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.
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.
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:
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.
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.
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.
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).
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.
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 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.
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.
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. Likewise, for those who have received two doses of Sinopharm or Sinovac overseas, a further dose of mRNA-CV may be recommended.
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.
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.
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).
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.
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).
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.
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.
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.
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.
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.
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