Health Minister Greg Hunt has confirmed that two elderly residents of a Queensland aged care home were given the wrong dosage of the Pfizer coronavirus vaccine.
The 88-year-old man and 94-year-old woman living at St Vincent’s (Holy Spirit) Care Services in the northern Brisbane suburb of Carseldine were given more than the prescribed dose of the coronavirus shot.
So far, neither of them has shown any adverse affects, but they are still being monitored.
The doctor involved has been taken off the vaccine rollout.
Whether that is a long-term decision will be up to his employers and the results of any investigations by health authorities.
Mr Hunt said clinical trials suggested patients did not suffer ill effects from being given more vaccine than the current recommended dose.
With the vaccine now being rolled out nationwide, we’ve taken a look at what safeguards are in place to make sure you get the right dose.
How much vaccine should be used?
Each vial of the Pfizer vaccine contains six doses — one dose is 0.3 millilitres — of vaccine.
In order to extract six doses from a single vial, special syringes need to be used.
These syringes, called low dead-volume syringes, are designed to waste less fluid by ensuring the plunger is shaped to fit the neck of the syringe, leaving less fluid behind when the vaccine is administered.
The low dead-volume syringe and needle combination should have a dead volume of no more than 35 microlitres.
If standard syringes and needles are used, vaccine can be wasted and there won’t be enough left in the vial to extract a sixth dose.
Australia’s Chief Medical Officer Paul Kelly said Pfizer/BioNTech conducted “experiments with different doses of its product, including one, three, or four times higher than what have eventually been the prescribed doses”.
He said there were no adverse side effects during those trials.
He also said Australia was aware of several cases of larger doses being administered to patients in residential aged care facilities in Germany and the UK.
The Therapeutic Goods Administration site has information that 52 study participants included in a clinical trial were mistakenly given 0.58mL, and were not negatively affected.
What checking processes are in place?
Mr Hunt said this morning that the incident was “a reminder of the importance of safeguards”.
“Firstly, the nurse on scene responded. Secondly, the company responded, and thirdly, the health care agencies — the cooperation between the Commonwealth and Queensland — responded,” he said.
Behind the scenes, all the health authorities governing the rollout of the coronavirus vaccines have established procedures in place to ensure patient safety.
Experts from the Australian Technical Advisory Group on Immunisation have published minimum requirements which outline the need for an adequate number of appropriately trained staff to ensure clinical safety.
Vaccinators must prepare and administer vaccines, team leaders need to direct clinic flow, and there must be staff to manage other staff, patient safety and stock safety, if and when required.
“Everyone administering vaccines must have appropriate training and/or qualifications in line with jurisdictional requirements, and have received adequate specific training in COVID-19 vaccination, including regarding the use of multi-dose vials”, ATAGI documentation reads.
There must also be a documented procedure for managing and recording training of staff handling vaccine doses, and there must be “first aid staff, additional to vaccinating staff as per jurisdictional requirements”.
What happens when something like this is picked up? Is there an investigation?
The short answer is, yes.
It seems like there will be more than one, too.
Professor Kelly said “a full incident reporting system had been actioned”.
The country’s Deputy Chief Medical Officer Michael Kidd will also review what happened and make any recommendations for changes that he deems necessary.
Queensland Health, the system in which these errors occurred, has policies and procedures in place for maintaining patient safety and has incident-reporting guidelines to follow internally.
What training do doctors and nurses go through?
Mr Hunt said the government adhered to “highly developed modules” to train doctors, nurses and pharmacists in administering the coronavirus vaccine.
Health professionals are authorised to deliver the vaccine in line with jurisdictional legislation and requirements.
In addition, all vaccinators must have completed COVID-19 vaccine-specific training.
“It’s a requirement that anybody who participates [in coronavirus vaccination in aged care] has completed those modules,” Mr Hunt said.
“In relation to the individual doctor, we’ll leave that to the investigation as to whether or not they either did not understand or did not complete [the training], but it was a serious breach in terms of following the protocol.
“Our advice is that both doses were administrated consecutively and, as a consequence of that, the nurse — and we say thank you for her strength of character and alertness — stepped in immediately.
“This is an individual practitioner who has clearly made an error.
“Because of the national focus on this, it’s natural and understandable that those things which would ordinarily occur are given greater prominence.”
As part of the training, Mr Hunt said there were “multiple” steps to ensure the right prescribed dose was given.
But he said if any changes were needed to the training, they would be made.
“We are confident they are good and comprehensive,” he said.
“We have had a couple of general practices making the point they thought it was too comprehensive, that it was tailored to the specific skill sets of the nurses, and perhaps it was too comprehensive for some of the doctors.
“In fact, it is comprehensive. And what it does mean is that everybody has to follow the protocols.”