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14 June 2021 Attention: DHB CEs, SROs, Clinical Leads and Quality Leads for CVIP
Tēnā koutou, COVID-19 Vaccinations to persons less than 16 years old Based on records in the COVID-19 Immunisation Register (CIR), we understand the Comirnaty/Pfizer COVID-19 vaccine has been administered to persons under 16 years in multiple DHBs. We recognise that at times this is a data entry error in the CIR or NHI however, in the past weeks we have confirmed several vaccination events for people under 16 years. At this stage, Medsafe has approved the use of Comirnaty vaccine for persons aged 16 years and over only, and the vaccination of those younger than this range is unapproved and outside of Ministry of Health policy, irrespective of sequencing Group. In the COVID-19 Vaccine Immunisation Programme (CVIP), vaccinating those aged 15 years or younger is a ‘never event’ – a serious incident that should not occur given appropriate quality and safety processes. We monitor these events, and all are examined by our Incident Review Team in conjunction with the DHB concerned. All these incidents require a CARM report and an open communication process with the person concerned and their care givers. As with all errors, there will be multiple factors contributing, and as a whole system we need to work together to minimise the risk of these incidents. At the Ministry of Health, we have created an alert in the CIR if a date of birth is entered that means the consumer is under 16 years – this will be live June 14. We have also worked with IMAC to initiate changes to the IMAC pre-assessment screening sheet and vaccinator training modules, altered the wording in our What to Expect and written consent documents, created a ‘how to’ guide on cancelling a second dose in the CIR record (so they are not offered dose 2), and worked with individual DHBs and sites. There will also be a presentation on this issue at our National Quality & Safety forum this month. As clinicians and providers, we ask you to have clear localised procedures and processes in place to prevent the vaccination of a person under 16 years. These measures should include verbally checking the age of the person being vaccinated in addition to date of birth, plus a signal/mechanism for the vaccinator to seek an additional check or support if they feel there may be a question on the age of the person they are about the vaccinate.
It is critical that our processes are high quality, safe and robust, in advance of any change being made to the recommended age range of the vaccine. To note, even following Medsafe approval to a younger age group, the Ministry of Health will make decisions around implementation and timing on the basis of vaccine stock, clinical safety, and risk of exposure. Yours sincerely
Jo Gibbs, National Director Operations COVID-19 Vaccine and Immunisation Programme Ministry of Health
Dr. Juliet Rumball-Smith CVIP Clinical Lead and Group Manager Clinical Quality and Safety Ministry of Health
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