That’s according to findings released by Coroner Sue Johnson today following Rory Nairn’s death from myocarditis in 2021.
Health and Disability Commissioner Morag McDowell has released her report concerning Nairn’s death, which the Coroner had earlier determined was directly caused by the Comirnaty (Pfizer/BioNTech) COVID-19 vaccine.
Nairn experienced chest discomfort and heart flutters following his vaccination at a pharmacy in November 2021 but was unaware that myocarditis was a potentially serious side effect.
The symptoms persisted for 12 days before he decided to go to the hospital but tragically, he collapsed and died before reaching medical help.
Following his death in November 2021, the Commissioner received a referral from the coroner highlighting key issues to be investigated.
Nairn’s parents and partner argued that he did not give informed consent due to the lack of information about the risks, such as myocarditis.
They acknowledged that while vaccinators were provided with considerable information, the specific risks were not adequately highlighted, and they believed this issue was widespread among vaccinators, not just specific to the pharmacy.
In July 2021, a person died from myocarditis after receiving the vaccine and MedSafe issued an alert to providers to inform consumers of this risk on July 21, 2021.
In the following months, Manatū Hauora (the National Immunisation Programme (NIP)) sent a significant volume of information to providers about the vaccine including 12 updates within three weeks.
Information about myocarditis was embedded in subsets of the information.
"There’s a million documents that are coming through and… we are doing the best that we can to see through everything that comes through and when it’s a link within a link, within a link you can only do the best you can," the pharmacy manager previously told the coroner’s court investigation.
The operating guidelines for the vaccination in September 2021 included an information and consent pack which included ‘what to expect’ and ‘after your immunisation’ fact sheets.
During Nairn’s vaccination, the guidance stated that post-vaccination advice must include telling people to seek medical advice if they experience chest pain.
Neither of those documents explicitly required the risk of myocarditis to be discussed with the consumer before the vaccination proceeded.
Ms. B, the pharmacist, testified to the Coroner that she followed her standard process, which included discussing common side effects listed on the information sheet but did not specifically mention myocarditis.
She remembered advising consumers about common flu-like symptoms and suggesting they contact the pharmacy or Healthline if they had concerns.
Ms B acknowledged knowing myocarditis was a rare side effect but did not believe there was a requirement to inform consumers about it at the time of Nairn’s vaccination.
Ms B explained that her practice was based on instructions to focus on common side effects and that consumers were encouraged to read the provided information sheets, though Nairn did not take one.
The HDC found at the time of Nairn’s vaccination it was intended by official agencies that consumers should be given safety-netting advice about myocarditis symptoms after receiving the vaccine.
Morag found the pharmacy had a responsibility to ensure its staff were informed about and communicated the risks associated with the vaccine and consequently, the pharmacy did not adequately inform Nairn about the risk of myocarditis or its symptoms, failing to uphold his right to be properly informed.
However, she determined that significant mitigating factors made it disproportionately harsh to find the pharmacy in breach of the Code, advocating for an educational approach instead.
However, she noted the vaccine was relatively new at the time, with ongoing updates about its risks and side effects, marked by the unprecedented response to the pandemic and a steady flow of information from official sources played a role in the failures.
McDowell pointed out none of the official information sources explicitly required vaccinators to inform consumers about the risk of myocarditis before vaccination and the importance of new information was not communicated to vaccination providers.
"A lack of clarity in official guidance will not always serve to mitigate an individual’s responsibility for providing the necessary information. However, as noted above, I am also mindful that the Comirnaty vaccine was, at the time, a relatively new medicine, and new information about its use, risk and side effects was still forthcoming.
McDowell noted while consumers’ rights to informed consent are crucial, Nairn wasn’t given the information he needed but given the unprecedented circumstances, an educational approach should be adopted rather than a breach of code.
"Manatū Hauora’s guidance should have stated explicitly that this was to be covered with patients both before and after vaccination.
"Given the seriousness of the risk of myocarditis and the volume of information, one could reasonably expect that in communication to the providers, the risk would be emphasized or highlighted in some way," she said.
While she did not find the pharmacy in breach of the Code, McDowell recommended it update standard operating procedures to include adequate safety-netting advice about myocarditis symptoms.
McDowell also recommended Te Whatu Ora update operating guidelines to clarify when providers should discuss the risks of myocarditis and report the update back to the commissioner within three months.
Coroner Johnson said she was satisfied she did not need to make any recommendations as the Health and Disability Commissioner had carried out a thorough investigation into whether Nairn’s rights as a health service consumer were met.
She said a copy the HDC report will also go to Te Tahu Hourora|Health Quality and Safety Commission to consider as part of its work to develop a prescribing and communications framework, to ensure emerging vaccine risks are appropriately communicated.
The NZ Royal Commission on COVID-19 will also be forwarded a copy to enable it to consider having one centralised portal for information to be sent to health workers.
Coroner Johnson has endorsed those plans, saying, "in my view, the people who read the HDC report will include those who are most likely to be in a position to make changes that will reduce the chances of future deaths occurring in circumstances similar to those in which Rory died."
- Shannon Pitman, Open Justice reporter
