Safety Information

Safety Information

Prescribing Information [External link]

Please refer to the Summary of Product Characteristics for full prescribing information.

An established safety profile¹

Clinical studies
In healthy children aged 12 months to 12 years (N=5185) given 1 dose of VARIVAX, the most frequent adverse events reported in temporal association with vaccination were:¹

In healthy children aged 12 months to 12 years given 2 doses of VARIVAX (≥3 months apart, N=1102), the rates of systemic clinical adverse events after a second dose were generally similar to, or lower than, those seen with the first dose. The rates of injection-site reactions (primarily erythema and swelling) were higher after a second dose.¹

The following serious adverse events temporally associated with the vaccine were reported: diarrhoea, febrile seizure, fever, post-infectious arthritis and vomiting.¹

Please refer to the Summary of Product Characteristics for further details on less frequent adverse events reported in people who received VARIVAX.

VARIVAX contraindications¹

• History of hypersensitivity to any varicella vaccine, to any of the excipients or to gelatin or neomycin (which may be present as trace residues)
• Blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the hemic and lymphatic systems
• Individuals receiving immunosuppressive therapy (including high doses of corticosteroids)
• Severe humoral or cellular (primary or acquired) immunodeficiency, e.g. severe combined immunodeficiency, agammaglobulinemia and AIDS or symptomatic HIV infection or an age-specific
• CD4+ T-lymphocyte percentage in children below 12 months: CD4+ <25%; children between 12 months and 35 months: CD4+ <20%; children between 36 months and 59 months: CD4+ <15%
• Individuals with a family history of congenital or hereditary immunodeficiency, unless the immune competence of the potential vaccine recipient is demonstrated
• Active untreated tuberculosis
• Any illness with fever >38.5°C; however, low-grade fever itself is not a contraindication to vaccination
• Pregnancy. Furthermore, pregnancy should be avoided for 1 month following vaccination

Special warnings and precautions for use¹

• 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 in children ages 1 to 12 years who were monitored for 42 days include: injection-site complaints: 19.3%; fever ≥38.9°C (102.0°F) oral: 14.7%. Frequently reported (≥10%) adverse reactions in adolescents and adults ages 13 years and older monitored for up to 42 days include: injection-site complaints: 24.4%; fever ≥37.8°C (100.0°F) oral: 10.2%. Other reported adverse reactions in all age groups include: varicella-like rash (injection site) and varicella-like rash (generalised).
• 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 (e.g., 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.

Interaction with other medicinal products and other forms
of interaction¹

Other injectable vaccines or other medicinal products must be given as separate injections and at different body sites.

Concomitant administration with other vaccines

VARIVAX has been administered to toddlers at the same time as, but at a different injection site from, a combined measles, mumps, and rubella vaccine, Haemophilus influenzae type b conjugate vaccine, hepatitis B vaccine, diphtheria/tetanus/whole-cell pertussis vaccine, and oral polio virus vaccine. There was no evidence of a clinically relevant difference in the immune responses to any of the antigens when co-administered with VARIVAX. If VARIVAX is not given concomitantly with measles, mumps, and rubella virus vaccine live, a 1-month interval between the 2 live virus vaccines should be observed. Concurrent administration of VARIVAX and tetravalent, pentavalent or hexavalent (diphtheria, tetanus, and acellular pertussis [DTaP])-based vaccines has not been evaluated. Vaccination should be deferred for at least 5 months following blood or plasma transfusions, or administration of normal human immune globulin or varicella zoster immune globulin (VZIG). Administration of varicella zoster virus antibody-containing blood products, including VZIG or other immune globulin preparations, within 1 month following a dose of VARIVAX may reduce the immune response to the vaccine and hence reduce its protective efficacy. Therefore, administration of any of these products should be avoided within 1 month after a dose of VARIVAX unless considered to be essential. Vaccine recipients should avoid use of salicylates for 6 weeks after vaccination with VARIVAX as Reye syndrome has been reported following use of salicylates during wild-type varicella infection.

Pregnancy and Lactation¹

Pregnancy

Pregnant women should not be vaccinated with VARIVAX. Studies have not been conducted with VARIVAX in pregnant women, and therefore it is not known whether VARIVAX can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity. Pregnancy should be avoided for 1 month following vaccination. Women who intend to become pregnant should be advised to delay.

Breastfeeding

Due to the theoretical risk of transmission of the vaccine viral strain from mother to infant, VARIVAX is not generally recommended for breastfeeding mothers.

Study design

Galea SA, et al.³
A review describing the 10-year safety profile of VARIVAX using 16,683 spontaneous post-marketing AE reports submitted to MSD between 1 May 1995 and 30 April 2005, together with results from the Varicella Zoster Virus Identification Program (VZVIP). All reported AEs temporally related to the administration of VARIVAX were added to the Worldwide Adverse Experience System database without regard to the likelihood of a causal relationship and coded in the terminology used by the reporter. VZVIP used polymerase chain reaction analysis to distinguish the Oka VZV strain from the wild-type VZV strain circulating in the United States. Clinical specimens were collected from patients with >50 vesicular lesions occurring within 42 days of vaccination, breakthrough cases of varicella, herpes zoster, encephalitis, aseptic meningitis, cerebellar ataxia, pneumonitis, and suspected secondary transmission.

References

1. VARIVAX Summary of Product Characteristics.
2. MSD Data on File. VACC-1246225-0000.
3. Galea SA, Sweet A, Beninger P, et al. The safety profile of varicella vaccine: a 10-year review. J Infect Dis. 2008;197:S165–S169.

Supporting documentation

Prescribing Information
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