CDC issues reminder on appropriate use of recombinant zoster vaccine
Early monitoring suggests that clinicians are confusing the administration and storage requirements of the older live attenuated virus vaccine with the recently approved recombinant zoster vaccine, the agency said.
The CDC recently reminded clinicians about the proper use of the new recombinant vaccine for prevention of herpes zoster.
The recombinant zoster vaccine (Shingrix), which was licensed in October 2017, is recommended by the Advisory Committee on Immunization Practices (ACIP) as the preferred vaccine for immunocompetent adults ages 50 years and older. Unlike the previously approved live attenuated virus vaccine (Zostavax), which is stored frozen and is administered as one subcutaneous dose, the recombinant zoster vaccine is stored in the refrigerator and is administered intramuscularly as a two-dose series, with the second dose given two to six months after the first. The ACIP recommends that people who previously received the live attenuated virus vaccine receive the full two-dose series of the new recombinant zoster vaccine.
In the first four months that use of the new vaccine was monitored, from Oct. 20, 2017, to Feb, 20, 2018, 155 related reports were made to the Vaccine Adverse Event Reporting System. Of these, 13 (8%) documented an administration error, with some reports documenting more than one error, the CDC said in a recent “Notes from the Field” communication published in the May 25 Morbidity and Mortality Weekly Report.
In nine cases, the recombinant zoster vaccine was given subcutaneously rather than intramuscularly, and patients in eight of these nine cases experienced injection-site reactions, such as pain, erythema, and pruritus. Two reports involved a 48-year-old patient and a 39-year-old patient despite the vaccine being approved and recommended only for those ages 50 years and older. In two cases, patients received a vaccine information statement for zoster vaccine live instead of the recombinant zoster vaccine and were not told they needed to return for a second dose.
Other errors included administration of the recombinant vaccine after it had been stored as frozen rather than as refrigerated and administration of only the adjuvant component of the vaccine. Nine of the 13 cases occurred in a pharmacy, two occurred in a clinician's office, and two occurred at unknown sites. The CDC also reported receiving 13 public inquiries about errors administering the recombinant zoster vaccine or questions asked to avoid errors.
The CDC noted that its ability to draw conclusions from these data are limited but that early monitoring suggests clinicians are confusing the administration and storage requirements of the older vaccine with the new one. Some of the reported errors could affect vaccine effectiveness, the CDC said. “To prevent [recombinant zoster vaccine] administration errors, vaccine providers should be aware of prescribing information, storage requirements, preparation guidelines, and ACIP recommendations for herpes zoster vaccines,” the agency said. The “Notes from the Field” communication includes a table comparing the recommended storage, use, and administration of the two vaccines.
ACP offers several resources offering education and information on herpes zoster vaccination. A series of videos on adult immunization featuring Sandra Adamson Fryhofer, MD, MACP, explains the ACIP's recommendations, including those on shingles. “Aging and Immunity: The Important Role of Vaccines,” is a guide developed by ACP, the American Gerontological Society of America, and the American Pharmacists Association with support from GlaxoSmithKline LLC. An article in the February 2018 ACP Internist provides more information on the recombinant zoster vaccine and how it may affect clinical practice.