Zostavax

Zostavax Side Effects

vaccine, varicella-zoster

Manufacturer:

MSD

Distributor:

Zuellig Pharma
Full Prescribing Info
Side Effects
In clinical trials, ZOSTAVAX has been evaluated for general safety in more than 32,000 adults 50 years of age or older. ZOSTAVAX was generally well tolerated.
Zostavax Efficacy and Safety Trial (ZEST) in Subjects 50 to 59 Years of Age: In the ZEST study, subjects received a single dose of either ZOSTAVAX (n=11,184) or placebo (n=11,212) and were monitored for safety throughout the study. During the study, a vaccine-related serious adverse experience was reported for 1 subject vaccinated with ZOSTAVAX (anaphylactic reaction).
All subjects received a vaccination report card (VRC) to record adverse events occurring from Days 1 to 42 postvaccination in addition to undergoing routine safety monitoring throughout the study.
The following very common (≥1/10) and common (≥1/100, <1/10) vaccine-related injection site and systemic adverse experiences were reported in the ZEST study. Several adverse experiences were solicited (Days 1-5 postvaccination) and are designated with the *symbol.
Nervous system disorders: Common: headache.
General disorders and administration site conditions: Very Common: erythema*, pain*, swelling*, pruritus.
Common: hematoma, warmth, induration.
Musculoskeletal and connective tissue disorders: Common: pain in extremity.
The overall incidence of vaccine-related injection-site adverse experiences was significantly greater for subjects vaccinated with ZOSTAVAX versus subjects who received placebo (63.9% for ZOSTAVAX and 14.4% for placebo).
Within the 42-day post vaccination reporting period in the ZEST, noninjection-site zosteriform rashes were reported by 34 subjects (19 for ZOSTAVAX and 15 for placebo). Of 24 specimens that were adequate for Polymerase Chain Reaction (PCR) testing, wild-type VZV was detected in 10 (3 for ZOSTAVAX, 7 for placebo) of these specimens. The Oka/Merck strain of VZV was not detected from any of these specimens.
Within the same 42-day postvaccination reporting period in the ZEST, varicella-like rashes were reported by 124 subjects (69 for ZOSTAVAX and 55 for placebo). Of 23 specimens that were available and adequate for PCR testing, VZV was detected in one of these specimens from the group of subjects who received ZOSTAVAX; however, the virus strain (wild type or Oka/Merck strain) could not be determined.
Shingles Prevention Study (SPS) in Subjects 60 Years of Age and Older: In the largest of these trials, the Shingles Prevention Study (SPS), 38,546 subjects received a single dose of either ZOSTAVAX (n=19,270) or placebo (n=19,276) and were monitored for safety throughout the study. During the study, vaccine-related serious adverse experiences were reported for 2 subjects vaccinated with ZOSTAVAX (asthma exacerbation and polymyalgia rheumatica) and 3 subjects who received placebo (Goodpasture's syndrome, anaphylactic reaction, and polymyalgia rheumatica).
In the Adverse Event Monitoring Substudy, a subgroup of individuals from the SPS (n=3,345 received ZOSTAVAX and n=3,271 received placebo) were provided vaccination report cards to record adverse events occurring from Days 0 to 42 postvaccination in addition to undergoing routine safety monitoring throughout the study.
The following very common (≥1/10) and common (≥1/100, <1/10) vaccine-related injection-site and systemic adverse experiences were reported in the Adverse Event Monitoring Substudy. Most of these adverse experiences were reported as mild in intensity. Several adverse experiences were solicited (Days 0-4 postvaccination) and are designated with the * symbol.
Nervous system disorders: Common: headache.
General disorders and administration site conditions: Very Common: erythema*, pain/tenderness*, swelling*.
Common: hematoma, pruritus, warmth.
The overall incidence of vaccine-related injection site adverse experiences was significantly greater for subjects vaccinated with ZOSTAVAX versus subjects who received placebo (48% for ZOSTAVAX and 17% for placebo).
The remainder of subjects in the SPS received routine safety monitoring, but were not provided report cards. The types of events reported in these patients were generally similar to the subgroup of patients in the Adverse Event Monitoring Substudy.
Within the 42-day postvaccination reporting period in the SPS, the number of reported zosteriform rashes among all subjects was small (17 for ZOSTAVAX, 36 for placebo; p=0.009). Of these 53 zosteriform rashes, 41 had specimens that were available and adequate for PCR testing. Wild-type VZV was detected in 25 (5 for ZOSTAVAX, 20 for placebo) of these specimens. The Oka/Merck strain of VZV was not detected from any of these specimens.
Within the same 42-day postvaccination reporting period in the SPS, the number (n=59) of reported varicella-like rashes was also small. Of these varicella-like rashes, 10 had specimens that were available and adequate for PCR testing. VZV was not detected in any of these specimens.
Other Studies: In other clinical trials in support of the initial licensure of the frozen formulation of ZOSTAVAX, the reported rates of noninjection site zosteriform and varicella-like rashes within 42 days postvaccination were also low in both zoster vaccine recipients and placebo recipients. Of 17 reported varicella-like rashes and non-injection site zoster-like rashes, 10 specimens were available and adequate for PCR testing, and 2 subjects had varicella (onset on Day 8 and 17) confirmed to be Oka/Merck strain.
In clinical trials evaluating ZOSTAVAX in subjects 50 years of age or older, including a study of concomitantly administered inactivated influenza vaccine, the safety profile was generally similar to that seen in the Adverse Event Monitoring Substudy of the SPS. However, in these trials, a higher rate of injection site adverse experiences of mild-to-moderate intensity was reported among subjects 50-59 years of age compared with subjects ≥60 years of age.
In a double-blind, placebo-controlled, randomized clinical trial, ZOSTAVAX was administered to 100 subjects 50 years of age or older with a history of herpes zoster (HZ) prior to vaccination to assess the immunogenicity of ZOSTAVAX and the safety profile. In this clinical trial, the safety profile was generally similar to that seen in the Adverse Event Monitoring Substudy of the SPS.
To address concerns for individuals with an unknown history of vaccination with ZOSTAVAX, the safety and tolerability of a second dose of ZOSTAVAX was evaluated. In a placebo-controlled, double-blind study, 98 adults 60 years of age and older received a second dose of ZOSTAVAX 42 days following the initial dose; the vaccine was generally well tolerated. The frequency of vaccine-related adverse experiences after the second dose of ZOSTAVAX was generally similar to that seen with the first dose.
Immunogenicity in subjects with HIV infection: In a double-blind, placebo-controlled randomized clinical trial, ZOSTAVAX was administered as a two-dose regimen to human immunodeficiency virus (HIV)-infected adults (18 years of age or older) on potent combination antiretroviral therapy with conserved immune function (CD4+ T cell count ≥ 200 cells/µL). Although a two-dose regimen was used in this study, ZOSTAVAX is administered as a single dose regimen (See Dosage & Administration). In this clinical trial, a total of 295 subjects received dose 1 and 286 subjects received dose 2. All vaccinated study patients were followed for adverse experiences. Vaccine relatedness was determined by the investigator based upon blinded data. To evaluate the adverse experiences temporally associated with study vaccination, patients were given a Vaccination Report Card (VRC) to record any injection-site adverse experiences, systemic adverse experiences, elevated temperatures, and rashes through Week 6 following each vaccination. Patients were followed for serious adverse experiences, regardless of whether the event was related to the study vaccine, throughout the course of the study (through Week 24 following dose 1). In this clinical trial, the safety profile was generally similar to that seen in the Adverse Event Monitoring Substudy of the SPS. (See Contraindications).
Post-marketing Experience: The following additional adverse reactions have been identified during post-marketing use of ZOSTAVAX. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to the vaccine.
Gastrointestinal disorders: nausea.
Infections and infestations: herpes zoster (vaccine strain).
Skin and subcutaneous tissue disorders: rash.
Musculoskeletal and connective tissue disorders: arthralgia; myalgia.
General disorders and administration site conditions: injection-site rash; injection-site urticaria; pyrexia; transient injection-site lymphadenopathy.
Immune system disorders: hypersentivity reaction including anaphylactic reactions.
Eye Disorders: Necrotizing retinitis (patients on immunosuppressive therapy).
Nervous system disorders: Guillain Barré syndrome, facial paralysis.
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