Information About Myocarditis Risk From Comirnaty Vaccine Not Clearly Highlighted Or Communicated 22HDC02256

Please note, this report involves a prima facie (1) breach of the Code of Health and Disability Services Consumers' Rights (the Code).

Health and Disability Commissioner Morag McDowell has today released a report relating to the vaccination of a man in his twenties who died from myocarditis found, by the Coroner, to have been directly caused by the Comirnaty (Pfizer/BioNTech) COVID-19 vaccine.

Following his vaccination at a pharmacy, the man experienced chest discomfort and heart flutters. Apparently unaware that myocarditis (inflammation of the heart) was a potentially serious side effect of the vaccine, the man experienced these symptoms for 12 days before making the decision to go to hospital. Tragically, he collapsed and died before he got there.

During his vaccination the man was informed of the common, but not the potentially serious, side effects of the vaccine. In the specific circumstances failing to provide this information was a prima facie breach of the Code of Health and Disability Services Consumers’ Rights (the Code).

Ms McDowell was satisfied that the risk of myocarditis was intended by official agencies to be communicated to consumers as part of the consent process and that consumers were also to be given safety-netting advice about myocarditis symptoms following their vaccination.

However, Ms McDowell concluded that, in light of significant mitigating factors, it would be disproportionately harsh to find the pharmacy in breach of the Code, and that an educational approach was more appropriate.

Ms McDowell also noted that that the Comirnaty vaccine was, at the time, relatively new and new information about its use, risk and side effects was still forthcoming.

The broader public context was also relevant for this case, Ms McDowell said. The event took place during the unprecedented international and national response prompted by the pandemic which was accompanied by a concurrent steady flow of information from official sources.

However, she found that none of the sources of official information explicitly required vaccinators to disclose the risk of myocarditis as part of the informed consent process prior to vaccination. She also noted there was evidence that the importance of new information, relative to other information, was not made clear to vaccination providers.

"Given the seriousness of the risk of myocarditis and the information volume, one could reasonably expect that in communication to the providers the risk would be emphasised or highlighted in some way," she said.

While she did not find the pharmacy in breach of the Code, Ms McDowell was critical that it did not update its standard operating procedure to ensure consumers were given adequate safety netting advice about the risk of the symptoms of myocarditis to look out for.

She also made an adverse comment about the pharmacist who vaccinated the man, but similarly did not find her in breach due to the mitigating factors outlined.

Ms McDowell made an educational comment to Manatū HauoraMinistry of Health, stating that, in relation to the Comirnaty vaccine it needed to provide clear and unambiguous guidance to vaccinating providers about what and when they needed to tell consumers about myocarditis.

This was particularly relevant following the first death in New Zealand from myocarditis following the Comirnaty COVID-19 vaccine, which occurred prior to this event.

Ms McDowell made a number of recommendations, outlined in the report, for both the pharmacy and Te Whatu Ora (given that the National Immunisation Programme is now part of Te Whatu Ora rather than Manatū Hauora).

Note:

(1) This is where there is evidence to indicate that there has been a breach of the Code. However, we then take into account the circumstances of the case and other evidence including any relevant mitigating factors. In this particular case, there were significant mitigating factors that did not justify a breach of the Code in these circumstances.

The full report of this case can be viewed on HDC’s website - see HDC's ' Latest Decisions'.

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