Medsafe came under scrutiny over how it communicated a rare side effect of the Covid-19 vaccine in a tense exchange on the final day of a coronial inquest into the death of a Dunedin man.
Rory Nairn died of myocarditis, an inflammation of the heart muscle, on November 17 lastyear at the home he shared with fiancee Ashleigh Wilson.
Last week, the court heard Mr Nairn was not informed about the potentially fatal side effect of the Pfizer vaccine when he made the impromptu decision to get vaccinated at a pharmacy.
Mr Nairn died 12 days later, moments before he and Ms Wilson decided to go to hospital over the ongoing chest discomfort he had experienced since his jab.
Yesterday, the head of Medsafe came under fire in the Dunedin District Court over its communication around the risk of myocarditis.
Rory Nairn aged 26 of Dunedin died 17 November. Pictured with fiancee Ashleigh Wilson. Photo / Supplied
Group manager Christopher James said the authority first heard of the rare side effect being linked to the vaccine in April 2021 and alerted healthcare professionals on July 21.
Mr James was questioned by Ben Taylor, counsel for the pharmacy at which Mr Nairn had been inoculated.
The lawyer repeatedly suggested there were no explicit instructions for vaccinators to tell people about myocarditis as part of the informed-consent process.
"You would say the meaning was crystal clear ... You don't think there could be any confusion?" Mr Taylor asked.
"From a healthcare professional's perspective, with the experience and training they've had, it should be very clear," Mr James replied.
Medsafe, as a medicine regulator, would not have the authority to enforce such a specific direction, he said.
He was also grilled by counsel assisting the coroner, Michael Parker, who said the only sentence in the July update that may have supported Mr James' view was "buried" between two other bullet points.
"If it was clear messaging, surely it would be in a different paragraph ahead of the other two," Mr Parker said.
In December, after the death of Mr Nairn, Medsafe told vaccinators they must inform people about the risk of myocarditis.
Mr James said they had "upped the ante" on the wording despite not having the power to compel healthcare professionals to provide such advice.
Earlier, Te Whatu Ora Health New Zealand Southern's vaccine rollout programme lead, Dr Karl Metzler, spoke about an online hub which was used to pass on information to vaccinators.
To suggestions that providers had been drowned in updates, he accepted there was a lot of advice but he had been mindful not to overwhelm them.
Two days after Medsafe's July 21 alert, the pharmacy at which Mr Nairn was inoculated completed a "wet run" to test its procedures — and passed.
Last week, the person who vaccinated Mr Nairn told the inquest she had not specifically warned him of myocarditis beforehand because it had not been pharmacy policy at the time; and while she was aware of the side effect, she did not know it could be fatal.
The manager of the pharmacy spoke of being overwhelmed by trying to keep on top of "millions" of emails from health authorities, along with an already increased workload from the vaccination campaign.
Speaking at the end of the inquiry yesterday, coroner Sue Johnson told the inquest it was only part of the broader inquiry into the death of Mr Nairn.
She would be seeking an expert opinion from a cardiologist about the extent to which early diagnosis could have saved Mr Nairn's life, along with further evidence about what information should have been brought to the attention of vaccinators.
She concluded the inquest by addressing Ms Wilson, the last person to see Mr Nairn alive.
She acknowledged the difficulty Ms Wilson had faced in sitting through the evidence and said the inquiry was focused on how to prevent any similar deaths from happening again in the future.
