Influenza vaccine safety in persons with egg allergy Vaccine Preventable Disease Programme Public Health Wales Flu season 2018-19 Vaccine Preventable Disease Programme: Promoting immunisation in Wales

Egg products in influenza vaccines All currently available influenza vaccines are manufactured using hens’ eggs Purification during production aims to remove egg products from the finished vaccine, leaving less than one millionth of a gram of ovalbumin protein per dose Flu vaccines containing less than 0.06 microgrammes ovalbumin per dose are designated very low ovalbumin vaccines

JCVI recommendations JCVI advise almost all individuals with egg allergy can safely receive influenza vaccine containing very low levels of ovalbumin (<0.06 μg/dose) in general practice Those with a history of severe anaphylaxis to egg requiring admission to intensive care are recommended egg-free vaccine or referral for immunisation in hospital No egg-free vaccine is currently available Immunisation against infectious disease (the Green Book) 2016 JCVI minutes February 2015

JCVI recommendations JCVI advise as a precaution that those with a history of severe anaphylaxis to egg that previously required admission to intensive care should be immunised in hospital with a very low ovalbumin vaccine (<0.06μg/dose) This is a very small group of patients JCVI’s view is that the benefits of vaccination generally outweighs the risk in this patient group, based on evidence of safety in large series of patients Immunisation against infectious disease (the Green Book) 2016

Safety data A large number of studies including thousands of individuals show flu vaccines containing very low levels of ovalbumin may be used safely in individuals with egg allergy (Des Roches et al, 2012) Des Roches A, Paradis L, Gagnon R, et al. (2012). Egg-allergic patients can be safely vaccinated against influenza. J Allergy Clin Immunol. 130(5):1213-6

Des Roches et al study Studied flu vaccination in 367 patients with egg allergy, including 132 with severe allergic reaction defined as the occurrence of anaphylaxis or cardiorespiratory symptoms on egg ingestion None of these 132 patients who received an egg based flu vaccine developed anaphylaxis Des Roches A, Paradis L, Gagnon R, et al. (2012). Egg-allergic patients can be safely vaccinated against influenza. J Allergy Clin Immunol. 130(5):1213-6

Other studies Des Roches identified a further 26 studies With their own data the series included 4172 patients, 513 of whom had a history of severe reactions All received egg grown flu vaccine None developed anaphylaxis Des Roches A, Paradis L, Gagnon R, et al. (2012). Egg-allergic patients can be safely vaccinated against influenza. J Allergy Clin Immunol. 130(5):1213-6

Estimated risk of anaphylaxis The risk based on the 513 patients with severe egg allergy (none of whom had anaphylaxis after flu vaccination) was calculated The risk of anaphylaxis was 0% - 0.62% (95% CI) Equivalent to 0 to 1 in 161 doses Des Roches A, Paradis L, Gagnon R, et al. (2012). Egg-allergic patients can be safely vaccinated against influenza. J Allergy Clin Immunol. 130(5):1213-6

Guidance document: Data for season 2018/19 is still awaited for flu vaccine brands with a low ovalbumin content:<0.06 μg for a 0.5 ml dose (equivalent to <0.12 μg /ml) This Management chart will be updated as soon as this information is available This resource can be viewed here: http://www.wales.nhs.uk/sitesplus/888/page/43510/

More at http://howis.wales.nhs.uk/immunisation

Acknowledgements PHW–VPDP intranet site Public Health England http://howis.wales.nhs.uk/sites3/home.cfm?orgid=474 Public Health England https://www.gov.uk/government/topics/public-health VPDP team members Other references included in slides Material contained in this document may be reproduced without prior permission provided it is done so accurately and is not used in a misleading context. Acknowledgement to Public Health Wales NHS Trust to be stated. © 2018 Public Health Wales NHS Trust.