GACVS statement regarding COVID-19 immunization errors in children

30 August 2022
Statement
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WHO is aware of an increasing number of reports regarding COVID-19 immunization errors in children.

The immunization errors have been reported through the passive vaccine safety surveillance systems and included in the media in a number of countries.  On 19 May 2022, the US Advisory Committee on Immunization Practices (ACIP) presented data showing that half of all non-serious adverse events following Pfizer BNT162b2 immunization in children aged 5-11 years submitted to the Vaccine Adverse Event Reporting System (VAERS) surveillance system through 24 April 2022 included an event associated with immunization error (1).  The Australian Therapeutic Goods Administration (TGA) also reported instances of immunization errors among 5–11-year-olds and made recommendations to reinforce the use of the paediatric version of the Comirnaty (Pfizer) vaccine which comes in a vial with an orange top(2).

According to the WHO global database of individual case safety reports (VigiBase data as of 10 July 2022), about 24% of all case safety reports in children after COVID-19 immunizations are related to immunization errors. The types of immunization errors include the use of adult dose in children, use in inappropriate age groups, underdose, overdose, use of unapproved COVID-19 vaccines, inappropriate scheduling between doses, preparation errors such as omitting a diluent before immunization, administering a COVID-19 vaccine instead of another vaccine, failure to adhere to requisite storage conditions and use of expired doses. Immunization errors have been reported with Pfizer-BioNTech, Moderna, AstraZeneca, Janssen, Sinovac, Novavax and other COVID-19 vaccines.  

Although in very rare instances serious adverse events have been documented after immunization against COVID-19 disease, none of these were verified to be related to immunization errors of any kind.  Children who received an incorrect dose of a COVID-19 vaccine or who received an inappropriately prepared vaccine have only reported expected adverse events like a sore arm, headache, and fever.

However, given the increasing number of reports of immunization errors in children, WHO would like to remind healthcare providers to be alert when storing, preparing, and administering COVID-19 vaccines. National immunization programs and relevant stakeholders should implement risk minimization activities to reduce the occurrence of immunization errors, including procedures to check the date of birth and current age of the child. Vaccine providers should have access to clear instructions for vaccine administration, including visual aids, and vaccine vials should be clearly labelled(3). Training for healthcare providers involved in COVID-19 immunization of children should be reinforced.

If a immunization error does occur, healthcare providers should immediately inform individuals and/or their guardians as well as report the incident to the relevant local vaccine safety surveillance system or immunization programme. Children who have received an incorrect dose or an incorrectly prepared vaccine should be monitored for any adverse events. Some countries have also prepared guidance on what to do with subsequent doses if an error in administration occurs(4).

 WHO will continue to consult the Global Advisory Committee on Vaccine Safety (GACVS) and other relevant experts as well as WHO advisory committees on the problem of immunization errors and will work closely with countries to manage potential risks, using science and data to drive response and recommendations.

 

(1)Shimabukuro T. COVID-19 vaccine safety updates: Primary series in children ages 5-11 years. Advisory Committee on Immunization Practices (ACIP). 19 May 2022 ( https://www.cdc.gov/vaccines/acip/meetings/slides-2022-05-19.html )

(2)Australian Therapeutic Goods Administration (TGA)  COVID-19 vaccine weekly safety report - 10-02-2022. 10 February 2022 (https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report-10-02-2022)

(3)Examples of practical guides on use of COVID-19 vaccines in children:

(4)Examples of guidance on what to do with subsequent doses if an error in administration occurs:

 

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