Vaccination to protect against shingles

Transcription

1 Vaccination to protect against shingles - An update for registered healthcare practitioners The programme from September 2018 and contraindications and precautions Revised July 2018 NES and HPS accept no liability, as far as the law allows us to exclude such liability, for the accuracy or currency of amendments, additions and/or revisions of

2 Update for Programme from September 2018 August 2019 All people aged years on1 st September 2018 not previously vaccinated with shingles vaccine are eligible

3 Current Epidemiology of shingles Current epidemiology of shingles and related complications and vaccine coverage is available on the Health Protection Scotland website

4 Vaccine efficacy A one dose schedule of Zostavax was assessed in clinical trials using 17,775 adults aged 70 years and over The vaccine reduced the incidence of shingles by 38% and provided protection for at least 5 years A recent study* of shingles vaccine effectiveness following the first 3 years of the programme in England showed 62% vaccine efficacy against shingles and 70-88% against PHN.

5 . Page 3 Update for Programme from September 2018 August 2019 Green Book Update In 2016, Chapter 28a of the Green Book (Shingles) was updated in relation to route of administration of Zostavax This chapter includes contraindications and precautions sections and can be found at the following website: It is crucial that practitioners refer to this chapter when administering the shingles vaccine Route of administration: Intramuscular injection preferably in the deltoid region of the upper arm The vaccine should be administered deep subcutaneously in patients with severe thrombocytopenia or any coagulation disorder Intramuscular administration is preferred due to comparable immune response and less frequent injection site adverse reactions than subcutaneous administration

6 Administration of Zostavax Contraindications The decision to administer Zostavax to immunosuppressed individuals should be based on a clinical risk assessment If the individual is under highly specialist care, and it is not possible to obtain full information on that individual s treatment history, then vaccination should not proceed until the advice of the specialist or a local immunologist has been sought Page 4

7 Administration of Zostavax Contraindications (contd.) The vaccine should not be given to a person who: 1. Has primary or acquired immunodeficiency states due to conditions including: acute and chronic leukaemias, lymphoma (including Hodgkin s lymphoma) immunosupression due to HIV/AIDs unless recommended by the specialist caring for patient cellular immune deficiencies those remaining under follow up for a chronic lymphoproliferative disorder including haematological malignancies such as indolent lymphoma, chronic lymphoid leukaemia, myeloma and other plasma cell dyscrasias (N.B: this list not exhaustive) Page 5

8 Administration of Zostavax Contraindications (contd.) The vaccine should not be given to a person who: 1. Has primary or acquired immunodeficiency states due to conditions including (contd.): those who have received an allogenic stem cell transplant (cells from a donor) in the past 24 months and only then if they are demonstrated not to have ongoing immunosuppression or graft versus host disease(gvhd) those who have received an autologous (using their own stem cells) haematopoietic stem cell transplant in the past 24 months and only then if they are in remission Page 6

9 Administration of Zostavax Contraindications (contd.) The vaccine should not be given to a person who: 2. Is on immunosuppressive or immunomodulating therapy including : those who are receiving or have received in the past 6 months immunosuppressive chemotherapy or radiotherapy for malignant disease or non-malignant disorders those who are receiving or have received in the past 6 months immunosuppressive therapy for a solid organ transplant (depending upon the type of transplant and the immune status of the patient) those who are receiving or have received in the past 12 months biological therapy (e.g. anti-tnf therapy such as alemtuzumab, ofatumumab and rituximab) unless otherwise directed by a specialist Page 7

10 The vaccine should not be given to a person who: Administration of Zostavax Contraindications (contd.) 2. Is on immunosuppressive or immunomodulating therapy including (contd.) those who are receiving or have received in the past 3 months immunosuppressive therapy including : i) short term high-dose corticosteroids (>40mg prednisolone per day for more than 1 week); ii) iii) long term lower dose corticosteroids (>20mg prednisolone per day for more than 14 days); non-biological oral immune modulating drugs e.g. methotrexate >25mg per week, azathioprine >3.0mg/kg/day or 6-mercaptopurine >1.5mg/kg/day 3. Has had a confirmed anaphylactic reaction to; - a previous dose of varicella containing vaccine or any component of the vaccine, including neomycin or gelatin 4. Is pregnant Page 8

11 Special considerations on vaccination of individuals on immunosuppressive therapy Patients anticipating immunosuppressive therapy The risk and severity of shingles is considerably higher amongst immunosuppressed individuals and therefore eligible individuals anticipating immunosuppressive therapy should ideally be assessed for vaccine eligibility before starting treatment that may contra-indicate future vaccination Eligible individuals who have not received Zostavax should receive a single dose of vaccine at the earliest opportunity and at least 14 days before starting immunosuppressive therapy, although leaving one month would be preferable if a delay is possible Page 9

12 Precautions Immunisation of individuals who are acutely unwell should be postponed until they have recovered fully Immunisation should be delayed in individuals who are being treated with either oral or intravenous antivirals (such as aciclovir) until 48 hours after cessation of treatment. This is due to the potential to lower effectiveness of the vaccine Zostavax is not recommended for the treatment of shingles or post herpetic neuralgia (PHN) Immunosuppression and HIV infection The decision to administer Zostavax to immunosuppressed individuals should be based on clinical risk assessment (see notes) Page 10

13 Precautions (contd.) Transmission As a precautionary measure, any person who develops a vesicular rash after receiving Zostavax should ensure the rash area is kept covered when in contact with a susceptible (chickenpox naïve) person until the rash is dry and crusted. If the person who received the vaccine is themselves immunosuppressed, they should avoid contact with susceptible people until the rash is dry and crusted, due to the higher risk of virus shedding. Prophylactic aciclovir can be considered in vulnerable patients exposed to a varicella like rash in a recent vaccinee Page 11

14 Testing of post-vaccination rashes In the event of a person developing a varicella (widespread) or shingles-like (dermatomal) rash post-zostavax, a vesicle fluid sample should also be sent for analysis to confirm the diagnosis and determine whether the rash is vaccine associated or wild type Health practitioners are requested to obtain vesicle swabs from their local hospital laboratories Page 12

15 Inadvertent vaccination in individuals under 50 years of age Zostavax is licensed for use in individuals over 50 years of age. Most adults below the age of 50 years are likely to be immune to varicella and therefore inadvertent vaccination with Zostavax is unlikely to result in serious adverse reactions Page 13

16 Inadvertent vaccination in immunosuppressed individuals Immunosuppressed individuals who are inadvertently vaccinated with Zostavax should be urgently assessed to establish the degree of immunosuppression As all individuals of this age group should be VZV antibody positive, varicellazoster immunoglobulin is unlikely to be of benefit but prophylactic aciclovir may be considered in those for whom the attenuated vaccine virus poses a significant risk Immunosuppressed individuals who develop a varicella rash following inadvertent vaccination should be urgently assessed and offered prompt treatment with IV high-dose aciclovir, given the risks and severity of disseminated zoster. Contact your local NHS Health Protection Team for advice Page 14

17 Inadvertent vaccination during pregnancy As a precautionary measure, clinicians should treat the inadvertent administration of Zostavax vaccine in a pregnant woman in the same way as a natural exposure to chickenpox infection and should urgently assess the woman s susceptibility to chickenpox For those women who are unable to give a reliable history of chickenpox infection or documented evidence of varicella vaccination, an urgent varicella antibody test (VZV IgG) should be performed Page 15

18 Page 16 Screening tool for contraindications for shingles vaccine Shingles vaccine is a live attenuated vaccine and is therefore contraindicated for some patients groups. A screening tool for contraindications for shingles vaccine has been produced by Health Protection Scotland and is available at ( This tool may be used to aid identification of patients who are contraindicated for this vaccine and includes explanatory notes for registered healthcare practitioners. The questions in the screening tool are designed for completion either by the patient or by the registered healthcare practitioner in a structured interview with the patient

19 Page 17 Administration of Zostavax Possible adverse reactions Most commonly reported (1:10 people vaccinated) Erythema (redness), pain and swelling in pruritis (itching) at the injection site Less commonly reported (1:100 of people vaccinated) Haematoma, induration and warmth at the injection site, pain in arm or leg and headache Very rarely reported (1:10,000 of people vaccinated) Varicella (chickenpox) infection

20 Page 18 Administration of Zostavax Reporting suspected adverse reactions Yellow card scheme Voluntary reporting system for suspected adverse reaction to medicines/vaccines Success depends on early, complete and accurate reporting Report even if uncertain about whether vaccine caused condition See See chapter 8 of Green Book for details