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 in Aotearoa who cannot receive it. 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…

Myocarditis 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 overseas studies, 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 ≥ 12 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 information for health practitioners, see ‘ In-depth information’ below.

Key points 

  • Following a press release issued by the Ministry of Health on 30 August regarding the death of a woman in the days following vaccination with the Pfizer COVID-19 vaccine, the Ministry of Health states the case has been referred to the Coroner and the cause of death has not yet been determined. The CV-ISMB considered that the myocarditis was probably due to vaccination but noted that there were other medical issues occurring at the same time which may have influenced the outcome following vaccination.
  • What is myocarditis and 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 in overseas studies, particularly in males under 30 years of age after the second vaccine dose.
  • Myocarditis symptoms include chest pain, feelings of having a fast-beating, fluttering or pounding heart and shortness of breath. 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. The risk of myocarditis from COVID-19 infection is almost four times higher than from vaccination. Confirmed cases are rare.
  • Cases after vaccination are more frequently reported following the second dose and in males 12 to 30 years. Even in this group, risk is less than 1 in 25,000 vaccine recipients.
  • 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 8 out of 10 of the reported cases have recovered quickly with rest and commonly used oral anti-inflammatory medications such as ibuprofen. 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 12 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]

 


Information in-depth for health professionals:

Potential risk

A risk of myocarditis and pericarditis has been observed in people who have received mRNA COVID-19 vaccines 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 ≥ 12 years of age who do not have any contraindications to the vaccine. Recent data from Israel showed three excess cases of myocarditis per 100,000 doses following Comirnaty vaccination versus 11 excess per 100,000 cases with COVID-19 infection.

Outcomes

Most myocarditis and pericarditis cases linked to mRNA vaccination receive hospital care for assessment and monitoring. Most reported cases have been mild and patients have recovered quickly with standard treatment. Longer-term follow-up of these cases is ongoing. However, sudden death may be a rare complication of myocarditis so careful assessment and management of suspected cases is important.

Diagnosis

Symptoms usually appear from 1 to 5 (median 2) days of vaccination and include acute chest pain or pressure, pain with breathing, palpitations, increased sweating, fainting or shortness of breath with exercise, at rest or when lying down. People who experience any of these symptoms after having Comirnaty should seek prompt medical attention.

Symptoms such as palpitations, chest pain or feeling short of breath can occur in the first hours after vaccination in some people – symptoms appearing in this time frame are consistent with an immunisation stress reaction. This is too soon after vaccine receipt for heart inflammation due to vaccination to appear.

Initial investigations for people presenting with symptoms or signs which may be consistent with myocarditis or pericarditis should include ECG, troponin, +/- CRP, chest X-ray, and investigations for other differential diagnoses as clinically indicated.

  • Findings consistent with myocarditis include elevated troponin and ECG changes including paroxysmal or sustained atrial or ventricular arrythmias, AV node conduction delays, intraventricular conduction defects or frequent atrial or ventricular ectopy. 
  • Those suggestive of pericarditis include a pericardial rub, and with a large pericardial effusion pulsus paradoxus and distant heart sounds may be evident on clinical examination.
  • ECG changes can include widespread ST segment elevation or PR depression.

If initial screening investigations are abnormal, patients should urgently be referred to hospital for further investigations and cardiac monitoring. Patients with more severe clinical presentations may require referral prior to full investigations.

If clinical suspicion of myocarditis or pericarditis is high, further advice should be sought, even if screening investigations are thought to be normal.

More information to assist in the diagnosis is available from Brighton Collaboration case definition including helpful pictorial algorithms.

Precautions to vaccination with cardiac conditions

Most pre-existing cardiac conditions are not regarded as contraindications to Comirnaty vaccine. However, young people who have active or clinically unstable heart disease, should be advised to seek medical care promptly if they develop new or worsening pre-existing symptoms. A precautionary review in the days after their vaccination may also be advised. Those with a history of pericarditis or myocarditis, unrelated to Comirnaty, may have the vaccination if the condition is completely resolved, (i.e. no symptoms and no evidence of ongoing heart inflammation).

Future vaccination

People who develop myocarditis or pericarditis attributed to their first dose of Comirnaty are advised to defer further doses. They should be referred to IMAC for clinical advice about alternate vaccine options. Vaccination is not advised for anyone with current active cardiac inflammation.  High intensity exercise should be avoided until complete resolution of inflammation and normalisation of cardiac function. 

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


 

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…

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

Additional resources:

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.

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.

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 armpit near to the injection-site. This usually settles after a few days after vaccination but may be detectable on a mammogram for up to a few weeks. In this case, it is advised to monitor such lymph node changes for at least 6 weeks after vaccination. You do not need to delay your vaccination or your mammogram.

Click this link for further information from BreastScreen Aotearoa.

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.

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.
 

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. 
 

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 fertilization 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
  • 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

Preprint papers, not peer-reviewed

  • Head Zauche, Bailey W, Smoots AN, 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. Research Square. 2021 (preprint).[accessed 13 Sep 2021; posted 9 Aug 2021] doi: 10.21203/rs.3.rs-798175/v1
  • 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
  • Safrai M, Reubinoff B  and Ben-Meir A. BNT162b2 mRNA Covid-19 vaccine does not impair sperm parameters medRxiv preprint [accessed 13 Sep 2021; posted 03 May 2021] doi: 10.1101/2021.04.30.21255690
     

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 
 

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 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.

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

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

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

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

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

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

Will children receive a COVID-19 vaccination?

Youth aged 12-15 years are now eligible to receive the COVID-19 vaccine in New Zealand.

Following Medsafe’s approval of the Pfizer/BioNTech COVID-19 vaccine for 12-15 year olds, the Government has now extended eligibility of the COVID-19 vaccination programme to include this age group.

Taking a whānau-centred approach, as parents become eligible to book in for a vaccination they will now also have the option to book their children aged 12 – 15 years to be vaccinated at the same time.

Consistent with the National Immunisation Schedule, IMAC recommends that a parent or guardian is present to provide verbal co-consent as best practice - particularly in a mass vaccination setting. While children aged 12 and up can legally give their own consent, the preference is that this should be the exception and not the rule.

Please note: until otherwise advised COVID-19 vaccinators working under supervision should only administer the COVID-19 vaccine to people 16 and over.

The safety and efficacy of mRNA-CV has not yet been established for use in those aged younger than 12 years. A clinical trial is ongoing in younger age groups. 

Other resources:

Reference:
Frenck, R. W., Klein, N. P., Kitchin, N., Gurtman, A., Absalon, J., Lockhart, S., . . . Gruber, W. C. (2021). Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents. New England Journal of Medicine 10.1056/NEJMoa2107456
 

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 mRNA COVID-19 vaccine to women who are breastfeeding and by being vaccinated, mothers can provide some protection against COVID-19 for their babies in breastmilk.

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

Also see this University of Auckland video giving positive recommendations from health professionals.

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