Notes from the Field: Vaccine Administration Errors Involving Recombinant Zoster Vaccine — United States, 2017–2018
Weekly / May 25, 2018 / 67(20);585–586
Tom T. Shimabukuro, MD1; Elaine R. Miller, MPH1; Raymond A. Strikas, MD2; Beth F. Hibbs, MPH1; Kathleen Dooling, MD3; Ravi Goud, MD4; Maria V. Cano, MD1 (View author affiliations)
View suggested citationTwo vaccines for the prevention of herpes zoster (shingles) are licensed for use in the United States and recommended by the Advisory Committee on Immunization Practices (ACIP). Zoster vaccine live (ZVL; Zostavax, Merck), licensed in 2006,* is a live attenuated virus vaccine administered as a single subcutaneous (SQ) dose. Although the Food and Drug Administration (FDA) approved ZVL for adults aged ≥50 years, ACIP recommends ZVL for immunocompetent adults aged ≥60 years (1). Recombinant zoster vaccine (RZV; Shingrix, GlaxoSmithKline), licensed October 2017,† is also approved by the FDA for adults aged ≥50 years and is recommended by ACIP for immunocompetent adults aged ≥50 years (2). RZV is administered as a 2-dose intramuscular (IM) series, with the second dose given anytime from 2 to 6 months after the first. RZV is preferentially recommended by ACIP over ZVL (2). Furthermore, ACIP recommends that persons previously vaccinated with ZVL receive the full 2-dose RZV series (2).
RZV and ZVL differ with regard to vaccine type, dose, and schedule; ACIP recommendation; route of administration; and storage requirements (Table). Prior experience indicates that administration errors are reported most frequently shortly after vaccine licensure and publication of recommendations, likely because of lack of vaccine provider familiarity with the new vaccine (3).
During the first 4 months of RZV monitoring (October 20, 2017–February 20, 2018), the Vaccine Adverse Event Reporting System (VAERS) (4) received 155 reports involving RZV, 13 (8%) of which documented an administration error, including some reports documenting more than one error. Among these reports, nine involved RZV given by the SQ route rather than the IM route; injection site reactions (e.g., pain, erythema, and pruritus) were described in eight of these nine reports. One of the nine reports describing errors in the route of administration also described vaccination of a person aged 48 years (inappropriate age), and two described patients receiving the vaccine information statement for ZVL instead of RZV and not being instructed to return for the second RZV dose. The remaining four reports included 1) administration of RZV instead of the intended varicella (Varivax) vaccine to a person of unreported age, 2) administration of RZV after incorrect frozen storage, 3) administration of RZV to a person aged 39 years, and 4) administration of only the adjuvant component without reconstitution with the vaccine antigen. Vaccine administration errors occurred in a pharmacy (nine reports), a health care provider’s office (two), and unknown sites (two). CDC also received 13 public inquiries concerning RZV administration errors or questions asked to avoid errors. Topics included SQ administration (five), reconstitution (five), incorrect interval or schedule (two), and administration of previously frozen vaccine (one).
Although data from passive reporting to VAERS and inquiries submitted to CDC limit the ability to draw conclusions regarding the cause of the administration errors, early monitoring indicates that vaccine providers might confuse administration procedures and storage requirements of the older ZVL and the newer RZV. Failure to reconstitute the vaccine and administration of only one component of RZV also appears to be occurring, similar to errors observed for other vaccines that require mixing (5). Whereas RZV administered through the appropriate IM route is associated with high rates of local and systemic reactions (2), erroneous SQ injection can increase the likelihood of these episodes (6). In addition, some errors could potentially affect vaccine effectiveness. To prevent RZV administration errors, vaccine providers should be aware of prescribing information, storage requirements, preparation guidelines, and ACIP recommendations for herpes zoster vaccines (1,2).
Conflict of Interest
No conflicts of interest were reported.
Corresponding author: Elaine R. Miller, emiller@cdc.gov, 404-498-0662.
1Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, CDC; 2Immunization Services Division, National Center for Immunization and Respiratory Diseases, CDC; 3Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, CDC; 4Division of Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
* Zostavax (zoster vaccine live) package insert. https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM132831.pdf.
† Shingrix (zoster vaccine recombinant, adjuvanted) package insert. https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM581605.pdf.
References
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- Dooling KL, Guo A, Patel M, et al. Recommendations of the Advisory Committee on Immunization Practices for use of herpes zoster vaccines. MMWR Morb Mortal Wkly Rep 2018;67:103–8.CrossRef PubMed
- Hibbs BF, Moro PL, Lewis P, Miller ER, Shimabukuro TT. Vaccination errors reported to the Vaccine Adverse Event Reporting System, (VAERS) United States, 2000–2013. Vaccine 2015;33:3171–8. CrossRef PubMed
- Shimabukuro TT, Nguyen M, Martin D, DeStefano F. Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS). Vaccine 2015;33:4398–405. CrossRef PubMed
- Su JR, Miller ER, Duffy J, Baer BM, Cano MV. Notes from the field: administration error involving a meningococcal conjugate vaccine—United States, March 1, 2010–September 22, 2015. MMWR Morb Mortal Wkly Rep 2016;65:161–2. CrossRef PubMed
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Abbreviations: ACIP = Advisory Committee on Immunization Practices, GSK = GlaxoSmithKline; RZV = recombinant zoster vaccine; ZVL = zoster vaccine live.
* Shingrix (zoster vaccine recombinant, adjuvanted) package insert. https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM581605.pdf.
† Zostavax package insert. https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM132831.pdf.
§ ZVL (Zostavax) may be stored or transported at refrigerator temperature between 2°C to 8°C (36°F and 46°F) for up to 72 continuous hours before reconstitution; vaccine stored between 2°C to 8°C (36°F and 46°F) that is not used within 72 hours of removal from -15°C (+5°F) storage should be discarded.
¶ Recommendations of the Advisory Committee on Immunization Practices for use of herpes zoster vaccines. https://www.cdc.gov/mmwr/volumes/67/wr/mm6703a5.htm?s_cid = mm6703a5_w.
** Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). https://www.cdc.gov/mmwr/PDF/rr/rr5705.pdf.
* Shingrix (zoster vaccine recombinant, adjuvanted) package insert. https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM581605.pdf.
† Zostavax package insert. https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM132831.pdf.
§ ZVL (Zostavax) may be stored or transported at refrigerator temperature between 2°C to 8°C (36°F and 46°F) for up to 72 continuous hours before reconstitution; vaccine stored between 2°C to 8°C (36°F and 46°F) that is not used within 72 hours of removal from -15°C (+5°F) storage should be discarded.
¶ Recommendations of the Advisory Committee on Immunization Practices for use of herpes zoster vaccines. https://www.cdc.gov/mmwr/volumes/67/wr/mm6703a5.htm?s_cid = mm6703a5_w.
** Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). https://www.cdc.gov/mmwr/PDF/rr/rr5705.pdf.
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