Technically Speaking: CDC Publishes Updated Guidance on the Use of Zoster Vaccines

A new vaccine for the prevention of herpes zoster was licensed by the Food and Drug Administration in October 2017. Recombinant zoster vaccine (RZV, Shingrix®; GSK) is a subunit vaccine that contains recombinant varicella zoster virus glycoprotein E in combination with a novel adjuvant (AS01B). Shingrix does not contain live varicella zoster virus. It is approved for people 50 years and older and administered as a two-dose series with doses separated by two to six months.

Recommendations

Recommendations of the Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines was published on Jan. 26, and is available on the MMWR website. The major recommendations contained in this guidance are:

• Shingrix is recommended for the prevention of herpes zoster and related complications for immunocompetent adults 50 years of age and older.
• It is recommended for the prevention of herpes zoster and related complications for immunocompetent adults who previously received zoster vaccine live (ZVL, Zostavax®; Merck).
• Zostavax remains a recommended vaccine for prevention of herpes zoster and its complications in immunocompetent adults 60 years of age and older. However, Shingrix is preferred over Zostavax in this age group.

Storage and administration

There are several important differences between Shingrix and Zostavax that staff must understand to avoid storage and administration errors.

Shingrix

• Must be stored in the refrigerator only. If the lyophilized vaccine, the adjuvant solution, or the reconstituted vaccine is frozen, it must be discarded.
• Must be reconstituted only with the adjuvant liquid suspension that is provided. After reconstitution, administer Shingrix immediately by the intramuscular route or store the reconstituted vaccine refrigerated between 2° and 8°C (between 36° and 46°F) and use within 6 hours. Discard reconstituted vaccine if not used within 6 hours or if frozen.
• Is administered intramuscularly (IM). It should not be administered subcutaneously.  However, CDC has advised that a dose administered by the subcutaneous route does not need to be repeated.

Zostavax

• Must be stored in a freezer at a temperature of between -50°C and -15°C (between -58°F and +5°F) until it is reconstituted. The diluent should be stored separately at room temperature or in the refrigerator.
• May be stored at refrigerator temperature between 2°C and 8°C (between 36°F and 46°F) for up to 72 continuous hours prior to reconstitution. Zostavax stored between 2°C and 8°C that is not used within 72 hours of removal from a freezer should be discarded.
• Is to be administered subcutaneously (Subcut) immediately after reconstitution to minimize loss of potency. If the vaccine is not administered within 30 minutes of reconstitution, it must be discarded.

Related resources

CDC and manufacturer resources

• Recommendations of the Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines
• Shingrix Package Insert (GSK)
• Zostavax Package Insert (Merck)
• GSK guidance about Shingrix
• Merck guidance on Zostavax vaccine use
• Merck guidance on Zostavax storage and handling

IAC resources

• Ask the Experts: Zoster Vaccine—CDC experts answer your questions
• Standing Orders for Administering Zoster Vaccine to Adults
• How to Administer Intramuscular and Subcutaneous Vaccine Injections
• How to Administer Intramuscular and Subcutaneous Vaccine Injections to Adults
• Vaccines with Diluents: How to Use Them