What is currently known about myocarditis and the Comirnaty vaccine?

‘In April, reports of myocarditis being diagnosed in the few days following receipt of Comirnaty vaccine, particularly following the second dose, started to appear in countries using this vaccine in younger adults from 16 years (Israel and USA). ‘

In April, reports of myocarditis being diagnosed in the few days following receipt of Comirnaty vaccine, particularly following the second dose, started to appear in countries using this vaccine in younger adults from 16 years (Israel and USA). The vast majority of the cases of myocarditis reported to US CDC (to the end of May) following Comirinaty vaccination have been discharged from hospital (95%) with most fully recovered (81%). CDC is currently reviewing data from the Vaccine Safety Datalink network, which is able to directly compare rates of various conditions occurring with and without receipt of Comirinaty vaccine in large numbers of people, to evaluate the relative incidence and gather information about severity of myocarditis in vaccinated and unvaccinated young adults.  

Myocarditis and pericarditis are uncommon conditions, usually thought to be related to viral infection leading to inflammation of the heart muscle or the tissue surrounding the heart. Chest pain is the most common symptom. Diagnosis is based on elevated levels of cardiac enzymes in blood tests, and by electrocardiogram and echocardiogram tests. Rates of incidence vary between populations and by gender and age; for example, the incidence in adolescent males aged 14 to 18 years is significantly higher than in females. 

MedSafe is closely monitoring for any reports of myocarditis following COVID-19 vaccination in New Zealand. For further information please refer to the WHO’s statement.

What is known about the AstraZeneca COVID-19 vaccine (in use overseas) and blood clots?

A very rare clotting disorder has been reported overseas following vaccination with viral vector COVID-19 vaccines in younger adults.

A very rare and new type of adverse event has been observed following vaccination with the AstraZeneca, and more recently the Janssen, viral vector COVID-19 vaccines overseas (including Australia). Although, the reason why this may occur is unknown, it has been proposed the vaccine can induce an immune response where the body incorrectly attacks its own cells to make platelets very sticky. This results in the formation of blood clots in unusual places such as the brain or abdomen. This is similar to a recognised side effect of heparin, a commonly used medication used in hospital.

The unusual characteristic of this type of clotting disorder (thrombosis) is that it is also associated with bleeding due to a lack of platelets in the blood (thrombocytopenia) - the sticky platelets clump together to form clots and this attracts more platelets from the blood - named thrombosis with thrombocytopenia syndrome (TTS). The only risk factor that has been identified so far is age - most cases have occurred in adults aged under 50 years. See the Brighton collaboration for the interim case definition.

This is a very rare event (around 7-10 cases per million doses in those aged under 50 years) and the risk from COVID-19 is significantly higher than the risk of TTS. For this reason, regulatory authorities overseas are weighing up the benefit and potential risk of this vaccine and some have advised age related precautions.

A MedSafe review, published 27 April, finds there is no current evidence of risk associated with the Comirnaty (Pfizer/BioNTech) vaccine and blood clots.

The AstraZeneca COVID-19 vaccine is not yet licenced for use in New Zealand.

To find out more about how vaccine safety is monitored and the risk of blood clots from COVID-19, COVID-19 vaccines and other causes, see this commentary.

References:
https://www.ema.europa.eu/en/news/astrazenecas-covid-19-vaccine-ema-fin…
https://www.gov.uk/government/publications/covid-19-vaccination-and-blo…

https://www.who.int/news/item/16-04-2021-global-advisory-committee-on-v…-(vaxzevria-and-covishield)

Why has the Janssen COVID-19 vaccine roll out been paused in some countries internationally?

Out of an abundance of caution, the roll out of the Janssen COVID-19 vaccine has been paused while further information on rare unusual clotting abnormalities can be collected.

As of 12 April 2021, six cases of abnormal clotting were reported to the Vaccine Adverse Event Reporting System (VAERS) in the US. While this is only a small number compared to the ~6.8 million doses administered, it is important all information is appropriately reviewed and this pause gives scientists the opportunity to do so. In the New Zealand setting, the only vaccine which has been approved for use is the Pfizer-BioNTech COVID-19 vaccine. There have been no reports of this particular clotting concern following 97.9 million doses administered of the Pfizer-BioNTech COVID-19 vaccine. Medsafe will carefully evaluate all the available and emerging data before approval to use can be given.

A MedSafe review, published 27 April, finds there is no current evidence of risk associated with the Comirnaty (Pfizer/BioNTech) vaccine and blood clots.

Reference: 
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-04/03-…

Can I have a COVID-19 vaccination before a CT scan?

It is important to advise your oncologist or radiographer if you have received the COVID-19 vaccine recently. This is because the vaccine can cause the lymph nodes in your armpit and neck to swell which can be detected by CT scans used to diagnose and monitor cancers.

This is particularly detected by FDG PET/CT scans, in which you are given a contrast medium containing a type of radioactive sugar that is taken up by active cells. When an immune response to a vaccine takes place, the cells in the lymph nodes near the injection site become very active and take up a lot of this sugar. Depending on the type of cancer, you may be able to request the injection on the opposite side to your tumour. If possible, have the vaccination at least 2 weeks before a scheduled scan or as soon as you can afterwards. Do not delay any treatment.

COVID-19 vaccine may cause swelling of local lymph nodes. Does this affect mammogram results?

When you attend a mammogram, it is recommended that you mention to your doctor or radiographer that you have had a COVID-19 vaccination recently.

This is because occasionally the vaccine can cause swelling of the lymph nodes in the arm pit near to the injection-site. This usually settles after a few days after vaccination but may be detectable on a mammogram for up to a few weeks. In this case, it is advised to monitor such lymph node changes for at least 6 weeks after vaccination. You do not need to delay your vaccination or your mammogram.

Click this link for further information from BreastScreen Aotearoa.

Can I receive the COVID-19 vaccine even though I have a compromised immune system or am receiving treatment for cancer?

Many people take medication that suppresses their immune system, especially for the treatment of cancer, severe asthma, autoimmune diseases or following organ transplantation, or have medical conditions that can affect the immune system, such as HIV infection or kidney failure.

These conditions put you at increased risk from COVID-19, and although you may not respond as strongly to the vaccine as someone with a fully functioning immune system, it is safe for you received COVID-19 vaccine and it will provide some protection against COVID-19, particularly against severe and life-threatening disease.

It is important and safe for those receiving active treatment with immunosuppressive medications to have the COVID-19 vaccine. If you are severely immunocompromised, it is recommended to talk to your GP or specialist to discuss the optimal timing for vaccination before the vaccine appointment. Ideally, vaccination should be conducted prior to any planned immunosuppression.

It is also important for the people around you, in your household, to have the vaccine when it is offered to them to widen your protection.


For information about Cancer care and COVID-19 vaccine see Te Aho o Te Kahu (Cancer Control Agency) information here.

How many doses of COVID-19 vaccine should I have? I already received a COVID-19 vaccination overseas.

If you were partially vaccinated overseas with one dose of Comirnaty (Pfizer/BioNTech) vaccine, you will need to have another dose at least 21 days after your previous dose. There is no maximum time limit between doses, so you do not need to repeat the first dose or receive a third dose.

If you received one dose of different vaccine (for example, COVID-19 vaccine AstraZenaca/Vaxzevria/Covishield or the Moderna mRNA COVID-19 vaccine), the current recommendation is to have one dose of the Comirnaty vaccine when it becomes available for your priority group at least 4 weeks after your first vaccine. These vaccines are not interchangeable, but you are likely to have a good response to just one dose. If you received one dose of the Janssen/Johnson & Johnson vaccine, you are considered fully immunised and do not require any further doses of COVID-19 vaccine.

Can I delay receiving my second dose of Comirnaty?

It is recommended to have the second dose of Comirnaty™ at least 21 days after the first dose. A delay for longer than 21 days is not considered to be a problem in terms of how you will respond to the second dose.

It is not yet known, for how long the first dose provides protection. If you are at risk of exposure to SARS-CoV-2, it is advisable to have the second dose when recommended. During clinical trials, the vaccine efficacy against symptomatic COVID-19 between the first and second doses was around 50% compared with 90% within 2 days of the second dose increasing to 95% after a week. Recent real-world data has shown that protected against SARS-CoV-2 infection was around 62 to 91% from 14 days after dose one and 68 to 97 % from 14 days after dose two in frontline workers. 

Can I have the COVID-19 vaccine if I am allergic to latex?

Comirnaty™ is latex-free. The vial stopper is made with synthetic rubber (bromobutyl), not natural rubber latex.

What happens if my job changes and I want to administer other vaccines after I have completed the Provisional Vaccinator Foundation Course?

You need to complete a full Vaccinator Foundation Course and meet the requirements of an authorised vaccinator or pharmacist vaccinator to administer other vaccines.

If, after June 2022 you wish to continue vaccinating, there will be a VFC specifically designed for you to become a fully authorised vaccinator or pharmacist vaccinator. This course will be available from November 2021 until the end of 2023.

Do pharmacists need to apply for provisional authorisation following the Provisional Vaccinator Foundation Course?

Yes. As they have not completed the full requirements to be a pharmacist vaccinator,

they are required to be authorised to give influenza and MMR vaccine. If a pharmacist wants to give the full scope of pharmacy vaccines, they will have to complete a full Vaccinator Foundation Course (VFC) and process.

Do I need a CPR certificate to become a provisionally authorised vaccinator?

You need an appropriate CPR certificate to apply for provisional authorisation. If you do not hold a current CPR certificate, you need to enrol and complete an appropriate CPR course as soon as practically possible. Currently appropriate CPR certificates that are less than 12 months expired are being accepted.

Appendix 4 of the Immunisation Handbook outlines the requirements of CPR courses for vaccinators. A range of providers offer courses (eg, internet search CPR courses for vaccinators). Check with the course provider that the course they are offering includes the following:

  • infant, child and adult CPR, including mouth-to-mouth, mouth-to-mask and the management of choking
  • administration of IM adrenaline for treatment of anaphylaxis
  • use of an automated external defibrillator
  • one- and two-person bag valve mask ventilation and mouth-to-mask technique.

It is the vaccinator’s responsibility to ensure that these core components are covered. Employers may require a higher level of CPR and more frequent updates than is necessary as a vaccinator. You can obtain your CPR certificate before or after completing your online assessment but need the CPR certification before submitting your authorisation application.

How do I apply for my provisional authorisation?

You need to complete the online course, online assessment and peer assessment. Complete the Provisional Authorisation application form and email, along with the necessary documentation including your completed peer assessment form, to the IMAC Education Office PVFC registrations ([email protected]). Once approved, the office will email you a letter of authorisation.

You must send a copy of your peer assessment and letter of authorisation to your local immunisation coordinator. Your local immunisation coordinator’s details are found on the IMAC website (immune.org.nz) under ‘Regional advisors and local coordinators’. It is recommended that all provisionally authorised vaccinators work as part of a vaccination team, that includes experienced authorised or pharmacist vaccinators.

How long does provisional authorisation via the Provisional Vaccinator Foundation Course last for?

Your provisional authorisation will expire on 30 June 2022.

To continue vaccinating after your provisional authorisation has expired, you will need to complete a specific IMAC bridging course, complete a clinical assessment by an immunisation coordinator and apply for authorisation from the Medical Officer of Health, or let PSNZ know if you are a pharmacist. The bridging course will have limited number of places and only be available for those vaccinators who will be delivering national immunisation schedule vaccines. IMAC will be working with the Ministry of Health and the DHBs regarding access to those places.

Do I have to be authorised by a Medical Officer of Health to complete the Provisional Vaccinator Foundation Course?

No, instead of Medical Officer of Health sign-off, provisional vaccinators are being authorised nationally by the Director of Public Health.

Once you have completed all the requirements and sent through your application for authorisation, IMAC will review the details and send you an authorisation letter.

What will provisional authorisation via the Provisional Vaccination Foundation Course cover?

Once you have met all the necessary criteria and received your authorisation letter from IMAC, you will have provisional authorisation to administer influenza and MMR vaccines to those aged 3 years and older.

Pharmacists are currently restricted to vaccinating those 13 years and above for influenza (funded and unfunded) and those aged 16–50 years for MMR.

The provisional authorisation allows you to vaccinate anywhere in New Zealand. Your provisional authorisation will expire on 30 June 2022. It is recommended that all provisionally authorised vaccinators work as part of a vaccination team, that includes experienced authorised or pharmacist vaccinators.

How long is the Provisional Vaccinator Foundation course available for?

IMAC is offering this course through to end of Dec 2021*.

*Once your registration has been accepted you will be provided with a package code. This needs to be entered into IMAC Learning before 1st December. Once entered, the course is available for completion up until 31st December 2021.

What if I have already done a vaccinator course and want to become a COVID-19 vaccinator?

If you have completed a Vaccinator Foundation Course (VFC) in the last five years, but did not do a clinical assessment, or have let your vaccinator status lapse by not completing the required 2-yearly updates, please contact your local immunisation coordinator to discuss the requirements to renew or achieve vaccinator status (either as a pharmacist or authorised vaccinator).

You do not need to do the PVFC and will be referred to the most appropriate course for your area of work.

What are the ingredients of COVID-19 vaccines?

Vaccine ingredients depend on the type of vaccine. As vaccines are approved for use, the contents and presentation of each vaccine is published by Medsafe as a data sheet and consumer medicine information.

These form part of the information that companies submit during the approval process. Find the ingredients for the Comirnaty (Pfizer/BioNtech) vaccine here.

Some other types of vaccines use human cell lines in the vaccine manufacturing process. This is known to be a safe and efficient way to produce vaccines. Both the Janssen and Oxford/AstraZeneca COVID-19 vaccine candidates use cell lines. NO cells from the manufacturing process remain in the vaccine because purification removes all the cell culture material and each batch undergoes thorough quality control checks. The Catholic Church has issued a formal statement saying it is morally acceptable to take vaccines that use cell lines. Find further information on fetal cells and COVID19 vaccines here.

How are COVID-19 vaccines authorised in New Zealand?

All medicines approved for use in New Zealand, including vaccines, go through strict review by Medsafe to make sure they meet local and international safety and efficacy guidelines.

Once Medsafe has reviewed all available data, it makes a recommendation to the NZ Government as to whether a medicine can be granted approval in New Zealand. More comprehensive information on this process is available on the Medsafe website.

Vaccinations against COVID-19 using the mRNA COVID-19 vaccine, Comirnaty™ (from Pfizer/BioNTech)  have begun. Currently, vaccinations are being given to those at highest risk of exposure to SARS-CoV-2 (the virus that causes COVID-19) and their close household contacts. There will be sufficient doses of this vaccine for everyone in New Zealand. See here for the current vaccine roll-out plan.

The exact date when other vaccines will be available in New Zealand is unknown. Their arrival depends on:

  • Data being available to review, particularly in relation to safety and effectiveness 
  • When Medsafe approval is granted
  • When the vaccine can arrive in New Zealand. 
  • To obtain approval for use in New Zealand, each vaccine needs to meet strictly defined safety and efficacy criteria.

The mRNA COVID-19 vaccine by Pfizer/BioNTech was granted provisional approval for use in New Zealand on 3 February 2021. This means that it has been approved for use in a defined group and on the condition that Medsafe continues to receive and review further data about this vaccine’s safety and effectiveness. Click here to find out more.

This approval differs from that granted in other countries, such as the US, UK and in Europe, in which these vaccines were granted ‘emergency-use approval’ based on early data and an urgent need to start vaccinating soon as safely possible. New Zealand has been fortunate to be able to wait, while receiving the most current clinical trial and post-licensure data, to make the decision to approve the use of this vaccine. Once sufficient data has been obtained, it is likely that Medsafe will convert the provisional consent to full consent in due course.

Watch this video from the Ministry of Health with Dr Ashley Bloomfield and MedSafe's Chris James for more on the vaccine approval process in New Zealand. 
 

What types of COVID-19 vaccines have been developed?

Multiple types of vaccines are being developed around the world.

We are familiar with some of the vaccine types, such as the protein subunit candidates, like those used in Hepatitis B and whooping cough vaccines; however, other vaccines are using newer technologies such as mRNA and viral vector vaccines. For further information on the types of vaccines that are being developed, please click here.

Will ACC provide cover for COVID-19 vaccination injuries?

ACC can provide treatment and support for injuries caused by COVID-19 vaccination if the criteria for treatment injury are met. This means there’s a physical injury caused by the vaccination, that’s not a necessary part or ordinary consequence of the treatment.

For example, inflammation around the site of the injection is common with COVID-19 vaccination (an ordinary consequence) and is unlikely to be covered. Infections (such as cellulitis or septic arthritis) due to the vaccination, and anaphylaxis resulting in injury, are not ordinary consequences and are likely to be covered. 
 
To make a treatment injury claim for a patient please complete an ACC2152 treatment injury claim form as well as an electronic or manual ACC45 injury claim form.
 
To help with reporting, ACC needs to know the COVID-19 vaccine brand name and vaccination dose number (i.e. dose one or two). This can be noted: 

  • on the ACC45: please tick the treatment injury box, identify this as an adverse event in the drop-down menu and then enter the COVID-19 vaccine brand name and vaccination dose number in the open comments section
  • on the ACC2152: in Section 3 - Treatment claimed to have caused the injury.

 
More information about lodging a treatment injury claim is available on the ACC website and in the treatment injury claim lodgement guide.
 
To find out more please contact ACC on 0800 222 070 or email [email protected]
 

Can mRNA COVID-19 vaccine affect fertility or affect future babies?

There is no biologically plausible reason why this vaccine could have any effect on our genes or fertility.

Upon injection, the lipid nanoparticle containing the mRNA is taken up by specialised cells (dendritic cells) at the injection site in the arm. These cells use the instructions from the vaccine mRNA to make only the SARS-CoV-2 spike protein and the mRNA degrades rapidly. The mRNA from the vaccine does not enter the nucleus of any cells. Furthermore, no components of the vaccine or the spike protein produced reach the ovaries or the testes. More information about how this concern arose can be found here.

Will the vaccine make a person test positive on COVID-19 tests?

No. The vaccine makes a person produce antibodies against the virus spike protein but the nasal swab looks for particles of virus.

The spike protein that is made in your body in response vaccine does not travel far and does not reach your nose.

How long will COVID-19 vaccine immunity (i.e. protection from the COVID-19 disease) last?

We would expect COVID-19 vaccines to provide protection for longer than 2 months, although exactly how long for, remains unknown at this stage. This is because not enough time has passed since the clinical trials started to be able to accurately answer this.

We know that the Pfizer/BioNTech COVID-19 vaccine lasts for AT LEAST two months, because data supporting this has been reviewed by Medsafe. As part of the conditional approval of the Pfizer/BioNTech COVID-19 vaccine, more data is to be provided as it becomes available. It is anticipated that further data will be provided on durability of the immune response post vaccination in coming months.

If a person is vaccinated against COVID-19, will they still be able to spread the virus to susceptible people?

An ideal vaccine stops everyone from carrying and passing on the infection as well as protecting them from becoming seriously ill. It is currently unclear whether COVID-19 vaccines only protect against symptomatic and severe disease, or if they can also stop all infection, including asymptomatic infection (i.e. showing no symptoms).

If the vaccine is only able to stop the symptoms of the disease, but unable to stop the virus from infecting us and reproducing, then the virus may still be able to be spread. Even in this case, by reducing the number of people with symptoms will help to reduce spread of the virus because fewer people will be coughing large quantities of virus on others. However, this possible limitation of the vaccine highlights the importance of continuing to follow public health advice such as hand washing and isolating if unwell, even post vaccination. For more information, please click here.

Recently published data from Israel showed that its mass COVID-19 vaccination campaign (using the Pfizer vaccine) was working well with two doses cutting symptomatic cases by 94% across all age groups. Data reported by the CDC in the US has also shown that mRNA COVID-19 vaccines were 90% effective in health care workers against SARS-CoV-2 infection (with and without symptoms).

Will other COVID-19 prevention measures such as social distancing be needed if a COVID-19 vaccine is available?

As not all New Zealanders are be able to be vaccinated at once, the current public health measures, including social distancing, mask usage, rapid contact tracing and managing cluster outbreaks, will continue for some time.

With an effective vaccine programme, it is anticipated these control measures can be reduced. This will require a high proportion of the population (estimated to be at least 8 out of 10 people) being immunised.

Even when we have a high proportion of population vaccinated, we will still need to maintain a level of public health measures particularly when we can travel more freely. See this infographic to explain why.

What side effects may be expected after vaccination?

The most common responses to the COVID-19 vaccine are injection-site reactions (sore arm for example) and general symptoms such as ‘flu-like’ illness, headache, chills, tiredness, nausea, fever, dizziness, weakness or aching muscles.

Generally, these potential responses happen within a day or two after the vaccination and are not associated with more serious or lasting illness. These types of reactions reflect the normal immune response to this vaccine. Not everyone experiences this type of response. They are more likely after the second dose and tend to resolve within a day or two. Pain relief, such as paracetamol or ibuprofen, is not recommended to be taken before having the vaccine but can be used after it if required. 

In addition, as with any vaccine or medicine, there is a risk of allergic reactions shortly after the vaccinations. Because of this people should wait at a vaccination centre as instructed after having their vaccine. Those with previous allergic reactions or anaphylaxis should tell their vaccinator before going ahead.  

For more information about what to expect after the vaccination see the Ministry of Health's website. 

Monitoring for adverse reactions and side effects is being conducted in New Zealand and worldwide. Vaccine recipients and their health care providers are encouraged to report possible side effects to CARM (Centre for Adverse Reactions Monitoring). See here for the latest Adverse Events following Immunisation report from Medsafe on Comirnaty 
 

What is the priority - an influenza vaccine or a COVID-19 vaccine?

The COVID-19 mRNA vaccine two-dose schedule should take priority over influenza (flu) vaccine.

The flu vaccine can be administered two weeks after the second dose of COVID-19 vaccine, which is given at least 21 days after the first dose. 

How should we space MMR, influenza and COVID-19 vaccination?

Please continue to allow a four-week gap when giving the MMR vaccine before the COVID-19 vaccine where possible. However, the gap can be reduced to two weeks when giving the MMR vaccine after the second dose of the COVID-19 vaccine. Complete both doses of the COVID-19 vaccine, 21 days apart, before giving another vaccine.

Please continue to allow a two-week gap between the COVID-19 vaccine and influenza vaccine where possible, regardless of the order they’re given.

Having a gap between the different types of vaccinations makes it easier to judge which vaccine may be responsible for any side effects. Note that there are no clinical safety concerns should the gap between vaccines be less than the recommendations above. Do not delay vaccination if such a gap is not possible.

The MMR and influenza vaccines can be given at the same time.

The Ministry of Health has put together a flowchart for healthcare providers managing MMR and influenza vaccinations around COVID-19.

Can other vaccines be administered with a COVID-19 vaccine?

Currently Medsafe advice is only available for the mRNA vaccine from Pfizer/BioNTech (Comirnaty™) vaccine.

A two-week gap is generally recommended after any non-live vaccine, including influenza, and the Comirnaty mRNA COVID-19 vaccine. If a live vaccine, such as MMR, varicella and zoster vaccine has been given, then a four-week gap is generally recommended before Comirnaty. If Comirnaty, is given first, then maintain a two week gap before any other vaccines. Do not delay if a gap between these vaccines is not practicable.

Please note that two doses of the mRNA vaccine are required, given at least 21-days apart. These recommendations are continually being reviewed.

Will booster doses of a COVID-19 vaccine be needed?

Not enough time has passed since first vaccinations were given to be able to answer this question.

People enrolled in clinical trials are being followed up closely, which will allow this question to be answered in due course. For more information, please click here.

It is expected that small adjustments may be made to the vaccine if the COVID-19 virus changes so much that vaccine loses effectiveness. In this case booster doses will be required to better match the virus variants in circulation, like for the influenza vaccine. How frequently these changes will need to be made is unknown. A major advantage of mRNA vaccine technology is that these changes can be made very quickly (new batches available within a few months compared with more than 6 months for seasonal flu vaccines).

What is the acceptable timeframe between the first and second doses of the Comirnaty vaccine?

To be fully immunised with Comirnaty requires two doses given at least 21 days apart.

Vaccinators are advised not to give the second dose earlier than this, and while longer spacing is acceptable, the recommended spacing is for the second dose to be given as close after 21 days as possible.

What is the guidance around receiving a COVID-19 vaccine and having a general anaesthetic?

Based on first principles and our experience with other vaccines, there is no expectation that an anaesthetic would affect the safety or immunogenicity of the mRNA COVID-19 vaccine.

The general recommendation when planning vaccination with any vaccine is explained in Section 3.1.3 in the Immunisation Handbook 2020

If more than one vaccine becomes available, could taking two different vaccines boost the effectiveness?

We do not know the answer to this yet as it is still being investigated in clinical trials. Currently, the COVID-19 vaccines are not interchangeable.

There is no data available on the interchangeability between COVID‑19 vaccines, such that, where possible other vaccines should not be substituted to complete the course. So far, the only COVID-19 vaccine available for use in New Zealand is Comirnaty (Pfizer/BioNTech). Other vaccines are undergoing the Medsafe approval process.

To be fully immunised with Comirnaty, two doses are required, to be given at least 21 days apart. There is no maximum duration between doses, so it is not necessary to restart the course or give a third dose if it has been longer than 21 days since dose one.

For more information, please click here.

Who can administer COVID-19 vaccines in New Zealand and how are they trained?

Staff administering COVID-19 vaccines must be authorised vaccinators or qualified medical staff.

The criteria for nurses to become authorised vaccinators is set out in appendix 4 of the Immunisation Handbook. Training for administering the COVID-19 vaccines is in addition to this criteria, therefore all vaccinators are already qualified and experienced. 

Training for the first cohort of vaccinators administering the Pfizer/BioNTech vaccine takes the form of online learning and webinars. This training includes detailed disease and vaccine-specific information, vaccination process information, paperwork and record-keeping, vaccine research and a review of the positive safety profile for this vaccine. They also cover responding to common concerns and where staff can go to access further support and clinical advice. This is followed by additional webinars to ask further questions and a clinical support line for vaccinators. Training will continue to expand and support more vaccinators to become authorised and complete the COVID course.  

What is the process New Zealand vaccinators are following to administer COVID-19 vaccines?

Vaccinators are following normal best practice in drawing up and administering the Pfizer/BioNTech vaccine. This is consistent with standard immunisation guidelines.

Some nurses are finding they can sometimes get up to six doses out of the vial, consistent with information from the vaccine manufacturer.

Is the Comirnaty vaccine safe and effective for people living with HIV?

The vaccine has been through rigorous testing to ensure safety and efficacy and is now being used widely overseas without any serious concerns appearing. People with HIV were included in clinical trials though efficacy and safety data specific to this group are not yet available.

With some vaccines people living with HIV can produce a weaker immune response. People living with HIV are encouraged to be vaccinated. People with HIV were included in clinical trials for the Pfizer vaccine, although the data specific to this group is not yet available there are no safety concerns.

Based on what we know about people living with HIV and their response to other vaccines:

  • those with a suppressed viral load are likely to have some protection from the COVID-19 vaccine
  • they may have a weaker response to some vaccines, including the COVID-19 vaccine

For people who are newly diagnosed and starting HIV treatment are advised to take advice from their specialist about the timing of their vaccination. Any medication being taken for HIV is not expected to change how effectiveness of the COVID-19 vaccine. The vaccine will not affect HIV medications.​

Will children receive a COVID-19 vaccination?

Medsafe has not approved a COVID-19 vaccine for use in children under the age of 16 as yet.

Further research with vaccine trials enrolling children is underway overseas. Initial data in 12-15 year-olds looks promising, with excellent efficacy and a similar safety profile to that seen in adults. Read this Stuff article with IMAC’s Dr Emma Best offering some helpful ideas on how to approach the topic of COVID-19 and vaccines with children.

Can a person who is currently sick with COVID-19 receive a vaccine?

Internationally, guidance states that people who are currently isolating or experiencing symptoms of COVID-19 should not be vaccinated until they have recovered and met the criteria to stop isolating.

If you had the virus and recovered, will you still be able to or need to get the vaccine?

Vaccination is being offered to people who have and have not had SARS-CoV-2 infection previously.

Data from clinical trials and from countries with a lot of COVID-19 cases have shown the vaccines to be safe and effective in this group of people. It is expected that the vaccine will boost the immune response and provide good protection for those who have previously had SARS-CoV-2 infection. Start your vaccination course at least 4 weeks after you have recovered. For more information, please click here.

Can COVID-19 vaccines be safely given to frail and elderly people?

There are no safety concerns around giving COVID-19 vaccine to older and frail adults. Multiple COVID-19 vaccine candidates have shown to protect against severe disease in older age groups.

A single dose of COVID-19 vaccine substantially reduced (over 70%) the risk of COVID-19-related hospitalisation in elderly, frail patients with extensive co-existing conditions in the UK. By 2 weeks after the second dose effectiveness against symptomatic COVID-19 in adults aged over 70 years was 85-93%. This is important, as increasing age is a risk factor for severe COVID-19.

Following reports of deaths of frail, elderly adults in residential care facilities after COVID-19 vaccination, independent reviews by both the CDC and the WHO concluded that the mortality rate in this population is typically high and a substantial number of deaths will occur coincidentally following vaccination. For further information, click here.

COVID-19 vaccines in pregnancy and breastfeeding

Pregnant people are encouraged to be vaccinated against COVID-19 at any stage of pregnancy.

In pregnancy, the risk of severe COVID-19 complications is much higher than in people who are not pregnant. The updated recommendation aligns with recommendations in other countries and is based on international evidence from a large number of people who have already received mRNA COVID vaccines when pregnant and no additional safety concerns have been shown. There is also increasing evidence that antibodies made by the mother after vaccination are shared with the baby in the cord blood that are likely to also protect her newborn baby against COVID-19.

As with all vaccines on the New Zealand Immunisation Schedule, there are no safety concerns about giving mRNA COVID-19 vaccine to women who are breastfeeding and by being vaccinated, mothers can provide some protection against COVID-19 for their babies in breastmilk.

Please refer to the Immunisation Advisory Centre's COVID-19 vaccination in pregnancy fact sheet for more information.

Reference

Shimabukuro TT, Kim SY, Myers TR, et al. Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons. N Engl J Med. 2021 DOI: 10.1056/NEJMoa21049