The Safety Profile of SHINGRIX

The safety profile of SHINGRIX was extensively studied in two large phase III clinical trials1-3

Serious adverse events table

Adapted from SHINGRIX Product Monograph.

Median follow-up period of 4.4 years (0–5.0 years)1

Study analysis: The safety profile of SHINGRIX was evaluated by pooling data from the two placebo-controlled clinical studies involving 29,305 subjects aged 50 years and older who received at least one dose of SHINGRIX (n=14,645) or placebo (n=14,660) administered according to a 0- and 2-month schedule. Safety endpoints (including serious adverse events, potential immune-mediated diseases and deaths) were collected during the entire follow-up period (median 4.4 years, ranging from 0–5.0 years) in ZOE-50 and ZOE-70.1

Solicited local and general adverse events within seven days of vaccination from ZOE-50 and ZOE-70 studies1*†

A subset of the total vaccinated cohort recorded with a 7-day diary card
Adverse events (ZOE-50 and ZOE-70) table Adverse events (ZOE-50 and ZOE-70) table

Adapted from SHINGRIX Product Monograph.

The majority of solicited adverse events seen with SHINGRIX were mild to moderate and were not long-lasting (median duration of three days).1

Pooled data on solicited local and general adverse events were collected using standardized diary cards for seven days following each vaccine dose or placebo (i.e., day of vaccination and the next six days) in a subset of subjects (n=4,884 receiving SHINGRIX, n=4,880 receiving placebo with at least one documented dose in the ZOE-50 and ZOE-70 studies).

* Solicited general adverse events are those experiences which do not occur at the site of injection and are temporally associated with the use of the vaccine, whether or not considered related.
Seven days included day of vaccination and the subsequent six days.
Fever defined as ≥37.5°C/99.5°F for oral, axillary, or tympanic route, or ≥38°C/100.4°F for rectal route.
§ Gastrointestinal symptoms including nausea, vomiting, diarrhea, and/or abdominal pain.

Solicited Grade 3 local and general reactions within seven days of vaccination from ZOE-50 and ZOE-70 studies4,5*†

Grade 3 local adverse reactions (ZOE-50 and ZOE-70) table Grade 3 local adverse reactions (ZOE-50 and ZOE-70) table

Adapted from Data on file.

Grade 3 definitions

For local adverse reactions, total vaccinated cohort for safety included all subjects with at least one documented dose (n).

n=4,884 receiving SHINGRIX (aged 50–69: n=2,626; aged ≥70: n=2,258) and n=4,880 receiving placebo (aged 50–69: n=2,617; aged ≥70: n=2,263) with at least one documented dose in the ZOE-50 and ZOE-70 studies.

For general adverse events, total vaccinated cohort for safety included all subjects with at least one documented dose (n).

n=4,876 receiving SHINGRIX (aged 50–69: n=2,624; aged ≥70: n=2,252) and n=4,881 receiving placebo (aged 50–69: n=2,617; aged ≥70: n=2,264) with at least one documented dose in the ZOE-50 and ZOE-70 studies. Gastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.

* Solicited general adverse events are those experiences which do not occur at the site of injection and are temporally associated with the use of the vaccine, whether or not considered related.
Seven days included day of vaccination and the subsequent six days.
Grade 3 fever defined as >39.0°C/102.2°F.
§ Gastrointestinal symptoms including nausea, vomiting, diarrhea, and/or abdominal pain.

References

  1. SHINGRIX Product Monograph. GlaxoSmithKline Inc., June 3, 2020.
  2. Lal H et al. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med 2015;372(22):2087-2096.
  3. Cunningham AL et al. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med 2016;375(11):1019-1032.
  4. Data on file. Study 113077. 2017.
  5. Data on file. Study 110390. 2017.
  6. Harpaz R, Ortega-Sanchez IR, Seward JF; Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention (CDC). Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2008;57(RR-5):1-30.
  7. Public Health Agency of Canada. An Advisory Committee Statement (ACS), National Advisory Committee on Immunization (NACI) – Updated Recommendations on the Use of Herpes Zoster Vaccines. Ottawa, Ontario: Public Health Agency of Canada; June 2018. Available at: https://www.canada.ca/en/services/health/publications/healthy-living/updated-recommendations-use-herpes-zoster-vaccines.html.
  8. Reproduction of information from the PIQ, 7th ed. Zona-SU section. Available at: http://www.msss.gouv.qc.ca/professionnels/vaccination/piq-vaccins/zona-su-vaccin-sous-unitaire-contre-le-zona/.
    The original French version of this information was published in 2018 by the Department of Health and Social Services. The Dept. declines any responsibility for any damage, loss or injury that may result from this translation into English. In case of contradiction between the English and French versions of this information, the latter will prevail. The Government of Quebec is and remains the only copyright owner of the work in French. The English version has not been validated by the Ministry of Health and Social Services.

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PM-CA-SGX-WCNT-210001 | November 2021