Childhood immunisations after COVID-19 infection

It is important to resume children's routine immunisations as soon as possible after COVID-19 infection.

Children can continue to receive their routine childhood and other immunisations as soon as they are no longer acutely unwell with COVID-19 and have been cleared to leave isolation. There is no need to wait.

For COVID-19 vaccine, it is recommended to wait at least 3 months after a positive COVID-19 test, if asymptomatic, or 3 months after recovery from symptoms. This is because the immune response to the infection itself will provide some protection. For a child at higher risk of reinfection and who has not completed the full vaccine course, COVID-19 vaccine can be given sooner than 3 months, based on clinical discretion.

Lymph nodes, CT scans and Mammograms

It is reasonably common to have swollen lymph nodes (commonly called ‘glands’), especially near the vaccination site eg under arm or in neck, after vaccination. It is one of the top 10 potential responses seen after COVID-19 vaccination, and occurs more commonly after booster doses than earlier doses. This is part of the normal immune response to vaccines and infections.

If you are having a CT scan or mammogram in the near future and have had the vaccination, or you are planning to have it, let your health professional know as it is possible you may need to reschedule. 

More information here: 

CT scan information

Mammogram information

 

Omicron

Omicron in brief

Omicron variant of the SARS-CoV-2 virus spread rapidly globally from late 2021 and became the dominant strain, outcompeting the Delta variant in many regions, including New Zealand in early 2022.

Genetic changes to the spike protein enable it to infect cells in the upper airway more readily than previous variants, even Delta. However, Omicron is less able to infect and transmit between cells in the lower airways in the lungs. For this reason, it has been associated with less severe disease than previous strains, although some people still develop severe disease and require hospital care.

As with other respiratory viruses, children with narrower airways are potentially at increased risk of conditions such as croup or exacerbation of asthma. Vaccination helps to reduce this risk.

Vaccinated individuals can still become infected and transmit this virus, but the vaccine continues to perform very well against severe disease and COVID-19 complications. Proportionally fewer people are needing hospital care, in part due to vaccination, but due to the enormous number of cases, hospitals can become under significant pressure.

Because this variant is highly infectious, high levels of neutralising antibody are required to block it. Antibody levels wane with time since vaccination, and this is most marked in those, such as older adults, who may not have had as good an initial response to the vaccine. Booster doses increase the antibody to a highly protective level in the short-term. In this way, they will help to reduce the risk of infection, development of symptoms and ongoing transmission, thereby slowing the spread of the virus.

Cellular immunity of vaccinated people continues to reduce the risk of severe disease, even when antibody levels are less able to prevent infection. 

https://www.cdc.gov/mmwr/volumes/71/wr/mm7104e4.htm?s_cid=mm7104e4_w

 

Willett BJ, Grove J, MacLean OA, et al. The hyper-transmissible SARS-CoV-2 Omicron variant exhibits significant antigenic change, vaccine escape and a switch in cell entry mechanism. medRxiv, 2022 (preprint): p. 2022.01.03.21268111.

Peacock TP, Brown JC, Zhou J, et al. The SARS-CoV-2 variant, Omicron, shows rapid replication in human primary nasal epithelial cultures and efficiently uses the endosomal route of entry. bioRxiv, 2022 (preprint): p. 2021.12.31.474653.

Zimmermann P ,Curtis N. Why does the severity of COVID-19 differ with age?: Understanding the mechanisms underlying the age gradient in outcome following SARS-CoV-2 infection. Pediatr Infect Dis J, 2022. 41(2): p. e36-e45.
 

Antiphospholipid syndrome

Antiphospholipid syndrome increases the risk of thrombosis, but there is no evidence that individuals with a prior history of thrombosis or known risk factors for thrombosis are more at risk of developing the immune complication thrombosis with thrombocytopenia syndrome (TTS) reported after having the AstraZeneca vaccine.

If an individual with the antiphospholipid syndrome has no contraindications to the AstraZeneca vaccine, then they can receive the AstraZeneca vaccine when the benefits of the vaccine outweigh the risk for that individual.

For the majority of individuals, the risk of recurrent thrombosis due to COVID-19 infection is far greater than the risk of this syndrome following vaccination with AstraZeneca.

For individuals who experience a clotting episode with concomitant thrombocytopenia following the first dose of the AstraZeneca vaccine, further vaccination should be deferred until their clotting has completely stabilised and should then be boosted with an alternative product.

The contraindications to vaccination with the AstraZeneca vaccine include individuals who have a history of heparin-induced thrombocytopenia and thrombosis (HITT or HIT type 2).

These individuals should be offered vaccination with an alternative COVID-19 vaccine.

Guillain Barre Syndrome (GBS) in those with past GBS

There is emerging evidence of a rare potential association with an increased incidence of GBS with certain COVID-19 vaccines, notably the viral vector COVID-19 vaccines (Vaxzevria and Janssen).

There is no evidence of a higher rate of reporting of GBS following COVID-19 vaccination in individuals who have previously had GBS.

In those who develop GBS following COVID-19 vaccination, the balance of risk-benefit is still in favor of completing a full COVID-19 vaccination schedule following complete recovery.

On a precautionary basis, where GBS occurs within six weeks of a Vaxzevria (AstraZeneca) vaccine, for any future doses, Comirnaty (Pfizer) vaccine is preferred.

References:

  • UK Health Security Agency. Information for healthcare professionals on Guillain-Barre Syndrome (GBS) following COVID-19 vaccination. [Updated 17 Dec 2021; accessed 16 May 2022]. https://www.gov.uk/government/publications/covid-19-vaccination-guillai…
  • Hanson KE, Goddard K, Lewis N, et al. Incidence of Guillain-Barré Syndrome After COVID-19 Vaccination in the Vaccine Safety Datalink. JAMA Netw Open. 2022;5(4):e228879-e. doi: 10.1001/jamanetworkopen.2022.8879
  • Shapiro Ben David S, Potasman I, Rahamim-Cohen D. Rate of Recurrent Guillain-Barré Syndrome After mRNA COVID-19 Vaccine BNT162b2. JAMA Neurology. 2021;78(11):1409-11. doi: 10.1001/jamaneurol.2021.3287

Anticoagulant medication

AstraZeneca can be given to individuals on stable anticoagulation treatment.

Expert hematologists advise against taking aspirin after the AstraZeneca Covid-19 vaccine because it will not affect the occurrence of the very rare vaccine-associated thrombosis and thrombocytopenia (VATT), which is driven by an immune response to the AstraZeneca Covid-19 vaccine.

Furthermore, one of the problems with VATT is a low platelet count which means there is an increased risk of bleeding if VATT occurs and aspirin could make this worse. Therefore a risk-benefit discussion should be had with their GP or specialist.

Charges for prescriptions

GP’s will be able to claim funding from the DHB for providing prescriptions for AstraZeneca. It should therefore be no cost to the patient.

If a person does not have a GP then they may be able to access out-of-hours services.
Ideally, sites offering AstraZeneca will be able to access a prescriber, but not all have had them so far. It is up to individual DHBs.

AstraZeneca Sites

Sites chosen to offer AstraZeneca will be selected by DHB’s. Please check locally for information regarding which sites are offering AstraZeneca.

Those sites will be clearly offered when booking online, or people can call to make an appointment and request AstraZeneca at that time.

Some DHBs will have a medical practitioner available at vaccination sites who can provide prescriptions but it is not universal so best to get a prescription from your GP. This can be done over the phone.

AZ: Post vaccination care and flags

It is important that vaccinators always discuss common side effects as well as serious but rare ones like thrombocytopaenia and thrombosis (TTS), as part of the pre-vaccination screening and in their vaccination advice.

Consumers must know that they should seek immediate medical attention if they develop symptoms in the days or weeks following your vaccination, such as:
• a severe or persistent headache, blurred vision, confusion or seizures
• shortness of breath, chest pain, leg swelling, leg pain or persistent abdominal pain
• unusual skin bruising or pinpoint round spots beyond the site of vaccination.

If they are unsure about the symptoms or if they get worse, call Healthline on 0800 358 5453. Or if they have an immediate concern about safety, call 111, and make sure you tell them you’ve had a COVID-19 vaccination so that they can assess you properly.

AstraZeneca use in breast feeding

There is no known risk associated with being given a non-live vaccine whilst breastfeeding. Breastfeeding women should be offered any suitable COVID-19 vaccine.

The developmental and health benefits of breastfeeding are clear and should be discussed with the woman, along with her clinical need for immunisation against COVID-19.

AstraZeneca for both doses

If AstraZeneca is requested for both doses you need a risk-benefit discussion. AstraZeneca is not the preferred vaccine and there is less experience with it.

There is no known risk associated with giving inactivated, recombinant viral or bacterial vaccines or toxoids during pregnancy. Since inactivated vaccines cannot replicate, they cannot cause infection in either the mother or the fetus.

Although the AstraZeneca COVID-19 vaccine contains a live adenovirus vector, this virus is not replicating so will not cause infection in the mother or the fetus.

Clinicians should discuss the risks and benefits of vaccination with the woman, who should be told about the limited evidence of safety for the vaccine in pregnancy.

Although clinical trials on the use of COVID-19 vaccines during pregnancy are not advanced, the available data do not indicate any harm to the pregnancy.

AZ: Thrombocytopenic patients

Thrombocytopaenia on its own is not a contraindication to receiving the AstraZeneca vaccine.

The contraindications to vaccination with the AstraZeneca vaccine include individuals who have a history of heparin-induced thrombocytopenia and thrombosis (HITT or HIT type 2). These individuals may be offered vaccination with an alternative COVID-19 vaccine.

In individuals who experience thrombosis with thrombocytopenia following the first dose of the AstraZeneca vaccine, further vaccination should be delayed until their clotting has completely stabilised and they should be considered for a second dose of an alternative COVID-19 vaccine.

Individuals with bleeding disorders can be vaccinated and further information is available in the UK Immunisation Against Infectious Disease Green Book chapter 14a on COVID-19, p13 under ‘Administration’.

Anaphylaxis and AstraZeneca

The rate of anaphylaxis reported to date after the AstraZeneca vaccine is in line with the expected rate of anaphylaxis to non-COVID vaccines.

The AstraZeneca vaccine does not contain PEG (polyethylene glycol) but does contain a related compound called polysorbate 80. Rarely, people with PEG allergy may also be allergic to polysorbate 80. However, polysorbate 80 is widely used in medicines and foods and is present in many medicines including monoclonal antibody preparations. 

Some injected influenza vaccines contain polysorbate 80. Individuals who have tolerated injections that contain polysorbate 80 (including the adjuvanted influenza vaccine, Fluad®, and the GlaxoSmithKline vaccine Fluarix®) are likely to tolerate the AstraZeneca vaccine.

AZ when Myocarditis or pericarditis after the 1st Pfizer dose

A risk/benefit discussion needs to be had with patients who have had myocarditis or pericarditis after having Pfizer. This should be carried out by their specialist or GP.

It is important that they are made fully aware of the possible signs of thrombosis with thrombocytopenia syndrome (TTS) and that they need to seek help should this occur.
The majority of events occur between 5 and 16 days following vaccination.

AstraZeneca Side effects

Some immune responses are common to both vaccines such as headache, sore arm, mild fever, muscle and body aches.

The rare side effects for AstraZeneca are different from Pfizer and include thrombosis with thrombocytopenia syndrome (TTS).

Further information on these side effects or immune responses, can be found at https://www.medsafe.govt.nz/profs/Datasheet/c/Covid19VaccineAstraZenecainj.pdf

Drawn-up AstraZeneca vaccines and refrigeration

Drawn-up AstraZeneca vaccines must be used within 5 hours. They should not be put back in the fridge.

There is no stability data around keeping the vaccine in syringes longer than 5 hours. If the drawn-up vaccine has not been used within this time then it should be disposed of in the sharps bin.

The best practice is to keep the vial within the cold chain and draw doses as required. The opened vial should then be destroyed after 48 hours.

Vial inversion - AstraZeneca

AstraZeneca does not require dilution so does not need to be inverted to mix. You should inspect the contents of the vial to ensure that it appears normal. It should be a clear liquid with a slight brown tint.

Needle and syringe for AstraZeneca

The needle and syringe preferred for AstraZeneca comes as one unit and is orange.

If you require a dose to be given in a longer needle, or there are not sufficient of the different syringes, then it is acceptable to use the same syringes as for Pfizer.

AstraZeneca syringes MUST BE CAREFULLY LABELLED to avoid confusion.
Pfizer multidose syringes should also always be clearly labeled.

AZ: Booster doses for immunocompromised

Immunocompromised individuals require a booster dose to extend protection from their primary course.

Boosters are recommended from three months after the third dose. Must be given with a prescription as this is off label use.

Note: Pfizer is the preferred vaccine in those with severe immunosuppression but AstraZeneca may be given on a case by case basis.

Immunocompromised: extra doses and booster doses

A third dose is recommended for the immunocompromised as part of the primary schedule.

A third vaccine dose should be offered to individuals aged 5 years and over who had severe immunosuppression in proximity to their first or second COVID-19 doses in the primary schedule. (NB: AstraZeneca is only available for those age 18+).

The third dose should be given between 8 to 12 weeks (ie between 2 to 3 months) after the second dose, but special attention needs to be paid to current or planned immunosuppressive therapies.

If there are current or planned immunosuppressive therapies, aim to delay the third dose of vaccine until two weeks after the period of immunosuppression, in addition to the time period for clearance of the therapeutic agent.

Those over 18y will still need a booster at least 3 months after the third dose (ideally 6 months after), and for 16-17-year-olds who finished their primary course at least 6 months ago.

Immunocompromise Schedule

A schedule of a primary course of 3 doses and a booster is recommended for the immunocompromised from 5 yrs. The 3rd dose is given optimally at 8 weeks and prior to 3 months post the 2nd dose. The 4th dose, which is a booster, can be given anytime from 3 months (ideally 6 months) post dose 3.

If 3rd primary dose was given over 3 months post second dose:

If the third dose has been given later than 3 months post the second dose it has essentially become a booster dose (not part of a primary course). However, IMAC does support that a fourth dose can still be offered anytime from 3 months (ideally 6 months) post the third dose. This would then be their booster dose.

Note: Boosters are available for all those over 18 years who finished their primary course at least 3 months ago, and for 16-17-year-olds who finished their primary course at least 6 months ago.

Operational note: 

Four doses in a series is off license so at least one of those needs to be scripted. For example:

  • If an immunocompromised patient gets a scripted third primary dose, then the fourth would be a booster and can be unscripted. 
  • If they have a 2-dose primary schedule and then a booster that is later is identified as a third primary dose, then their fourth dose would need a prescription. In this case the third dose will be entered into CIR as their booster and the fourth dose will be recorded as an additional vaccine in the primary/standard case schedule.

More detailed information is available in this fact sheet on extra doses for immunocompromsied.

Time between doses

There is a balance between the level of protection provided and rapidly obtaining the improved level of immunity.

If the need is urgent then a minimum gap of 4 weeks (28 days) is recommended when receiving AstraZeneca (eg during an outbreak), however, 8 weeks or longer may provide slightly better protection.

Overseas vaccination

The overseas vaccine schedule is recognised in New Zealand. The dose/s will need to be entered onto the CIR to obtain a vaccine pass. This will take up to 2 weeks to process.

If the patient has had a 1st dose of AstraZeneca overseas and wishes to complete with AstraZeneca in New Zealand then no prescription is required.

Note: it is not clinically recommended to have a full two-dose course of Pfizer in addition to a course of AstraZeneca.

Prescription or written consent

A prescription is required if the person has already had a dose of Pfizer, or if they choose to have AstraZeneca as their booster dose.

If the person is choosing to be vaccinated with AstraZeneca and has not had a COVID-19 vaccination previously, then written consent is sufficient.

Mixed schedules of Pfizer and AstraZeneca

Written consent is recommended for all doses of AstraZeneca to ensure there is a discussion about the risks and benefits of the vaccine.

Giving a mixed schedule is off-license so requires a prescription from a medical practitioner. A vaccinator is not authorised to give vaccines off license.

If the patient has decided to have AstraZeneca and has not had any other vaccination or previous AstraZeneca then no prescription is required.

Criteria for using AstraZeneca vaccine

AstraZeneca can be used for patients who have had a serious adverse event following dose 1 of Pfizer (eg Anaphylaxis or Myocarditis) or have a known allergy to a component of the Pfizer vaccine.

AstraZeneca is limited to those aged 18 and over but anyone in the right age range can choose to have the course as an alternative to Pfizer. However, if they have had a dose of Pfizer they will need a prescription for AstraZeneca.

It is important that the risks of thrombosis with thrombocytopenia syndrome (TTS) are discussed with anyone wanting the AstraZeneca vaccine as part of the informed consent process.

COVID Vaccinators Working Under Supervision

A COVID Vaccinator Working Under Supervision is not currently able to administer AstraZeneca.

Provisional vaccinators

Provisional Vaccinators can give AstraZeneca provided they have completed the online training and gained the certificate of competence.

Overseas vaccination

If the patient has had a 1st dose of AstraZeneca overseas and wishes to complete with AstraZeneca in New Zealand then no prescription is required

Prescription or written consent

A prescription is required if the person has already had a dose of Pfizer or if they choose to have AstraZeneca as their booster dose.

If the person is choosing to be vaccinated with AstraZeneca and has not had a vaccination previously, then written consent is sufficient.

Mixed schedules of Pfizer and AstraZeneca

Written consent is recommended for all doses of AstraZeneca to ensure there is a discussion about the risks and benefits of the vaccine.

Giving a mixed schedule (a mixture of AstraZeneca doses and Pfizer) is off-license so requires a prescription from a medical practitioner. A vaccinator is not authorised to give vaccines off-license.

If the patient has decided to have AstraZeneca and has not had any other vaccination or previous AstraZeneca– no prescription is required.

Prescreening tool link

Before giving AstraZeneca use the screening tool provided by the hyperlink below.

Is there a need to aspirate before giving the COVID vaccine?

We are aware that occasionally consumers are requesting that the vaccinators aspirate the needle [pull back slightly to check for any minor blood vessels] prior to administration of the COVID vaccine. While this is currently not best practice and may be more uncomfortable for the patient, there is no danger associated with accommodating the consumer's requests.

Can people who have had rheumatic fever and rheumatic heart disease have the COVID-19 vaccine?

It is important for people age 12 years and older with underlying health conditions, including rheumatic heart disease, to be vaccinated against COVID-19. Although most healthy children and young people have mild COVID-19, those with certain medical conditions are at increased risk from severe COVID-19. These include heart conditions, like (non-acute) rheumatic heart disease.

People with other pre-existing heart conditions, including congenital heart disease and a history of Kawasaki disease, are also highly recommended to have the COVID-19 vaccine. Other groups highly recommended COVID-19 vaccine from aged 12 years include those with respiratory conditions (eg, asthma and cystic fibrosis), nervous system disabilities (like cerebral palsy) and diabetes (type 1 or type 2).

To find out more about COVID-19 immunisation for children aged 12 and over, see the Kids Health page here

The video below features Blues rugby player Matt Johnson sharing his story about rheumatic fever and his choice to be vaccinated against COVID-19.

 

 

Who can't have the Pfizer/BioNTech COVID-19 vaccine?

The Pfizer/BioNTech COVID-19 vaccine has an excellent safety profile and there are only a handful of people (fewer than 100) in Aotearoa who cannot receive it at all. Almost everyone can have at least one dose. The list of reasons why the Pfizer/BioNTech COVID-19 vaccine may not be suitable is short:

Before the first dose: 

  • History of severe allergic reaction (anaphylaxis) to an ingredient of the vaccine. This is very rare, and only applies to previous anaphylaxis to a stabiliser in the vaccine called polyethylene glycol (PEG). However, this is often unclear as problems with PEG most commonly occur after having it by mouth and there may not be any problem with having it in a vaccine. Cases like this require expert assessment by an immunology specialist. 

After problems with the first dose: 

  • People who had a severe allergic reaction (anaphylaxis) after the first dose – this typically occurs within 15 minutes of receiving it and is the main reason for waiting after vaccination. Even when suspected anaphylaxis has occurred after the first dose, increasing experience now shows that many people can be revaccinated safely in a specialist immunology clinic setting.
  • Those who had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining around the heart) after their first dose of this vaccine. Myocarditis or pericarditis after the vaccine is rare. Diagnosis requires special tests and often assessment by a heart specialist. 

Find more information about who can't have the Pfizer/BioNTech COVID-19 vaccine here.

What happens if a death occurs after vaccination?

In New Zealand, adverse events following immunisation (AEFI) are reported to the Centre for Adverse Reactions Monitoring (CARM).

An Adverse event following immunisation (AEFI) is an untoward medical event which follows immunisation and does not necessarily have a causal relationship with the administration of the vaccine.

A medical assessor evaluates each report to determine whether there is a plausible association between the adverse reaction and a vaccine, and those confirmed as likely AEFI are investigated further by Medsafe. This is important as, by chance, some people will experience new illnesses or die from a pre-existing condition shortly after vaccination. As part of the review process, all adverse events that may be associated with a vaccine are reviewed by an independent safety monitoring board. Deaths are also referred to the Coroner for determination of cause of death. This can be a lengthy process so deaths can be under investigation for some time.

Additionally, to determine if there are any specific trends or patterns that might indicate a safety concern, it is important to compare natural death rates to observed death rates following vaccination. International collaboration is also important to monitor for very rare events and potential safety concerns.

For more information about vaccine safety monitoring see https://www.immune.org.nz/vaccines/vaccine-safety 

Medsafe safety reports showed that, as of 28 August 2021, a total of 40 deaths had been reported following COVID-19 vaccination in New Zealand. Of these, 19 were deemed not likely related to the vaccine, five could not be assessed due to insufficient information and 15 remain under investigation, as described above. One death has been considered likely due to vaccine-induced myocarditis, a known rare side effect of the Pfizer COVID-19 vaccine, the cause of death is yet to be determined by the Coroner. As might be anticipated, most deaths (34 out of 40) have been in people aged 60-79 and over 80 years, and no deaths have been reported in people under 30.
To date, Medsafe has reported the observed number of deaths reported after COVID-19 vaccination is actually less than the expected number of natural deaths.

In the US, healthcare providers are required to report any death after COVID-19 vaccination, whether or not it is deemed likely to be related to vaccine administration. Over 380 million COVID-19 vaccines were administered from December 14 2020 and September 13 2021 and there were 7,653 deaths reported (0.002% of those vaccinated). A review of available clinical information has not established any causal link between Pfizer COVID-19 vaccination and death. 

External links
-    https://www.medsafe.govt.nz/COVID-19/safety-monitoring.asp
-    https://www.medsafe.govt.nz/COVID-19/vaccine-report-overview.asp
-    https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-event…

Can a person be vaccinated early if they want to travel overseas?

Vaccination is now widely available to everyone aged from 12 years - there is no need to apply for early vaccination. Two doses are required to be fully immunised.

It is important that anyone travelling overseas is fully vaccinated against COVID-19. This is primarily to protect them in countries with widespread infection from serious illness, but also to reduce the risk of returning to New Zealand with infection. To be fully immunised, two doses of Comirnaty are required given preferably at least 6 weeks apart (and no less than 21 days apart). You are considered fully immunised from 7 days after your second dose.

If you are required to travel urgently:

  • ensure you have at least one dose before departing to give you some protection
  • preferably, if you have time before departure, get your second dose at least 21 days later.
  • make sure you get a second dose on return (there is no maximum time limit to have your second dose, if you are away longer than 6 weeks).

Be aware that some countries have border restrictions and entry requirements for COVID-19 vaccination. Check these before you leave.

Also check with your health provider if there are any other vaccines you need, such as MMR, influenza, meningococcal vaccines, or country-specific travel vaccines.

Medical appointments and treatment planning with vaccination

Some people experience swollen lymph nodes in their armpit 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. If you are severely immunosuppressed, 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.

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.
  • For information about COVID-19 vaccination and treatments for autoimmune disease from Arthritis New Zealand, see video here.

Myocarditis, pericarditis and the COVID-19 vaccine in New Zealand

An increased risk of heart inflammation (myocarditis, pericarditis, or both) has been observed in people who have received mRNA COVID-19 vaccines in New Zealand and overseas, particularly in males under 30 years of age after the second vaccine dose.

IMAC emphasises that the overwhelming benefits of vaccination in protecting against COVID-19 greatly outweigh the rare risk of these conditions, and Comirnaty (Pfizer mRNA vaccine) continues to be recommended for all people ≥ 5 years of age who do not have any contraindications to the vaccine.

For 1-3 days after vaccination, some people can feel unwell with headaches, tiredness, muscles aches, chills or a mild fever, this a normal response, and is more common after the second dose and in younger people. If unwell, you are advised to rest, drink plenty of fluids and to avoid vigorous exercise, until you are feeling better. If symptoms persist after a few days or worsen, to seek medical advice.

For further in-depth information for health practitioners, see our factsheet here.

Please also find "Guidelines for COVID-19 vaccination post proven or probable myocarditis or pericarditis after mRNA COVID-19 vaccine" here

Key points 

  • What are myocarditis and pericarditis? Can it occur after Pfizer (Comirnaty) vaccination? An increased risk of heart inflammation (myocarditis, pericarditis, or both) has been observed in people who have received mRNA COVID-19 vaccines. Myocarditis occurs particularly in males under 30 years of age after the second vaccine dose. Pericarditis is observed in a range of age groups.
  • Myocarditis and pericarditis symptoms. A key symptom of myocarditis is chest pain. Other symptoms may include chest heaviness, discomfort or tightness, shortness breath or breathing difficulty, feeling lightheaded, faint or dizzy, heart palpitations, racing or fluttering heart, or a feeling of skipped beats. Fever has also been reported. One or more of these symptoms can occur shortly after vaccination due to stress or anxiety. However, if anyone experiences these symptoms after receiving Comirnaty (Pfizer mRNA vaccine) from more than 6 hours to 7 days (typically around 1 to 5 days), they should seek immediate medical attention.
  • The benefits of vaccination in protecting against COVID-19 greatly outweigh the risks of adverse events including myocarditis. Confirmed cases are rare.
  • Cases after vaccination are more frequently reported following the second dose and in males 12 to 29 years. Even in this group, risk has been reported internationally to be from 1 to 10 per 100,000 vaccine doses. There is increasing evidence that the rate declines as the interval between doses increases up to 8 weeks and the risk following booster doses is lower than after dose two.
  • How severe is myocarditis? Most reported cases of myocarditis and pericarditis, linked to mRNA vaccination, have required hospital care for assessment and monitoring, because sudden death is a rare complication of myocarditis (read more: what happens if a death occurs following immunisation). More than 80% of reported cases have recovered quickly with rest and commonly used oral medications. Longer-term follow-up of these cases is ongoing.

Advice about being vaccinated

Comirnaty (Pfizer mRNA vaccine) continues to be recommended for all people from 5 years of age. The only contraindication to the vaccine is anaphylaxis to a vaccine component which is very rare and requires specialist review.

If feeling unwell after vaccination, it is advised to rest, drink plenty of fluids and avoid vigorous activities, such as going to the gym. Seek medical advice if symptoms worsen, or persist for longer than 3 days.

All episodes of myocarditis and pericarditis following Comirnaty should be reported to CARM.

For further advice and for plans for the patient’s next vaccination, please call 0800 IMMUNE (0800 466 863) or email [email protected]


References

  • Gargano JW, Wallace M, Hadler SC, et al. Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine Recipients: Update from the Advisory Committee on Immunization Practices - United States, June 2021. MMWR Morb Mortal Wkly Rep. 2021;70(27):977-82. doi: 10.15585/mmwr.mm7027e2
  • COVID-19 subcommittee of the WHO Global Advisory Committee on Vaccine Safety (GACVS): updated guidance regarding myocarditis and pericarditis reported with COVID-19 mRNA vaccines.   Retrieved 12 July 2021, from https://www.who.int/news/item/09-07-2021-gacvs-guidance-myocarditis-per…
  • Barda N, Dagan N, Ben‑Shlomo Y et al (2021) Safety of the BNT162b2 mRNA Covid-19     Vaccine in a Nationwide Setting DOI: 10.1056/NEJMoa2110475
  • Medsafe. Myocarditis and pericarditis – rare adverse reactions to Comirnaty (Pfizer COVID-19 vaccine). Alert Communication 21 July 2021. Retrieved 15 September 2021 from https://www.medsafe.govt.nz/safety/Alerts/comirnaty-myocarditis-alert.h…
  • Mevorach D, Anis E, Cedar N, et al. Myocarditis after BNT162b2 mRNA vaccine against COVID-19 in Israel. N Engl J Med. 2021;385(23):2140-9. doi: 10.1056/NEJMoa2109730
  • Buchan SA, Seo CY, Johnson C, et al. Epidemiology of myocarditis and pericarditis following mRNA vaccines in Ontario, Canada: by vaccine product, schedule and interval. medRxiv. 2021 (preprint):2021 doi: 10.1101/2021.12.02.21267156
  • Hause A, Baggs J, Marquez P, et al. Safety Monitoring of COVID-19 Vaccine Booster Doses Among Adults — United States, September 22, 2021–February 6, 2022. MMWR Morb Mortal Wkly Rep, 2022;71:249–254.

 

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.


Reference

  • Shrotri M, Krutikov M, Palmer T, et al. Vaccine effectiveness of the first dose of ChAdOx1 nCoV-19 and BNT162b2 against SARS-CoV-2 infection in residents of long-term care facilities in England (VIVALDI): a prospective cohort study. The Lancet Infectious Diseases. 2021 Jun 23.

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.

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)

https://vimeo.com/569211460 (The Melbourne Vaccine Education Centre - Thrombosis with Thrombocytopenia Syndrome (TTS) animation)

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.

See also https://covid.immune.org.nz/faq/covid-19-vaccine-may-cause-swelling-local-lymph-nodes-does-affect-mammogram-results


Reference

McIntosh LJ, Bankier AA, Vijayaraghavan GR, et al. COVID-19 Vaccination-Related Uptake on FDG PET/CT: An Emerging Dilemma and Suggestions for Management. American Journal of Roentgenology. 2021. doi: 10.2214/AJR.21.25728
 

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

When you attend breast screening appointments, mammogram, breast ultrasound or other types of cancer screening, it is recommended to mention to your doctor or radiographer that you have had a COVID-19 vaccination recently.

This is because it is quite common for the vaccine to cause swelling of the lymph nodes nearest to the injection-site, such as armpit and neck. This occurs most commonly after the second or booster dose. Swollen lymph nodes (medically called lymphadenopathy) is one of the top ten events reported to Medsafe through the CARM reporting system. 

Swelling of lymph nodes near to the site of injection, in the case of vaccines, or closest to an infection is a normal response when the immune system is stimulated. It usually occurs within one or two days and settles after a few days but can persist for a few weeks and may be detectable on a mammogram or scan for a month or two. 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, your mammogram or treatment. 

Click this link for further information from BreastScreen Aotearoa.

See also information about PET CT scans. https://covid.immune.org.nz/faq/can-i-have-covid-19-vaccination-ct-scan


Reference

Edmonds CE, Zuckerman SP ,Conant EF. Management of unilateral axillary lymphadenopathy detected on breast MRI in the era of coronavirus disease (COVID-19) vaccination. AJR: American Journal of Roentgenology, 2021.

Garreffa E, Hamad A, O'Sullivan CC, et al. Regional lymphadenopathy following COVID-19 vaccination: Literature review and considerations for patient management in breast cancer care. European Journal of Cancer, 2021. 159: p. 38-51.

Medsafe. 2022 Adverse events following immunisation with COVID-19 vaccines: Safety Report #40 – 31 January 2022. online. URL: https://www.medsafe.govt.nz/COVID-19/safety-report-40.asp. (accessed 25 February 2022)

People with compromised immune systems or 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. Others 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 to receive the 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.

For information about COVID-19 vaccination and treatments for autoimmune disease from Arthritis New Zealand, see video 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 6 weeks after your previous dose (or at least 3 weeks if you are at high risk of exposure to individuals with COVID-19). There is no maximum time limit between doses, so you do not need to repeat the first dose or receive a third dose.

Although, different COVID-19 vaccines are not interchangeable, it is recommended that if you have received one dose of any two-dose COVID-19 vaccine (including Vaxzevria/Covishield/AstraZeneca, or Spikevax/Moderna) outside of New Zealand that you have one dose of Comirnaty (Pfizer/BioNTech) at least 4 weeks after the first vaccine dose.

If you received one dose of COVID-19 Vaccine Janssen, you are considered fully immunised. However, in certain groups (such as border workers) at high risk of exposure to people infected with COVID-19 virus, may be advised to have a further dose of the Pfizer vaccine at least 4 weeks later.

Can I delay receiving my second dose of Comirnaty?

To be fully immunised with Comirnaty requires two doses given at least 21 days apart. The current recommendation is for the two doses to be given six weeks apart. A delay for longer than six weeks is not considered harmful, however it is important to remember that two vaccine doses are needed for full protection, particularly against the Delta variant.

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.

What if the person has an allergy or is allergic to latex?

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

The only contraindication for Comirnaty is a history of anaphylaxis to a previous dose of this vaccine or its contents. Find more information on severe allergic reactions after immunisation here, and the contents of Comirnaty here.

Those with a history of immediate allergic response to another product or vaccine can receive this vaccine but are asked to wait to be observed for a little longer after vaccination. 

Individuals who have anaphylaxis following a previous dose of Comirnaty can be offered an other COVID-19 vaccine (currently, Astrazeneca COVID-19 vaccine) if not contraindicated.
 

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. For the data sheets giving details of the ingredients for the 30 microgram Comirnaty (Pfizer/BioNtech) vaccine (for ages 12 years or over, purple cap) here or here for the 10 microgram paediatric formulation of Comirnaty (for ages 5-11 years, orange cap).

Some types of vaccines use human cell lines to produce the active ingredient as part of 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 vaccines 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 such cell lines. Find further information on fetal cells and COVID19 vaccines here.

For ingredients of the COVID-19 vaccine AstraZeneca see 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 and there is strong evidence it does not.

Vaccination is recommended before and during pregnancy

Women who are trying to become pregnant need not to delay the vaccination nor avoid becoming pregnant. COVID-19 is a potentially very serious disease. Pregnant women and their unborn babies are greater risk of needing hospital care than women who are not pregnant

For more information: see here for advice from the Ministry of Health and here for the advice of the Royal Australian and New Zealand College of Obstetricians and Gynecologists.

Comirnaty and fertility

Shortly after the Pfizer mRNA vaccine, Comirnaty, became available overseas misinformation circulated on social media about negative effects on fertility of vaccinated women. Such statements are misleading and calculated to cause unnecessary fear. There is no plausible reason why this vaccine (or any previously) could have such effects and there is strong evidence that is does not.

Preclinical studies

Every new vaccine or new medicine is tested thoroughly before it can be given to humans, to check for any potential harms prior to conception, during pregnancy or to the baby. If a vaccine candidate fails this stage of testing, further research will be stopped. 

Animal studies have shown no effects on fertility – for this vaccine or other the COVID-19 vaccines approved in New Zealand. For example, when female rats were given very large doses of the Pfizer COVID-19 vaccine (300 times the human dose) before mating and during pregnancy, no changes were seen in mating performance, fertility or any ovarian or uterine measurement. In addition, no effects were seen before or after birth on the survival, growth, physical development or neurofunctional development of the babies.

The vaccine is short-lived

Comirnaty vaccine contains messenger ribonucleic acid (mRNA) inside a fatty bubble which is delivered to muscle cells in the arm when you are vaccinated. The mRNA and its protective bubble are very fragile, so that it needs to be stored at very cold temperatures to stop it from degrading.

Once outside of its lipid bubble, mRNA is quickly destroyed by enzymes (ribonucleases) found everywhere, including inside and outside of our cells. It only has a day or two to do its work. The components of the lipid bubble are also cleared from our body as a waste product. The vaccine gives the body the recipe to make replicas of the COVID-19 virus spike protein and is completely gone within a couple of days.

The quantity of this protein produced after vaccination is much lower than the amount seen in people with COVID-19 infection with the virus spreading throughout their body. Furthermore, as soon as it is produced, this protein is dismantled inside specialist cells and the pieces are shown to the immune system in the lymph nodes nearest to the arm muscle.

The ovaries and testes are protected.

The ovaries or testicles are protected, from infection and damage, by special cells (such as Sertoli cells in males and columnar epithelial cells in females) which prevent cells of the immune system or antigens (such as parts of any vaccine) from entering.

Evidence from fertility clinics

In Israel, patients attending fertility clinics have been carefully studied after having the Comirnaty vaccine. No difference in the in vitro fertilisation (IVF) cycle outcomes, including the number of eggs collected; the number of matured eggs; the fertilisation rate; and the number and quality of embryos at day 3, were seen in women who had intracytoplasmic sperm injections (ICSI) before and after two doses of Comirnaty (time from first dose 57± 24 days). Additionally, the number and percentage of clinical pregnancies did not differ significantly between the pre and post vaccination groups. Another study, which looked at women having eggs collected shortly after vaccination (mean 12 days among those having had one dose and 49 days after first dose among those having had two doses), found no differences in follicular function, including hormone production, and oocyte (egg) quality biomarkers. In addition, sperm parameters including semen volume, sperm concentration, sperm motility, and total motile sperm count have been the same in men following vaccination (33 days after first dose). Studies in America have also found no differences in embryo implantation or early pregnancy development nor sperm parameters.

Vaccinated women can fall pregnant

As well as this detailed information about the lack of impact on factors related to fertility, the real-world experience with the vaccine is also reassuring. Numerous women have conceived following Comirnaty vaccination. Looking at participants in the v-safe pregnancy registry in the US, found no difference from the expected spontaneous abortion rate in women who received an mRNA vaccine from 30 days before the first day of their last menstrual period through to 14 days after (NIH preprint).

False alarms

Any alleged similarity between the SARS-CoV-2 spike protein and the human protein, syncytin-1, has been completely disproven. Any amino acid sequences in common are much too short to activate an immune response. Furthermore, antibodies in the serum of women previously infected with COVID-19 cannot recognise or bind to syncytin-1.

Some women have reported their menstrual periods may be early or heavy following the vaccination. This is possible since there is a connection between the immune system and the bleeding of menstrual cycles, but such changes can also occur coincidentally or due to anxiety that some people experience when being vaccinated. Any potential effect is brief and will not affect long term fertility. There is no effect on the placenta during pregnancy because different biological processes maintain the uterus lining.


References

Published articles

  • Bentov Y, Beharier O, Moav-Zafrir A, et al. Ovarian follicular function is not altered by SARS-CoV-2 infection or BNT162b2 mRNA COVID-19 vaccination. Hum Reprod. 2021;36(9):2506-13. doi: 10.1093/humrep/deab182
  • Bowman CJ, Bouressam M, Campion SN, et al. Lack of effects on female fertility and prenatal and postnatal offspring development in rats with BNT162b2, a mRNA-based COVID-19 vaccine. Reproductive Toxicology. 2021;103:28-35. doi: https://doi.org/10.1016/j.reprotox.2021.05.007
  • Gonzalez DC, Nassau DE, Khodamoradi K, et al. Sperm parameters before and after COVID-19 mRNA vaccination. JAMA. 2021;326(3):273-4. doi: 10.1001/jama.2021.9976
  • Zauche LH, Wallace B, Smoots AN, Olson CK, Oduyebo T, Kim SY, et al.. Receipt of mRNA COVID-19 vaccines preconception and during pregnancy and risk of self-reported spontaneous abortions, CDC v-safe COVID-19 Vaccine Pregnancy Registry 2020-21. 2021;
  • Morris RS. SARS-CoV-2 spike protein seropositivity from vaccination or infection does not cause sterility. F&S Reports. doi: 10.1016/j.xfre.2021.05.010
  • Safrai M, Herzberg S, Imbar T, Reubinoff B, Dior U, Ben-Meir A. The BNT162b2 mRNA Covid-19 vaccine does not impair sperm parameters. Reproductive BioMedicine Online 2022;44(4):685–8.

Preprint papers, not peer-reviewed

  • Safrai M, Rottenstreich A, Herzberg S et al.  Stopping the misinformation: BNT162b2 COVID-19 vaccine has no negative effect on women’s fertility medRxiv preprint  [accessed 13 Sep 2021; posted 01 June 2021] doi: 10.1101/2021.05.30.21258079

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 to be immunised.

Even when we have a high proportion of the 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 
 

Do we need a gap between MMR, influenza or other vaccines and COVID-19 vaccination?

Since we are now much more familiar with the side effects of the COVID-19 vaccine, other vaccines can be given at the same time or immediately before or after COVID-19 vaccination.

COVID-19 vaccine can been given at the same time or close to other vaccinations on the National Immunisation Schedule, including MMR (measles, mumps, rubella vaccine), influenza (flu), human papillomavirus vaccine (HPV, Gardasil 9), whooping cough and tetanus (Tdap, Boostrix) and meningococcal vaccines. If given at the same time, the vaccines at separate places on your arms and with different syringes. 

When visiting your GP or pharmacist, ask if there are any other vaccines you can have - you may have missed them in the past. Pregnant women are also recommended to have influenza and whooping cough vaccines. Young adults may have missed MMR and HPV.

The only exception to this is the shingles vaccines, Zostavax, for which a seven day gap is recommended. This is to ensure the immune response to both vaccines is good. Zostavax can still be given at the same time as the influenza vaccine. 

The Varicella vaccine, which is a lower concentration and used mainly with children so their immune systems are much better than those over 50, can also be given at the same time as the COVID-19 vaccine.

Not that the mass COVID-19 vaccination clinics, including drive-through sites, are not likely to have other vaccines, so ask your usual health provider for advice.

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

Yes, at present, a booster is required from three calendar months after the primary course, It is especially for those with additional health concerns or the elderly, and those at highest risk of exposure to COVID-19 infected people. The amount of time between the first vaccination series and a booster has been adjusted in the light of the spread of the highly infectious Omicron variant. The timing of booster doses is continually being evaluated based on scientific evidence.

In the long term, it is expected that small adjustments may be made to the vaccine if the COVID-19 virus changes so much that immunity generate by the vaccine loses effectiveness. In this case, additional booster doses for those at highest risk from infection may 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 six 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 and preferably 6 weeks 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 at 6 weeks after the first dose.

People at highest risk of exposure to others with COVID-19 are advised to have their second dose at least 21 days after the first to provide more immediate protection. Everyone else can allow 6 weeks between doses to provide a strong immune response and good protection after the second dose. See here for more information.

A closer spacing (at least 21 days) may also be advised for people who are due to commence planned immunosuppressive treatments for longer than 28 days, to provide a good immune response before treatment starts. Do not delay treatment or vaccination. Those who are already receiving such treatments are advised to allow 6 weeks between doses to give the best immune response.

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 immune response to the mRNA COVID-19 vaccine.

After surgery, you can have any vaccination as soon as you are recovered and well. It is preferable to avoid booking a vaccination within 48 hours of any major elective surgery in case responses to the vaccine, such as fever, cause delay in surgery or anaesthesia. Do not delay any urgent surgery after vaccination.

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

In certain circumstances, in situations where it is the pragmatic best option for an individual, it is safe to vaccinate in surgery while under anaesthetic.

Mixing vaccines to boost effectiveness

Could taking two different vaccines boost the effectiveness?

Pfizer continues to be the main COVID-19 vaccine used in New Zealand but AstraZeneca is available for people aged 18 and older who cannot have the Pfizer vaccine or people who want to have a different COVID-19 vaccine.

Written consent is required for all AstraZeneca doses, and a prescription is required when AstraZeneca is given as a mixed schedule with another COVID-19 vaccine. The reason for this is that a mixed schedule is ‘off-label' usage. While there are not expected to be any safety concerns with using a mixed schedule, it does not yet have Medsafe approval.

For the WHO position on mixing COVID-19 vaccines, 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.​

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.

Vaccination after COVID-19 infection

Vaccination is being offered to people who have had SARS-CoV-2 infection.

Data from clinical trials and from countries with a lot of COVID-19 cases have shown the vaccines to be safe and effective for those who have had COVID-19 ie SARS-CoV-2 infection. This includes those who were asymptomatic.

IMAC recommends that if someone has had COVID-19 infection, then they should start or continue their vaccination from 3 months after recovery; if they have had a positive test but were asymptomatic, then vaccination can start 3 months after the first positive test. 

NOTE: In all instances, if there are clinical reasons for vaccinating earlier, they can be vaccinated from 4 weeks post-infection.

For all other vaccinations, including flu, vaccination can commence from when the person is no longer acutely unwell.

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 of the same age who are not pregnant. Data from the UK found that one in four pregnant women hospitalised with COVID-19 had pneumonia and one in five required support with breathing. Older mothers-to-be and those with other health conditions such as kidney disease, diabetes or obesity are at even higher risk from COVID-19. The recommendation to be vaccinated aligns with those in other countries and is based on international evidence from a large number of people who have already received mRNA COVID vaccines when pregnant. No additional safety concerns have been shown. There is also increasing evidence that antibodies made by the mother after vaccination are shared with her infant.

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

Booster doses in pregnancy 

Pregnant women/people aged from 18 years can receive a booster dose of Pfizer or AstraZeneca COVID vaccine at any stage of pregnancy, from three or more months after a primary course. Comirnaty is the preferred vaccine for use during pregnancy.

More information:

References

  • 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
  • Vousden N, Ramakrishnan R, Bunch K, et al (2021 preprint). Impact of SARS-CoV-2 variant on the severity of maternal infection and perinatal outcomes: Data from the UK Obstetric Surveillance System national cohort. medRxiv, 2021.2007.2022.21261000. 10.1101/2021.07.22.21261000