Vaccine administration. Dr Brenda Corcoran National Immunisation Office

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Vaccine administration Dr Brenda Corcoran National Immunisation Office School immunisation programme Workshop 21 st April 2015

Overview Contraindications/ Precautions Adverse events 4 in 1 vaccine HPV vaccine MenC adolescent programme

Contraindications/ Precautions Each chapter of the Immunisation Guidelines states In some circumstances, advice in these guidelines may differ from that in the Summary of Product Characteristics of the vaccines. When this occurs, the recommendations in these guidelines, which are based on current expert advice from NIAC, should be followed.

Contraindications Anaphylaxis to any of the vaccine constituents or a constituent of the syringe, syringe cap or vial (e.g. latex anaphylaxis). Vaccines in vials or syringes with dry natural rubber or rubber latex may be given to those with contact allergy to latex gloves. Live vaccines Pregnancy Immunocompromised

Precautions Acute severe febrile illness Stop topical immunomodulators 28 days before MMR or BCG and do not restart for 28 days. No issue with inactivated vaccines.

4 in 1 vaccine Local reactions Rate of local booster reactions 50-85% pain or tenderness at the injection site 25-30% swelling and redness increases with the number of doses with higher levels of pre existing tetanus anti toxin if tetanus toxoid administered subcutaneously in larger children Vaccines Plotkin S et al 6 th edition 2013

4 in 1 vaccine Adverse events 4th dose is more reactogenic 4th dose Hot, swollen, red and tender arms from the shoulder to elbow Large, localised swelling (diameter > 50 mm) occurring around the injection site Begins within 48 hours of vaccination Resolves spontaneously Antibiotics not indicated Not usually associated with significant pain or limitation of movement Inform parents in advance

HPV vaccine Vaccine safety HPV vaccines generally safe and well-tolerated Adverse events pain at injection site most frequent local reaction. serious adverse events similar in vaccine and control groups. No deaths from the introduction of the two HPV vaccines have been attributed to vaccines Satisfactory results from studies on the safety of the vaccine in some populations men women older than 25 years HIV+ girls Expert Opin. Drug Saf. (2015) 14(5) 1-16

HPV vaccine Impact in Australia High Grade Cervical Lesions <18 years Incidence 0.80 2007: Start of nationwide vaccination programme ~50% decline in incidence of high grade cervical lesions Incidence 0.42 2003 2004 2005 2006 2007 2008 2009 2010 Brotherton et al Lancet 2011; 377: 2085 92

HPV vaccine Vaccine Impact in Australia Genital warts Women <21years HPV vaccine 83% 1st dose uptake 93% decline in genital warts no genital warts in vaccinated women (2011) Men 82% decline in genital warts in heterosexual men attributable to herd immunity % Australian born diagnosed with genital warts by age group 2004-2011 Women Men

HPV 9 vaccine 5 additional oncogenic HPV types (31,33,45,52,58) 97% effective in preventing high-grade lesions of the cervix, vagina and vulva Generally well tolerated Expect vaccine to protect against infection and diseases caused by 9 HPV types (80-90% of the cancers, high grade lesions and genital warts caused by HPV) Licensed in US (3 dose schedule) Due to be licensed in EU in 2015

Gardasil licensed for use for prevention of genital warts anal cancer elicits the same or higher immunogenicity in boys most cost effective when uptake in girls is low reduce transmission in MSM (? cost effective up to 26 years) http://ecdc.europa.eu/en/publications/publications/20120905_gui_hpv_vaccine_update.pdf

Estimating the clinical benefits of vaccinating boys and girls against HPV-related diseases in Europe Up to half of head and neck cancers associated with HPV Modelling study Largest incremental impact 66% reduction in head and neck cancer No efficacy studies Vaccine not licensed Marty et al. BMC Cancer 2013, 13:10 http://www.biomedcentral.com/1471-2407/13/10

Adolescent MenC booster vaccine Peak rates of MenC disease under 5 years and 15-19 years Concerns about waning immunity in adolescents Recent study those vaccinated at <1 year, vaccine effectiveness decreased by 50% after 10 years those vaccinated with one dose at 12 19 years showed no change in vaccine effectiveness vaccination at 12 years related to a low number of vaccine failures and a higher and longer protection over time

Adolescent MenC booster vaccine UK MenC adolescent booster introduced in 2013 Cases of Men W increased from 22 cases in 2009 to 117 in 2014 Not travel related March 2015 JCVI recommended Men ACWY for 14-18 year olds (routine + catch up) Likely to be introduced in 2015/2016 Number of laboratory confirmed cases of MenW disease and associated deaths by age group and year of diagnosis over six epidemiological years in England and Wales. http://cid.oxfordjournals.org/content/early/2014/ 1/10/cid.ciu881.abstract No increase in Men W cases in Ireland