2 doses of VARIVAX
administered subcutaneously demonstrated 98% estimated
vaccine efficacy against
the varicella virus in children
Actor Portrayal
Estimated vaccine efficacy for VARIVAX administered subcutaneously for the 10-year observation period
(n=1114) P<0.001
(n=1102) P<0.001
of developing varicella >42 days postvaccination with a 2-dose regimen vs a 1-dose regimen over a 10-year observation period
a2.2% with 2 doses vs 7.5% with 1 dose.
Study Design
In a clinical trial, a total of 2216 children 12 months to 12 years of age with a negative history of varicella were randomized to receive either 1 dose of VARIVAX or 2 doses of VARIVAX given 3 months apart. Subjects were actively followed for varicella, any varicella-like illness, or herpes zoster and any exposures to varicella or herpes zoster on an annual basis for 10 years after vaccination. Persistence of varicella-zoster virus antibody was measured annually for 9 years.
IM Administration
Study Design
In an open label clinical trial (NCT00432523), 752 children 12 through 18 months of age received VARIVAX either intramuscularly (n=374) or subcutaneously (n=378), concomitantly with M-M-R®II. Ninety-five percent of enrolled children were seronegative to varicella virus at baseline.
Prespecified Primary Analysis Results
In the prespecified primary analysis, seroresponse rates to varicella virus were noninferior in the intramuscular group compared to the subcutaneous group (the lower bound of the 95% CI for the difference in seroresponse rates [intramuscular group minus subcutaneous group] was ≥–10%). The proportions of children achieving antibody titers above the seroresponse thresholds for varicella virus were 88.4% (95% CI: 84.5, 91.6) of children in the intramuscular group and 85.5% (95% CI: 81.3, 89.0) of children in the subcutaneous group.
- Antibody responses to varicella virus were measured by gpELISA using sera obtained 6 weeks postvaccination.
- Seroresponse rate was defined as the percentage of initially seronegative children who achieved antibody titers above the seroresponse threshold for the assay 6 weeks postvaccination.
- The seroresponse threshold was defined as 5 gpELISA units for anti-varicella virus antibodies.
Indications and Usage for VARIVAX
VARIVAX is a vaccine indicated for active immunization for the prevention of varicella in individuals 12 months of age or older.
Selected Safety Information for VARIVAX
- Do not administer VARIVAX to individuals with: a history of anaphylactic or severe allergic reaction to any component of the vaccine (including neomycin and gelatin) or to a previous dose of a varicella-containing vaccine; immunosuppressed or immunodeficient individuals; an active febrile illness; active untreated tuberculosis; or those who are pregnant or planning to become pregnant in the next 3 months.
- Vaccination should be deferred in individuals with a family history of immunodeficiency until it can be confirmed the individual is immunocompetent. Vaccine recipients should avoid close contact with high-risk individuals susceptible to varicella due to possible risk of transmission. Varicella vaccine virus transmission may occur between vaccine recipients and contacts susceptible to varicella including healthy individuals. Immune Globulins and other blood products should not be given concomitantly with VARIVAX. Avoid use of salicylates for 6 weeks following administration of VARIVAX to children and adolescents.
- Frequently reported (≥10%) adverse reactions for subcutaneous injections in children ages 1 to 12 years who were monitored for 42 days include: injection-site complaints: 19.3%; fever ≥102.0°F (38.9°C) oral: 14.7%. Frequently reported (≥10%) adverse reactions for subcutaneous injections in adolescents and adults ages 13 years and older monitored for up to 42 days include: injection-site complaints: 24.4%; fever ≥100.0°F (37.8°C) oral: 10.2%. Other reported adverse reactions in all age groups include: varicella-like rash (injection site) and varicella-like rash (generalized).
- Adverse reactions reported for both subcutaneous and intramuscular injections of VARIVAX include: fever, injection-site reactions (pain/tenderness/soreness, erythema, and swelling); and rash on the body or at the injection site.
- In a clinical trial involving children who received 2 doses of VARIVAX 3 months apart, the incidence of injection-site clinical complaints (primarily erythema and swelling) observed in the first 4 days following vaccination was slightly higher post-dose 2 (overall incidence 25.4%) than post-dose 1 (overall incidence 21.7%), whereas the incidence of systemic clinical complaints in the 42-day follow-up period was lower post-dose 2 (66.3%) than post-dose 1 (85.8%).
- VARIVAX may establish latency of varicella zoster virus in immunocompetent individuals, with the potential for later development of herpes zoster.
- There are insufficient data to assess the rate of protection of VARIVAX against the serious complications of chickenpox in adults (eg, encephalitis, hepatitis, pneumonia), and during pregnancy (congenital varicella syndrome).
- The duration of protection from varicella infection after vaccination with VARIVAX is unknown.
- Vaccination with VARIVAX may not result in protection of all healthy, susceptible children, adolescents, and adults.
- A boost in antibody levels has been observed in vaccinees following exposure to wild-type varicella, which could account for the apparent long-term persistence of antibody levels in these studies.
- Due to the concern for transmission of vaccine virus, vaccine recipients should attempt to avoid, whenever possible, close association with susceptible high-risk individuals for up to 6 weeks following vaccination.
- VARIVAX is contraindicated for use in pregnant women because the vaccine contains live, attenuated varicella virus, and it is known that wild-type varicella virus, if acquired during pregnancy, can cause congenital varicella.
- It is not known whether varicella vaccine virus is excreted in human milk.
- The long-term effect of VARIVAX on the incidence of herpes zoster, particularly in those vaccinees exposed to wild-type varicella, is unknown at present.
Dosage and Administration
- Each dose is approximately 0.5 mL and is administered intramuscularly or subcutaneously.
- Children (12 months to 12 years of age): The first dose is administered between 12 and 15 months of age. The second dose is administered between 4 to 6 years of age. There should be a minimum interval of 3 months between doses.
- Adolescents (≥13 years of age) and Adults: Two doses are administered with a minimum interval of 4 weeks between doses.
Before administering VARIVAX, please read the accompanying Prescribing Information. The Patient Information also is available.
Indications and Usage for VARIVAX
VARIVAX is a vaccine indicated for active immunization for the prevention of varicella in individuals 12 months of age or older.
VARIVAX is a vaccine indicated for
VARIVAX is a vaccine indicated for active immunization for the prevention of varicella in individuals 12 months of age or older.
Selected Safety Information for VARIVAX
- Do not administer VARIVAX to individuals with: a history of anaphylactic or severe allergic reaction to any component of the vaccine (including neomycin and gelatin) or to a previous dose of a varicella-containing vaccine; immunosuppressed or immunodeficient individuals; an active febrile illness; active untreated tuberculosis; or those who are pregnant or planning to become pregnant in the next 3 months.
- Vaccination should be deferred in individuals with a family history of immunodeficiency until it can be confirmed the individual is immunocompetent. Vaccine recipients should avoid close contact with high-risk individuals susceptible to varicella due to possible risk of transmission. Varicella vaccine virus transmission may occur between vaccine recipients and contacts susceptible to varicella including healthy individuals. Immune Globulins and other blood products should not be given concomitantly with VARIVAX. Avoid use of salicylates for 6 weeks following administration of VARIVAX to children and adolescents.
- Frequently reported (≥10%) adverse reactions for subcutaneous injections in children ages 1 to 12 years who were monitored for 42 days include: injection-site complaints: 19.3%; fever ≥102.0°F (38.9°C) oral: 14.7%. Frequently reported (≥10%) adverse reactions for subcutaneous injections in adolescents and adults ages 13 years and older monitored for up to 42 days include: injection-site complaints: 24.4%; fever ≥100.0°F (37.8°C) oral: 10.2%. Other reported adverse reactions in all age groups include: varicella-like rash (injection site) and varicella-like rash (generalized).
- Adverse reactions reported for both subcutaneous and intramuscular injections of VARIVAX include: fever, injection-site reactions (pain/tenderness/soreness, erythema, and swelling); and rash on the body or at the injection site.
- In a clinical trial involving children who received 2 doses of VARIVAX 3 months apart, the incidence of injection-site clinical complaints (primarily erythema and swelling) observed in the first 4 days following vaccination was slightly higher post-dose 2 (overall incidence 25.4%) than post-dose 1 (overall incidence 21.7%), whereas the incidence of systemic clinical complaints in the 42-day follow-up period was lower post-dose 2 (66.3%) than post-dose 1 (85.8%).
- VARIVAX may establish latency of varicella zoster virus in immunocompetent individuals, with the potential for later development of herpes zoster.
- There are insufficient data to assess the rate of protection of VARIVAX against the serious complications of chickenpox in adults (eg, encephalitis, hepatitis, pneumonia), and during pregnancy (congenital varicella syndrome).
- The duration of protection from varicella infection after vaccination with VARIVAX is unknown.
- Vaccination with VARIVAX may not result in protection of all healthy, susceptible children, adolescents, and adults.
- A boost in antibody levels has been observed in vaccinees following exposure to wild-type varicella, which could account for the apparent long-term persistence of antibody levels in these studies.
- Due to the concern for transmission of vaccine virus, vaccine recipients should attempt to avoid, whenever possible, close association with susceptible high-risk individuals for up to 6 weeks following vaccination.
- VARIVAX is contraindicated for use in pregnant women because the vaccine contains live, attenuated varicella virus, and it is known that wild-type varicella virus, if acquired during pregnancy, can cause congenital varicella.
- It is not known whether varicella vaccine virus is excreted in human milk.
- The long-term effect of VARIVAX on the incidence of herpes zoster, particularly in those vaccinees exposed to wild-type varicella, is unknown at present.
Dosage and Administration
- Each dose is approximately 0.5 mL and is administered intramuscularly or subcutaneously.
- Children (12 months to 12 years of age): The first dose is administered between 12 and 15 months of age. The second dose is administered between 4 to 6 years of age. There should be a minimum interval of 3 months between doses.
- Adolescents (≥13 years of age) and Adults: Two doses are administered with a minimum interval of 4 weeks between doses.
Before administering VARIVAX, please read the accompanying Prescribing Information. The Patient Information also is available.
Do not administer VARIVAX to individuals with: a history of anaphylactic or severe allergic
Do not administer VARIVAX to individuals with: a history of anaphylactic or severe allergic reaction to any component of the vaccine (including neomycin and gelatin) or to a previous dose of a varicella-containing vaccine; immunosuppressed or immunodeficient individuals; an active febrile illness; active untreated tuberculosis; or those who are pregnant or