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The Immunisation Advisory Centre supports the best practice approach of a recommended 20-minute post-vaccination wait.
However, during the 2020 Influenza season, if the risk of exposure to infectious disease in a crowded waiting rooms is higher than the low risk of anaphylactic events; adolescents and adults who meet ALL the following criteria may not need to wait for 20 minutes post-vaccination:
1) do not have a history of severe allergic reactions
2) have been assessed for any immediate post vaccination adverse reactions (5 minutes)
3) are aware of when they need to and how to seek post-vaccination advice
4) will have another adolescent or adult with them for the first 20 minutes post vaccination
5) have the ability to contact emergency services if required.
Background
The New Zealand Immunisation Standards, as published by the Ministry of Health, require that all persons vaccinated are advised to wait within the health care facility for 20 minutes post vaccination. https://www.health.govt.nz/system/files/documents/publications/immunisation-handbook-2017-2nd-edition-mar2018-v8.html
The rationale for the 20-minute waiting time is the very low risk of an anaphylactic event post vaccination – currently thought to be between 1 and 3.3 cases per million doses of vaccine. https://pediatrics.aappublications.org/content/112/4/815.full and https://adc.bmj.com/content/archdischild/97/6/487.full.pdf.
Data from the Centre for Adverse Reactions Monitoring (CARM) indicates that in New Zealand over the last 30 years 18 cases of anaphylaxis occurred post trivalent influenza vaccination, three of these were immediate onset and a further eight were within 20 minutes post vaccination. In 2019 there was one case, to a quadrivalent vaccine occurring within 10 minutes of administration. Over 1.35 million doses of influenza vaccine were distributed in 2019.
International practice
International evidence would indicate that many anaphylactic events post-vaccination occur outside the current 20-minute waiting time https://www.sciencedirect.com/science/article/pii/S0091674915011604 and https://adc.bmj.com/content/archdischild/97/6/487.full.pdf
The United Kingdom Immunisation handbook; advises there is no evidence to support the practice of keeping patients under longer observation in the surgery https://www.sciencedirect.com/science/article/pii/S0091674915011604 and https://adc.bmj.com/content/archdischild/97/6/487.full.pdf
The United Kingdom Royal College of Nursing current advice is that there is no need to keep patients waiting post vaccination. https://www.rcn.org.uk/clinical-topics/public-health/immunisation/practical-and-clinical-guidance-for-vaccine-administration
Fact Sheet 22 March 2020
Australia currently has a 15-minute waiting time post-vaccination recommendation. https://immunisationhandbook.health.gov.au/vaccination-procedures/after-vaccination
The United States of America does not appear to have any stated requirement around post vaccination waiting time The example here is the Vaccine Information Sheet for Inactivated Influenza vaccine https://www.cdc.gov/vaccines/hcp/vis/vis-statements/flu.html
Need
The 2020 Influenza vaccination season has coincided with the COVID-19 pandemic. While at present there is no community spread of COVID-19 within New Zealand, there is already significant pressure on primary care services including pharmacy related to the pandemic. There is also significant concern from providers about the infectious disease risk for those most vulnerable - elderly patients and patients with comorbidities when sitting for 20-minutes post influenza vaccination in busy waiting rooms.
All vaccinators are expected to undertake a thorough pre-vaccination check which includes a risk assessment around anaphylaxis history and known allergic reactions.
Recommendation
Taking into account the information from international programmes and current data from New Zealand, IMAC recommends that:
The 20-minute waiting period is continued as the best option when the waiting area is adequate and safe.
For all other situations, providers review the 20-minute post vaccination wait for adolescent and adult vaccination during the 2020 influenza vaccination season, based on a risk assessment related their working environment. Adolescents and adults meet ALL the following criteria may not need to wait for 20 minutes port vaccination:
1) do not have a history of severe allergic reactions
2) have been assessed for any immediate post vaccination adverse reactions (5 minutes)
3) are aware of when they need to and how to seek post-vaccination advice
4) will have another adolescent or adult with them for the first 20 minutes post vaccination
5) have the ability to contact emergency services if required.
Bibliography:
Ministry of Health. 2018. Immunisation Handbook 2017 (2nd edn). Wellington: Ministry of Health. Accessed from https://www.health.govt.nz/publication/immunisation-handbook-2017
Medicines Regulations 1984 (SR 1984/143) New Zealand. Accessed http://www.legislation.govt.nz/regulation/public/1984/0143/latest/whole.html#DLM96579
World Health Organization. 2015. Immunization training resources. Access from https://www.who.int/immunization/documents/training/en/
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