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The ‘informed consent’ issue

Earlier this week, Coroner Sue Johnson released her finding that 26-year-old Dunedin man Rory Nairn may not have died as a result of myocarditis after receiving the Comirnaty [Pfizer/BioNTech] covid-19 vaccine if he had been given more information about the potential risks.

Nairn died in November 2021 after experiencing chest discomfort and heart flutters for 12 days after being vaccinated at a pharmacy.

Because he was unaware that myocarditis was a potentially serious side effect of the vaccine, he waited almost two weeks before deciding to go to hospital.

Tragically, he died before he had the chance to receive medical help. [His death was determined in 2022 as being directly caused by the vaccine.]

Another report was also released this week about Nairn’s death, this one from Health and Disability Commissioner Morag McDowell.

McDowell found that when Nairn was vaccinated, it was the intention government agencies that people receive “safety-netting advice” about myocarditis symptoms after receiving the vaccine, and that the pharmacy where he received ‘the jab’ had a responsibility to ensure its staff were informed about and communicated the risks associated with the vaccine to those receiving it.

The pharmacist administering Nairn’s vaccination failed to do this – she told the coroner that she followed her standard process, which included discussing common side effects listed on the official information sheet, but she did not specifically mention myocarditis because she did not believe it was a requirement at the time, although she acknowledged knowing it was a “rare” side effect.

McDowell, therefore, found that the pharmacy had failed to uphold Nairn’s right to be properly informed about the risk of myocarditis or its symptoms.

However, because of several mitigating factors, including that none of the official information sources explicitly required vaccinators to warn of the potential of myocarditis, McDowell did not find the pharmacy in breach of the Code of Health and Disability Services Consumers’ Rights, although she has recommended it update its standard operating procedures around covid-19 vaccination to include advice about this.

She has also recommended that various agencies clarify when advice should be provided about the risks of myocarditis and ensure that emerging vaccine risks are appropriately communicated.

A copy of McDowell’s report will also be sent to the NZ Royal Commission on covid-19, primarily so it can consider the desirability of having one centralised conduit for sending information to health workers.

One also hopes the Royal Commission will consider the role the government’s public messaging about the covid-9 vaccine may have played in Nairn’s death.

Although a large segment of the population appears to have been only too happy to forget a great deal of what went on during ‘the pandemic years’, surely some readers will remember the adverts that were a ubiquitous part of the nation’s vaccination drive?

“Safe and effective,” it was repeated ad nauseam. “Safe and effective.”

None of the qualifiers about potential side effects that a pharmaceutical company is legally required to include in any advertising to consumers.

No room for doubt. No patience for dissent.

“Safe and effective” went the steady drumbeat of the communication campaign, at the same time as many medical professionals who expressed misgivings about the new vaccine were drummed out of the profession.

Is it beyond the realm of possibility that the insistent “safe and effective” mantra meant many vaccinators were actively hesitant to ensure their patients were in a position to provide fully informed consent?

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