Replacement Vaccine - FAQ

Southern DHB is actively contacting individuals affected by a Pfizer COVID-19 vaccine storage issue impacting a subset of the vaccinations delivered by an occupational health provider in the Queenstown Lakes area.  

Initial investigations have identified that just over 1500 people have received an affected vaccination that was stored at incorrect temperature. The people affected received their vaccinations at various locations in Queenstown Lakes and Central Otago between 1 December 2021 and 28 January 2022. This group of people are encouraged to receive a replacement vaccination to ensure that they benefit from a high level of immunity against COVID-19.

Southern DHB recognises the inconvenience and anxiety it may cause for the affected individuals. We sincerely apologise to those people who have been impacted by this incident, and also to their whānau,

All people impacted by the incident will be contacted by phone, or email and letter within the next three working days. Detailed information will be provided regarding each individual’s circumstances and the recommended course of action.

People affected are able to access a fully funded GP consultation if they have any concerns and require further advice on a replacement vaccination. People can also talk to their trusted health professional such as their pharmacist or can call 0800 28 29 26 (7 days a week, 8am to 8pm). 

People affected by this incident who wish to book their replacement vaccination should call 0800 28 29 26 (7 days a week, 8am to 8pm) for more information. 

Frequently Asked Questions

How do I know that my vaccination was definitely impacted by this incident? 
Southern DHB have matched the vaccination records with the affected vaccine batches to establish a comprehensive list of all people who received the compromised vaccine. These people will receive direct communication from Te Whatu Ora Southern. If you were vaccinated by a pharmacy or a GP then you are not affected.

If you weren't vaccinated by a pharmacy or GP, and received your vaccination in the Queenstown Lakes or Central Otago area between 1 December 2021 and 28 January 2022, you can call 0800 28 29 26 if you think you were affected.

I am a mandatory worker required to be vaccinated under the COVID-19 Mandatory Vaccination Orders, how will this affect me?
The dose/s you originally received still count for Order purposes. You are not required to have a replacement dose to meet the requirements of the Order. However, we highly recommend you get a replacement dose. To minimise the risk of COVID transmission in the workplace, PPE with social distancing, site capacity limits and short-term arrangements to limit customer/consumer facing activities should be utilised until replacement vaccination.

Are there any issues around re-immunisation? 
IMAC and the Ministry of Health recommend a replacement dose as the vaccine you received may have been ineffective. Following a dose of a COVID vaccine there may be side effects. If you have any symptoms of concern following your vaccination, please seek urgent medical care. 

What if I choose not to have my vaccination repeated? 
We are following the advice given to us from IMAC (Immunisation Advisory Agency) and the Ministry of Health, we are recommending that you have your vaccine replaced as it is has been determined that the vaccine you received did not work. If you don’t have it replaced, you may not be protected against Covid.  

The concern is that we cannot guarantee that the vaccine was effective, hence the need to re-vaccinate to protect against COVID. 

I’m pregnant, will this affect my baby or my pregnancy? 
COVID vaccinations are effective, safe and recommended during pregnancy to protect you and your baby. If you wish to discuss this further, you can opt to have a free consultation with your General Practitioner. 

I am immune compromised, what does this mean for me? 
We recommend you receive a replacement vaccination. You should discuss this with your General Practitioner or Specialist. Should you choose to see your General Practitioner, the consultation will be free of charge. 

I live with someone who is vulnerable/immune-compromised, what does this mean for them?
We recommend you receive a replacement vaccination as your protection against COVID may have been compromised putting you and your vulnerable family member at more risk of Covid. 

Is it possible that the vaccine you have already given me may cause other side effects because it wasn’t stored properly? 
The advice from IMAC (Immunisation Advisory Agency) is that the compromised vaccine should not cause any additional side effects. 

Is it safe to get a replacement vaccination – what about myocarditis or other serious side effects? 
As with any vaccine, there is a chance of side effects. As with any dose of a COVID vaccine, there is a small chance of serious side effects including myocarditis. If you have any symptoms of concern following your vaccination, please seek urgent medical care. It is important to have your replacement vaccination at the recommended interval which you will be advised of. You will be given an information sheet at the time of your COVID vaccination which describes the possible side effects. 

Complaints

I want to make an official complaint. 
You can provide feedback or make a complaint by contacting Health New Zealand | Te Whatu Ora - Southern Consumer Experience Feedback Team. 

You can:

• Talk to a Health New Zealand | Te Whatu Ora - Southern staff member 
• Phone Patient Affairs office 03 4709533
• E-mail: Feedback@southerndhb.govt.nz  
• Health New Zealand | Te Whatu Ora - Southern Feedback | Southern Health | He hauora, he kuru pounamu
• If you are unable to e-mail your feedback you can write to us at the address below: 
  Health New Zealand | Te Whatu Ora - Southern
  Patient Enquiries 
  Private Bag 1921 
  Dunedin 9054 
• You can also raise a concern or complaint directly with the Health and Disability Commissioner: 
  National Freephone: 0800 11 22 33
  Postal address: PO Box 1791, Auckland 1140 
  General enquiries email: hdc@hdc.org.nz  

About the incident

How do I know that this problem won’t happen again with another provider? 
Southern DHB will review their processes to ensure all the relevant standards are being fully met for all providers. 

What happened to the vaccine to make it ineffective? 
IMAC have advised that as the vaccine may have experienced temperature events outside of the acceptable range while being stored in a refrigerator with the provider, the vaccine is likely not to be effective. This is based on the information from the vaccine manufacturer Pfizer.  

Were any children affected? 
This provider only provided COVID vaccinations to people aged 12 years and above. There were some children aged 12 years and over who were affected. 

What is a cold chain failure? 
The vaccine is stored at very specific temperatures. In this situation, the vaccination storage has dropped below what is expected and this has affected the effectiveness of the stored vaccine. 

What has been done to ensure this doesn’t happen again? 
A full independent review of this incident will be undertaken to ensure the risk of this happening again is minimised.  We are reviewing all processes and will urgently implement any identified improvements to the COVID vaccination programme.  It should be noted that cold chain management processes have been significantly enhanced over earlier years, and it is these enhancements which have ultimately led to this issue being identified.

Why put our trust in vaccinations if they’re so open to problems? 
This is not a vaccine failure, but it is a systems/process failure which meant the vaccine was exposed to temperatures that were too cold. 

Are there guidelines for the transport and storage of immunisations? 
There are specific guidelines to ensure cold chain is maintained for vaccinations throughout any transport and storage. Special fridges and chilly bins with temperature monitors are used for storing and transporting the immunisations. 

There are national standards for the transportation and monitoring of immunisations. Southern DHB is reviewing their processes to ensure national standards are maintained at all times. 

Why did it take so long to notify me of this? 
Southern DHB were made aware of the cold chain failure on 2^nd March 2022, and our staff have worked tirelessly to ensure all affected individuals have been identified and the actions including recommendation of an additional vaccination is safe and supported by evidence, including IMAC support. 

How did this happen, fridges are not meant to freeze, why didn’t someone notice sooner?
Fridges used for vaccine storage must have temperature loggers and alarms to inform the provider of any temperature problems. We are working through exactly what happened in this situation, and why the issue was not picked up earlier. 

What is the correct procedure to ensure the fridge is operating correctly and why was this not adhered to? 
The Ministry of Health National Standards for Vaccine Storage and Transportation for Immunisation Providers 2017 outline the correct procedures. All vaccination providers are required to have cold chain accreditation and ensure their fridges are operating correctly. Southern DHB is working through exactly what happened in this situation. 

Is the provider still delivering vaccinations? 
No, the provider is not currently providing vaccination 

What will happen to the provider? 
Southern DHB will work with the provider and fully investigate how this cold chain failure occurred. The provider is not currently providing vaccinations.