Can a person be vaccinated early if they want to travel overseas?
Vaccinations are being rolled out according to a prioritisation schedule. Travelling overseas for leisure purposes, does not change priority of vaccine scheduling. Under certain circumstance, meeting strict criteria, it is possible to apply for an early vaccination for travel overseas.
Medical appointments and treatment planning with vaccination
Some people experience swollen lymph nodes in their arm pit and neck after vaccination. This is where the immune response is taking place and is expected. Swollen lymph nodes are also detected by screening tests for cancers, so it is important to inform your radiographers or oncologist if you have been vaccinated recently.
Some treatments can reduce your immune response to the vaccine. You may like to discuss the timing of your COVID-19 vaccination with your specialist to try to time it between treatments to provide the best possible protection. It is important not to delay treatments or avoid vaccinations.
What is currently known about myocarditis and the Comirnaty vaccine?
A statement from the WHO Global Advisory Committee on Vaccine Safety on 9th July 2021 noted that clinicians need to be aware of the risks of myocarditis and pericarditis following mRNA vaccination and those most likely to be affected. Presentation includes acute chest pain, shortness of breath and palpitations, especially in young males.
Since April, increased reports of myocarditis or pericarditis being diagnosed in the few days following receipt of Comirnaty vaccine, particularly following the second dose and in younger males, were being noted in countries with the largest number of vaccine recipients aged under 30 years, initially in Israel and the much larger US population.
Based on confirmed cases reported VAERS (passive surveillance system equivalent of CARM in the US), the incidence of myocarditis or pericarditis in young men aged 12-29 years was approximately 40 cases per million second doses of an mRNA vaccine (or 1 in 25,000). Case in young women were around 10-fold lower (4.2 cases per million or 1 in 250,000). The incidence in those aged over 30 years is lower again (about 1 in 400,000 in males and 1 per million in females). Although about 90% of the 303 confirmed cases of myocarditis reported to the US CDC occurring following mRNA vaccination were hospitalised, as of 23 June, 95% had been discharged from hospital and 81% were fully recovered.
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 (troponin) and specific cardiac tests of electrical activity (ECG) and structure (echocardiogram). Rates of incidence vary between populations and by gender and age; for example, the incidence in adolescent males aged 14 to 18 years is consistently higher than in females. Estimates of how common these occur depend on how carefully the diagnosis is being looked for.
It is important to rule out other potential causes of myocarditis, such as viral infections including COVID-19, or rheumatological causes. Suspected cases should be evaluated, provided guidance and followed up by a consultant cardiologist.
Report all such cases to CARM. MedSafe is closely monitoring for any reports of myocarditis following COVID-19 vaccination in New Zealand. See WHO statement here:
Webinar replay: The mRNA COVID-19 vaccine in NZ: understanding variants and safety signals including myocarditis
20 July 2021: This webinar covers vaccine effectiveness with COVID-19 variants and current information around vaccine safety.
Presenters: Dr Joan Ingram & Dr Peter McIntyre, Medical Advisors for the Immunisation Advisory Centre
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 guidance statement has been produced.
Guidance statement for COVID-19 vaccination of frail elderly
Guidance has been prepared to clarify the use of the COVID-19 vaccination for the frail elderly.
In general, it is recommended that all eligible adults, including the frail and elderly with comorbidities are offered vaccination against COVID-19, if there are no contraindications to its administration, to provide protection for the individual as well as their community.
As with all clinical interventions, there needs to be an individual risk/benefit appraisal and shared decision making between clients, whanau, surrogate decision makers, and clinicians on the individual and collective benefits and risk of COVID-19 vaccination. For frail elderly people with a prognosis of a short number of weeks (including those in terminal decline or on an end of life care pathway) the individual risk/benefit appraisal will be particularly important.
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.
When vaccinating an elderly person who has an intercurrent or comorbid condition, it is wise to ensure they are stabilised or as well as possible before they have the vaccine. Following vaccination ensure good hydration and careful management of potential systemic adverse events, such as fever. It is advisable for them to be with someone else for 24 hours after receipt of the vaccine to help manage such adverse events.
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. Also please find a video by The Melbourne Vaccine Education Centre explaining TTS in more detail.
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.
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.
People with compromised immune systems or receiving treatment from 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, 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.
If the person has had a dose of COVID-19 vaccine 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.
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
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.