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Safety Information

Updated on 17/04/2018

VACCINES

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

Contraindications

  • History of hypersensitivity to the active substance, to any of the excipients or trace residuals (e.g. neomycin).
  • Primary and acquired immunodeficiency states due to conditions such as: acute and chronic leukaemias; lymphoma; other conditions affecting the bone marrow or lymphatic system; immunosuppression due to HIV/AIDS; cellular immune deficiencies.
  • Immunosuppressive therapy (including high-dose corticosteroids); however, ZOSTAVAX is not contraindicated for use in individuals who are receiving topical/inhaled corticosteroids or low-dose systemic corticosteroids or in patients who are receiving corticosteroids as replacement therapy, e.g., for adrenal insufficiency.
  • Active untreated tuberculosis.
  • Pregnancy. Furthermore, pregnancy should be avoided for 1 month following vaccination.

Special warnings and precautions for use

Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic/anaphylactoid reaction following the administration of the vaccine, as there is a possibility of hypersensitivity reactions, not only to the active substances, but also to the excipients and trace residuals (e.g. neomycin) present in the vaccine.

Neomycin allergy generally manifests as a contact dermatitis. However, a history of contact dermatitis due to neomycin is not a contraindication to receiving live virus vaccines.

ZOSTAVAX is a live, attenuated varicella-zoster vaccine and administration to individuals who are immunosuppressed or immunodeficient may result in disseminated varicella-zoster virus disease, including fatal outcomes. Patients who previously received immune suppressive therapy should be carefully evaluated for the reconstitution of the immune system prior to receiving Zostavax.

The safety and efficacy of ZOSTAVAX have not been established in adults who are known to be infected with HIV with or without evidence of immunosuppression however, a phase II safety and immunogenicity study in HIV-infected adults with conserved immune function (CD 4+T cell count ≥200 cells/µL) has been completed.

This vaccine should be given subcutaneously to individuals with severe thrombocytopenia or any coagulation disorder, because these individuals may bleed following intramuscular injections.

ZOSTAVAX is not indicated for treatment of zoster or PHN.

Immunisation should be postponed in individuals suffering from moderate to severe acute febrile illness or infection.

As for any vaccine, vaccination with ZOSTAVAX may not result in protection in all vaccine recipients.

Transmission

In clinical trials with ZOSTAVAX, transmission of the vaccine virus has not been reported. However, post-marketing experience with varicella vaccines suggests that transmission of vaccine virus may occur rarely between vaccinees who develop a varicella-like rash and susceptible contacts [for example, varicella-zoster virus (VZV) susceptible infant grandchildren]. Transmission of vaccine virus from varicella vaccine recipients who do not develop a varicella-like rash has also been reported. This is a theoretical risk for vaccination with ZOSTAVAX. The risk of transmitting the attenuated vaccine virus from a vaccinee to a susceptible contact should be weighed against the risk of developing natural zoster and potentially transmitting wild-type VZV to a susceptible contact.

Interaction with other medicinal products and other forms of interaction

ZOSTAVAX can be administered concomitantly with inactivated influenza vaccine as separate injections and at different body sites.
ZOSTAVAX and 23-valent pneumococcal polysaccharide vaccine should not be given concomitantly because concomitant use in a clinical trial resulted in reduced immunogenicity of ZOSTAVAX.
Therefore, administration of the two vaccines should be considered to be separated by at least 4 weeks. No data are currently available regarding concomitant use with other vaccines. Concurrent administration of ZOSTAVAX and anti-viral medications known to be effective against VZV has not been evaluated.

Pregnancy and Lactation

Pregnancy

There are no data on the use of ZOSTAVAX in pregnant women. However naturally-occurring varicella-zoster virus infection is known to sometimes cause foetal harm. ZOSTAVAX is not recommended to be administered to pregnant women. In any case, pregnancy should be avoided for one month following vaccination.

Breast-feeding

It is unknown whether varicella-zoster virus is secreted in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to not administer ZOSTAVAX taking into account the benefit of breast-feeding for the child and the benefit of vaccination for the woman.

Adverse Events

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Merck Sharp & Dohme Limited (tel: 01992 467272).

Useful links

Shingles Aware
Shingles Aware is a website developed, funded and maintained by MSD.

PHE Shingles Programme

PHE Shingles Vaccine Coverage Rate data

Green Book

Supporting documentation

Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

VACC-1250417-0000 | Date of Preparation: April 2018