The doctor responsible for delivering four times the recommended dose of the Pfizer Covid-19 vaccine to two elderly residents of a Brisbane nursing home did not receive immunisation training.
The doctor has been stood down after an 88-year-old man and a 94-year-old woman were each given the wrong dose.
The federal health minister Greg Hunt said the error occurred at the Holy Spirit Nursing Home in Carseldine. On Wednesday afternoon Hunt said he had been given new information which revealed the doctor never received the compulsory training for the vaccine. Hunt was initially advised the doctor had been trained.
“This is being investigated by Healthcare Australia and we are expecting a report later today,” Hunt told parliament. “I have again reaffirmed my apologies to the family… I have asked the department [of health to take action against the company and the doctor for what is a clear breach on both fronts.”
The two residents were being closely monitored. The doctor had not administered the vaccine at any other locations, Hunt said.
“The safeguards that were put in place immediately kicked into action and a nurse on the scene identified the fact that a higher than prescribed amount of the dose was given to two patients,” he said.
“The important thing is advice that we have … is that both patients are being monitored and both patients are showing no signs at all of an adverse reaction. But it is a reminder of the importance of the safeguards.”
He thanked the nurse who noticed the error and stepped in to help.
“I want to thank her for her strength of character and her professionalism,” he said. “Secondly, the contractor has stood down, the doctor in question, from the program.”
While the first doses being rolled out across Australia are largely being administered at hospitals, a vaccination taskforce is also visiting aged care and disability care residents, who may be less mobile and unable to attend a hospital. Aged care is the responsibility of the federal government.
The federal government’s deputy chief medical officer Prof Paul Kidd, who is also a general practitioner, will review the error and make recommendations about any changes needed.
“The most important thing is we engage in the transparency,” Hunt said. “When we know, we provide that information. And significantly the patients themselves are showing, at this point, on the latest advice that I have, absolutely no adverse reaction.”
He added that in clinical trials, a variety of doses were given to patients to determine the most effective dose, and those patients had not suffered issues.
Opposition health spokesman Mark Butler said it was a case of “serious misadministration, a very substantial overdose to two elderly residents in an aged care facility in Queensland”.
“Australians can expect that every single worker contracted by the government to provide vaccines to elderly Australians has completed the relevant training,” he said. “Public confidence in this vaccine rollout is crucial, and to maintain that the government simply has to do better than this.”
Professor of infectious diseases and physician at Canberra Hospital, Peter Collignon, said this excessive dosing had also occurred overseas. The Pfizer vaccine vial is designed to contain enough doses for several people, he said.
“The vaccine comes in an ampoule [a sealed glass capsule] and you basically dilute it up, and then draw out the appropriate doses.” Collignon said. “Depending on the vaccine it might have enough doses for four to six people. The mistake people sometimes can make if they are not well trained is they may give too much to one person or assume the whole vial is for one person.
“But the main issue in most cases will be the waste of the vaccine rather than any serious side effects.”
He said this was why calls to push out the vaccine faster than necessary were ill-advised, because training of staff is a significant component of any rollout. Given Australia’s enviable position compared with the rest of the world, this training should be being done thoroughly, he said.
“I’m not aware of any adverse events from [a higher dose] occurring but you’d certainly get a more sore arm due to the larger volume of vaccine, and some more prominent side effects,” he said.
The chief medical officer, Prof Paul Kelly, said in early clinical trials of the Pfizer vaccine, researchers experimented with different doses, including one, three or four times higher than what would become the recommended prescribed doses.
“During those trials, the side effect data was not a higher problem, so there’s that element,” he said.
“Second of all, we are aware of several cases like this happening early in the phased rollout through residential aged care facility dents in Germany and the UK. Again, the side-effect profile was minimal, particularly in older people, so that gives us hope.
“However, when we were notified of this yesterday evening by the company concerned that is doing the rollout in those facilities, we took immediate action. I was assured that everything that had been done on the site was what we would have expected and that a full incident reporting system had been actioned.”
It comes at a time when federal, state and territory governments are urging Australians to get the vaccine once they become eligible. Professor Julie Leask, a social scientist at the University of Sydney whose research focuses on infectious disease and immunisation controversies and communication, said the government had done the right thing in being upfront about the situation.
“What they have done is to be really upfront and these administration errors do sometimes happen,” she said. “This is a large complex program, staff are being newly trained in giving multi-dose vials, and a good safety culture is one that is upfront about these things and addresses them proactively in a transparent way.”
She said it was heartening that the nurse identified the issue. “It made me feel really proud of nurses,” she said. “They are taught about patient safety and all health professionals are taught to speak up when they see an error, and it’s great that this nurse did.
“Of course yes, these things will always make some people feel a bit more cautious about the vaccine, but it’s much better to be upfront rather than it getting leaked out some other way.
“Trust is the most precious resource when you have a big health program that needs public cooperation, and what must be prioritised is sustaining that trust.”
Lincoln Hopper, the CEO of St Vincent’s Care Services which manages the Holy Spirit Nursing Home Carseldine, said the two residents were not “out of the woods yet” though they so far they had not shown any concerning reaction.
The error will be reported to the Australian Health Practitioner Regulation Agency.
“This incident has been very distressing to us and to their family and it is also very concerning,” he said.
“It has caused us to question whether some of the clinicians given the job of administering the vaccine have received the appropriate training. Certainly, health authorities and contracted vaccination providers should be re-emphasising to their teams the need to exercise greater care so an error like this does not happen again.
“The regulator will need to understand what happened and what caused the error but it is distressing to us, our residents and their families … you can imagine how upset they would be. Having had this road to travel over the last 18 months to get to this end of the vaccination and then to have an error that threatens the health of their loved ones, they are very concerned about this, as we all are.”