Chickenpox

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Pharmaceutical Name

Trade (marketing or proprietary) name: Varivax®

Generic (nonproprietary or active ingredient) name: Varicella Virus Vaccine Live

Indication and Usage

Reason the product has been approved for sale on the market.

For active immunization for the prevention of varicella (chickenpox) in individuals 12 months of age and older.

Manufacturer Insert

Manufacturer Insert Icon
Varivax®

Ingredients

Also known as “excipients” for vaccines.

Oka/Merck strain of live, attenuatedvaricella virus. The virus was initially obtained from a child with wild-type varicella, then introduced into human embryonic lung cell cultures, adapted to and propagated in embryonic guinea pig cell cultures and finally propagated in human diploid cell cultures (WI-38). Further passage of the virus for varicella vaccine was performed at Merck Research Laboratories (MRL) in human diploid cell cultures (MRC-5) that were free of adventitious agents. This live, attenuated varicella vaccine is a lyophilized preparation containing sucrose, phosphate, glutamate, and processed gelatin as stabilizers.

Each approximately 0.5 mL dose also contains approximately 24 mg of sucrose, 12.0 mg hydrolyzed gelatin, 3.1 mg of sodium chloride, 0.5 mg of monosodium L-glutamate, 0.44 mg of sodium phosphate dibasic, 0.08 mg of potassium phosphate monobasic, and 0.08 mg of potassium chloride. The product also contains residual components of MRC-5 cells including DNA and protein and trace quantities of sodium phosphate monobasic, EDTA, neomycin and fetal bovine serum. The product contains no preservative.

Contraindications

Per the FDA, contraindications are conditions in a recipient that increases the risk for a serious adverse reaction. Product should not be administered when a patient has a listed contraindication.

Severe Allergic Reaction: 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.

Immunosuppression: Do not administer VARIVAX to individuals who are immunodeficient or immunosuppressed due to disease or medical therapy. Disseminated varicella disease and extensive vaccine-associated rash have been reported in individuals who are immunosuppressed or immunodeficient who were inadvertently vaccinated with a varicella containing vaccine.

Moderate or Severe Febrile Illness: Do not administer VARIVAX to individuals with an active febrile illness with fever >101.3°F (>38.5°C).

Active Untreated Tuberculosis: Do not administer VARIVAX to individuals with active, untreated tuberculosis (TB).

Pregnancy: Do not administer VARIVAX to individuals who are pregnant or planning on becoming pregnant in the next 3 months. Wild-type varicella is known to cause fetal harm

Warnings and Precautions

Per the FDA, warnings are clinically significant adverse reactions or risks. According to the CDC, a precaution is a condition in a recipient that might increase the risk for a serious adverse reaction, might cause diagnostic confusion, or might compromise the effectiveness of the product. In general, a product should be deferred when a precaution is present.

Family History of Immunodeficiency: Vaccination should be deferred in individuals with a family history of congenital or hereditary immunodeficiency until the individual’s immune status has been evaluated and the individual has been found to be immunocompetent.

Use in HIV-Infected Individuals: The Advisory Committee on Immunization Practices (ACIP) has recommendations on the use of varicella vaccine in HIV-infected individuals.

Risk of Vaccine Virus Transmission: Post-marketing experience suggests that transmission of varicella vaccine virus (Oka/Merck) resulting in varicella infection including disseminated disease may occur between vaccine recipients (who develop or do not develop a varicella-like rash) and contacts susceptible to varicella including healthy as well as high-risk individuals.

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 six weeks following vaccination with VARIVAX. Susceptible high-risk individuals include:

  • Immunocompromised individuals;
  • Pregnant women without documented history of varicella or laboratory evidence of prior infection;
  • Newborn infants of mothers without documented history of varicella or laboratory evidence of prior infection and all newborn infants born at <28 weeks gestation regardless of maternal varicella immunity.

Immune Globulins and Transfusions: Immune Globulins (IG) and other blood products should not be given concomitantly with VARIVAX. These products may contain antibodies that interfere with vaccine virus replication and decrease the expected immune response. The ACIP has specific recommendations for intervals between administration of antibody containing products and live virus vaccines.

Salicylate Therapy: Avoid use of salicylates (aspirin) or salicylate-containing products in children and adolescents 12 months through 17 years of age for six weeks following vaccination with VARIVAX because of the association of Reye syndrome with salicylate therapy and wild-type varicella infection.

Manufacturer-Listed Adverse Reactions

Per the CDC, adverse reactions are an undesirable medical condition that has been demonstrated to be caused by a vaccine. Evidence for the causal relation is usually obtained through randomized clinical trials, controlled epidemiologic studies, isolation of the vaccine strain from the pathogenic site, or recurrence of the condition with repeated vaccination (i.e., rechallenge); synonyms include side effect and adverse effect.

Anaphylaxis/anaphylactic shock, Angioneurotic edema, Facial edema, Peripheral edema, Necrotizing retinitis (in immunocompromised individuals), Aplastic anemia, Thrombocytopenia (including idiopathic thrombocytopenic purpura (ITP)), Varicella (vaccine strain), Encephalitis, Cerebrovascular accident (Stroke), Transverse myelitis, Impetigo, Guillain-Barré syndrome, Bell’s palsy, Ataxia, Non-febrile seizures, Aseptic meningitis, Meningitis, Dizziness, Paresthesia, Pharyngitis, Pneumonia/pneumonitis, Stevens-Johnson syndrome, Erythema multiforme, Henoch-Schönlein purpura, Cellulitis, Herpes zoster (shingles)

Specific Populations

Pregnancy

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 syndrome.

Breastfeeding

It is not known whether varicella vaccine virus is excreted in human milk.

Fertility

The insert does not contain Section 13.1, which typically addresses fertility concerns.

Chickenpox Vaccine Fertility Issues
Pediatric

No clinical data are available on safety or efficacy of VARIVAX in children less than 12 months of age.

Mechanism of Action

This is the specific biochemical interaction through which a drug or vaccine substance produces its pharmacological effect. This section also includes the minimum protective level designated for a certain disease.

VARIVAX induces both cell-mediated and humoral immune responses to varicella-zoster virus. The relative contributions of humoral immunity and cell-mediated immunity to protection from varicella are unknown.

The duration of protection of VARIVAX is unknown; however, long-term efficacy studies have demonstrated continued protection up to 10 years after vaccination. A boost in antibody levels has been observed in vaccinees following exposure to wild-type varicella which could account for the apparent long-term protection after vaccination in these studies.

Analytical Deep Dive


What is informed consent?

Alternatives

Looking for Chickenpox vaccine alternatives? Here are some products to research:

The alternative to the Chickenpox (Varicella) vaccine is to not accept it and treat the virus naturally when needed. Here are some things to research if you suspect you or your child has chickenpox.

Chickenpox FAQ

Chickenpox FAQ

Do you worry about chickenpox and have been recommended the chickenpox (or varicella) vaccine? Click the image above for prevention and treatment protocols + products to research for educated and empowered medical decisions.

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