other five components)

For complete details, see “Billing Codes, National Drug Codes, and Immunization Registry Codes for Vaxelis” or for a printable version, access the PDF.

Other important information

• To check on the availability of Vaxelis through the VFC program in your state, contact your local health department or VFC coordinator or check your state’s VFC website.
• The vaccine is available as a ready-to-use suspension in single-dose vials; they are available in packages of 10 vials (NDC # 49281-0590-05).
• Storage:
  • Vaxelis should be stored at 2^o to 8^o C (36^o to 46^o F).
  • Do not freeze. Product which has been exposed to freezing should not be used.
  • Do not use after the expiration date.
  • Vaxelis does not contain a preservative.
• Administration:
  • Vaxelis is administered in 0.5 mL per dose, given intramuscularly.
  • The vaccine does not need to be reconstituted, but should be shaken prior to administration until a uniform, white, cloudy suspension results. If the vial or syringe contains particulate matter or is discolored, the vaccine should not be administered.
  • Vaxelis can be administered at the same visit with other vaccines, but in separate syringes. Specifically, it should not be mixed with or used to reconstitute any other vaccine.
• Documentation for combination vaccines:
  • Record the generic abbreviation for the vaccine type given (e.g., DTaP-IPV-Hib-HepB) in each of the sections that correspond to the separate antigens listed on the record (e.g., DTaP section).
  • Medication-error experts recommend avoiding the use of trade names because they may be misinterpreted or discontinued. However, because of the unusual length of this vaccine's generic name, an exception may be appropriate. Consider also using information-technology approaches (e.g., bar coding).

Additional helpful web links

• Transition tool for healthcare providers – offers guidance for giving Vaxelis to children who began their vaccination series with other products
• Information for patients’ families
  • Brochure
  • Patient Information Sheet
• Multi-vaccine Vaccine Information Statement (with translations) – offered by the Immunization Action Coalition (IAC)